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 A21 - IRB Review of Big Data Research
Talks & Presentations

A21 - IRB Review of Big Data Research

Date: November 6, 2017
Speakers: Jacob Metcalf, PhD; Laura Odwazny, JD, MA; Ivor A. Pritchard, PhD; Stephen J. Rosenfeld, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Clarifying “Exceptions” and “Departures”: How to Identify, Track, and Report

Date: January 30, 2018
Authors: Alice Huang, PhD, CPIA, Elizabeth Meek, DVM, MPH, Richelle Scales, CPIA
Description: Identifying, tracking, and accurately reporting "exceptions" and "departures" from the Guide for the Care and Use of Laboratory Animals and the USDA Animal Welfare Act Regulations presents a challenges for IACUCs. It can be difficult to keep track of which terms and rules apply to which situations. This webinar helps to clarify these common areas of confusion, by defining the similarities and differences between the OLAW and USDA terminology and requirements and outlining scenarios.

Time: 1-2 Hours

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SBER Network Resources

Final Rule Case Study – UNM IRB

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Case Studies and Snapshots

Research Ethics Snapshot: Decision-Making for Preexisting Studies

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Poster Abstracts

"A Real Super Ethical Super Moral Perspective": The Research Ethics of Research Participants

Category: 2015 AER Conference

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Historical Documents and Regulations

"Normal Exposure" and Inoculation Syphilis: A PHS "Tuskegee" Doctor in Guatemala, 1946-48

In 2011, Susan M. Reverby, a professor at Wellesley College, uncovered research abuses conducted by the US PHS in Guatemala.

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Workplace Tools

2017 IACUC Workload and Salary Survey

Date: June 30, 2017
Authors: PRIM&R
Description: One of PRIM&R's goals is to provide our members with tools that will help them become even more successful professionally. One such tool is our Workload and Salary Survey. PRIM&R’s Workload and Salary Surveys generates crucial data on workloads, salaries, and staffing patterns for resource management and professional advancement. The results of this 2017 survey, geared toward professionals who work primarily with institutional animal care and use committees, provide important insight into the trends and opportunities of this field.

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 Curriculum Sets

Genetics and Return of Results

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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Talks & Presentations

Yourprof Lecture 1: Global Health Research Ethics

Speaker: Jim Lavery, MSc, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Workplace Tools

2017 IRB Workload and Salary Survey

Date: June 30, 2017
Authors: PRIM&R
Description: One of PRIM&R's goals is to provide our members with tools that will help them become even more successful professionally. One such tool is our Workload and Salary Survey. PRIM&R’s Workload and Salary Surveys generates crucial data on workloads, salaries, and staffing patterns for resource management and professional advancement. The results of this 2017 survey, geared toward professionals who work primarily with institutional review boards, provide important insight into the trends and opportunities of this field.

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Poster Abstracts

"Approval Parties!" Faculty Ad-Hoc Meetings for Exempt/Expedited Determinations

Category: 2015 AER Conference

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SBER Network Resources

Things to Consider when Implementing the Final Rule

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Talks & Presentations

Yourprof Lecture 2: Why is Global Health Science Complicated?

Speaker: Ross Upshur, MD, MSc

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Case Studies and Snapshots

Research Ethics Snapshot: Development of a Broad Consent Document

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Webinars

Electronic Informed Consent: Ethical, Regulatory, and Practical Implications

Date: March 7, 2017
Authors: Cheryl Grandinetti, PharmD, Christian Simon, PhD
Description: In recent years, there has been increased interest in and greater use of electronic methods of informed consent (eIC) in research. IRBs and investigators need understand the regulations from the FDA and OHRP, address challenges of eIC, and be prepared to take advantage of its potential benefits.

Time: 1-2 Hours

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 A4 - You'll Know It When You See It, or Will You?: Defining
Talks & Presentations

A4 - You'll Know It When You See It, or Will You?: Defining "Human Subjects Research" Under the Revised Common Rule

Date: November 6, 2017
Speakers: Warren Capell, MD; Dean R. Gallant, AB; Julia G. Gorey, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

A Guide to Informed Consent - Information Sheet

This detailed information sheet expands on the FDA’s regulations relating to informed consent. Issues such as assent, non-English speaking subjects, and documentation are among the topics covered.

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 Curriculum Sets

Structuring Postapproval Monitoring Programs

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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 Curriculum Sets

The 3Rs and Alternatives

Covering a wide range of topics in oversight of human subjects research and animal research, our Curriculum Sets assemble a variety of PRIM&R’s educational resources on a single topic, to facilitate comprehensive education in targeted subject areas.

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Historical Documents and Regulations

Agriicultural Bioterrorism Protection Act of 2002

Under this act, all entities that use, possess, or transfer agents or toxins deemed a threat to health and safety must register the select agentswith the appropriate federal department.

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 A5 - Facilitating Informed Consent in Light of the Revised Common Rule
Talks & Presentations

A5 - Facilitating Informed Consent in Light of the Revised Common Rule

Date: November 6, 2017
Speakers: Susie R. Hoffman, RN, BSN, CIP; Angela Hvitved, PhD, MA; Jerry A. Menikoff, MD, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

EU General Data Protection Regulations: What US Research Institutions Need to Know

Date: April 25, 2018
Authors: Nick Wallace, JD
Description: On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) went into effect in the EU/EEA. This webinar will provide an introduction to the potential application of the GDPR to the US-based research community; implications for individuals and institutions to which the GDPR applies, including issues regarding data subject consent; and recommended steps.

Time: 1-2 Hours

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Case Studies and Snapshots

Research Ethics Snapshot: Reviewing Patient Records Without Consent

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Poster Abstracts

"But I WANT You to Review My Project!" An IRB’s Experience with Implementing Policy Change for Reviewing Undergraduate-Initiated Research Proposals

Category: 2015 AER Conference

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SBER Network Resources

Final Rule Topics

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Talks & Presentations

Yourprof Lecture 3: Health Research in Developing Countries

Speaker: Jerome Singh, LLB, LLM, PhD, MHSc

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 4: The Challenge of Seeking Consent

Speaker: Susan Bull, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Webinars

Introduction to Medical Device Research and Making the Risk Determination

Date: June 17, 2009
Authors: Fabienne Santel, Marian Serge

Time: 1-2 Hours

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 A8 - The Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Talks & Presentations

A8 - The Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Date: November 6, 2017
Speakers: Owen Faris, PhD; Karen L. Ulisney, MS, CRNP;
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

American Veterinary Medical Guidelines on Euthanasia

Endorsed by the US Department of Agriculture (USDA) and the National Institutes of Health Office of Laboratory Animal Welfare (NIH OLAW), these guidelines classify methods of euthanasia and define their acceptability. Public Health Service (PHS) Policy requires adherence to these guidelines.

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A Novel VBA-Based System Not Only Dramatically Facilitates IRB Protocol Pre-Review, but also Reveals
Poster Abstracts

A Novel VBA-Based System Not Only Dramatically Facilitates IRB Protocol Pre-Review, but also Reveals Previously Unrecognized Frequent Findings

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Benign Behavioral Interventions

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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SBER Network Resources

Minimal Risk Categories – University of New Mexico (UNM) IRB

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Case Studies and Snapshots

Research Ethics Snapshot: Broad Consent

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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SBER Network Resources

SBER Network Virtual Roundtable: Things to Consider when Implementing the Final Rule

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A Review of the New York State Psychiatric Institute’s IRB Serious Adverse Event Policy
Poster Abstracts

A Review of the New York State Psychiatric Institute’s IRB Serious Adverse Event Policy

Category: 2015 AER Conference

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Historical Documents and Regulations

Animal Care Resource Guide Policies

A collection of policies related to the care and use of animals issued by the US Department of Agriculture.

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 C15 - Final Rule for Clinicaltrials.gov: Requirements and Implementation
Talks & Presentations

C15 - Final Rule for Clinicaltrials.gov: Requirements and Implementation

Date: November 7, 2017
Speakers: Sherry Mills, MD, M.P.A.; Sarah A. White, MPH, CIP; Rebecca J. Williams, PharmD, MPH
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Introduction to Research Misconduct for IACUC, IRB, and IBC Professionals

Date: May 17, 2017
Authors: Kathy Partin, Jim Kroll
Description: It is essential that research and oversight professionals understand how to recognize and report misconduct, and be aware of what investigations by various regulatory agencies can entail. This webinar will help professionals who work in both human subjects protections and animal care and use understand their role in the context of research misconduct.

Time: 1-2 Hours

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Talks & Presentations

Yourprof Lecture 5: Caring for Participants and Communities

Speaker: Alex John London, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 6: Why Communities Matter

Speaker: Fern Brunger, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Webinars

IRB Review of mHealth Research

Date: December 2, 2015
Authors: Jeremy Block, PhD, MPP, and John Wilbanks

Time: 1-2 Hours

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 C21 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Healt
Talks & Presentations

C21 - The Intersections of Data Security, Privacy, Confidentiality, and Compliance in Digital Health and Mobile Health (mHealth) Research

Date: November 7, 2017
Speakers: Jeremy N. Block, PhD, MPP; Brenda L. Curtis, PhD, MSPH;
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Animal Welfare Act

First codified in 1966, this federal law sets forth the minimum acceptable standard for the treatment of animals in research, exhibition, transport, and by dealers. This document reflects the most recent update in 2010.

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A Solution to Creating and Managing your Regulatory Binder Electronically
Poster Abstracts

A Solution to Creating and Managing your Regulatory Binder Electronically

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Limited IRB Review

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Case Studies and Snapshots

Research Ethics Snapshot: Research Subject to Multiple Regulations

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Adherence to Integrity and Ethical Conduct in Publications by the Authors
Poster Abstracts

Adherence to Integrity and Ethical Conduct in Publications by the Authors

Category: 2015 AER Conference

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Historical Documents and Regulations

Animal Welfare Act of 1966

The text of the original Animal Welfare Act, which was published in 1966 as a result of public outcry. The document sets forth guidelines for the treatment of animals in research, exhibition, transport, and by dealers in the US that are still in place today.

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 Closing General Session Luncheon: The “Nuremberg Code” After 70 Years: Foundational or Forgotten?
Talks & Presentations

Closing General Session Luncheon: The “Nuremberg Code” After 70 Years: Foundational or Forgotten?

Date: November 8, 2017
Speakers: Alexander M. Capron, LLB; Tessa Chelouche, MD; Alex John London, PhD; Susan M. Miller, MD, MPH, FACP; Sheldon Rubenfeld, MD, FACP, FACE
Conference: 2017 AER Conference

Time: 1-2 Hours

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Talks & Presentations

Yourprof Lecture 7: The Relevance of Culture

Speaker: Godfrey Tangwa, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Webinars

SBER Across Borders: IRB Considerations and Cases for International Studies

Date: February 20, 2018
Authors: John R. Baumann, PhD, Kelly O’Keefe, MPH
Description: IRBs and ethics committees that review research conducted in international settings face particular challenges, as the reviewing IRB must possess adequate knowledge of laws and regulations in the country where the research is taking place, as well as the cultural norms of that area. This webinar provides guidance on regulatory requirements, mitigating risks, and best practices for IRB policies, and offers case studies that focus on common challenges in international SBER.

Time: 1-2 Hours

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Webinars

Social Media as a Research Recruitment Tool: Ethical Considerations and Guidelines for IRBs

Date: February 23, 2017
Authors: Luke Gelinas, PhD, Laura Odwazny, JD, MA
Description: The use of social media for research recruitment is increasing, but there are novel ethical considerations that go along with it. This webinar looks at the norms and regulations of working in this new context.

Time: 1-2 Hours

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 D12 - Essential Documentation: IRB Membership, Record Keeping, Minutes, and More
Talks & Presentations

D12 - Essential Documentation: IRB Membership, Record Keeping, Minutes, and More

Date: November 7, 2017
Speakers: Janet C. Donnelly, RAC; Ada Sue Selwitz, MA; Irene E. Stith-Coleman, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Animal Welfare Regulations

This set of regulations drafted by the US Department of Agriculture (USDA) provides the regulatory basis for enforcement by the Department. Institutions receiving funding from PHS are required to adhere to these regulations. The Animal Welfare Regulations serve to implement the Animal Welfare Act, which provides for the minimum standards of care and treatment of certain animals used in research, exhibition, transport, and by dealers.

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An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Except
Poster Abstracts

An Institutional Experience Regarding the Classification and Approval Rates of Single Patient Exceptions to Clinical Trials in the Committee on Human Research

Category: 2015 AER Conference

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Case Studies and Snapshots

Research Ethics Snapshot: Scholarly and Journalistic Activities

Research Ethics Snapshots are page-long, deeper dives into specific aspects of the revised Common Rule to aid IRB staff in understanding the regulations and in sharing their new knowledge with their IRB members.

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Talks & Presentations

Yourprof Lecture 8: Guidelines Authority and Challenges

Speaker: Eric Meslin, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Talks & Presentations

Yourprof Lecture 9: The Expanding Role of the Private Sector

Speaker: Trudo Lemmens, LLM, DCL

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Analysis of the Barriers in the IRB Pre-Review Process
Poster Abstracts

Analysis of the Barriers in the IRB Pre-Review Process

Category: 2015 AER Conference

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Historical Documents and Regulations

Behavioral Study of Obedience

In 1963, social psychologist Stanley Milgram designed a study to investigate what he termed “destructive obedience.” This infamous study, the results of which were published in this article, has fostered many discussions on obedience to authority and the use of deception in research.

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 D16 - IRB Noncompliance and Liability in the Single IRB Era
Talks & Presentations

D16 - IRB Noncompliance and Liability in the Single IRB Era

Date: November 7, 2017
Speakers: Kate Gallin Heffernan, JD; Megan Kasimatis Singleton, JD, MBE, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Suicidal Individuals in Research: Ethical and Safety Considerations

Date: October 17, 2017
Authors: Galia Siegel, PhD, Barbara Stanley, PhD
Description: Including suicidal or potentially suicidal individuals in clinical research can advance suicide prevention efforts, but researchers and IRBs may tend to exclude these individuals from studies to avoid potential risks. However, it is important that suicidal individuals are not excluded from research unnecessarily. This webinar will summarizes the National Institute of Mental Health (NIMH) guidance for conducting research with subjects at elevated risk of suicide, focusing on the relevant areas for IRBs.

Time: 1-2 Hours

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 D25 - Understanding the Benign Behavioral Intervention Exemption
Talks & Presentations

D25 - Understanding the Benign Behavioral Intervention Exemption

Date: November 7, 2017
Speakers: Karen Christianson, RN, BSN; David H. Strauss, MD; Ivor A. Pritchard, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt
Poster Abstracts

Attitudes Towards and Prevalence of Research Misconduct Among Investigators in Egypt

Category: 2015 AER Conference

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Historical Documents and Regulations

Biosafety in Microbiological and Biomedical Laboratories

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Webinars

Adopting and Retiring Research Animals: Best Practices and Lived Experiences

Date: November 7, 2019

Authors: Lyndon J Goodly, DVM, DACLAM, MS; Eric K. Hutchinson, DVM, DACLAM

Description: Many institutions have well-established practices pertaining to adoption/retirement of research animals. As legislative efforts at the federal and state levels increasingly make such practices mandatory, it’s in the interest of research institutions to proactively create and improve their adoption/retirement programs. Such programs enable institutions to maintain control of their own practices, gain public trust, and provide alternatives for healthy post-study animals that meet institutional adoption/retirement criteria.

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credits towards recertification

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Talks & Presentations

Yourprof Lecture 10: Priority Settings in Global Health Research

Speaker: Jim Lavery, MSc, PhD

Members have complimentary access to a 10-part series of online Yourprof, Inc. lectures. Each lesson is original, and has been sourced and recorded to help give you a new perspective on the thought-provoking subject of global health research ethics in a convenient and accessible way. Each talk features an expert from around the world, specially chosen to help you gain an understanding on ideas, events and the people behind them.

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Webinars

Advanced Noncompliance Scenarios for IACUCs: Laboratory Animals and Wildlife

Date: June 20, 2019

Authors: Stacy Pritt, DVM, MS, MBA, CPIA, CHRC, DACAW; Tracy Thompson, DVM

Description: IACUCs may struggle with how to identify noncompliance, how and when to report, and what approaches are best to correct and prevent noncompliance in the future. This is especially true for non-typical research, such as activities involving wildlife. This webinar will briefly review the current standards and guidance while presenting interactive scenarios to assist IACUCs in navigating the challenges associated with identifying, investigating, reporting, correcting, and preventing future noncompliance at their institution, whether in the lab or in the field. 

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credits towards recertification

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Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy?
Poster Abstracts

Can Meaningful Use Improve Informed Consent Forms that Advance Health Literacy?

Category: 2015 AER Conference

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Historical Documents and Regulations

CCAC Guidelines on Animal Use Protocol Review

The Canadian Council on Animal Care (CCAC) published these guidelines in 1997 in order to assist protocol reviewers in obtaining a complete and accurate description of proposed animal use.

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 D4 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule
Talks & Presentations

D4 - Tissue Repositories and Data Banks in the Era of the Revised Common Rule

Date: November 7, 2017
Speakers: Mark Barnes, JD, LLM; Julie Kaneshiro, MA; Susan Stayn, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 E24 - SBER in International Settings: Identifying Challenges and Finding Solutions Through Case Stu
Talks & Presentations

E24 - SBER in International Settings: Identifying Challenges and Finding Solutions Through Case Studies

Date: November 8, 2017
Speakers: Leslie D. Cannold, PhD; Kelly O'Keefe, MPH; Katie B. Speanburg, EdMA
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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Centralizing IRB Review Functions for a Growing, Urban HealthCare System
Poster Abstracts

Centralizing IRB Review Functions for a Growing, Urban HealthCare System

Category: 2015 AER Conference

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Historical Documents and Regulations

Certificates of Confidentiality Kiosk

These standards for the use of recombinant DNA in research provide guidance on containment and safe research practices.

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Webinars

Agricultural Research with Farm Animals: IACUC Scenarios and Considerations

Date: January 30, 2020

Authors: Juliette Hanson; Dr. Susan B. Harper

Description: Agricultural research involving farm animals can present interesting challenges for defining appropriate environmental and housing conditions, assessing potential pain and distress animals may experience, and identifying potential hazards that can impact the safety of both animals and personnel. During this webinar, speakers will review scenarios that demonstrate some of the challenges encountered during the review of research involving agricultural animals.

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credits towards recertification

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Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’
Poster Abstracts

Changing Culture: Introducing Post Approval Monitoring Through a ‘Soft-Rollout’

Category: 2015 AER Conference

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Historical Documents and Regulations

Comparison of FDA and HHS Human Subject Protection Regulations

Issued by the FDA, this table compares the central FDA and HHS regulations for the protection of human subjects.

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Webinars

Aligning SOPs and New Electronic Systems for a Successful Implementation

Date: September 13, 2018
Authors: Paul Accardi, CPIA, Nancy A. Olson, JD
Description: Transitioning to a new electronic system requires a lot of time, money, and infrastructure, and it’s essential that institutions conduct a concurrent review and revision of existing policies and standard operating procedures (SOPs) during a transition. The presenters of this webinar, n animal program operations manager and an HRPP director, address important considerations for animal care and use and human subjects protections professionals who are switching to new electronic systems for research review.

Time: 1-2 Hours

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 Innovations A: Innovations in Emergency and Disaster Research Settings
Talks & Presentations

Innovations A: Innovations in Emergency and Disaster Research Settings

Date: November 7, 2017
Speakers: Emily E. Anderson, PhD, MPH; Michael Linke, PhD, CIP; Joan Patrice Packenham, PhD; Kristen Sullivan, PhD, MSW, MBA, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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 Keynote Address: Low Hanging Fruit in the Reproducibility and Translatability Crisis: How IRBs Can
Talks & Presentations

Keynote Address: Low Hanging Fruit in the Reproducibility and Translatability Crisis: How IRBs Can Critically Assess Animal Data Before Approving First-In-Human-Studies

Date: November 16, 2016
Speakers: Joseph Garner, DPhil
Conference: 2016 AER Conference

Time: 1-2 Hours

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Webinars

Assessing and Mitigating Risk in SBER

Date: March 20, 2019

Authors: Amy Ben-Arieh, JD, MPH; Lara Sloboda, PhD

Description: The risks associated with social, behavioral, and educational research (SBER) are often hard to identify, inconsistent, subjective, and unpredictable. Even the most experienced reviewers struggle with identifying and quantifying the potential harms. During this webinar, speakers will provide foundational knowledge and strategies for identifying, assessing, and mitigating SBER risks. Using illustrative case studies from diverse areas of SBER, speakers will discuss how SBER methods and context may exacerbate subject vulnerabilities, and suggest ways to tease out the risks these studies introduce. Once identified, they will explore practical application of common mitigation strategies, preparing attendees to carefully tailor guidance for researchers and IRBs.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Historical Documents and Regulations

Concentration Camps for Dogs

This 1966 article from Life Magazine, which details housing conditions at an animal dealer, is one of the two articles that prompted the US government to pass the Animal Welfare Act.

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Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External E
Poster Abstracts

Collaboratively Delivering QA/QI Support, Tools, and Resources by Leveraging Internal and External Expertise: A Harvard Catalyst Model

Category: 2015 AER Conference

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Conflict of Interest: A National Perspective
Poster Abstracts

Conflict of Interest: A National Perspective

Category: 2015 AER Conference

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Historical Documents and Regulations

Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines

Updated in 2002, this document aims to assist countries in "defining national policies on the ethics of biomedical research, applying ethical standards in local circumstances, and establishing or redefining adequate mechanisms for ethical review of research involving human subjects."

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Webinars

Building an Exceptional Animal Care and Use Program Through Engaged Leaders and Continuous Improvement

Date: April 18, 2018
Authors: Christina Savidge, BS-Animal Science LATG, Sally Thompson-Iritani, DVM, PhD, CPIA
Description: An exceptional animal care and use program actively balances science, animal welfare, and compliance. During this webinar, the speakers provide a framework for building a strong animal care and use program or strengthening an established program, including the four important features of an effective program, and the key elements to foster a culture of care.

Time: 1-2 Hours

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 Keynote Address: The Continuum from Truth and Knowledge Generation to Opinion to False Information:
Talks & Presentations

Keynote Address: The Continuum from Truth and Knowledge Generation to Opinion to False Information: Do We Have the Right Balance?

Date: November 7, 2017
Speakers: Robert M. Califf, MD, MACC
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Keynote Address: The Ethics Beat: Writing About Ethics for the Front Page and Beyond
Talks & Presentations

Keynote Address: The Ethics Beat: Writing About Ethics for the Front Page and Beyond

Date: November 6, 2017
Speakers: Amy Dockser Marcus, MBE
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Capacity to Consent to Research: Assessing and Improving your HRPP’s Strategy

Date: January 18, 2018
Authors: Tamyra Armbrust, CIP, Courtney Jarboe, MA, MS, CIP
Description: When research subjects’ capacity to consent is absent, diminished, or fluctuating, additional consent safeguards and support may be required by the IRB. IRBs are required to provide additional protection; however, the regulations are generally silent on the specifics of what this involves.This advanced-level webinar lays out policies and procedures to enhance protections for these vulnerable subjects.

Time: 1-2 Hours

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Historical Documents and Regulations

Country-Specific Animal Research Regulations

AAALAC International maintains a list of links to regulations and guidance documents for many countries.

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Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/
Poster Abstracts

Considerations for Informed Consent Process for a Rehabilitation Program for People Living with HIV/AIDS in a Lower Middle Income Country

Category: 2015 AER Conference

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Coordinating Multi-Site Input for Central IRBs
Poster Abstracts

Coordinating Multi-Site Input for Central IRBs

Category: 2015 AER Conference

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Webinars

Compassion in Science: The Benefits of Caring and the IACUC’s Role

Date: September 10, 2019

Author: J. Preston Van Hooser, BS

Description: Laboratory animal professionals may struggle to balance the compassion they feel for the animals in their care with the scientific imperatives that require the use of animals in research, which can lead to compassion fatigue (CF). CF can lead to increased illness, high turnover, and low morale in the workplace, negatively impacting the program overall. By encouraging “healthy compassion,” institutional leaders can foster a strong animal welfare program that also optimizes scientific advancements. Through avenues such as semiannual inspections, training, and advocating for animal caregivers, IACUCs can support programs and tools that build resiliency among laboratory animal professionals.

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credits towards recertification

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Historical Documents and Regulations

Cruely to Animals Act of 1876

Widely regarded as the world’s first law governing research involving animals, this act was passed in Britain in 1876.

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 Lifetime Achievement Award Plenary Address by Ruth Macklin, PhD: Dealing With Controversies in Rese
Talks & Presentations

Lifetime Achievement Award Plenary Address by Ruth Macklin, PhD: Dealing With Controversies in Research Ethics: Four Decades of Experience

Date: November 6, 2017
Speakers: Ruth Macklin, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel I - New Frontiers: The Changing Landscape of Research Regulations
Talks & Presentations

Panel I - New Frontiers: The Changing Landscape of Research Regulations

Date: November 6, 2017
Speakers: Michele Russell-Einhorn, JD, Melissa E. Abraham, PhD, MS, John R. Baumann, PhD, Emily Chi Fogler, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Department of Veterans Affairs Administration Handbook 1058.01

This Veterans Health Administration (VHA) Handbook sets forth the requirements for reporting research compliance events to research review committees, facility officials, and the Office of Research Oversight (ORO).

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Webinars

Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation

Date: April 12, 2017
Authors: Alex John London, PhD, Elizabeth Ripley, MD, MS, RAC
Description: The practice of offering payment to study subjects in order to achieve recruitment goals is controversial. Ethicists disagree on what is appropriate, and want to avoid inducing someone to participate against their better judgement. This webinar outlines the regulations, ethical questions, and best practices for IRBs to consider.

Time: 1-2 Hours

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Creating a New Pathway to Differentiate QI and Human Subjects’ Research
Poster Abstracts

Creating a New Pathway to Differentiate QI and Human Subjects’ Research

Category: 2015 AER Conference

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Webinars

Complexity in Clinical Trial Design: A Primer on Adaptive and Platform Trials

Date: June 18, 2020

Author: Luke Gelinas, PhD, MA; Marianne Kearney Chase

Description: In recent years, the demand for creative approaches to drug development has increased. Trials in which key components are modified during the course of the study, and in response to information accrued within the trial, may be described under a number of terms—including as adaptive, umbrella, and platform trials. During this webinar, speakers will define key terms, explore ethical and regulatory challenges, and provide strategies and examples to bridge the gap between IRBs and researchers in understanding adaptive trial designs.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credit towards recertification

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Historical Documents and Regulations

Department of Veterans Affairs Administration Handbook 1200.05

This Veterans Health Administration (VHA) directive outlines the requirements for the protection of human subjects in Department of Veterans Affairs (VA) research and the operation of the Institutional Review Board (IRB) for VA facilities.

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Decisions for Non-Significant Risk Device Studies: Laboratory-Developed Tests
Poster Abstracts

Decisions for Non-Significant Risk Device Studies: Laboratory-Developed Tests

Category: 2015 AER Conference

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 Panel III - The Role of Research Ethics Consultation in IRB-Reviewed Research: Opportunities and Ch
Talks & Presentations

Panel III - The Role of Research Ethics Consultation in IRB-Reviewed Research: Opportunities and Challenges

Date: November 6, 2017
Speakers: Steven Joffe, MD, MPH; [Susan Z. Kornetsky, MPH; photo] Susan Z. Kornetsky, MPH; Holly A. Taylor, PhD, MPH; Benjamin S. Wilfond, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel IV - What Is Comparative Effectiveness Research (CER) and Does it Raise Any Unique Ethical Is
Talks & Presentations

Panel IV - What Is Comparative Effectiveness Research (CER) and Does it Raise Any Unique Ethical Issues?

Date: November 7, 2017
Speakers: Ruth Macklin, PhD; Scott Y.H Kim, MD, PhD; John D. Lantos, MD; Jerry A. Menikoff, MD, JD; Charles Natanson, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Department of Veterans Affairs Use of Animals in Research

All research, testing, and teaching activities involving animals within the VA are subject to the principles and procedures within this handbook.

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Developing a Practice and Guidance Committee to Document IRB Standard Procedures and Pilot Projects
Poster Abstracts

Developing a Practice and Guidance Committee to Document IRB Standard Procedures and Pilot Projects

Category: 2015 AER Conference

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Webinars

COVID-19: How HRPPs are Preparing and Responding—A Discussion Forum

Date: March 23, 2020

Authors: Bruce G. Gordon, MD; Martha F. Jones, MA, CIP; Megan Kasimatis Singleton, JD, MBE, CIP; Michele Russell-Einhorn, JD

Description: The COVID-19 pandemic is impacting human subjects research in unprecedented ways. This forum will provide an opportunity to hear from HRPP leaders representing universities, academic health care systems, and an independent IRB on the key issues and strategies HRPPs should be considering and implementing in the face of the COVID-19 pandemic.

Time: 1.5 hours

This webinar is free to all. Click here to access the webinar recording.

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Webinars

Data and Safety Monitoring: Advanced Issues and Case Studies

Date: July 12, 2017
Authors: Stephen Davis, MPA, MSW, Susan Ellenberg, PhD
Description: Data and safety monitoring boards (DSMBs) and IRBs are two distinct but related committees concerned with the ethical and safe conduct of research. How can DSMBs, IRBs, investigators, and sponsors work together to ensure scientific integrity and subject safety? This webinar expands on foundational knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program's Biomedical Basic course.

Time: 1-2 Hours

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Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia
Poster Abstracts

Development and Implementation of a Graphic Aid to Consent for an Ebola Vaccine Trial in Liberia

Category: 2015 AER Conference

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Historical Documents and Regulations

DHHS 45 CFR 46

Often referred to as the Common Rule, these regulations from the DHHS (and adopted by 18 other federal agencies) are the basis for research regulations in the US today.

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 Panel IX - Bioethics in the Biopharmaceutical Industry: A Glimpse of Bioethics in a Different Setti
Talks & Presentations

Panel IX - Bioethics in the Biopharmaceutical Industry: A Glimpse of Bioethics in a Different Setting

Date: November 8, 2017
Speakers: Barbara E. Bierer, MD; Karla Childers, MSJ; Tatjana Poplazarova, MSc, MA-Bioethics; Luann E. Van Campen, PhD, MA-Bioethics
Conference: 2017 AER Conference

Time: 1-2 Hours

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 Panel V - Social, Behavioral, and Biomedical Transgender Research: Needs and Challenges
Talks & Presentations

Panel V - Social, Behavioral, and Biomedical Transgender Research: Needs and Challenges

Date: November 7, 2017
Speakers: Jeremy Sugarman, MD, MPH, MA; Sean Cahill, PhD; Rimah Jaber
Conference: 2017 AER Conference

Time: 1-2 Hours

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Development of Automated Methods for Big Data to Achieve Compliance with IRB, Institutional, and Fed
Poster Abstracts

Development of Automated Methods for Big Data to Achieve Compliance with IRB, Institutional, and Federal Requirements

Category: 2015 AER Conference

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Historical Documents and Regulations

Directive 2010/63/EU of the European Parliament and of the Council on the Protection of Animals Used for Scientific Purposes

This 2010 directive governs the use of animals in research in the European Union.

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Webinars

Data Sharing in SBER: Balancing Transparency and Human Research Protections

Date: May 1, 2019

Authors: Dessislava (Dessi) Kirilova, MA; Kathleen Murphy, PhD, CIP

Description: Enthusiasm for data sharing and research transparency is increasing across the social sciences, and the long-standing mandate to minimize risks for human subjects in research has begun to overlap with this newer scholarly imperative. IRBs are a critical player in this realm; often, an IRB’s recommendations on a social science research protocol will determine whether or not the data obtained through the study may be shared in the future. During this webinar, speakers will provide knowledge and strategies for IRBs to help their institution’s social scientists approach data sharing in an ethical and responsible manner.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Historical Documents and Regulations

Ethical Considerations in Biomedical HIV Prevention Trials

The global burden of disease and death related to HIV continues to increase resulting in a need for continued research on preventive interventions. This document, drafted by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the Wolrd Health Organization (WHO), highlights the ethical issues involved with conducting such research.

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Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Foc
Poster Abstracts

Differences in Opinion on Incidental Finding Review and Disclosure in Neuroimaging Research from Focus Group Discussions

Category: 2015 AER Conference

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Webinars

Digital Health Technology and Human Subjects Research: What IRBs Need to Know

Date: February 8, 2018
Authors: Jeremy Block, PhD, MPP, Jennifer S. Geetter, Esq.
Description: Advances in digital health applications, tools, and technologies are occurring rapidly and are developed by companies that may lack a strong foundation in health care norms. In addition, many of these technologies may not be subject to FDA oversight. This webinar provides strategies to help IRBs assess the new technology's suitability to protect the data, privacy, and confidentiality of research subjects.

Time: 1-2 Hours

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 Panel VIII - Making Consent Meaningful in the Context of the Revised Common Rule
Talks & Presentations

Panel VIII - Making Consent Meaningful in the Context of the Revised Common Rule

Date: November 8, 2017
Speakers: Neal W. Dickert, Jr., MD, PhD; Rebecca S. Dresser, JD; Jerry A. Menikoff, MD, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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2015 IACUC Conference Town Hall Meeting
Talks & Presentations

2015 IACUC Conference Town Hall Meeting

Date: March 20, 2015
Speakers: F. Claire Hankenson, Christian Newcomer
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Webinars

Early Feasibility Studies for Investigational Devices: Facilitating Innovation While Protecting Subjects

Date: March 22, 2017
Authors: Andrew Farb, MD
Description: Early feasibility studies (EFS), or clinical evaluations of devices in the early stage of testing, are increasing in prevalence in the US, so IRBs need to become familiar with the regulations associated with them. The level of uncertainy in these studies creates a challenge for the IRB, so this webinar aims to provide guidance and best practices when dealing with an EFS.

Time: 1-2 Hours

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Historical Documents and Regulations

Ethics and Clinical Research

Many attribute the birth of clinical research ethics as it exists today to this 1966 article written by Henry K. Beecher, an anesthesiologist.

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Establishing a Cancer Research Ethics Committee in Resource Limited Setting
Poster Abstracts

Establishing a Cancer Research Ethics Committee in Resource Limited Setting

Category: 2015 AER Conference

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Historical Documents and Regulations

Euroguide on the Accommodation and Care of Animals Used for Experimental and Other Scientific Purposes

The Federation of European Laboratory Animal Science Associations (FELASA) publishes guidelines, recommendations, and reports regarding animal care and use in Europe, including this document, which is widely cited.

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Webinars

Every Day with Every Interaction: Deepening the IACUC’s Understanding of Positive Reinforcement Training

Date: April 17, 2019

Authors: Kelly Morrisroe

Description: Every day and with every interaction, animals learn how to respond to the people in their research environment. Positive reinforcement training (PRT) techniques can improve animals’ level of compliance with research tasks, as well as their physiological response to their environment. PRT reduces the need for coercive methods of handling and improves animal welfare for all species. It’s critical that IACUC members have a working knowledge of classical and operant conditioning in order to critically assess research proposals to ensure that the protocols include appropriate PRT.

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credits towards recertification

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Expanding a Post-Approval Monitoring Program: Building on Success
Poster Abstracts

Expanding a Post-Approval Monitoring Program: Building on Success

Category: 2015 AER Conference

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A New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engi
Talks & Presentations

A New Framework for Human Subjects Research? An Update From the National Academies of Sciences, Engineering, and Medicine

Date: November 14, 2016
Speakers: Alexander M. Capron, Barbara E. Bierer, Steven Joffe, Heather H. Pierce
Conference: 2016 AER Conference

Time: 1-2 Hours

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A14 - Considerations When Transitioning to the Revised Common Rule
Talks & Presentations

A14 - Considerations When Transitioning to the Revised Common Rule

Date: November 6, 2017
Speakers: Lauren Hartsmith, JD; P. Pearl O'Rourke, MD; Heather H. Pierce, JD, MPH
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Expectation vs. Reality: Reporting Obligations to the IRB

Date: June 5, 2019

Authors: Linda Coleman, JD; Mitchell Parrish, JD, RAC, CIP

Description: Understanding which events to report to the IRB is an ongoing challenge for researchers and IRBs alike. Institutional policies and procedures vary widely, which can further complicate the reporting process. Using real-world scenarios and data, as well as instructive diagrams and charts, speakers will clarify common areas of confusion when it comes to reporting unanticipated problems, adverse events, and safety-related information to the IRB and the institution.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Historical Documents and Regulations

Experiments in Torture: Evidence of Human Subjects Research and Experimentation in the "Enhanced" Interrogation Program

This 2010 paper from Physicians for Human Rights examines reports of experimentation that occurred during the administration of President George W. Bush.

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Facilitating the Ethical Conduct of Research
Poster Abstracts

Facilitating the Ethical Conduct of Research

Category: 2015 AER Conference

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Webinars

Exploring and Enhancing Diversity for IACUCs and IRBs

Date: May 23, 2018

Authors: Duke Morrow, MDiv, DMin, Donna Matthews Jarrell, DVM, DACLAM

Description: IACUCs and IRBs should comprise skilled and knowledgeable individuals committed to the goal of ensuring ethical conduct of research. While most institutions have a diversity policy or program, the focus is often on demographic characteristics. This webinar provides information and strategies for IACUCs and IRBs to help them expand the definition of diversity and understand how it can strengthen the committee's ability to carry out its mission.

Time: 1.5 hours

CE: Webinar participants holding the CPIA credential may apply 1.5 continuing education credits towards recertification

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Historical Documents and Regulations

FDA 21 CFR 312

Investigational new drugs and devices must be reviewed by the FDA. The regulations at 21 CFR 312 outline this requirement for the investigational drug submission process.

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Genomic Advisory Panel: Human Subjects Protection in a Brave New World
Poster Abstracts

Genomic Advisory Panel: Human Subjects Protection in a Brave New World

Category: 2015 AER Conference

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Talks & Presentations

Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient

Date: November 11, 2019

Authors: Gretchen L. J Anding, MA; Elizabeth A. Buchanan, PhD

Description: The criteria for IRB approval have always included a requirement that IRBs consider, when appropriate, that there are sufficient protections in place to maintain the confidentiality of data. The revised Common Rule, specifically the new requirements for limited IRB review, place emphasis on this review criterion. Minimal guidance exists to assist IRBs in determining whether proposed safeguards for research data are sufficient. This session will review the challenges IRBs face in reviewing protocols to determine if the plans for maintaining confidentiality are sufficient, and it will highlight solutions for how data management and security review may be incorporated into the IRB review process.

Time: 1.25 hours

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Talks & Presentations

Assessing Plans to Maintain Confidentiality: Q&A

Q&A: Is Your Data Security Plan Sufficient?
Date: May 12, 2020
Speakers: Gretchen L. J Anding, MA; Elizabeth A. Buchanan, PhD; Sharon C. Freitag

As part of 2020's Member Appreciation Month, PRIM&R released a recording of AER19 session D12: Assessing Plans to Maintain Confidentiality: How IRBs Determine Whether Data Security and Management Plans Are Sufficient and hosted a live Q&A with the session speakers and Membership Committee co-chair, Sharon Freitag exclusively for PRIM&R members.

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Webinars

Focus on the Revised Common Rule: Biospecimens and Identifiable Private Information

Date: June 15, 2017

Authors: Karen Christianson, RN, BSN, CCRP and Paula McAllister, PhD, CIP

Description: Part of the Focus on the Revised Common Rule webinar series.

Time: 1.5 hours

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Historical Documents and Regulations

FDA 21 CFR 314

Marketed drugs and devices are regulated by the FDA. The regulations at 21 CFR 814 are for marketed drugs.

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How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes
Poster Abstracts

How Instituting a Formalized Pre-IRB Review Process Improves IRB Review Outcomes

Category: 2015 AER Conference

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Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions
Poster Abstracts

Implementation of an Educational Initiative for Addressing “Common Pitfalls” With IRB Submissions

Category: 2015 AER Conference

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Historical Documents and Regulations

FDA 21 CFR 50

Clinical investigations involving test articles that meet the FDA definition are subject to the guidelines laid out by the FDA in 21 CFR 50 and 21 CFR 56. 21 The regulations at 21 CFR 50are the FDA rules for the protection of human subjects, with sections devoted to informed consent and research with children.

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Webinars

Focus on the Revised Common Rule: Exemption Categories and Select Types of Review

Date: June 8, 2017

Authors: Karen Christianson, RN, BSN, CCRP and Paula McAllister, PhD, CIP

Description: Part of the Focus on the Revised Common Rule webinar series.

Time: 1.5 hours

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B12 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule, or Is it Exe
Talks & Presentations

B12 - Back to Basics: Does My Project Fall Within the Scope of the Revised Common Rule, or Is it Exempt?

Date: November 6, 2017
Speakers: Angela Hvitved, PhD, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

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B14 - Tips and Tools for Implementing Single IRB Review
Talks & Presentations

B14 - Tips and Tools for Implementing Single IRB Review

Date: November 6, 2017
Speakers: Carol Pech, PhD; Kimberly K. Summers, PharmD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Focus on the Revised Common Rule: Implications for Social, Behavioral, and Educational Research

Date: June 22, 2017

Authors: Elizabeth Buchanan, PhD and Jeffrey Cohen, PhD, CIP

Description: Part of the Focus on the Revised Common Rule webinar series.

Time: 1.5 hours

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Historical Documents and Regulations

FDA 21 CFR 56

Clinical investigations involving test articles that meet the FDA definition are subject to the guidelines laid out by the FDA in 21 CFR 50 and 21 CFR 56. 21 CFR 50 comprises the FDA regulations for the protection of human subjects, with sections devoted to informed consent and research with children. The regulations at 21 CFR 56 outline requirements for IRBs, including IRB organization and function, and circumstances in which waivers or exemptions from IRB review are allowed.

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Improved Data Security via Collaboration Between the Information Security Office and the IRB
Poster Abstracts

Improved Data Security via Collaboration Between the Information Security Office and the IRB

Category: 2015 AER Conference

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Improving the IRB Meeting Minutes Approval Process
Poster Abstracts

Improving the IRB Meeting Minutes Approval Process

Category: 2015 AER Conference

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Historical Documents and Regulations

FDA 21 CFR 58

FDA guidelines for good laboratory practices for conducting nonclinical laboratory studies include regulations on the care and use of animals in such research.

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Webinars

Focus on the Revised Common Rule: Informed Consent

Date: June 1, 2017

Authors: Jeremy Corsmo, MPH, CIP, CHRC and Paula McAllister, PhD, CIP

Description: Part of the Focus on the Revised Common Rule webinar series.

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B16 - Mastering Master Agreements: When Are Broad-Based Standardized Agreements Beneficial to Resear
Talks & Presentations

B16 - Mastering Master Agreements: When Are Broad-Based Standardized Agreements Beneficial to Research Collaborations?

Date: November 6, 2017
Speakers: Nichelle Cobb, PhD; Libby D. Salberg, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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B18 -
Talks & Presentations

B18 - "Let it Go": What Should Be Exempt and How to Limit IRB Review of These Studies (Including Those With Sensitive Data)

Date: November 6, 2017
Speakers: Teresa Doksum, MPH, PhD; Lauren Hartsmith, JD; Daniel K. Nelson, MSc, CIP; Sean Owen, CISSP, CAP, CRISC; Katie B. Speanburg, EdM
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Forward-Looking Strategies for IRBs in the Genomic Age: Preparing for Shifting Concepts of Identifiability

Date: May 10, 2018

Authors: Jiayan Chen, JD, Suzanne Rivera, PhD, MSW

Description: Breakthroughs in genomics research and technology hold the potential for significant scientificand societal benefit. The ability to share vast amounts of genomic information has disrupted traditional notions of identifiability and have introduced new considerations for IRBs, researchers, and research subjects. This webinar offers a framework to help IRBs adapt to the shifting landscape of genomics research.

Time: 1.5 Hours

CE: Webinar participants holding the CIP credential may apply 1.5 continuing education credits towards recertification

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Historical Documents and Regulations

FDA 21 CFR 812

Investigational new drugs and devices must be reviewed by the FDA. The regulations at 21 CFR 812 outlines this process for investigational devices. Regulations 21 CFR 314 and 814 are for marketed drugs and devices.

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Innovation in IRB Reliance: A New Model Advances Multi-Site Research
Poster Abstracts

Innovation in IRB Reliance: A New Model Advances Multi-Site Research

Category: 2015 AER Conference

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Innovative Tools and Approaches for Streamlining the Research Review Process for American Indian Tri
Poster Abstracts

Innovative Tools and Approaches for Streamlining the Research Review Process for American Indian Tribal IRBs

Category: 2015 AER Conference

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Historical Documents and Regulations

FDA 21 CFR 814

Marketed drugs and devices are regulated by the FDA. The regulations at 21 CFR 814 are for marketed devices.

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Webinars

Governance, Trust, and Culture: Strengthening Tribal-Academic Research Partnerships

Date: October 10, 2018

Authors: Yvette Roubideaux, MD, MPH; Julie Lucero, PhD, MPH

Description: Partnerships between American Indian/Alaska Native (AI/AN) tribal nations and academic research institutions have the potential to be mutually beneficial and long-lasting, and to contribute to tribal sovereignty and research sustainability. he National Congress of American Indians (NCAI) Policy Research Center and the University of Nevada, Reno recently partnered to develop a research-based toolkit, Holding Space: A Guide for Partners in Tribal Research, to share informed practices for meaningful tribal-academic research partnerships. This framework can help inform and improve many aspects of community-based research, including IRB review of research with AI/AN tribal nations.

Time: 1.5 hours

CE: Webinar participants holding the CIP credential may apply 1.5 continuing education credits towards recertification

This webinar is free to all. Watch it now.

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B24 - SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Change
Talks & Presentations

B24 - SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Changes

Date: November 6, 2017
Speakers: Yvonne Lau, MBBS, MBHL, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Health Literacy: Fostering Comprehension in Research and Clinical Care

Date: October 1, 2015
Authors: Cynthia Baur, Laurie Myers, Walter L. Straus

Time: 1-2 Hours

View the webinar recording (FREE!)

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Historical Documents and Regulations

Federal Policy on Research Misconduct

This policy, published by the Office of Science and Technology Policy, was drafted in order to achieve uniform Federal policies on research misconduct. Several federal agencies have adopted regulations in order to adhere to this policy.

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Could this Happen to You? Lessons Learned from the University of Minnesota Reports
Talks & Presentations

Could this Happen to You? Lessons Learned from the University of Minnesota Reports

Date: November 13, 2015
Speakers: Elisa A. Hurley Brian Herman Steven Joffe Martha Jones
Conference: AER15 Conference

Time: 1-2 Hours

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Internal QA/QI Process for an University IRB
Poster Abstracts

Internal QA/QI Process for an University IRB

Category: 2015 AER Conference

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IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Sy
Poster Abstracts

IRB and Patient Safety Office Collaboration to Improve Participant Safety in Clinical Research: A Systems Approach eFeedback Model

Category: 2015 AER Conference

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Fallout from the Freedom of Information Act (FOIA)
Talks & Presentations

Fallout from the Freedom of Information Act (FOIA)

Date: March 20, 2015
Speakers: B. Taylor Bennett, Jori Leszczynski, David Lyons
Conference: 2015 IACUC Conference

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Webinars

IACUC Operations: Pandemic & Beyond

Date: September 17, 2020

Speakers: Kathryn Cavanaugh, Dr. Stacy Pritt
 
Description: During the COVID-19 pandemic, IACUCs across the nation have had to adjust their operations to accommodate working remotely. This has necessitated the leveraging of electronic programs and processes to carry out IACUC functions, some of which may have already been in place. In this webinar speakers share methods for conducting IACUC business electronically and virtually and explore strategies for keeping IACUC staff connected and engaged while working remotely.
 
Time: 1.25 hours
 
CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credit towards recertification

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Historical Documents and Regulations

Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs: Improving Human Subject Protection

This guidance document is intended to assist researchers in interpreting FDA requirements for adverse event reporting.

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Historical Documents and Regulations

Guidance for Clinical Trial Data Monitoring Committees

This document reflects current FDA guidance on determining when a data monitoring committee (DMC) is needed and how it should function.

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Field and Laboratory Animal Research in Emerging Zoonoses
Talks & Presentations

Field and Laboratory Animal Research in Emerging Zoonoses

Date: March 19, 2015
Speakers: Darin Carroll
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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IRB Grand Rounds: A Novel Educational Format for Human Subject Research Protection Programs
Poster Abstracts

IRB Grand Rounds: A Novel Educational Format for Human Subject Research Protection Programs

Category: 2015 AER Conference

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Webinars

IRB Operations During a Pandemic

Date: October 15, 2020

Speakers: Jeremy N. Block, PhD, MPP; Dorean J. Flores, BS, MPA, CIP; Hallie Kassan, MS, CIP; Jon Newlin, CIP

Description: The SARS-CoV-2 pandemic continues to impact the entire global research enterprise. All aspects of human subjects research protections programs are seeing challenges to their operations. The resulting environment for research oversight due to the global public health crisis will continue for a considerable period of time. In this webinar, the presenters focus on a number of critical areas of IRB operations during a pandemic.

Time: 1.5 hours

CE: Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification.

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Webinars

IRB Review of Research Involving Prisoners: Foundational Frameworks and Present Challenges

Date: February 20, 2020

Authors: Sarah Archibald, PhD; Jessica Rowe, MA, MS, CCRP

Description: Prisoners who participate in research are considered a vulnerable population and are afforded additional protections under subpart C of HHS regulations, 45 CFR 46. It’s critical that IRB members understand the historical and ethical basis of the regulations in order to make informed decisions around the challenges and gray areas associated with including individuals who are, or have been, incarcerated in today’s research context. During this webinar, speakers will provide an ethical, regulatory, and historical foundation regarding research involving prisioners.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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IRB Staff Meetings: Not Your Average Meeting
Poster Abstracts

IRB Staff Meetings: Not Your Average Meeting

Category: 2015 AER Conference

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Historical Documents and Regulations

Guidance for Industry: Financial Disclosure by Clinical Investigators

Under FDA policy, anyone who submits a marketing application for a drug, device, or biologic is required to submit information regarding the financial interests of the clinical investigator. This guidance document outlines that requirement and provides answers to frequently asked questions.

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Henry Spira Memorial Lecture: Running Interference: What Don’t You Know?
Talks & Presentations

Henry Spira Memorial Lecture: Running Interference: What Don’t You Know?

Date: March 20, 2018
Speakers: Kathleen R. Pritchett-Corning, DVM, DACLAM
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Henry Spira Memorial Lecture: The Increased Relevance of the 3Rs, the Evolving Role of the IACUC, an
Talks & Presentations

Henry Spira Memorial Lecture: The Increased Relevance of the 3Rs, the Evolving Role of the IACUC, and Opportunities to Manifest Change for the Betterment of Animal Welfare and Human Health

Date: April 1, 2016
Speakers: Joseph Garner, DPhil
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Guidance on Prompt Reporting to OLAW Under the PHS Polic on Humane Care and Use of Laboratory Animals

Guidance document issued by OLAW intended to assist institutional animal care and use committees and institutional officials in determining what, when, and how situations should be reported under PHS Policy.

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Webinars

IRBs and Research Ethics Consultation Services: An Emerging Resource and Opportunity for Collaboration

Date: April 23, 2019

Authors: Kathryn M. Porter, JD, MPH; Benjamin S. Wilfond, MD

Description: The principal source of ethical review for human subjects research has traditionally been the IRB. For a variety of reasons, increasing numbers of institutions are developing research ethics consultation services to provide guidance to investigators, study teams, research subjects, and IRBs about ethical issues arising in particular research studies. The presence of an additional source of ethics input and guidance raises important questions about the relationships between these ethics consultation services and IRBs. During this webinar, speakers will address such questions and more.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Leave No Man Behind: A Novel Approach to Study Team Member Training
Poster Abstracts

Leave No Man Behind: A Novel Approach to Study Team Member Training

Category: 2015 AER Conference

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Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections
Poster Abstracts

Managing Non-Compliance: Systematic Approach that Improves Human Subject Research Protections

Category: 2015 AER Conference

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Webinars

Is This Public or Private? Determining Review Requirements for Research Conducted Online and In-Person

Date: January 16, 2020

Authors: Danielle Griffin; Cheri Pettey

Description: Determining whether a behavior or activity is considered “public” or “private”—whether online or in-person—poses ethical and operational dilemmas for IRBs and researchers. Expectations around the right to privacy and perceptions of public spaces or behaviors may differ among individuals and cultures. What factors help determine whether something is public or private? Do IRBs and researchers ever have an obligation to disclose that research is occurring in what some might consider the public domain? During this webinar, speakers will explore the ethical issues surrounding these questions as well as related IRB determinations, considerations, informed consent requirements, HRPP policies, and more.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Innovations in IRB Operations
Talks & Presentations

Innovations in IRB Operations

Date: November 13, 2015
Speakers: Elyse Summers, Charles Ryan, Rachael Sak, Jon Newlin
Conference: AER15 Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Guidance Regarding Administrative IACUC Issues and Efforts to Reduce Regulatory Burden

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Historical Documents and Regulations

Guidance to IACUCs Regarding Use of Designated Member Review for Animal Study Proposal Review Subsequent to Full Committee Review

This guidance, issued by OLAW, informs IACUCs on the proper procedure to follow when they decide modifications are needed following FCR.

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Keynote Address: Beyond Pain: Alleviating Suffering in Laboratory Animals
Talks & Presentations

Keynote Address: Beyond Pain: Alleviating Suffering in Laboratory Animals

Date: April 1, 2016
Speakers: Bernard E. Rollin
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Webinars

Meaningful Metrics: How HRPPs Can Use Their Data Effectively

Date: April 14, 2020

Author: Kim Serpico, MEd, CIP, EdD Candidate

Description: HRPPs generate an abundance of performance data and metrics. When used effectively, this information can help HRPPs meet programmatic and institutional goals, and improve the HRPP overall. Metrics, however, must be grounded in human insight; a deep awareness and understanding of the system that produced the data is necessary in order to leverage analytics for future action or improvement. This webinar will present case examples and actionable strategies for wise data use.

Time: 1 hour

CE: Webinar participants holding the CIP credential may apply 1 continuing education credit towards recertification

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Multicenter Protocol Management at a Large Comprehensive Cancer Center
Poster Abstracts

Multicenter Protocol Management at a Large Comprehensive Cancer Center

Category: 2015 AER Conference

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Webinars

Mouse Anesthesia for IACUCs and Researchers

Date: September 20, 2017

Authors: Jim Marx, DVM, PhD, DACLAM

Description: Because of their small size, administering and monitoring anesthesia in mice presents many challenges not seen with other species. This webinar, presented by a veterinarian whose research focuses on improving the care of mice in biomedical research, will teach the fundamentals of mouse anesthesia to researchers and IACUC staff who may not be familiar with anesthesiology.

Time: 1 hour

CE: Webinar participants holding the CPIA credential may apply 1 continuing education credit towards recertification.

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On-Target With On-Site IRB Reviews and Approvals
Poster Abstracts

On-Target With On-Site IRB Reviews and Approvals

Category: 2015 AER Conference

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Historical Documents and Regulations

Guide for the Care and use of Laboratory Animals

Published by the National Research Council of the National Academies, this book serves as the primary reference for the humane care and use of animals in research, testing, and teaching. This is the eighth edition of the Guide, and it was officially adopted by NIH OLAW in December 2011.

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C12 - Let's Review a Protocol: Identifying and Applying Federal Regulations to the Review of Researc
Talks & Presentations

C12 - Let's Review a Protocol: Identifying and Applying Federal Regulations to the Review of Research That Requires Expedited or Full Board Review

Date: November 7, 2017
Speakers: Warren Capell, MD; Ada Sue Selwitz, MA; Amy C. Waltz, JD, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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C19 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Socia
Talks & Presentations

C19 - Situational Vulnerability: Considerations and Safeguards When Exploring Gender Identity, Social/Economic Challenges, and At-Risk Behavior

Date: November 7, 2017
Speakers: Sean Cahill, PhD; John A. Guidry, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Guidelines for Biosafety Laboratory Competency

This guidance from the CDC establishes the behaviors and knowledge necessary for laboratory workers to work safely with biologic material.

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Webinars

Navigating the New Reliance Agreement Landscape

Date: July 12, 2016
Authors: Emily Chi Fogler, Tracy Ziolek
Description: Recent policies indicate a shift to a regulatory and funding landscape requiring single IRB review of multisite research. How can institutions and IRBs prevent problems and address the challenges that may arise from reliance arrangements?

Time: 1-2 Hours

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Optimizing Pathways to Reliance on Academic Health Center Central IRB Review for Private Practice Gr
Poster Abstracts

Optimizing Pathways to Reliance on Academic Health Center Central IRB Review for Private Practice Group Research Sites

Category: 2015 AER Conference

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Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers
Poster Abstracts

Patient Lay Summaries: Meeting the Ethical Obligation to Share Trial Results With Study Volunteers

Category: 2015 AER Conference

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Webinars

Pediatric Risk Determination: IRB Considerations and Cases

Date: September 18, 2019

Authors: Rich Gorman, MD; Donna L. Snyder, MD

Description: When assessing risk for pediatric studies, an IRB must evaluate all procedures and interventions against four categories of research. To make this determination properly, the IRB has to decide on two inconsistently defined concepts: 1) is there prospect of direct benefit? Or 2) does the research present minimal risk or a minor increase over minimal risk? During this webinar, speakers will address such questions and more.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Historical Documents and Regulations

Guiding Principles for Animal Welfare

From the World Organisation for Animal Health or OIE, this document puts forth eight basic tenets for ensuring animal welfare.

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C5 - Building Bridges Through IRB Education Outreach
Talks & Presentations

C5 - Building Bridges Through IRB Education Outreach

Date: November 7, 2017
Speakers: Colleen P. Gilrane, PhD; Joy Jurnack, RN, CCRC, CIP;
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Health Research Extension Act of 1985

The federal law that established the mandate that resulted in the Public Health Service (PHS) Policy on the Humane Use and Care of Laboratory Animals.

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Closing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings
Talks & Presentations

Closing General Session: Errors of Enthusiasm: Responsible Communication of Research Findings

Date: November 16, 2016
Speakers: David H. Strauss, Karen Kaplan, Lisa M. Lee, Vinay K. Prasad, Gary Schwitzer
Conference: 2016 AER Conference

Time: 1-2 Hours

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Webinars

Postapproval Monitoring as a Strategy for Animal Care and Use Program Improvement

Date: December 5, 2018

Authors: David Cannon, CPIA; Sandy Wilkins, LVT, CPIA, RLATG

Description: Since postapproval monitoring (PAM) validates that research is being carried out in the manner that was originally approved by the IACUC, many institutions employ PAM as a self-auditing mechanism to check on compliance. A well-run PAM program, however, can also lead to improved animal welfare, science, and collaboration among departments in the animal care and use program. During this webinar, speakers will provide operational strategies for conducting PAM within a framework where PAM benefits institutional culture and program performance as a whole.

Time: 1.5 hours

CE: Webinar participants holding the CPIA credential may apply 1.5 continuing education credits towards recertification

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Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mhealth Study
Poster Abstracts

Persons Who Inject Drugs’ Perspectives on the Risks and Benefits of Participation in a mhealth Study of Polydrug Use

Category: 2015 AER Conference

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Historical Documents and Regulations

Inclusion of Children in Research

NIH policy on the inclusion of children in research that is supported or conducted by NIH.

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Webinars

Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape

Date: March 7, 2018
Authors: Richard Klein, Beth E. Roxland, JD, Mbioethics
Description: Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has increasingly sparked discussion and debate in recent years. Currently, US federal regulations allow manufacturers to provide investigational drugs to patients with serious diseases or conditions who have exhausted approved therapeutic options, and cannot participate in a clinical trial. IRBs review and approve expanded access protocols, so members need to stay current with legal and regulatory developments. This webinar provides an overview, of legislation, ethical issues, and the role of the IRB in expanded access.

Time: 1-2 Hours

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Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentatio
Poster Abstracts

Protocol Information Management System Regulator Binder: Streamlining Regulatory Binder Documentation Maintenance and Improving Compliance

Category: 2015 AER Conference

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D10 - NIH-FDA Clinical Trial Protocol Template: Making Protocol Writing Easier for the Investigator,
Talks & Presentations

D10 - NIH-FDA Clinical Trial Protocol Template: Making Protocol Writing Easier for the Investigator, While Enhancing Quality

Date: November 7, 2017
Speakers: Melissa W. Riddle, PhD; Carrie D. Wolinetz, PhD;
Conference: 2017 AER Conference

Time: 1-2 Hours

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E12 - Writing and Updating Standard Operating Procedures (SOPs) in Light of the Revised Common Rule
Talks & Presentations

E12 - Writing and Updating Standard Operating Procedures (SOPs) in Light of the Revised Common Rule

Date: November 8, 2017
Speakers: Jeffrey A. Cooper, MD, MMM; Karen N. Hale, RPh, MPH; Lauren Hartsmith, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Qualitative Review of Ethical Guidelines for Epidemiological Studies
Poster Abstracts

Qualitative Review of Ethical Guidelines for Epidemiological Studies

Category: 2015 AER Conference

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Webinars

Preserving a Role For Tribal Review of Research in the Context of Single IRB Policies

Date: September 20, 2016

Authors: Daniel J. Calac, Malia Villegas

Description: PRIM&R is pleased to present this complimentary webinar in collaboration with Northwest Indian College, which aims to provide recommendations for future guidance with regards to operationalizing the exceptions clause, and to reinforce the vital role local review plays in AI/AN research.

Time: 1.5 hours

CE: Webinar participants holding the CIP credential may apply 1.5 continuing education credits towards recertification

This webinar is free to all. Watch it now.

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Historical Documents and Regulations

Inclusion of Women and Minorities as Participants in Research Involving Human Subjects

NIH policy on the inclusion of women and minorities in clinical research. Guidance on reporting analyses of sex/gender and racial/ethnic differences in intervention effects is also included.

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Historical Documents and Regulations

Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

This series of information sheets offer guidance on interpreting FDA regulations. Topics addressed include cooperative research, emergency use of an investigational drug or biologic, payment to research subjects, and much more.

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Webinars

PRIM&R’s Primer on the Notice of Proposed Rulemaking (NPRM)

Date: September 15, 2015
Authors: Heather H. Pierce, JD, MPH, and P. Pearl O’Rourke, MD

Time: 1-2 Hours

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Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program
Poster Abstracts

Raising the Bar: Improving Quality of Research Conduct Through a Study Initiation Program

Category: 2015 AER Conference

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E18 - Secondary Research in the New Age: Thinking Through Your Options
Talks & Presentations

E18 - Secondary Research in the New Age: Thinking Through Your Options

Date: November 8, 2017
Speakers: Karen Blackwell, MS, CIP; Kate Gallin Heffernan, JD; Julie Kaneshiro, MA
Conference: 2017 AER Conference

Time: 1-2 Hours

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E22 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections
Talks & Presentations

E22 - The Regulatory Intersection of Research Misconduct and Human Subjects Protections

Date: November 8, 2017
Speakers: Yvonne Lau, MBBS, MBHL, PhD; Kathy M. Partin, PhD; Lisa Rooney, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

 

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Webinars

The "P" in PCOR: IRB Oversight and the Role of the Patient

Date: July 16, 2015
Authors: Jeremy Block, Jeremy Corsmo

Time: 1-2 Hours

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Reducing Unnecessary IRB Oversight
Poster Abstracts

Reducing Unnecessary IRB Oversight

Category: 2015 AER Conference

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Historical Documents and Regulations

Institutional Animal Care and Use Committee Guidebook

Drafted by NIH OLAW and the Applied Research Ethics National Association (ARENA), the second edition of this guidebook provides insight into issues facing institutional animal care and use committees.

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Historical Documents and Regulations

International Compilation of Human Research Standards

Provided by DHHS, this comprehensive list of human subjects protections guidelines provides information on regulations in more than 100 countries.

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Research Common Core: Revitalizing the Monthly Research Education Conference
Poster Abstracts

Research Common Core: Revitalizing the Monthly Research Education Conference

Category: 2015 AER Conference

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Webinars

Maximizing Benefits to Research with Human Subjects Through Data Sharing

Date: June 23, 2015
Authors: Stacey Donnelly, MPA, and Bernard Lo, MD

Time: 1-2 Hours

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E5 - Improving Informed Consent Through Effective Communication Strategies and the Potential Use of
Talks & Presentations

E5 - Improving Informed Consent Through Effective Communication Strategies and the Potential Use of Decision Aids

Date: November 8, 2017
Speakers: George Gasparis, CIP; John A. Sauceda, PhD, MSc
Conference: 2017 AER Conference

Time: 1-2 Hours

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Henry Spira Memorial Lecture: Assumptions and Certainty
Talks & Presentations

Henry Spira Memorial Lecture: Assumptions and Certainty

Date: March 20, 2017
Speakers: William White, VMD, MS, DACLAM, Dip. ECLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Webinars

FDA Oversight and IRB Review of Studies that Include In-Vitro Diagnostics

Date: May 14, 2015
Authors: Jonathan M. Green, E. David Litwack

Time: 1-2 Hours

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Shifting Perspectives: Changing the Way the IRB is Perceived Through Education and Superior Customer
Poster Abstracts

Shifting Perspectives: Changing the Way the IRB is Perceived Through Education and Superior Customer Service

Category: 2015 AER Conference

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Historical Documents and Regulations

International Conference on Harmonization - Guidelines for Good Clinical Practice

Created through a partnership between the European Union, the US, and Japan, these guidelines attempt to set standards for clinical trials involving human subjects.

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Historical Documents and Regulations

International Guiding Principles for Biomedical Research Involving Animals

First drafted in 1985by the Council for International Organizations of Medical Sciences (CIOMS), the principles set forth in this document are intended to assist members of the global biomedical community in developing programs for the humane care and use of animals in research. The principles were updated for the first time in December 2012.

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Keynote Address: Ethics in Animal Research: Why Investigators Must Lead the Way
Talks & Presentations

Keynote Address: Ethics in Animal Research: Why Investigators Must Lead the Way

Date: March 20, 2018
Speakers: Jerrold Tannenbaum, JD
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Standardizing Implementation of the Good Participatory Practice Guidelines: A Distance Learning Appr
Poster Abstracts

Standardizing Implementation of the Good Participatory Practice Guidelines: A Distance Learning Approach

Category: 2015 AER Conference

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Webinars

Earning the CPIA Credential: Is It Right for You, Right Now?

Date: May 12, 2015
Authors: Deb Frolicher, Toni K. O’Connell

Time: 1-2 Hours

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Webinars

Earning the CIP Credential: Is It Right for You, Right Now?

Date: May 6, 2015
Authors: Gregorio Lim, Ross A. HIckey

Time: 1-2 Hours

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Teamwork Makes the Dream Work! The Implementation of an Immersion Based Group Training Program for N
Poster Abstracts

Teamwork Makes the Dream Work! The Implementation of an Immersion Based Group Training Program for New IRB Staff Members

Category: 2015 AER Conference

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Keynote Address: Game Changer: A Boy, a Dog, and a Cure
Talks & Presentations

Keynote Address: Game Changer: A Boy, a Dog, and a Cure

Date: March 21, 2018
Speakers: Martin (Casey) K. Childers, DO, PhD, Alison Rockett Frase
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Jesse's Intent

Jesse Gelsinger passed away while participating in a gene therapy clinical trial at the University of Pennsylvania. In part due to his father’s advocacy, his case has become a pivotal example of research misconduct. In this piece, his father, Paul Gelsinger, shares Jesse’s story.

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Keynote Address: Pain in Mice and Man: Ironic Adventures in Translation
Talks & Presentations

Keynote Address: Pain in Mice and Man: Ironic Adventures in Translation

Date: April 2, 2016
Speakers: Jeffrey S. Mogil, BSc, PhD
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Legislative and Regulatory Options for Animal Welfare

This document, drafted by the United Nations in 2010, provides guidelines for legislators and policymakers around the world who are drafting animal welfare legislation.

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The Impact of Student-Specific Workshops on IRB Applications
Poster Abstracts

The Impact of Student-Specific Workshops on IRB Applications

Category: 2015 AER Conference

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Webinars

Practical and Effective Approaches To Educate IRB Members

Date: April 7, 2015
Authors: Mina Busch and Scott Lipkin

Time: 1-2 Hours

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The Long and Winding Road: Development of a Central IRB Reliance Program at an Academic Medical Cent
Poster Abstracts

The Long and Winding Road: Development of a Central IRB Reliance Program at an Academic Medical Center

Category: 2015 AER Conference

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Historical Documents and Regulations

Memorandum of Understanding Among APHIS, FDA, and NIH

Document establishing reciprocal cooperation between APHIS, FDA, and NIH in the promotion of animal care and welfare.

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Modeling the Origins and Mechanisms of Cystic Fibrosis
Talks & Presentations

Modeling the Origins and Mechanisms of Cystic Fibrosis

Date: March 19, 2015
Speakers: David Meyerholz
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Webinars

Hot Topics in Online Survey Research: Subject Identification, Consent, and Risk

Date: March 12, 2015
Authors: Elizabeth Buchanan, B. R. Simon Rosser

Time: 1-2 Hours

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Webinars

Data Security Incidents: the Role of IRBs and Information Security

Date: February 26, 2015
Authors: Teresa Doksum, Sean Owen

Time: 1-2 Hours

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Historical Documents and Regulations

NASA Principles for the Ethical Care and Use of Animals (Sundowner Report)

Following in the footsteps of the Belmont Report, this 1996 document establishes the ethical considerations for the humane conduct of research involving animals.

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Panel I: IACUC Oversight: Addressing the Challenges, Understanding the Consequences
Talks & Presentations

Panel I: IACUC Oversight: Addressing the Challenges, Understanding the Consequences

Date: April 1, 2016
Speakers: F. Claire Hankenson, JR Haywood, Cindy Pekow, Andrew Buermeyer
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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The Road to Success: Rolling Out Electronic Animal Study Protocol (ASP) Software
Poster Abstracts

The Road to Success: Rolling Out Electronic Animal Study Protocol (ASP) Software

Category: 2015 IACUC Conference

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Table Topics: A No-Cost IACUC Member Continuing Education Program
Poster Abstracts

Table Topics: A No-Cost IACUC Member Continuing Education Program

Category: 2015 IACUC Conference

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Historical Documents and Regulations

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Following the unearthing of the abuses at Tuskegee, Congress created this Commission in 1974 to help shape bioethics policy. Since that time, several iterations of the Commission have continued influence federal policy, including the present day Presidential Commission for the Study of Bioethical Issues.

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Innovations A: Innovations in Public Perceptions of Research and Risks
Talks & Presentations

Innovations A: Innovations in Public Perceptions of Research and Risks

Date: November 15, 2016
Speakers: Warren Capell, Linda Petree, Jonathan Rabinowitz, Donald J. Willison
Conference: 2016 AER Conference

Time: 1-2 Hours

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Webinars

Meeting the Challenges in Oversight of Wildlife Research

Date: February 12, 2015
Authors: Robert Sikes, John Bryan

Time: 1-2 Hours

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Innovations B: Innovations in IRB Function
Talks & Presentations

Innovations B: Innovations in IRB Function

Date: November 7, 2017
Speakers: Cheryl A. Savini, CIP; Serah W. Gitome, MB ChB, MPH, CIP; Melissa J. Ricker, MEd; Megan Williams, MPA
Conference: 2017 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

NIH Guidelines for Research involving Recombinant DNA Molecules

Research conducted at or sponsored by an entity receiving support from the National Institutes of Health (NIH) is required to adhere to these guidelines, which outline biosafety and containment measures for recombinant DNA research.

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Webinars

Quality Management Systems

Date: July 16, 2020

Speakers: Catherine Bens; Elaine Kim, BS, CPIA

Description: This webinar will cover concepts, tools, and processes commonly used in a Quality Assurance (QA) or Quality Control (QC) program that can be adapted with a similarly beneficial effect in a high-quality Animal Care and Use Program (ACUP).

Time: 1.25 hours

CE: Webinar participants holding the CPIA credential may apply 1.25 continuing education credit towards recertification

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Scripting the Way for Rodent Procedure Recordkeeping Compliance
Poster Abstracts

Scripting the Way for Rodent Procedure Recordkeeping Compliance

Category: 2015 IACUC Conference

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Webinars

Race-Based Medicine and Race-Based Research: Ethical Considerations for IRBs

Date: February 21, 2019

Authors: Michael Henderson, JD, LLM, MS; Kathleen Reeves, MD; Nicolle Strand, JD, MBioethics

Description: As genomics and personalized medicine advance, there is increased awareness that "race" is an inappropriate proxy for groups that may share a genetic background. However, proposals are still being submitted and approved at institutions across the country that assume that self-reported race correlates with biological/genetic difference. These studies are scientifically out-of-date, as genetic evidence reveals that the difference between races is smaller than differences among individuals of any particular race. Furthermore, such studies, even when conducted with the best intentions, risk perpetuating racist stereotypes, inappropriately influencing clinical medicine, and reinforcing inaccurate ideas about biology and race. Race is a social construct, not a biological.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

This webinar is free to all. Watch it now.

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Postural Movements of Rabbits in Variable Height Caging
Poster Abstracts

Postural Movements of Rabbits in Variable Height Caging

Category: 2015 IACUC Conference

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Historical Documents and Regulations

NIH Policy for Data and Safety Monitoring

Policy developed by NIH for the oversight and monitoring of the conduct of clinical trials in order to ensure participant safety and data integrity.

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Innovations B: Innovations in Respecting Persons
Talks & Presentations

Innovations B: Innovations in Respecting Persons

Date: November 15, 2016
Speakers: Emily E. Anderson, PhD, MPH, Michele Antisdel, MBA, CCRP, CIP, Susan J. Goo, MSN, RN, Jessica Macha, BA, CIP
Conference: 2016 AER Conference

Time: 1-2 Hours

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Innovations C: Innovations in Building Global Infrastructure for Ethical Research
Talks & Presentations

Innovations C: Innovations in Building Global Infrastructure for Ethical Research

Date: November 15, 2016
Speakers: Delia Y. Wolf, MD, JD, MSCI, Megan Kasimatis Singleton, JD, MBE, CIP, Marina Topuridze, MD, MS, Barthalomew Wilson
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Occupational Health and Safety in the Care and Use of Research Animals

Drafted by the National Research Council, this report provides information on ensuring the health and safety of the people who care for animals used in research.

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Post-Approval Monitoring: Making it Stick
Poster Abstracts

Post-Approval Monitoring: Making it Stick

Category: 2015 IACUC Conference

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Webinars

Real-World Approaches to Informed Consent under the Revised Common Rule

Date: October 23, 2019

Authors: Karen Blackwell, MS, CIP; Patrick Herbison, MEd, CIP; Ann Johnson, PhD, MPH

Description: How have we acclimated to the revised Common Rule’s implications for informed consent? Many institutions have incorporated the new requirement for a summary of key information to assist potential research subjects in understanding the reasons why they might or might not want to participate in a study. There is less clarity, however, around other items, including return of research results and future use of identifiable data and biospecimens. In lieu of official guidance, learning from one another is paramount. During this webinar, three panelists will share insights related to their institutional policies and procedures in this area.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Webinars

Reducing Self-Imposed Regulatory Burden in Your Animal Care and Use Program

Date: September 22, 2016
Authors: John Bradfield, Jennifer Perkins
Description: Although stricter and more detailed policies may lead to increased compliance, they may also increase institutional costs without resulting in improved animal welfare. Weighing the costs and benefits of such practices is necessary in order to maintain an efficient and productive animal care and use program.

Time: 1-2 Hours

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Historical Documents and Regulations

OCR 45 CFR 160

Human subjects research conducted in a covered entity must adhere to the federal Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. HIPAA regulations outline how Private Health Information (PHI) may be used by covered entities for research purposes. Detailed answers to commonly asked questions can be found on the OCR website.

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Innovations C: Innovations in Research With Overlooked Ethical Perspectives
Talks & Presentations

Innovations C: Innovations in Research With Overlooked Ethical Perspectives

Date: November 7, 2017
Speakers: Warren Capell, MD; Suzanne Carlberg-Racich, MSPH, PhD; Wendy A. Cook, PhD, MA, RN, CCNS; Carol Juliet Weil, JD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Implementing an Animal Welfare Quality Monitoring Program for Third Parties
Poster Abstracts

Implementing an Animal Welfare Quality Monitoring Program for Third Parties

Category: 2015 IACUC Conference

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Keynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials
Talks & Presentations

Keynote Address: “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials

Date: November 15, 2016
Speakers: Patricia Furlong
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

OCR 45 CFR 162

Human subjects research conducted in a covered entity must adhere to the federal Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. HIPAA regulations outline how Private Health Information (PHI) may be used by covered entities for research purposes. Detailed answers to commonly asked questions can be found on the OCR website.

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Webinars

Research with Aquatic Species: New Strategies to Improve Health and Welfare

Date: December 13, 2017
Authors: Victoria Braithwaite, DPhil
Description: The use of aquatic species is increasing in scientific research fields, and there are unique considerations when using these species. This webinars provides guidance on social housing and environmental enrichment for aquatic animals, as well as methods for minimizing their pain and distress.

Time: 1-2 Hours

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From AAALAC Trends to a Complete Occupational Health and Safety (OH&S) Program
Poster Abstracts

From AAALAC Trends to a Complete Occupational Health and Safety (OH&S) Program

Category: 2015 IACUC Conference

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Evaluation of Electronic Database Solutions for IACUC Operations
Poster Abstracts

Evaluation of Electronic Database Solutions for IACUC Operations

Category: 2015 IACUC Conference

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Webinars

Research with Children and Adolescents in Elementary and Secondary Schools

Date: February 14, 2017
Authors: Shannon Sewards, MA, CIP, Julie Slayton, PhD, JD
Description: Research conducted with students in elementary and secondary school settings presents specific considerations for IRBs and researchers. This webinar will address IRB considerations such as consent, level of risk, and particular challenging scenarios in the classroom.

Time: 1-2 Hours

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Historical Documents and Regulations

OCR 45 CFR 164

Human subjects research conducted in a covered entity must adhere to the federal Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. HIPAA regulations outline how Private Health Information (PHI) may be used by covered entities for research purposes. Detailed answers to commonly asked questions can be found on the OCR website.

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Keynote Address: Gut Microbiota and Reproducibility of Rodent Models of Disease
Talks & Presentations

Keynote Address: Gut Microbiota and Reproducibility of Rodent Models of Disease

Date: March 20, 2017
Speakers: Craig Franklin, DVM, PhD, DACLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Keynote Address: Integrating Systems Biology and Public Health to Implement
Poster Abstracts

Keynote Address: Integrating Systems Biology and Public Health to Implement

Date: March 21, 2017
Speakers: Elaine Faustman, PhD
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Historical Documents and Regulations

PHS 42 CFR 50 and 93

All institutions receiving PHS grants or cooperative agreements are subject to this code of federal regulation which addresses conflicts of financial interests. This regulation, also known as Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, was updated in 2011 and became effective in August 2012.

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Webinars

Responsible Conduct of Research: What IRBs Need to Know

Date: October 25, 2018

Authors: Fariba Houman, PhD, CIP; Julie F. Simpson, PhD

Description: Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. While the US federal mandates concerning the Responsible Conduct of Research (RCR) primarily require institutions to provide training in specific topic areas, the movement to enhance integrity in research has grown worldwide. RCR principles are broad and provide scientists and scholars from every discipline with a framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. What should you, as an IRB professional or IRB member, know about RCR, and how can you recognize and manage RCR issues to enhance and promote ethical research?

Time: 1 hour

CE: Webinar participants holding the CIP credential may apply 1 continuing education credit towards recertification

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Establishing an Agricultural Animal Care and Use Committee: All Hands on Deck!
Poster Abstracts

Establishing an Agricultural Animal Care and Use Committee: All Hands on Deck!

Category: 2015 IACUC Conference

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Current and Prospective Status for Scientific Research on Fish Welfare in Egypt
Poster Abstracts

Current and Prospective Status for Scientific Research on Fish Welfare in Egypt

Category: 2015 IACUC Conference

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Webinars

Return of Individual Research Results: the NASEM Report and the Role of the IRB

Date: October 3, 2018

Authors: Jeffrey Botkin, MD, MPH; Amy McGuire, JD, PhD

Description: Whether and how to return individual research results to subjects has been an ongoing area of uncertainty and controversy for investigators and research institutions. Often, experimental results are not validated, and disclosure could lead to harmful decisions on the part of the subject. Nevertheless, many subjects want and expect to receive their personal results after being involved in clinical research.

Time: 1 hour

CE: Webinar participants holding the CPIA credential may apply 1 continuing education credit towards recertification

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Historical Documents and Regulations

PHS Policy on the Humane Care and Use of Laboratory Animals

Following a legislative mandate in 1985, the policies contained within this document were drafted to ensure the proper care and treatment of animals used in research. PHS-supported activities involving animals are subject to the guidelines put forth by this document.

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Keynote Address: The Challenges of Clinical Trials and Community Trust in the 21st Century
Talks & Presentations

Keynote Address: The Challenges of Clinical Trials and Community Trust in the 21st Century

Date: November 8, 2017
Speakers: Robert A. Winn, MD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Keynote Address: When Human Subjects, Science, and Consumer Rights Collide
Talks & Presentations

Keynote Address: When Human Subjects, Science, and Consumer Rights Collide

Date: November 14, 2016
Speakers: Mary L. Gray, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Policy for Sharing of Data Obtained in NIH Supported Or Conducted Genome-Wide Association Studies

Genome-wide association studies (GWAS) can identify common genetic factors that influence health and disease. In order to facilitate this type of research, NIH outlines data sharing policies for GWAS data.

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Webinars

Studying Effectiveness: Ethical and Regulatory Considerations in Pragmatic Clinical Trials

Date: April 26, 2017
Authors: P. Pearl O’Rourke, MD, Jeremy Sugarman, MD, MPH
Description: Pragmatic clinical trials, which evaluate the effectiveness of interventions under real-life, routine practice conditions, present challenges in research design and raise perhaps more complex issues for IRBs than other kinds of studies. This webinar gives an overview of regulatory and ethical issues associated with these trials, and provides strategies for IRBs to implement.

Time: 1-2 Hours

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Continuing Education for IACUC Members
Poster Abstracts

Continuing Education for IACUC Members

Category: 2015 IACUC Conference

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Association of Primate Veterinarians (APV) Nonhuman Primate (NHP) Housing Survey
Poster Abstracts

Association of Primate Veterinarians (APV) Nonhuman Primate (NHP) Housing Survey

Category: 2015 IACUC Conference

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Webinars

The Future of Internet Research: What We Can Learn from the Facebook Emotional Contagion Study

Date: October 30, 2014
Authors: Elizabeth Buchanan, Mary Gray, Christian Sandvig

Time: 1-2 Hours

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Historical Documents and Regulations

Proceedings of the Symposium on Animal Welfare and Scientific Research: 1985-2010

This supplemental issue of the Institute for Laboratory Animal Research (ILAR) Journal traces the history of animal care from 1985 to 2010 by presenting a series of thought-provoking transcripts from leaders in the field.

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Oversight of Protocols With Aquatics
Talks & Presentations

Oversight of Protocols With Aquatics

Date: April 2, 2016
Speakers: Robert S. Sikes, Terence Bradley, George Sanders, David Parichy
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Panel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?
Talks & Presentations

Panel I: 50 Years After Beecher's Bombshell: Where Are We Now, What Have We Learned?

Date: November 14, 2016
Speakers: Alexander M. Capron, Barbara E. Bierer, Susan E. Lederer, David H. Strauss
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Issued by the Department of Defense (DoD), this document establishes policy and assigns responsibilities for the protection of human subjects in DoD-supported research.

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A Survey of Animal User Training Programs Across Academia, Industry, and Medical Centers
Poster Abstracts

A Survey of Animal User Training Programs Across Academia, Industry, and Medical Centers

Category: 2015 IACUC Conference

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Webinars

Community Engagement in International Research: Considerations for Ethics Review

Date: September 27, 2012

Authors: James Lavery, Katherine King

Description: 

An integral part of the institutional review board (IRB)  formula, the role of community member is also often misunderstood. During this webinar, faculty with a wide spectrum of experience came together to discuss the role, responsibilities, and experiences of community IRB members, with special emphasis made on enhancing community member participation.

Time: 1.5 hours

Read more about this webinar on Ampersand.

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A Global Approach to Building a Positive Reinforcement Training (PRT) Program for Research Animals
Poster Abstracts

A Global Approach to Building a Positive Reinforcement Training (PRT) Program for Research Animals

Category: 2015 IACUC Conference

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Webinars

Anticipate and Communicate for IRBs: Ethical Management of Incidental and Secondary Findings

Date: October 7, 2014
Authors: Elizabeth Pike, Nicolle K. Strand

Time: 1-2 Hours

View a recording of this webinar (FREE!)

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Historical Documents and Regulations

Required Education in the Protection of Human Research Participants

Personnel submitting applications for NIH funding are required to complete education on the protection of human research participants. This notice outlines the policy.

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Panel I: Virtual IACUC: This Meeting Is in Session!
Talks & Presentations

Panel I: Virtual IACUC: This Meeting Is in Session!

Date: March 20, 2018
Speakers: Janet D. Stemwedel, PhD, Valerie K. Bergdall, DVM, DACLAM, Gary L. Borkowski, DVM, MS, DACLAM, Patricia A. Brown, VMD, MS, DACLAM, Christopher Dillon, BA, LATG, CPIA, Robert M. Gibbens, DVM, Samuel K. Kulp, DVM, PhD, Sally E. Light, BA, CPIA, Drusilla D. Qualman, Robert A. Skipper, Jr., PhD
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Panel I: Virtual IACUC: This Meeting Is in Session! (2017)
Talks & Presentations

Panel I: Virtual IACUC: This Meeting Is in Session! (2017)

Date: March 20, 2017
Speakers: Mindy Hollander, MS, CPIA. Robert Barbee, PhD, Joel Brown, PhD, Patricia Brown, VMD, MS, Larry Carbone, DVM, PhD, DACAW, DACLAM, Carol Clarke, DVM, DACLAM, Clarissa Dirks, PhD, Andrew Grady, DVM, MS, DACLAM, Jennifer Perkins, MA, CPIA, Janet Stemwedel, PhD
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Webinars

IRB Administration: Providing Stellar Support to your IRB

Date: September 23, 2014
Authors: Maria Arnold, Megan Kasimatis Singleton

Time: 1-2 Hours

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Historical Documents and Regulations

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

This document from the WHO aims to provide a minimum set of standards for research ethics committees around the world.

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A Collaborative Approach To The Development Of A Chinese Animal Ethics Committee
Poster Abstracts

A Collaborative Approach To The Development Of A Chinese Animal Ethics Committee

Category: 2015 IACUC Conference

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“Readiness Rounds”: Involving the Technical Staff in Post-Approval Monitoring (PAM)
Poster Abstracts

“Readiness Rounds”: Involving the Technical Staff in Post-Approval Monitoring (PAM)

Category: 2015 IACUC Conference

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Historical Documents and Regulations

Syphillis Victims in US Study Went Untreated for 40 Years

In 1972, the story broke that for 40 years, poor, African-American men with syphilis had been followed but left untreated in a US Public Health Service (PHS) Study at Tuskegee, AL. This article, authored by Jean Heller and published in the New York Times, broke the story.

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Panel II - Sovereignty in Research
Talks & Presentations

Panel II - Sovereignty in Research

Date: November 6, 2017
Speakers: Sara Chandros Hull, PhD, Heather L. Larsen, MEd, Terry J. M Powell, Bobby R. Saunkeah, RN, MSHCE, CIP
Conference: 2017 AER Conference

Time: 1-2 Hours

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Webinars

Laboratory Animal Enrichment: Bridging Compliance with Science

Date: September 17, 2014
Authors: Genevieve Andrews-Kelly

Time: 1-2 Hours

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Panel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)
Talks & Presentations

Panel II: Empirical Research About Attitudes on the Ethics of Research on Medical Practices (ROMP)

Date: November 14, 2016
Speakers: Jeremy Sugarman, MD, MPH, MA, Leonard Glantz, JD, Steven Joffe, MD, MPH, Kevin P. Weinfurt, PhD, Benjamin S. Wilfond, MD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

The Advisory Committee on Human Radiation Experiments: Reflections on a Presidential Commission

The first reports of federally funded human radiation experiments in the US emerged in the late 1970s and early 1980s. It was not until 1994 that the Advisory Committee on Human Radiation Experiments was established and the reports were explored. In this piece, Chair, Ruth Faden, PhD, MPH, reflects on the committee’s work.

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Webinars

Reviewing Student Research: Best Practices and Future Directions

Date: July 10, 2014
Authors: Amy King, J. Michael Oakes

Time: 1-2 Hours

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Developing Elements of an Effective Safety Compliance Program by Collaboration of the IACUC and the
Poster Abstracts

Developing Elements of an Effective Safety Compliance Program by Collaboration of the IACUC and the Office for Research Safety

Category: 2018 IACUC Conference

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Webinars

Complex Protocols: Digging Deeper to Better Protect Human Subjects

Date: June 24, 2014
Authors: Lori Roesch

Time: 1-2 Hours

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Proactive Versus Reactive Post-Approval Monitoring: Effective Strategies Towards Fostering a Culture
Poster Abstracts

Proactive Versus Reactive Post-Approval Monitoring: Effective Strategies Towards Fostering a Culture of Compliance

Category: 2018 IACUC Conference

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Historical Documents and Regulations

The Belmont Report

This document, drafted in 1979, identified the basic ethical principles that underlie the conduct of research involving human subjects. It serves as the ethical foundation for the current US regulations governing human subjects research.

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Panel II: Options/Opportunities to Address Regulatory/Administrative Burden
Talks & Presentations

Panel II: Options/Opportunities to Address Regulatory/Administrative Burden

Date: March 21, 2018
Speakers: B. Taylor Bennett, DVM, PhD, DACLAM, DACAW, Patricia A. Brown, VMD, MS, DACLAM, Joseph R. Haywood, PhD, Sally Thompson-Iritani, DVM, PhD, CPIA
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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Panel II: Overcome the Fear: The Life Changing Magic of Tidying Up Your Animal Care and Use Program
Talks & Presentations

Panel II: Overcome the Fear: The Life Changing Magic of Tidying Up Your Animal Care and Use Program

Date: March 21, 2017
Speakers: Sally Thompson-Iritani, DVM, PhD, CPIA, Joel Brown, PhD, William Greer, BS, CPIA, LAT, Mindy Hollander, MS, CPIA
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Historical Documents and Regulations

The Ethics of Research Involving Animals

From the Nuffield Council on Bioethics, this 2005 report reviews and analyzes the ethical issues associated with the use of research involving animals in the United Kingdom.

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Preparation of the Veterinary Clinical Trial IACUC Protocol
Poster Abstracts

Preparation of the Veterinary Clinical Trial IACUC Protocol

Category: 2018 IACUC Conference

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Webinars

Working Through Conflict: Helping IRB Staff Communicate More Effectively with Investigators

Date: May 22, 2014
Authors: Helen Panageas and Suzanne Rivera

Time: 1-2 Hours

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A Day at the PUB: The University of Washington’s Solution to IACUC Policy Bloat
Poster Abstracts

A Day at the PUB: The University of Washington’s Solution to IACUC Policy Bloat

Category: 2018 IACUC Conference

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Historical Documents and Regulations

The Ethics of Research Related to Healthcare in Developing Countries

This report from the Nuffield Council on Bioethics addresses the ethical questions and the risk of exploitation when research is conducted in developing countries.

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Panel II: Oversight of Protocols With Aquatics
Talks & Presentations

Panel II: Oversight of Protocols With Aquatics

Date: April 2, 2016
Speakers: Robert S. Sikes, PhD, Terence Bradley, PhD, David M. Parichy, PhD, George E. Sanders, DVM, MS, Certified Fish Pathologist (AFS/FHS)
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Webinars

Making Your Alternatives Searches More Valuable

Date: May 15, 2014
Authors: Tim Allen and Joanne Zurlo

Time: 1-2 Hours

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Panel III: The Research Community’s Roles and Responsibilities in Outreach and Advocacy: How Can the
Talks & Presentations

Panel III: The Research Community’s Roles and Responsibilities in Outreach and Advocacy: How Can the IACUC Contribute to Public Understanding?

Date: March 21, 2018
Speakers: Jennifer A. Perkins, MA, CPIA, Matthew R. Bailey, Allyson J. Bennett, PhD, Ken Gordon
Conference: 2018 IACUC Conference

Time: 1-2 Hours

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The Role of Bioethics in the Pharmaceutical Industry: Informal Review of Five-Year Trends and One Co
Poster Abstracts

The Role of Bioethics in the Pharmaceutical Industry: Informal Review of Five-Year Trends and One Company’s Systematic Approach

Category: 2015 AER Conference

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Historical Documents and Regulations

The Lost Pets That Stray to the Labs

In 1965 this story, about Pepper the Dalmatian was featured in Sports Illustrated. The story, which attracted a great deal of attention, was one of two cited as igniting the public outcry that resulted in the Animal Welfare Act in 1966.

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Webinars

Central IRBs: Models, Logistics, and Implications

Date: April 15, 2014
Authors: Emily Chi Fogler, Elizabeth Hohmann, P. Pearl O'Rourke

Time: 1-2 Hours

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Historical Documents and Regulations

The Nuremberg Code

Developed after the Nuremberg Trials, during which Nazi physicians were prosecuted for conducting medical experiments on prisoners during World War II, this is the first code to set forth ethical principles for research with human subjects.

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Throwing the Baby Out With the Bathwater and Other Changes Made to Improve Office Operations: Succes
Poster Abstracts

Throwing the Baby Out With the Bathwater and Other Changes Made to Improve Office Operations: Successes and Missteps

Category: 2015 AER Conference

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Webinars

Practicing Good Science Through Ethical Study Design

Date: March 19, 2014
Authors: Susan S. Fish

Time: 1-2 Hours

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Panel III: The Three Rs: Putting the Principles Into Practice
Poster Abstracts

Panel III: The Three Rs: Putting the Principles Into Practice

Date: March 21, 2017
Speakers: B. Bennett, DVM, PhD, DACLAM, DACAW, Christopher Dillon, BA, LATG, CPIA, Jennie Lofgren, DVM, MS, DACLAM, Letty Medina, DVM, DACLAM
Conference: 2017 IACUC Conference

Time: 1-2 Hours

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Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?
Talks & Presentations

Panel III: Research With Children and Adolescents: Who and How Is the Decision Made to Participate?

Date: November 14, 2016
Speakers: Susan Z. Kornetsky, Janet L. Brody, Celia B. Fisher, Eric Kodish
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

The Willowbrook Hepatitis Studies Revisited: Ethical Aspects

The Willowbrook State School was a school for students with intellectual disabilities. Beginning in 1955, institutionalized students were intentionally infected with live hepatitis virus in order for researchers to work on finding a vaccine. In this article, one of the original researchers, Saul Krugman, reflects on the study.

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Transcending Turnover by Standardizing Staff Training
Poster Abstracts

Transcending Turnover by Standardizing Staff Training

Category: 2015 AER Conference

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Webinars

Best Practices for Assessing Risk in Social and Behavioral Research

Date: February 12, 2014
Authors: Jeffrey Cohen

Time: 1-2 Hours

Read more about this webinar on Ampersand.

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Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience
Poster Abstracts

Transformation to an All-Videoconference Flexible IRB Model: One Institution’s Experience

Category: 2015 AER Conference

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Historical Documents and Regulations

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Drafted by an interagency panel, this document comprises the official human research ethics policy of the federal funding agencies in Canada.

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Panel III: Virtual IACUC: This Meeting Is in Session! (2016)
Talks & Presentations

Panel III: Virtual IACUC: This Meeting Is in Session! (2016)

Date: April 2, 2016
Speakers: Mary Jo Shepherd, DVM, CPIA, John F. Bradfield, PhD, DVM, DACLAM, Patricia A. Brown, VMD, MS, DACLAM, Andrew Burich, DVM, MS, DACLAM, CPIA, Carol Clarke, DVM, DACLAM, Alan B. Ekstrand, BS, CPIA, RLATG, Cynthia C. Goodwin, Norman J. Kleiman, PhD, Kari Lyn Koszdin, DVM, MS, Dipl. ACLAM, CPIA CPIA
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Webinars

Investigator-Initiated Device Studies: How IRBs Can Help Researchers Work with the FDA

Date: January 30, 2014
Authors: Owen Faris, Soma Kalb, Matthew Wladkowski

Time: 1-2 Hours

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Panel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research
Talks & Presentations

Panel IV: Echoes of Tuskegee in 2016? African Americans and Participation in Research

Date: November 15, 2016
Speakers: Owen Garrick, MD, MBA, Jonca C. Bull, MD, Coleman K. Obasaju, MD, PhD, Vickie M. Mays IV, PhD, MSPH
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

Update on the Requirement for Instruction in the Responisble Conduct of Research

This notice released by NIH serves to update the agency’s policy on the responsible conduct of research, offer guidance on best practices, and provide additional information in order to foster adherence to the policies set forth.

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Webinars

AVMA Guidelines for the Euthanasia of Animals: Key Changes in 2013

Date: November 12, 2013
Authors: Samuel Cartner, Michael Huerkamp

Time: 1-2 Hours

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Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Re
Poster Abstracts

Using In-Person Express Reviews to Accelerate Exempt Determinations and Foster Collaboration with Researchers

Category: 2015 AER Conference

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Violations Submissions via Protocol Information Management System-Phase II
Poster Abstracts

Violations Submissions via Protocol Information Management System-Phase II

Category: 2015 AER Conference

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Historical Documents and Regulations

US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

These nine principles, drafted by Interagency Research Animal Committee in 1985, are the foundation for the human care and use of laboratory animals in the United States.

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Webinars

Protecting Human Subjects in Qualitative Research

Date: October 24, 2013
Authors: Julie Simpson

Time: 1-2 Hours

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Panel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Fund
Talks & Presentations

Panel IX: Can't Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle With Participant Funding and Influence

Date: November 16, 2016
Speakers: Melissa E. Abraham, PhD, MS, Elizabeth L. Hohmann, MD, Glenn O'Neill, Govind Persad, JD, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Panel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?
Talks & Presentations

Panel V: Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?

Date: November 15, 2016
Speakers: P. Pearl O’Rourke, Ysabel Duron, Nancy E. Kass
Conference: 2016 AER Conference

Time: 1-2 Hours

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Historical Documents and Regulations

USDA Research Facility Inspection Guide

The reference document used by USDA inspectors to ensure that all policies are met.

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Webinars

Doing More with Less: Best IRB Practices for Institutions with Small Research Programs

Date: September 18, 2013
Authors: Scott Lipkin, Lori Roesch

Time: 1-2 Hours

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Welcome to the Electronic Age: Successes and Challenges of Implementing an eIACUC System
Poster Abstracts

Welcome to the Electronic Age: Successes and Challenges of Implementing an eIACUC System

Category: 2018 IACUC Conference

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 Independent Work and Critical Thinking: Effective Approaches of Training Husbandry Technicians for
Poster Abstracts

Independent Work and Critical Thinking: Effective Approaches of Training Husbandry Technicians for Proficiency and Consistency Screen reader support enabled.

Category: 2018 IACUC Conference

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Webinars

Overcoming Obstacles to Research with Pregnant Women

Date: June 19, 2013
Authors: Maggie Little, Katherine Wisner

Time: 1-2 Hours

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Historical Documents and Regulations

Use of Animals in Department of Defense Programs

This directive applies to all research conducted within DoD organizational entities.

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Panel VI - When Citizens Do Science: The Democratization of Research
Talks & Presentations

Panel VI - When Citizens Do Science: The Democratization of Research

Date: November 7, 2017
Speakers: P. Pearl O'Rourke, MD; Jamie Holloway, PhD; Sally Okun, RN, BSN, MMHS; Alicia Zhou, PhD
Conference: 2017 AER Conference

Time: 1-2 Hours

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Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent E
Talks & Presentations

Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist

Date: November 15, 2016
Speakers: Christine Grady, RN, PhD, Michelle H. Biros, MD, Neal Dickert Jr., MD, PhD, Robert Silbergleit, MD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Webinars

Convergence of Biomedical and Social/Behavioral Research: Implications for IRBs and Investigators

Date: June 11, 2013
Authors: Monika Markowitz, J. Michael Oakes

Time: 1-2 Hours

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Developing IACUC Expectations for the Evaluation of Challenging Experimental Housing Conditions Via
Poster Abstracts

Developing IACUC Expectations for the Evaluation of Challenging Experimental Housing Conditions Via a Working Group

Category: 2018 IACUC Conference

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Historical Documents and Regulations

World Medical Association Declaration of Helsinki

Originally developed primarily for physicians, the Declaration of Helsinki has influenced the conduct of research ethics throughout the world.

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Webinars

Career Paths: Advancing in Animal Care and Use Professions

Date: May 16, 2013
Authors: Michael Fallon, Bruce Kennedy, Natalie Mays

Time: 1-2 Hours

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Panel VII - Race Matters: Ethical Challenges for the Use of Racial Categories in Research
Talks & Presentations

Panel VII - Race Matters: Ethical Challenges for the Use of Racial Categories in Research

Date: November 8, 2017
Speakers: John J. Whyte, MD, MPH; Albert J. Allen, MD, PhD; Khiara M. Bridges, JD, PhD; Owen Garrick, MD, MBA
Conference: 2017 AER Conference

Time: 1-2 Hours

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New Design: Dr. Abdel-Baset Aref and Dr. Hoda Saady Research Center For Academic Biological Experime
Poster Abstracts

New Design: Dr. Abdel-Baset Aref and Dr. Hoda Saady Research Center For Academic Biological Experiments Achieves Three Rs: Reduction, Replacement, and Refinement of Experimental Animals

Category: 2017 IACUC Conference

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Panel VII: Amplifying the Challenges: Return of Results in Pediatric Research
Talks & Presentations

Panel VII: Amplifying the Challenges: Return of Results in Pediatric Research

Date: November 16, 2016
Speakers: Albert J. Allen, Celia B. Fisher, David G. Forster, Jill McNair
Conference: 2016 AER Conference

Time: 1-2 Hours

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Webinars

Career Paths: Advancing in IRB Administration

Date: May 9, 2013
Authors: Eric Allen, Claire Dunne, Melissa Epstein

Time: 1-2 Hours

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Creation of a Risk Assessment and Operational Procedures Matrix for the Use of Hazardous Animal Prot
Poster Abstracts

Creation of a Risk Assessment and Operational Procedures Matrix for the Use of Hazardous Animal Protocol Related Chemicals in the Animal Facility

Category: 2017 IACUC Conference

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Webinars

QA/QI: Study Review from Conception to Completion

Date: April 25, 2013
Authors: Kristen Burt, Eunice Yim Newbert

Time: 1-2 Hours

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Panel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan
Talks & Presentations

Panel VIII: Beyond Vulnerability, Toward Inclusion: Comparable Access for Women Across the Lifespan

Date: November 16, 2016
Speakers: Laura Odwazny, JD, MA, Christine Grady, RN, PhD, Anne Drapkin Lyerly, MD, MA, Robert M. Nelson, MD, PhD
Conference: 2016 AER Conference

Time: 1-2 Hours

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Optimization of the Animal Protocol Form: Utilizing Model Specific Questions
Poster Abstracts

Optimization of the Animal Protocol Form: Utilizing Model Specific Questions

Category: 2017 IACUC Conference

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Webinars

Online Research, Social Media, and the IRB: Assessing Ethics, Norms, and Risk

Date: March 12, 2013
Authors: Elizabeth Buchanan, Joseph Konstan

Time: 1-2 Hours

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Patients with Lethal Diseases: Experiments in Research Design
Talks & Presentations

Patients with Lethal Diseases: Experiments in Research Design

Date: November 12, 2015
Speakers: Alexander Capron, Jeffrey Clark, Richard Penson
Conference: AER15 Conference

Time: 1-2 Hours

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Streamlining the Amendment Review Process: Separate Forms for Administrative Amendments
Poster Abstracts

Streamlining the Amendment Review Process: Separate Forms for Administrative Amendments

Category: 2017 IACUC Conference

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Webinars

PRIM&R's Primer on the HIPAA/HITECH Act Omnibus Final Rule

Date: March 4, 2013
Authors: Emily Chi Fogler, Jennifer Geetter

Time: 1-2 Hours

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Picked Out of a Crowd: Privacy and Re-Identification Research
Talks & Presentations

Picked Out of a Crowd: Privacy and Re-Identification Research

Date: November 13, 2015
Speakers: Laura Odwazny, Jim Adler, Madeleine Price Ball, Michelle Meyer
Conference: AER15 Conference

Time: 1-2 Hours

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Developing an Ergonomic Safety Risk Assessment and Identification Program for Workplace Injury in an
Poster Abstracts

Developing an Ergonomic Safety Risk Assessment and Identification Program for Workplace Injury in an Animal Care Organization

Category: 2017 IACUC Conference

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Developing and Retaining Professional IACUC Staff
Poster Abstracts

Developing and Retaining Professional IACUC Staff

Category: 2017 IACUC Conference

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Webinars

Key Decision Points: Is it Research Involving Human Subjects? Is it Exempt? Is IRB Review Required?

Date: February 28, 2013
Authors: Karen Hale, Daniel Nelson

Time: 1-2 Hours

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Primate Social Intelligence
Talks & Presentations

Primate Social Intelligence

Date: March 20, 2015
Speakers: Frans de Waal
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Structuring Your IACUC for Efficiency and to Facilitate Research
Talks & Presentations

Structuring Your IACUC for Efficiency and to Facilitate Research

Date: March 19, 2015
Speakers: Melinda Hollander, Valerie Bergdall, Sally Light, Leo Otterbein
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Webinars

Ethics, Scientific Merit Review, and Harm-Benefit Analysis in Animal Research

Date: January 30, 2013
Authors: Jerry Collins, Ernest Prentice

Time: 1-2 Hours

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 A Survey of Institutional Post-Approval Monitoring Programs Screen reader support enabled.
Poster Abstracts

A Survey of Institutional Post-Approval Monitoring Programs Screen reader support enabled.

Category: 2017 IACUC Conference

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All In: A Revolution From a Fully Paper-Based IACUC and Animal Care and Use Program to a 100% Electr
Poster Abstracts

All In: A Revolution From a Fully Paper-Based IACUC and Animal Care and Use Program to a 100% Electronic System: From Protocol Review to Animal Procurement, Census, and Billing

Category: 2017 IACUC Conference

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Studies of Animals When They Are the Targeted Beneficiaries
Talks & Presentations

Studies of Animals When They Are the Targeted Beneficiaries

Date: March 19, 2015
Speakers: Robert Sikes, Jeremy Coleman, David Skelly, Darin Carroll
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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Webinars

Including Children in Research: Stakeholder Perspectives, Ethical Challenges, and IRB Strategies

Date: November 13, 2012
Authors: Victoria Pemberton, Yoram Unguru

Time: 1-2 Hours

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Libraries and the IACUC: Benefits and Characteristics of Successful Relationships
Poster Abstracts

Libraries and the IACUC: Benefits and Characteristics of Successful Relationships

Category: 2017 IACUC Conference

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The Challenges of Research on Campus Sexual Violence: Ethical, Scientific, and Political Dimensions
Talks & Presentations

The Challenges of Research on Campus Sexual Violence: Ethical, Scientific, and Political Dimensions

Date: November 12, 2015
Speakers: Claude Ann Mellins, Elizabeth Armstrong, Shamus Khan, Sharyn Potter
Conference: AER15 Conference

Time: 1-2 Hours

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Webinars

The IRB’s Role in Achieving Diversity in Research

Date: November 10, 2020

Speakers: Barbara E. Bierer, MD; David H. Strauss, MD; Sarah White, MPH

Description: The lack of appropriate representation in subject populations is a long-standing challenge for clinical research. The IRB plays a central role in considering and promoting diversity and inclusion in human subjects research. This webinar will review the rationale for improving diversity and inclusion in clinical studies and will discuss how the IRB can promote diversity during routine reviews of clinical research protocols. Case examples and practical resources will be presented.

Time: 1.5 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Webinars

Update from the Department of Justice

Date: October 25, 2012
Authors: Patrick Clark, Cheryl Crawford Watson

Time: 1-2 Hours

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Reducing Regulatory Burden: Running Delegated Member Review
Poster Abstracts

Reducing Regulatory Burden: Running Delegated Member Review

Category: 2017 IACUC Conference

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Virtual IACUC: This Meeting Is in Session!
Talks & Presentations

Virtual IACUC: This Meeting Is in Session!

Date: April 2, 2016
Speakers: Mary Jo Shepherd, Carol Clarke, Patricia Brown, John Bradfield, Kari Koszdin, Andrew Burich, Norman Kleiman, Cindy Goodwin, Alan Ekstrand
Conference: 2016 IACUC Conference

Time: 1-2 Hours

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Reducing Regulatory Burden: Protocol Form Focus on Deviations from Standards
Poster Abstracts

Reducing Regulatory Burden: Protocol Form Focus on Deviations from Standards

Category: 2017 IACUC Conference

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 Henry Spira Memorial Lecture: Improving the Treatment of Animals: A Practical Perspective
Talks & Presentations

Henry Spira Memorial Lecture: Improving the Treatment of Animals: A Practical Perspective

Date: March 30, 2009
Speakers: Temple Grandin
Conference: 2009 IACUC Conference

Time: 1-2 Hours

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Webinars

Research Involving "Edge" Populations: Ethical and Regulatory Considerations

Date: October 18, 2012

Authors: Cynthia Gómez, Julia Gorey

Description: There are many ethical considerations for research studies involving “edge” populations, and this program will provide an investigator perspective as well as the regulatory angle on research with subjects who are homeless, substance abusers, and/or HIV-positive. Cynthia Gómez, PhD, discussed a multi-site study with HIV-positive participants and the work of the research team to ensure protection and sensitivity to issues, while the second half of the presentation featured Julia Gorey, JD, with the regulatory perspective on research involving “edge” populations.

Time: 1.5 hours

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Webinars

The IACUC's Role in Environmental Enrichment Programs

Date: October 9, 2012
Authors: Jennifer Camacho, Christina Winnicker

Time: 1-2 Hours

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The Launch: Getting
Poster Abstracts

The Launch: Getting "Lean" to Streamline Animal Use Protocol Review

Category: 2017 IACUC Conference

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Virtual IACUC: This Meeting Is in Session! (2015)
Talks & Presentations

Virtual IACUC: This Meeting Is in Session! (2015)

Date: March 20, 2015
Speakers: Mary Jo Shepherd, Patricia Brown, Carol Clarke, Michael Huerkamp, Natalie Mays, Tammy Dellovade, Leo Otterbein, Janet Stemwedel, John Bradfield
Conference: 2015 IACUC Conference

Time: 1-2 Hours

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When the Lines are Blurred Between SBER and Biomedical Research: Challenges for SBER IRBs
Talks & Presentations

When the Lines are Blurred Between SBER and Biomedical Research: Challenges for SBER IRBs

Date: November 13, 2015
Speakers: Celia Fisher, Melissa Abraham, Michele Kuchera, Elena Leonidovna Grigorenko
Conference: AER15 Conference

Time: 1-2 Hours

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Webinars

Research Ethics Beyond Respect, Beneficence and Justice

Date: September 12, 2012

Authors: Elisa A. Hurley, PhD

Description: Most human research protections professionals are familiar with the ethical principles of respect, beneficence, and justice as laid out in the Belmont Report and as codified in the US federal regulations governing research with human subjects. However, the domain of research ethics encompasses much more than these three principles, and engaging directly with the other important concepts can help research ethics professionals better understand and more thoughtfully fulfill their roles. This webinar looked beyond the Belmont principles to explore some of the additional ethical questions and concepts that come into play during the protocol review process, but are not well delineated or defined in the regulations.

Time: 1 hour

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Novel Strategies to Manage Departures from the Guide
Poster Abstracts

Novel Strategies to Manage Departures from the Guide

Category: 2017 IACUC Conference

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Mechanism for Reporting Adverse Events and Serious Adverse Events
Poster Abstracts

Mechanism for Reporting Adverse Events and Serious Adverse Events

Category: 2017 IACUC Conference

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Webinars

Conflicts of Interest in the Wake of NIH's New Policy

Date: July 11, 2012
Authors: Jeffrey Botkin, Ross McKinney

Time: 1-2 Hours

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Founding the Future
Poster Abstracts

Founding the Future

Category: 2017 IACUC Conference

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Webinars

Introduction to Adaptive Clinical Trial Designs

Date: June 20, 2012
Authors: Roger Lewis, William Meurer

Time: 1-2 Hours

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Characterization of a Behavioral Assay to Assess the Affective State of Mice
Poster Abstracts

Characterization of a Behavioral Assay to Assess the Affective State of Mice

Category: 2017 IACUC Conference

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Webinars

Data Sharing in Genomics Research: Participant Attitudes and Ethical Issues

Date: May 24, 2012
Authors: Laura Lyman Rodriguez, Amy McGuire

Time: 1-2 Hours

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Evaluation of Rat Well-Being During Euthanasia
Poster Abstracts

Evaluation of Rat Well-Being During Euthanasia

Category: 2017 IACUC Conference

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Webinars

Ethical Internet Research: Informed Consent Regulations and Realities

Date: March 15, 2012
Authors: Elizabeth Buchanan, Laura Odwazny

Time: 1-2 Hours

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Post-Approval Monitoring: The Binding Material for the Three Legged Stool of Animal Welfare, and the
Poster Abstracts

Post-Approval Monitoring: The Binding Material for the Three Legged Stool of Animal Welfare, and the Vehicle for Exchanging Knowledge Between Researchers

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Webinars

Using Policies and Guidances to Manage Your Animal Care and Use Program

Date: February 16, 2012
Authors: Deb Frolicher, Natalie Mays

Time: 1-2 Hours

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Evaluation of Essential Personnel on Their Knowledge and Awareness of the IACUC Emergency Disaster P
Poster Abstracts

Evaluation of Essential Personnel on Their Knowledge and Awareness of the IACUC Emergency Disaster Plan

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Webinars

A Roadmap to Success for New IRB Chairs

Date: January 26, 2012
Authors: Melissa Lewis, Melissa Frumin

Time: 1-2 Hours

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Establishing an IACUC Grant-Protocol Congruency Review Team
Poster Abstracts

Establishing an IACUC Grant-Protocol Congruency Review Team

Category: 2017 IACUC Conference

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Webinars

Post-Approval Monitoring: From Primer to Production

Date: November 15, 2011
Authors: David Cannon, Jaimie Graff

Time: 1-2 Hours

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Start-up Meetings Improve Safety and Fulfill Training Expectations
Poster Abstracts

Start-up Meetings Improve Safety and Fulfill Training Expectations

Category: 2017 IACUC Conference

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Webinars

Wearing Multiple Hats in your Research Compliance Program

Date: May 15, 2019

Authors: Ross Hickey, JD, CIP, CPIA, Katie L. Gillespie, MS, CIP

Description: Research compliance professionals often “wear multiple hats”, responsible for oversight of some combination of IACUC, IRB, IBC, Responsible Conduct of Research (RCR), and Conflict of Interest (COI) at their institution. Particularly at small or under-resourced institutions, those involved in multiple areas of compliance know that time and funds are precious. How can you make the most of what you have, avoid reinventing the wheel, and achieve balance in your work? This interactive webinar provided a space for attendees to learn and share strategies with others who are in the same boat.

Time: 1.25 hours

CE: Webinar participants holding the CIP or CPIA credential may apply 1.25 continuing education credits towards recertification

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Webinars

Soldiers as Subjects: What IRBs and DOD-Funded Investigators Need to Know about Research with Military Personnel

Date: December 5, 2019

Authors: Amy Adler, PhD; Carson Cancel, MA, CIP; Natalie Klein, PhD, CIP; Kimberly Odam, MS, CIP; Susan Proctor, DSc

Description: The imperative to advance the health and performance of service members must be fulfilled through ethical and compliant human subjects research. During this webinar, speakers from the Department of Defense (DOD) will introduce key regulatory requirements, specific population considerations, and best practices for including service members in research. Investigators will learn how to plan for successful research in this domain, and IRBs will gain an understanding of how to assess service member-centric protocols.

Time: 1.25 hours

CE: Webinar participants holding the CIP credential may apply 1.25 continuing education credits towards recertification

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Development and Implementation of an Overcrowding Policy for Rodents
Poster Abstracts

Development and Implementation of an Overcrowding Policy for Rodents

Category: 2017 IACUC Conference

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Promotion of Alternatives and the Three Rs: An Animal Health Industry Perspective
Poster Abstracts

Promotion of Alternatives and the Three Rs: An Animal Health Industry Perspective

Category: 2017 IACUC Conference

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Webinars

When SBER Involves Drugs and Devices: Cases to Clarify FDA Oversight

Date: September 20, 2018

Authors: Patrick McNeilly, PhD Robin Tyndall

Description: Increasingly, social, behavioral, and educational research (SBER) incorporates techniques and devices that are more traditionally found in biomedical research, creating challenges for IRBs in determining whether a study falls under US Food and Drug Administration (FDA) oversight. The FDA’s authority includes drugs, biologics, and medical devices. FDA oversight may also extend to mobile medical applications and other innovations, which can create challenging regulatory questions as to whether a study falls under FDA jurisdiction.

Time: 1.5 hours

CE: Webinar participants holding the CIP credential may apply 1.5 continuing education credits towards recertification

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Webinars

When The Stakes Are High: Managing Communication and Public Opinion in Research Settings

Date: October 18, 2011
Authors: Suzanne Rivera, Michael Stebbins

Time: 1-2 Hours

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IACUC Site Visit 101: An Institution's Inside Journey to Create Tools and Training for Better IACUC
Poster Abstracts

IACUC Site Visit 101: An Institution's Inside Journey to Create Tools and Training for Better IACUC Semi-Annual Facility Inspections

Category: 2017 IACUC Conference

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Cultivating a Successful Partnership Between Institutions and Central IRBs
Poster Abstracts

Cultivating a Successful Partnership Between Institutions and Central IRBs

Category: 2017 AER Conference

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Webinars

Improving Informed Consent: Innovations in Form and Process

Date: September 22, 2011
Authors: Margo Michaels, Heather Pierce

Time: 1-2 Hours

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Webinars

PRIM&R's Primer on the ANPRM

Date: July 28, 2011
Authors: P. Pearl O'Rouke

Time: 1-2 Hours

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Animal Research Coordinator Certification: How Disseminating Knowledge Increases Compliance and Effi
Poster Abstracts

Animal Research Coordinator Certification: How Disseminating Knowledge Increases Compliance and Efficiency in an Animal Welfare Program

Category: 2017 IACUC Conference

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Webinars

Community IRB Members: Supporting Their Involvement to Advance Research

Date: July 12, 2011
Authors: Malena Avila Hough, David Strauss

Time: 1-2 Hours

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Progress Under the Animal Welfare Act in Humane Animal Care from 1966 to the Present
Poster Abstracts

Progress Under the Animal Welfare Act in Humane Animal Care from 1966 to the Present

Category: 2017 IACUC Conference

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Design and Development of an IACUC
Poster Abstracts

Design and Development of an IACUC

Category: 2017 IACUC Conference

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Webinars

DHHS and FDA Regulations: What’s Different, What’s Similar, and What Does it all Mean for my HRPP?

Date: June 29, 2011
Authors: Lisa Buchanan, Richard Klein

Time: 1-2 Hours

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Inconsistencies Among IRBs’/Ethics Committees’ Approvals When Determining the Risk-Benefit Category
Poster Abstracts

Inconsistencies Among IRBs’/Ethics Committees’ Approvals When Determining the Risk-Benefit Category for Research with Children

Category: 2017 AER Conference

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Webinars

No More Excuses: Building Trust and Capacity through the Bioethics Research Infrastructure Initiative

Date: June 14, 2011

Authors: Stephen Thomas, Sandra Crouse Quinn

Description: This is the third webinar in a three-part series that sought to facilitate the development and presentation of educational programs that improve research literacy for and respectful engagement with minority communities.

Time: 1.5 hours

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Insider Experiences: United States Military Service Members as Participants in Health Research
Poster Abstracts

Insider Experiences: United States Military Service Members as Participants in Health Research

Category: 2017 AER Conference

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Webinars

Preparing for the CIP® Certification Exam: What You Need to Know

Date: May 25, 2011
Authors: Jaime Arango, Susan Delano

Time: 1-2 Hours

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The Consent Paradox: the 2018 Common Rule Revisions Leave HIPAA-Covered Researchers in the Dark
Poster Abstracts

The Consent Paradox: the 2018 Common Rule Revisions Leave HIPAA-Covered Researchers in the Dark

Category: 2017 AER Conference

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Webinars

Preparing for the CPIA® Certification Exam: What You Need to Know

Date: May 18, 2011
Authors: Jamie Gothro, Mary Jo Shepherd

Time: 1-2 Hours

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Electronic Consent: Pros, Cons and Cautions
Poster Abstracts

Electronic Consent: Pros, Cons and Cautions

Category: 2017 AER Conference

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Webinars

Lessons from Researchers: Best Practices for Respectful Engagement with Minority Communities

Date: March 2, 2011

Authors: Stephen Thomas, Sandra Crouse Quinn

Description: The result of a partnership with the Building Trust between Minorities and Researchers Initiative at the University of Maryland Center for Health Equity, this webinar sought to improve research literacy for and respectful engagement with minority communities by presenting the findings from an in-depth and unique survey and interviews of researchers, research staff, and IRB members. Topics included researchers' attitudes toward community engagement, challenges in building community partnerships, best practices for community partnerships, the impact of community engagement on recruitment and retention, and much more.

Time: 1.5 hours

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Webinars

International Research: Applying Ethical Principles and Research Guidelines in Global Settings

Date: February 16, 2011
Authors: David Borasky, Nancy Kass

Time: 1-2 Hours

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Risk-Benefit Analysis Under the 2016 Council for International Organizations of Medical Sciences (CI
Poster Abstracts

Risk-Benefit Analysis Under the 2016 Council for International Organizations of Medical Sciences (CIOMS) Guidelines

Category: 2017 AER Conference

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Webinars

Practical Strategies for Common Challenges: What Your IACUC Needs to Know

Date: February 3, 2011
Authors: John Bradfield, Beth Ford

Time: 1-2 Hours

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Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov
Poster Abstracts

Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov

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Conducting Science in Disasters: Recommendations from the NIH/National Institute of Environmental He
Poster Abstracts

Conducting Science in Disasters: Recommendations from the NIH/National Institute of Environmental Health Sciences Working Group for Special IRB Considerations in the Review of Disaster Related Researc

Category: 2017 AER Conference

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Webinars

Top Tips for IRBs in 2011

Date: January 18, 2011
Authors: Jeffrey Cooper, Susan Ellenberg

Time: 1-2 Hours

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IRB Restructuring and Researcher Satisfaction
Poster Abstracts

IRB Restructuring and Researcher Satisfaction

Category: 2017 AER Conference

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Webinars

Genetic Research: Benefits, Risks, and Ethical Issues

Date: October 26, 2010
Authors: Ingrid Holm, Lisa Lehmann

Time: 1-2 Hours

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Webinars

The Guatemalan Inoculation Study: Susan M. Reverby on Research Ethics and Lessons for HRPPs

Date: October 20, 2010
Authors: Susan Reverby

Time: 1-2 Hours

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Utilizing Peer Review for Quality Improvement and Training in Research
Poster Abstracts

Utilizing Peer Review for Quality Improvement and Training in Research

Category: 2017 AER Conference

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IRB Assessment of Internal Auditing Reports
Poster Abstracts

IRB Assessment of Internal Auditing Reports

Category: 2017 AER Conference

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Webinars

Conflicting Interest and Conflicting Expectations: Challenges Presented by NIH's New Rule

Date: October 6, 2010
Authors: Heather Pierce, Patrick Taylor

Time: 1-2 Hours

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Creating a Post-approval Monitoring (PAM) Checklist for Social-behavioral Researchers
Poster Abstracts

Creating a Post-approval Monitoring (PAM) Checklist for Social-behavioral Researchers

Category: 2017 AER Conference

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Webinars

Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices

Date: September 15, 2010
Authors: George Gasparis, Richard Klein

Time: 1-2 Hours

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Webinars

Distrust, Race, and Research: Overcoming Barriers to Recruitment and Retention of Minority Populations

Date: July 14, 2010

Authors: Stephen Thomas, Sandra Crouse Quinn

Description: This webinar addressed concrete objectives for RCR education under the guidance of two distinguished ethicists from Vanderbilt University and Saint Louis University. The faculty explored results from a consensus panel funded by the Office of Research Integrity, which identified nine objectives for RCR education.

Time: 1.5 hours

This webinar is free to all. Watch it now.

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Decreasing Participating Site Time-to-Activation on Investigator-Initiated Multicenter Studies
Poster Abstracts

Decreasing Participating Site Time-to-Activation on Investigator-Initiated Multicenter Studies

Category: 2017 AER Conference

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Understanding How to “Walk the Line”: A Novel Survey of Institutional Human Subject Compliance Progr
Poster Abstracts

Understanding How to “Walk the Line”: A Novel Survey of Institutional Human Subject Compliance Programs (CPs) and Determinations of Serious and Continuing Noncompliance

Category: 2017 AER Conference

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Webinars

Promoting Science and Safety: NIH Oversight of Human Gene Transfer Research

Date: June 16, 2010
Authors: Marcia Finucane, Allan Shipp

Time: 1-2 Hours

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Webinars

Speaking Confidence: A PRIM&R Toolbox

Date: May 26, 2010
Authors: Melissa Lewis, Gigi McMillan

Time: 1-2 Hours

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Transitioning to In-House Reviewers for Expedited IRB Submissions
Poster Abstracts

Transitioning to In-House Reviewers for Expedited IRB Submissions

Category: 2017 AER Conference

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Webinars

The Havasupai Settlement: Implications for HRPPs, IRBs, and Researchers

Date: May 20, 2010

Authors: William Freeman, P. Pearl O'Rourke

Description: The Havasupai Settlement left many IRB and HRPP members, as well as researchers, wondering how this significant decision would affect human subjects research. Discussion in this webinar sought to shed light on  questions raised about informed consent and the implications of this striking new precedent. 

Time: 1 hour

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Analysis of the Present Recognition Toward Central IRB System in Japanese Medical Schools
Poster Abstracts

Analysis of the Present Recognition Toward Central IRB System in Japanese Medical Schools

Category: 2017 AER Conference

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Webinars

Legal Issues for HRPPs: Investigator-Initiated Research and HITECH Privacy Requirements

Date: April 28, 2010
Authors: Susan Stayn, Mark Barnes

Time: 1-2 Hours

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Innovations to Promote Longevity and Ongoing Development of IRB Staff
Poster Abstracts

Innovations to Promote Longevity and Ongoing Development of IRB Staff

Category: 2017 AER Conference

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UP AND RUNNING: IRB Submission Assistance Program – Centralized Application Support for Investigator
Poster Abstracts

UP AND RUNNING: IRB Submission Assistance Program – Centralized Application Support for Investigators in Need

Category: 2017 AER Conference

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Webinars

Educating for the Responsible Conduct of Research: Strategies for Research Institutions

Date: April 8, 2010
Authors: Elizabeth Heitman, James DuBois

Time: 1-2 Hours

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Webinars

Top Tips for IACUCs: Perspectives on Animal Care

Date: February 9, 2010
Authors: Patricia Brown, Monte Matthews

Time: 1-2 Hours

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The Collaborative Academic IRB
Poster Abstracts

The Collaborative Academic IRB

Category: 2017 AER Conference

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Characterization of Biomedical IRB Effort for Reportable New Information within a Large Academic Med
Poster Abstracts

Characterization of Biomedical IRB Effort for Reportable New Information within a Large Academic Medical Center

Category: 2017 AER Conference

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Webinars

Who "Moved" My Approval? Managing Suspended Research

Date: January 28, 2010
Authors: Michele Russell-Einhorn, Don Workman

Time: 1-2 Hours

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Clinical Coordination Center and Academic Central IRB: The Central IRB Liaison Team -- The Tie That
Poster Abstracts

Clinical Coordination Center and Academic Central IRB: The Central IRB Liaison Team -- The Tie That Binds Them

Category: 2017 AER Conference

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Webinars

Strategies for Institutional Officials: Addressing Conflicts of Interest and Quality Control

Date: April 30, 2009
Authors: Suzanne Rivera, David Wynes

Time: 1-2 Hours

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Standardizing the Meeting Minutes Developing and Review Process
Poster Abstracts

Standardizing the Meeting Minutes Developing and Review Process

Category: 2017 AER Conference

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Webinars

If It's Not Broken, Improve It: New Strategies in Laboratory Animal Care

Date: June 4, 2009
Authors: Donna Matthews Jarrell, Steve Niemi

Time: 1-2 Hours

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User Attitudes Towards Implementation of a Commercial Electronic Review System at a Naval Medical Ce
Poster Abstracts

User Attitudes Towards Implementation of a Commercial Electronic Review System at a Naval Medical Center

Category: 2017 AER Conference

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Webinars

New Solutions to Ongoing Problems When Reviewing Social, Behavioral, and Educational Research

Date: February 25, 2009
Authors: Mary Marshall Clark, J. Michael Oakes

Time: 1-2 Hours

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Webinars

Tools and Tips to Ensure Your IACUC's Success

Date: February 10, 2009
Authors: Chris Newcomer, Lauretta Gerrity

Time: 1-2 Hours

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Negotiating Change: A Qualitative Analysis of Meeting Discussions during the Implementation of an El
Poster Abstracts

Negotiating Change: A Qualitative Analysis of Meeting Discussions during the Implementation of an Electronic IRB Work Management System

Category: 2017 AER Conference

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Webinars

Refocusing on Crucial Issues for IRBs

Date: January 29, 2009
Authors: Bruce Gordon, Moira Keane

Time: 1-2 Hours

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Using Lean Methodology to Improve the Implementation of a Web-Based IRB Submission System
Poster Abstracts

Using Lean Methodology to Improve the Implementation of a Web-Based IRB Submission System

Category: 2017 AER Conference

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Using Reliable Methods and Simple Rules to Encourage Consistency in IRB Review
Poster Abstracts

Using Reliable Methods and Simple Rules to Encourage Consistency in IRB Review

Category: 2017 AER Conference

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Webinars

Implementing Best Practices in the Evolving World of IACUCs

Date: October 21, 2008
Authors: Monte Matthews, John Miller

Time: 1-2 Hours

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Using Advanced Statistics to More Accurately Predict IRB Outcomes
Poster Abstracts

Using Advanced Statistics to More Accurately Predict IRB Outcomes

Category: 2017 AER Conference

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Webinars

The NIH Genome Wide Association Studies (GWAS) Policy: Responsibilities of Investigators and IRBs

Date: September 23, 2008
Authors: P. Pearl O'Rouke, Laura Lyman Rodriguez

Time: 1-2 Hours

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Webinars

Handling Incidental Findings in Human Subjects Research

Date: July 15, 2008
Authors: Michelle Mello, Benjamin Wilfond

Time: 1-2 Hours

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The Heat of Summer: Managing Visiting Summer Student Researchers
Poster Abstracts

The Heat of Summer: Managing Visiting Summer Student Researchers

Category: 2017 AER Conference

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Webinars

Hot Topics for IRBs/HRPPs

Date: April 16, 2008
Authors: Mark Barnes, Jeffrey Cohen

Time: 1-2 Hours

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From Zero to Phase I – Blast Off!
Poster Abstracts

From Zero to Phase I – Blast Off!

Category: 2017 AER Conference

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Webinars

Recruiting, Educating, and Retaining Non-Affiliated IRB Members

Date: September 18, 2006
Authors: Moira Keane, Gigi McMillan, Bernard Schwetz, Mary Lou Smith

Time: 1-2 Hours

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Use of Statistical Reviewers on an IRB
Poster Abstracts

Use of Statistical Reviewers on an IRB

Category: 2017 AER Conference

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Integration of Department of Veterans Affairs (VA) Medical Facilities into the Stroke Trial Network
Poster Abstracts

Integration of Department of Veterans Affairs (VA) Medical Facilities into the Stroke Trial Network (NIH StrokeNet)

Category: 2017 AER Conference

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Webinars

Building a Relationship with your Research Integrity Office

Date: March 17, 2016
Authors: Ross Hickey
Description: IRBs and RIOs play distinct but related roles in research oversight and compliance. This webinar discusses best practices for effective communication among IRBs, RIOs, and their respective staff and members.

Time: 1-2 Hours

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Building an Effective, Collaborative, and Accountable Human Research Protection Program
Poster Abstracts

Building an Effective, Collaborative, and Accountable Human Research Protection Program

Category: 2017 AER Conference

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Webinars

Big Data Research: Practical Solutions to Emerging Challenges for IRBs

Date: February 10, 2016
Authors: Betsy Draper, Sean Owen
Description: "Big data" has great potential for scientific advances in both biomedical and social, behavioral, and education research (SBER), and in recent years, institutional review boards (IRBs) have seen an influx of research involving large data sets. As our society as a whole and the research community continue to produce and utilize large data sets, IRBs need to know how to best protect human subjects when reviewing a protocol that involves big data.

Time: 1-2 Hours

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Webinars

Reducing Noncompliance While Facilitating Research: Strategies for IACUCs

Date: January 24, 2017
Authors: Barbara Garibaldi, DVM, DACLAM; Emily Hearne, MS
Description: Noncompliance in animal research is defined as any action that does not adhere to federal regulations and policy, an institutional policy, or the approved protocol. Fostering a culture of compliance is essential to ensuring animal welfare, institutional credibility, and positive working relationships between researchers and the IACUC.

Time: 1-2 Hours

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The Professionalization of IRB Staff Members
Poster Abstracts

The Professionalization of IRB Staff Members

Category: 2017 AER Conference

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Webinars

PRIM&R’s Primer on the Revised Common Rule

Date: January 26, 2017
Authors: P. Pearl O'Rourke, Heather Pierce
Description: On January 19, 2017, the Office of the Federal Register published a revised Federal Policy for the Protection of Human Subjects, marking the first significant changes to the Federal Policy for the Protection of Human Subjects, or "Common Rule," since 1991.
These changes will have important and wide-reaching implications for the human subjects research enterprise. This webinar provides an overview of the critical changes presented in the Rule as well as an explanation of the rulemaking process and the various possible outcomes.

Time: 1-2 Hours

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Joint Ethics Review of a Clinical Trial in Sudan: Experiences and a Way Forward
Poster Abstracts

Joint Ethics Review of a Clinical Trial in Sudan: Experiences and a Way Forward

Category: 2017 AER Conference

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Webinars

New Ethical Challenges in Experimental Political Science

Date: June 8, 2016
Authors: Scott Desposato, Trisha Phillips
Description: Over the past two decades, political scientists have adopted experimental methods to interact directly with subjects in the United States and globally. How can IRBs guide political scientists in conducting ethically sound research while continuing to generate valuable knowledge about the political, economic, and cultural sphere?

Time: 1-2 Hours

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Smart Checklists in the Boston Medical Center and Boston University Medical Campus Electronic System
Poster Abstracts

Smart Checklists in the Boston Medical Center and Boston University Medical Campus Electronic System

Category: 2017 AER Conference

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Webinars

Making Good Meetings Happen for IACUCs and IRBs

Date: May 24, 2016
Authors: Melissa Frumin, Rachel Murray
Description: Once you’ve learned the regulatory and operational requirements, how do you best facilitate a lively, efficient meeting? From managing conflict and keeping time, to encouraging member participation, administrators and chairs confront many interpersonal and organizational challenges during IACUC and IRB meetings. 

Time: 1-2 Hours

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Establishing a Single IRB Team
Poster Abstracts

Establishing a Single IRB Team

Category: 2017 AER Conference

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Webinars

Identify, Recruit, Train, Retain: Building a Diverse, Qualified IRB

Date: February 24, 2016

Authors: Courtney Jarboe, Ann Morrison

Description: IRBs should be diverse, skilled, knowledgeable, and committed to the common goal of protecting human subjects. During this advanced-level webinar, presenters provided approaches for strategically identifying, recruiting, training, and retaining IRB members to create a healthy and qualified board.

Time: 1.5 hours

CE: Webinar participants holding the CIP credential may apply 1.5 continuing education credits towards recertification

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Building Capacity by Engaging Chief Residents and Fellows as Committee Members
Poster Abstracts

Building Capacity by Engaging Chief Residents and Fellows as Committee Members

Category: 2017 AER Conference

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Webinars

Grant and Protocol Congruency for IACUCs

Date: January 13, 2016
Authors: Patricia A. Brown and Richelle Scales
Description: It is an institution's responsibility to ensure that the research described in a grant application is congruent with any corresponding protocols approved by the institutional animal care and use committee (IACUC). IACUC administrators and other institution staff are tasked with ensuring approved animal research protocols are in agreement with the grants that sponsor them. During this basic-level webinar, presenters will discuss considerations for congruency reviews from the perspectives of the Office of Laboratory Animal Welfare and an IACUC protocol analyst.

Time: 1-2 Hours

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Implementing a Central IRB at an Academic Medical Center: Lessons Learned
Poster Abstracts

Implementing a Central IRB at an Academic Medical Center: Lessons Learned

Category: 2017 AER Conference

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Webinars

Familiar Faces: Addressing the Challenge of Simultaneous and Sequential Study Enrollment

Date: April 13, 2016
Authors: Stephanie Collins Reed, Ilene Wilets
Description: Seeing a familiar face at a study site is not uncommon in research. Learning to weigh the risks associated with simultaneous and sequential study enrollment enables IRBs and researchers to make informed decisions to prevent and manage problems.

Time: 1-2 Hours

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Ch...Ch...Changes and Their Management: Creating a Process to Improve Outcomes
Poster Abstracts

Ch...Ch...Changes and Their Management: Creating a Process to Improve Outcomes

Category: 2017 AER Conference

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A Conscientious Consenting Process for Research in Drug-Using Populations
Poster Abstracts

A Conscientious Consenting Process for Research in Drug-Using Populations

Category: 2017 AER Conference

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Webinars

Data Sharing in Research with American Indians and Alaska Natives: Informed Practices, Considerations, and Case Studies

Date: October 26, 2017
Authors: Deana Around Him, Marcia O'Leary, Lizabeth Malone, Amy Elliott, Jyoti Angal
Description: It is critical that researchers rely on informed practices when developing data sharing arrangements with tribes, and that IRBs and funding agencies are aware of these practices and the unique considerations that must be given to this type of research.

Time: 1-2 Hours

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FDA and IRB Approval of a Novel Prehospital Consent Process for Emergency Research
Poster Abstracts

FDA and IRB Approval of a Novel Prehospital Consent Process for Emergency Research

Category: 2017 AER Conference

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Webinars

Incorporating Active Learning into IACUC Training

Date: May 3, 2017
Authors: Alison Pohl, Trina Smith
Description: Active learning approaches have been shown to enhance knowledge transfer and increase the effectiveness of adult education by emphasizing critical thinking, analytical skills, and hands-on learning. During this webinar, two IACUC professionals discuss how active learning techniques have shaped their own training programs.

Time: 1-2 Hours

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Webinars

Top Tips for 2008: What Every IACUC Should Know

Date: February 7, 2008
Authors: Molly Greene, Marky Pitts, Mary Lou James, Monte Matthews

Time: 1-2 Hours

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Understandable to the Subject' -- Plain Language IRB Informed Consents for Research
Poster Abstracts

Understandable to the Subject' -- Plain Language IRB Informed Consents for Research

Category: 2017 AER Conference

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Webinars

The Top 7 Tips for 2007: What Every IRB Should Know

Date: January 17, 2007
Authors: Mark Barnes, Jeffrey Cohen

Time: 1-2 Hours

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Informed Consent Process when Conducting Genomic Research in Populations Characterized to Have Low L
Poster Abstracts

Informed Consent Process when Conducting Genomic Research in Populations Characterized to Have Low Literacy Levels

Category: 2017 AER Conference

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Webinars

Identifying and Preventing Distress in Laboratory Animals

Date: October 1, 2015
Authors: Mollie A. Bloomsmith and Eric Hutchinson
Description: Is your institution equipped to diagnose and prevent distress in the animals used for research purposes?
Stress and distress can negatively impact the welfare of laboratory animals and have adverse consequences for research. Minimizing distress in animals is mandated by federal regulations and remains an ethical obligation for research and compliance staff. To take measures to minimize distress, it is essential to understand its causes and manifestations among the various species of laboratory animals. Planning to reduce or prevent distress should be included in the initial design and review of research projects.

Time: 1-2 Hours

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Creation of Transnational Collaboration to Strengthen Ethics Review of Human Subject Research
Poster Abstracts

Creation of Transnational Collaboration to Strengthen Ethics Review of Human Subject Research

Category: 2017 AER Conference

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Webinars

Tools, Templates, and Checklists for Streamlining IRB Protocol Review

Date: May 5, 2016
Authors: Sharon Freitag, Megan Kasimatis Singleton
Description: Using examples from typically challenging areas of protocol review, the presenters will demonstrate how to identify, develop, and successfully implement targeted tools, templates, and checklists.

Time: 1-2 Hours

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Pregnant Women & the Zika Virus Vaccine Research Agenda: Recommendations for Ethical Priorities and
Poster Abstracts

Pregnant Women & the Zika Virus Vaccine Research Agenda: Recommendations for Ethical Priorities and Pathways

Category: 2017 AER Conference

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Risk and Surrogate Benefit for Pediatric Phase 1 Trials in Oncology: A Systematic Review with Meta-A
Poster Abstracts

Risk and Surrogate Benefit for Pediatric Phase 1 Trials in Oncology: A Systematic Review with Meta-Analysis

Category: 2017 AER Conference

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Webinars

Responding to Noncompliance in Human Subjects Research

Date: October 31, 2016
Authors: James DuBois, Jessica Randall
Description: Noncompliance involves the failure to act in accordance with federal regulations, state and local laws, institutional policies, or IRB requirements in human subjects research. This webinar examines empirical evidence on factors that contribute to investigator noncompliance and offer recommendations for addressing it.

Time: 1-2 Hours

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Scientific Misconduct as Injury: Employing Public Health Tools
Poster Abstracts

Scientific Misconduct as Injury: Employing Public Health Tools

Category: 2017 AER Conference

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Webinars

IRB Review of Human Gene Transfer Protocols: New Guidelines and Considerations

Date: October 19, 2016
Authors: Charlotte Coley, Joan Robbins
Description: NIH guidelines released in 2016 detail a new system in which IRBs are responsible for assessing whether review by the Recombinant DNA Advisory Committee (RAC) is warranted in Human Gene Transfer (HGT) studies. With the IRB’s role in this research increasing, how can the efficient and timely review of HGT studies be facilitated while continuing to protect human subjects?

Time: 1-2 Hours

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 Women’s Views about Rules Governing Reproductive Issues in the Context of Biomedical Clinical Trial
Poster Abstracts

Women’s Views about Rules Governing Reproductive Issues in the Context of Biomedical Clinical Trials

Category: 2017 AER Conference

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Redefining Minimal Risk Standards
Poster Abstracts

Redefining Minimal Risk Standards

Category: 2017 AER Conference

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From Belmont (1979) to Helsinki (2013). A New Perspective on Vulnerability in Council for Internatio
Poster Abstracts

From Belmont (1979) to Helsinki (2013). A New Perspective on Vulnerability in Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Re

Category: 2017 AER Conference

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Controlling Privacy Risk in Database Studies for Human Subject Protection (HSP) via a Privacy Budget
Poster Abstracts

Controlling Privacy Risk in Database Studies for Human Subject Protection (HSP) via a Privacy Budgeting System

Category: 2017 AER Conference

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Understanding the Full Continuum of Identifiable to De-identifiable Data in the World of Big Data to
Poster Abstracts

Understanding the Full Continuum of Identifiable to De-identifiable Data in the World of Big Data to Minimize Privacy Risk in Database Studies

Category: 2017 AER Conference

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Recognizing Dignity Harms as Legitimate Risks Warranting Integration Into Research Practice
Poster Abstracts

Recognizing Dignity Harms as Legitimate Risks Warranting Integration Into Research Practice

Category: 2017 AER Conference

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Agency in Photovoice Research: Exploring the Lived Experience of Persons who Inject Drugs (PWIDs)
Poster Abstracts

Agency in Photovoice Research: Exploring the Lived Experience of Persons who Inject Drugs (PWIDs)

Category: 2017 AER Conference

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Pregnancy Prevention in Clinical Trials (Steps Toward Increasing Adherence to Birth Control Requirem
Poster Abstracts

Pregnancy Prevention in Clinical Trials (Steps Toward Increasing Adherence to Birth Control Requirements in Study Enrollees)

Category: 2017 AER Conference

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 New IRB Member Training and On-boarding Program
Poster Abstracts

New IRB Member Training and On-boarding Program

Category: 2017 AER Conference

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Improving IRB Application Success through a Learning Management System
Poster Abstracts

Improving IRB Application Success through a Learning Management System

Category: 2017 AER Conference

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Dedicated IRB Educator Impact on Researcher Satisfaction
Poster Abstracts

Dedicated IRB Educator Impact on Researcher Satisfaction

Category: 2017 AER Conference

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Training Needs Assessment of Research Ethics Committees in a Low-income Country
Poster Abstracts

Training Needs Assessment of Research Ethics Committees in a Low-income Country

Category: 2017 AER Conference

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Quality Assurance without Carrots or Sticks: Using Feedback Loops for Good Clinical Practice Audits
Poster Abstracts

Quality Assurance without Carrots or Sticks: Using Feedback Loops for Good Clinical Practice Audits

Category: 2017 AER Conference

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Face-to-Face Education is Coming: The Downfall of a Web-Based Training Program
Poster Abstracts

Face-to-Face Education is Coming: The Downfall of a Web-Based Training Program

Category: 2017 AER Conference

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Improving Quality through Comprehensive IRB Staff Training for Taking IRB Meeting Minutes
Poster Abstracts

Improving Quality through Comprehensive IRB Staff Training for Taking IRB Meeting Minutes

Category: 2017 AER Conference

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Improving HRPP Assessment of Community Outreach Activities
Poster Abstracts

Improving HRPP Assessment of Community Outreach Activities

Category: 2017 AER Conference

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Knowledge is Power: Developing a Suite of Educational Materials for Research Participants
Poster Abstracts

Knowledge is Power: Developing a Suite of Educational Materials for Research Participants

Category: 2017 AER Conference

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Re-Engaging Ethics: Development of Stakeholder-Driven Recommendations for the Ethical Review and Con
Talks & Presentations

Re-Engaging Ethics: Development of Stakeholder-Driven Recommendations for the Ethical Review and Conduct of Engaged Scholarship

Category: 2017 AER Conference

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Multi-Site Survey of Cancer Patients Who Donated Excess Surgical Tissue for Broad Future Research Us
Poster Abstracts

Multi-Site Survey of Cancer Patients Who Donated Excess Surgical Tissue for Broad Future Research Uses

Category: 2017 AER Conference

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The Million Veteran Program: Enhancing and Expanding Recruitment for a Representative Cohort
Poster Abstracts

The Million Veteran Program: Enhancing and Expanding Recruitment for a Representative Cohort

Category: 2017 AER Conference

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Before the Subjects Arrive: Advanced Planning of Critical Human Subjects Protections with Researcher
Poster Abstracts

Before the Subjects Arrive: Advanced Planning of Critical Human Subjects Protections with Researchers

Authors: Katherine W. Todman, LCSW-C; Carol J. Squires, LCSW; Mary Ellen Cadman, RN, MSN, LCSW-C; Julie Brintnall-Karabelas, LCSW-C; and Maryland Pao, MD
National Institute of Mental Health
Programmatic Submission
Category: 2016 AER Conference

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Development of Vulnerable Population Checklist as an Alarm System in Changhua Christian Hospital, Ta
Poster Abstracts

Development of Vulnerable Population Checklist as an Alarm System in Changhua Christian Hospital, Taiwan

Authors: Shu-Yu Chen; Ying-Ming Chiu; Sock-Ping Ng; Chin-San Liu; and Shou-Jen Kuo
Changhua Christian Hospital, Taiwan
Programmatic Submission
Category: 2016 AER Conference

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Parental Opinion About Pediatric Biospecimen Permission
Poster Abstracts

Parental Opinion About Pediatric Biospecimen Permission

Authors: Francis J. DiMario, Jr., MA, MD, CIP, University of Connecticut School of Medicine, Connecticut Children's Medical Center; Julia M. Vresilovic, BS, Trinity College
Scientific Submission
Category: 2016 AER Conference

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United States Military Service Members' Reasons for Deciding to Participate in Health Research
Poster Abstracts

United States Military Service Members' Reasons for Deciding to Participate in Health Research

Authors: Wendy A. Cook, PhD, MA, RN, CCNS, Naval Medical Center San Diego, University of Washington; Kristal C. Melvin, PhD, NP-C, Brooke Army Medical Center; Ardith Z. Doorenbos, PhD, RN, FAAN, University of Washington
Scientific Submission
Category: 2016 AER Conference

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Approaches and Challenges of Research Ethics Policy Development in the Country of Georgia
Poster Abstracts

Approaches and Challenges of Research Ethics Policy Development in the Country of Georgia

Authors: Marina Topuridze, MD, MS Epidemiology, National Center for Disease Control and Public Health, Georgia; Ketevan Shermadini, MD, Infectious Diseases, AIDS, and Clinical Immunology Research Center, Georgia; Givi Javashvili, MD, PhD, The National Council on Bioethics of Georgia; Andrei Fomenco, MD, Legal Medicine State Service of the Republic of Belarus; Sean Philpott-Jones, PhD, MSB, Clarkson University
Programmatic Submission
Category: 2016 AER Conference

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Challenges and Barriers in the Research Ethics Committee System and Regulations in the Country of Ge
Poster Abstracts

Challenges and Barriers in the Research Ethics Committee System and Regulations in the Country of Georgia

Authors: Ketevan Shermadini, MD, Infectious Diseases, AIDS, and Clinical Immunology Research Center, Georgia; Marina Topuridze, MD, MS Epidemiology, National Center for Disease Control and Public Health, Georgia; Givi Javashvili, MD, PhD, The National Council on Bioethics of Georgia; Andrei Famenka, MD, MS, Legal Medicine State Service of the Republic of Belarus; Martin A. Strosberg, MA, MPH, PhD, Union College; Sean Philpott-Jones, PhD, MSB, Clarkson University
Scientific Submission
Category: 2016 AER Conference

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Mobilizing the Troops: A Model for Preparing Investigators and the IRB for Research Supported by the
Poster Abstracts

Mobilizing the Troops: A Model for Preparing Investigators and the IRB for Research Supported by the DOD

Authors: Elizabeth Jach, MA; Therese Barenz, CCRC, CIP; Patricia Katopol, PhD; Michele Countryman, CIP; and Laura Dallas, CIP
University of Iowa
Programmatic Submission
Category: 2016 AER Conference

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Breaking it Off: Ending IRB Oversight When Applications and Proposals Lack Definite Plans for Involv
Poster Abstracts

Breaking it Off: Ending IRB Oversight When Applications and Proposals Lack Definite Plans for Involvement of Human Subjects

Authors: Allison Blodgett, PhD, CIP, University of Massachusetts Medical School; Michael Centola, MHS, CIP, New England Independent Review Board; Sharon Wang, CIP, CIM, University of Massachusetts Medical School
Programmatic Submission
Category: 2016 AER Conference

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Content Analysis of Free Newspaper Clinical Trial Advertisements
Poster Abstracts

Content Analysis of Free Newspaper Clinical Trial Advertisements

Authors: Cristóbal S. Berry-Cabán, PhD and Cheri L. Portee, BSN, Womack Army Medical Center; Sara Boltinhouse, BSCR; Devan Conley, BSCR; and Kaylyn Thompson, BSCR, Campbell University College of Pharmacy and Health Sciences
Scientific Submission
Category: 2016 AER Conference

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An Example of Interinstitutional Cooperation Through the Network of Research Ethics Committees in Ca
Poster Abstracts

An Example of Interinstitutional Cooperation Through the Network of Research Ethics Committees in Cali, Colombia

Authors: Paula Albarello, BS, MBA, Centro Médico Imbanaco de Cali South America; Jackeline Bravo Chamorro, RN, Centro Internacional de Entrenamiento e Investigaciones Médicas
Programmatic Submission
Category: 2016 AER Conference

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Understanding Ethical Oversight Perceptions of a Predominately Undergraduate University Research Com
Poster Abstracts

Understanding Ethical Oversight Perceptions of a Predominately Undergraduate University Research Community

Authors: James K. Vance; and Elizabeth A. Buchanan, PhD
University of Wisconsin-Stout
Programmatic Submission
Category: 2016 AER Conference

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Human Subject Research Regulatory Compliance Programs: Structures, Responsibilities, Processes, and
Poster Abstracts

Human Subject Research Regulatory Compliance Programs: Structures, Responsibilities, Processes, and Determinations of Serious/Continuing Noncompliance

Authors: Madelon Baranoski, PhD; Jessica Randall, MA, CIP; and Jeri Barney, JD, MS, CIP
Yale University
Scientific Submission
Category: 2016 AER Conference

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Clinical Trials Integrity from the Research Directorate Perspective
Poster Abstracts

Clinical Trials Integrity from the Research Directorate Perspective

Author: Tam Nguyen, PhD, MBA
St. Vincent's Hospital Melbourne, Australia
Programmatic Submission
Category: 2016 AER Conference

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Conducting a QA/QI Program Risk Assessment
Poster Abstracts

Conducting a QA/QI Program Risk Assessment

Authors: Julie Moore, JD, MS, PA; and Wendy Duncan, RN, BS
University of South Florida
Programmatic Submission
Category: 2016 AER Conference

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Aligning Processes and Procedures: Lessons Learned from the Implementation of a QA/QI Database
Poster Abstracts

Aligning Processes and Procedures: Lessons Learned from the Implementation of a QA/QI Database

Authors: Michele Gomez, BA, CIP and Sarah A. White, MPH, CIP, Partners Healthcare System, Inc.; Sana Khoury-Shakour, PhD, CCRP and Terry M. VandenBosch, PhD, RN, CIP, CCRP, University of Michigan; Avery Avrakotos, MPH Candidate, University of Michigan School of Public Health
Programmatic Submission
Category: 2016 AER Conference

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Using Metrics to Perform Risk-Based Assessments of HRPPs
Poster Abstracts

Using Metrics to Perform Risk-Based Assessments of HRPPs

Authors: Monique Hawkins, BA, CIP, Office of Naval Research; COL Molly Klote, MD, Army Human Research Protections Office
Programmatic Submission
Category: 2016 AER Conference

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IRB QI Initiative: Creating a Self-Certification Tool for QI and Program Evaluation Activities
Poster Abstracts

IRB QI Initiative: Creating a Self-Certification Tool for QI and Program Evaluation Activities

Authors: Gretchen Anding, MA and Nichelle Cobb, PhD, University of Wisconsin-Madison; D. Paul Moberg, PhD, University of Wisconsin-Madison
Programmatic Submission
Category: 2016 AER Conference

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Use of Lean Methodologies to Streamline the Continuing Review Process at a Large Academic Medical Ce
Poster Abstracts

Use of Lean Methodologies to Streamline the Continuing Review Process at a Large Academic Medical Center

Authors: Liz Tioupine, CIP; and Christopher M. Ryan, PhD
University of California, San Francisco
Programmatic Submission
Category: 2016 AER Conference

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Development of a Specialized IRB for Genetics and Genomics Research
Poster Abstracts

Development of a Specialized IRB for Genetics and Genomics Research

Authors: Brenda Ruotolo; Alan Teller; Deirdre Lombardi; and Michael Rossano
Columbia University
Programmatic Submission
Category: 2016 AER Conference

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Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium
Poster Abstracts

Use of a Single, Independent IRB: Case Study of an NIH Funded Consortium

Author: Brandy Stoffel, JD, LLM, CIP
University of Wisconsin-Madison
Programmatic Submission
Category: 2016 AER Conference

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Use of IRB Reliance in Multi-Site Studies: An Evaluation of Contributing Factors
Poster Abstracts

Use of IRB Reliance in Multi-Site Studies: An Evaluation of Contributing Factors

Authors: Todd Rice; Emily Sheffer; Jull Pulley; Terri Edwards; Julie Ozier, MHL, CIP; and Gordon Bernard Vanderbilt University Medical Center
Scientific Submission
Category: 2016 AER Conference

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Limiting Pre-Meeting Stipulations Improves Overall Time to Approval
Poster Abstracts

Limiting Pre-Meeting Stipulations Improves Overall Time to Approval

Author: Kate Nolan, MPH, CIP; Ann Lazar, PhD, MS; and Christopher M. Ryan, PhD
University of California, San Francisco
Programmatic Submission
Category: 2016 AER Conference

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Implementation of Internal Audit to Monitor the Quality of Review in Changhua Christian Hospital, Ta
Poster Abstracts

Implementation of Internal Audit to Monitor the Quality of Review in Changhua Christian Hospital, Taiwan

Authors: Sock-Ping Ng; Kun-Tu Yeh; Chin-San Liu; and Shou-Jen Kuo
Changhua Christian Hospital, Taiwan
Programmatic Submission
Category: 2016 AER Conference

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Risk-Based Review of Ethics Applications: A Service Framework to Meet Increasing Demand
Poster Abstracts

Risk-Based Review of Ethics Applications: A Service Framework to Meet Increasing Demand

Authors: Kim Madison, BA (Psych Hons), DipEd, MAppSocRes, Assoc MAPS; and Rick Williams, B.Comm, M.TechMgt
Griffith University, Australia
Programmatic Submission
Category: 2016 AER Conference

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When Does QI Need IRB Review and Approval?
Poster Abstracts

When Does QI Need IRB Review and Approval?

Category: 2015 AER Conference

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Working Meetings with IRB Chairs: An Opportunity Not to Be Missed
Poster Abstracts

Working Meetings with IRB Chairs: An Opportunity Not to Be Missed

Authors: Judith Birk, JD; and Claudia Krcmarik, BS
University of Michigan Medical School
Programmatic Submission
Category: 2016 AER Conference

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Breaking Apart Institutional Review and IRB Review
Poster Abstracts

Breaking Apart Institutional Review and IRB Review

Authors: Hallie Kassan; Cerdi Beltre; and Cynthia Hahn
Northwell Health
Programmatic Submission
Category: 2016 AER Conference

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Integration of an Electronic External Interest Review Process into the HRPP Review Process
Poster Abstracts

Integration of an Electronic External Interest Review Process into the HRPP Review Process

Authors: Hallie Kassan; Emmelyn Kim; Scott Beardsley; and Gerry Kassoff
Northwell Health
Programmatic Submission
Category: 2016 AER Conference

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Implementing Flexibility and Being Flexible
Poster Abstracts

Implementing Flexibility and Being Flexible

Authors: Alexis Clasca, CIP; and Carmen Lam, CIP
University of California, Berkeley
Programmatic Submission
Category: 2016 AER Conference

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Improving IRB Efficiency Using Logic Models for Non-Traditional IRB Determinations
Poster Abstracts

Improving IRB Efficiency Using Logic Models for Non-Traditional IRB Determinations

Author: Adriana Brigatti, JD, MPH, LLM, CIP
Children's National Medical Center
Programmatic Submission
Category: 2016 AER Conference

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The National Approach: A Model of Single Ethical Review in the Australian Public Health System
Poster Abstracts

The National Approach: A Model of Single Ethical Review in the Australian Public Health System

Authors: Pamela Blaikie, PhD, St. Vincent's Hospital Sydney, Australia; Tam Nguyen, PhD, MBA, St. Vincent's Hospital Melbourne, Australia
Programmatic Submission
Category: 2016 AER Conference

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Establishing a Central IRB for a Large, Multi-Site Network
Poster Abstracts

Establishing a Central IRB for a Large, Multi-Site Network

Author: Kathleen A. Seabolt, CIM, CIC
Phoenix Children's Hospital
Scientific Submission
Category: 2016 AER Conference

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Restructure of Regulatory Analyst Roles to Promote Professional Development and Advancement
Poster Abstracts

Restructure of Regulatory Analyst Roles to Promote Professional Development and Advancement

Authors: Judith Birk, JD; Diana Miller, MS; and S. Joseph Austin, JD, LLM
University of Michigan Medical School
Programmatic Submission
Category: 2016 AER Conference

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Assent: How Young is Too Young? A Physician's Perspective
Poster Abstracts

Assent: How Young is Too Young? A Physician's Perspective

Authors: Rebecca Abel, MA, CIP and Julie Ozier, MHL, CIP, Vanderbilt University Medical Center; Cathryn Oldmixon, RN; and Nancy Ringwood, RN, CCRA, Massachusetts General Hospital
Programmatic Submission
Category: 2016 AER Conference

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Broad Consent Template for Prospective Permission from Vulnerable Populations for the Storage and Us
Poster Abstracts

Broad Consent Template for Prospective Permission from Vulnerable Populations for the Storage and Usage of Samples in Future Unspecified Research

Authors: Alberto (Betto) A. Ortiz-Osorno, MS, PMP, CIPM; and Linda A. Ehler, RN, MN
Protection of Participants, Evaluation, and Policy Branch, Division of AIDS, NIH, HHS
Programmatic Submission
Category: 2016 AER Conference

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Consent Consultation
Poster Abstracts

Consent Consultation

Authors: Monika Lau, MEd, CIP; Michele Antisdel, MBA, CIP; Jennifer Reese, MS, CIP; and Cathleen Montano, JD, CIP
Yale University
Programmatic Submission
Category: 2016 AER Conference

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An Indian Perspective Regarding Research Participants' Perceptions of Informed Consent
Poster Abstracts

An Indian Perspective Regarding Research Participants' Perceptions of Informed Consent

Author: Shubhan Alva, BDS
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Conducting Research in an International Setting: Resources and Guidelines
Poster Abstracts

Conducting Research in an International Setting: Resources and Guidelines

Authors: Adrienne Tanner, CIP; and Colleen Kohashi, MA, CIP
University of California, Berkeley
Programmatic Submission
Category: 2016 AER Conference

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Building Global Ethics Review Capacity: An Innovative Model for IRB Administrator Training
Poster Abstracts

Building Global Ethics Review Capacity: An Innovative Model for IRB Administrator Training

Authors: Megan Kasimatis Singleton, JD, MBE, CIP, University of Pennsylvania; Ana Sofia Fabian Ortiz, BA, University of Pennsylvania, Universidad de Francisco Marroquin; Candida Franco Lemus, DDS, MBE and Luis Manuel López Dávila, MSocSc, MA, MD, Dr.PH, Universidad de San Carlos de Guatemala; Francis Barchi, PhD, MBE, Rutgers, The State University of New Jersey; Erwin Calgua Guerra, MD, Universidad de San Carlos de Guatemala; Sergio Martinez-Siekavizza, MD, Universidad de Francisco Marroquin; Jon F. Merz, MBA, JD, PhD, University of Pennsylvania
Programmatic Submission
Category: 2016 AER Conference

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Adapting Standard Clinical Trial Monitoring for Implementation Science in a Global HIV Context
Poster Abstracts

Adapting Standard Clinical Trial Monitoring for Implementation Science in a Global HIV Context

Authors: Tanya Jennings LMSW; Dhelia Williamson PhD; Carin Molchan, MS; and Katina Pappas-DeLuca, PhD
Centers for Disease Control and Prevention
Programmatic Submission
Category: 2016 AER Conference

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State-of-the-Art Adverse Event Monitoring for Behavioral Health Clinical Trials
Poster Abstracts

State-of-the-Art Adverse Event Monitoring for Behavioral Health Clinical Trials

Authors: Stacey Young-McCaughan, RN, PhD; Allison Hancock, PhD; John Roache, PhD; Jeslina Raj, PsyD; Tabatha Blount, PhD; Antionette Brundige, MS; and Alan Peterson, PhD, ABPP
University of Texas Health Science Center, San Antonio
Programmatic Submission
Category: 2016 AER Conference

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Awareness of Scientific Misconduct Among Tertiary Hospital Healthcare Professionals
Poster Abstracts

Awareness of Scientific Misconduct Among Tertiary Hospital Healthcare Professionals

Authors: Pooja Shetty, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Setting Maximal Risk Threshold
Poster Abstracts

Setting Maximal Risk Threshold

Authors: Joanna K. Rozynska, PhD
University of Warsaw
Scientific Submission (ethical analysis)
Category: 2016 AER Conference

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Health Literacy Challenges of Returning Neuroimaging Incidental Finding Radiology Reports in Researc
Poster Abstracts

Health Literacy Challenges of Returning Neuroimaging Incidental Finding Radiology Reports in Research

Authors: Jody Shoemaker, MS, CCRP, CIP and Caitlin Rancher, BA, Mind Research Network; Linda Petree, BA, CIP, The University of New Mexico; Mark Holdsworth, PharmD; John Phillips, MD; and Deborah Helitzer, ScD, University of New Mexico Health Sciences Center
Scientific Submission
Category: 2016 AER Conference

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Simultaneous and Sequential Study Enrollment Among 34,237 Clinical Trial Patients and Patients' Moti
Poster Abstracts

Simultaneous and Sequential Study Enrollment Among 34,237 Clinical Trial Patients and Patients' Motivation for Duplicate Enrollment

Authors: Jonathan Rabinowitz, PhD, Bar Ilan University; Nomi Werbeloff, PhD, University College London; Francine Mandel, PhD, Pfizer; Shitij Kapur, MBBS, PhD, FMedSci, King's College London
Scientific Submission
Category: 2016 AER Conference

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Attitudes and Perceptions in an Authorized Deception Placebo Analgesia Research Study
Poster Abstracts

Attitudes and Perceptions in an Authorized Deception Placebo Analgesia Research Study

Authors: Susan J. Goo, MSN, RN, Clinical Center Nursing Department, NIH; Emily A Richards, BA, National Center for Complementary and Integrative Health, NIH; Lucy Justement, BSN, MA, RN; and Patrick Korb, BSN, RN, Clinical Center, NIH; Brian Walitt, MD, MPH, National Institute of Nursing Research, NIH; M. Catherine Bushnell, PhD, National Center for Complementary and Integrative Health, NIH
Scientific Submission
Category: 2016 AER Conference

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 Ethical Perspectives in the Use of Personal Data from Medical Records for Health Research
Poster Abstracts

Ethical Perspectives in the Use of Personal Data from Medical Records for Health Research

Authors: Vijaya Hegde, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
A.J. Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Applications for Research Concerning Fetal or Placental Tissue and Expected IRB Responses
Poster Abstracts

Applications for Research Concerning Fetal or Placental Tissue and Expected IRB Responses

Authors: Lynn Borgatta, MD, MPH, Quorum Review, Inc.; David Babaian, JD, LLM, Kinetiq, Inc.; Judith P. Kelly, BSN, MS, Boston University School of Public Health; Mary Banks, BS, BSN, Boston University School of Medicine; David Kaufman, ScD, Boston University School of Public Health
Scientific Submission
Category: 2016 AER Conference

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Increasing Attendance at IRB Education and Training
Poster Abstracts

Increasing Attendance at IRB Education and Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Guiding Researchers Through the IRB Submission Process by Diversifying IRB Educational Resources and
Poster Abstracts

Guiding Researchers Through the IRB Submission Process by Diversifying IRB Educational Resources and Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Using Lean Management Principles to Decrease IACUC Protocol Review Time
Poster Abstracts

Using Lean Management Principles to Decrease IACUC Protocol Review Time

Authors: Lindsay Pascal, Katie Pasichnyk
Category: 2016 IACUC Conference

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The Incorporation of a Research Study Plan to Enhance Support of Research Oversight Activities
Poster Abstracts

The Incorporation of a Research Study Plan to Enhance Support of Research Oversight Activities

Authors: K. A. Overhulse, C. Cheevers, E. Nelson, P. Trennery
Category: 2016 IACUC Conference

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Tackling the Challenge of Tracking and Training Students Involved in Animal Activities
Poster Abstracts

Tackling the Challenge of Tracking and Training Students Involved in Animal Activities

Authors: Astrid Haakonstad
Category: 2016 IACUC Conference

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Successfully Implementing Protocol Software: Creating Efficiencies & Avoiding Disruptions
Poster Abstracts

Successfully Implementing Protocol Software: Creating Efficiencies & Avoiding Disruptions

Authors: Patti Shanders
Category: 2016 IACUC Conference

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Stepping into the Future: The Blueprint to Creating a Fully Electronic IACUC Office
Poster Abstracts

Stepping into the Future: The Blueprint to Creating a Fully Electronic IACUC Office

Authors: Mandy Kozlowski, Paul Mireles, Russuell Greene, Angela Brinkley
Category: 2016 IACUC Conference

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Reducing Semiannual Review Burden Using the One Page Project Management Tool
Poster Abstracts

Reducing Semiannual Review Burden Using the One Page Project Management Tool

Authors: Lindsay Pascal, Katie Pasichnyk
Category: 2016 IACUC Conference

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Performance Evaluation of Institutional Animal Care and Use Committees in Egypt
Poster Abstracts

Performance Evaluation of Institutional Animal Care and Use Committees in Egypt

Authors: Abeer Badr; Sohair Fahmy; Kareem Morsy; Amel Soliman; Ibrahim Abdel Kader; Kohar Varjabedian; Ahmed Afifi; Ayman Saber; Atef Abdel Monem; Khadiga Gaafar Faculty of Science, Cairo University Elham Hassan; Fathy Zaki Faculty of Veterinary Medicine, Cairo University Azza Azzelarab Faculty of Oral and Dental Medicine, Cairo University Azza Hassan; Gamalat Othman; Saber Sakr Faculty of Science, Menoufia University Khaled Sharafeldin Faculty of Science, Benha University Maram Zaghloul Children Cancer Hospital Egypt 53753 Maiada Moustafa Faculty of Science, Helwan University
Category: 2016 IACUC Conference

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Managing Expired Protocols: A Process Improvement Initiative
Poster Abstracts

Managing Expired Protocols: A Process Improvement Initiative

Authors: Anne Clancy, Donna Matthews Jarrell, Jane Branca, Gerard M. Cronin, Mark Depathy, Nicole Freeman, Jason Fuller, Diane McCabe, Robin Minkel
Category: 2016 IACUC Conference

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Incorporation of the OLAW Guidance on Significant Changes to Animal Activities
Poster Abstracts

Incorporation of the OLAW Guidance on Significant Changes to Animal Activities

Authors: V. Cuevas, K. Blanchette
Category: 2016 IACUC Conference

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Environmental Monitoring to Support Extended Cage Change Frequency in Mouse Individually Ventilated
Poster Abstracts

Environmental Monitoring to Support Extended Cage Change Frequency in Mouse Individually Ventilated Cages (IVCs)

Authors: Andrea Swanson, Jeffrey W. Grimm
Category: 2016 IACUC Conference

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Collaborative Approach to Enhance IACUC Member Training through an Annual Educational Retreat
Poster Abstracts

Collaborative Approach to Enhance IACUC Member Training through an Annual Educational Retreat

Authors: Farah I. Moulvi, Paul A. Mackley, Archie O. Ellwood
Category: 2016 IACUC Conference

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Addressing the 3Rs: Process to Request an Animal Care and Use Protocol Literature Search
Poster Abstracts

Addressing the 3Rs: Process to Request an Animal Care and Use Protocol Literature Search

Authors: Toni O'Connell, Kevin Ogborne, Donna Zyry
Category: 2016 IACUC Conference

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IRB Member Comprehensive Handbook Resource
Poster Abstracts

IRB Member Comprehensive Handbook Resource

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Increasing Accuracy and Efficiency by Refreshing IRB Member Training
Poster Abstracts

Increasing Accuracy and Efficiency by Refreshing IRB Member Training

Authors: Meghan Wright, MEd; and Christine Davison, MBE, CIP
Virginia Commonwealth University
Programmatic Submission
Category: 2016 AER Conference

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Perception of Donation of Teeth to Science Among Dentists and Patients at a Tertiary Care Hospital i
Poster Abstracts

Perception of Donation of Teeth to Science Among Dentists and Patients at a Tertiary Care Hospital in India

Authors: Bhakti Sadhu, MDS, Postgraduate Diploma in Bioethics and Medical Ethics
Coorg Institute of Dental Sciences, India
Scientific Submission
Category: 2016 AER Conference

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Implementation of Post IRB Approval Education Targeting Novice Investigators
Poster Abstracts

Implementation of Post IRB Approval Education Targeting Novice Investigators

Authors: Judith A. Pride, RN, MSHS, CCRC, CCRP, CIP; Susan M. Garrow-Sloan, RN, BSN, CCRP; and Jennifer L. Pacheco, MPH, CIM, CIP
Baystate Health System
Category: 2016 AER Conference

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Developing a New IRB Administrator
Poster Abstracts

Developing a New IRB Administrator

Authors: Mary Prather, RN, MPH, CIP; Thomasena Williams, MPH; Helen Collins, RN, MN, LPC; and Shelli Golson-Mickens, MPH
Palmetto Health
Programmatic Submission
Category: 2016 AER Conference

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Knowledge and Practice of Research Ethics Among Biomedical Researchers in Southern Nigerian Tertiary
Poster Abstracts

Knowledge and Practice of Research Ethics Among Biomedical Researchers in Southern Nigerian Tertiary Institutions

Authors: Florence Ogunrin, PhD, University of Benin Nigeria; Olubunmi Ogunrin, MD, FWACP, FRCP, University of Liverpool, University of Benin; Bobbie Murray MS, I-O (Psych) HPA, US Army Command and General Staff College
Scientific Submission
Category: 2016 AER Conference

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Houston We Have a Problem: What Happened When We Added a Hospital to Our System
Poster Abstracts

Houston We Have a Problem: What Happened When We Added a Hospital to Our System

Authors: Tara Moore; and Elayne Grim
WellSpan Health
Programmatic Submission
Category: 2016 AER Conference

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The Network of Human Research Ethics Committees in Cali, Colombia: Institutional Expertise
Poster Abstracts

The Network of Human Research Ethics Committees in Cali, Colombia: Institutional Expertise

Authors: Arturo Herreño Marin, San Buenaventura University; Gloria I. Palma, Universidad del Valle; Jackeline Bravo Chamorro, RN, Centro Internacional de Entrenamiento e Investigaciones Médicas
Programmatic Submission
Category: 2016 AER Conference

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The Clinical Research Training and Mentoring Program, University of Maryland Baltimore, 2012-2016
Poster Abstracts

The Clinical Research Training and Mentoring Program, University of Maryland Baltimore, 2012-2016

Authors: Robert Edelman, MD; James D. Campbell, MD, MS; Anthony Sadzewicz, MS; and Julie Doherty, MSN, RN, CIP
University of Maryland, Baltimore
Programmatic Submission
Category: 2016 AER Conference

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Creating a Culture of Compliance With Integrity: It Takes More Than Solid Policies and a Snazzy Subm
Poster Abstracts

Creating a Culture of Compliance With Integrity: It Takes More Than Solid Policies and a Snazzy Submission System

Authors: Hila F. Berger, MPH, CIP; Amy Krenzer, CIP; Mylka Biascochea, CIM; and Susan Pereny
Montclair State University
Programmatic Submission
Category: 2016 AER Conference

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Social Mobilization and Communication: An Essential Component of Success of the Partnership for Rese
Poster Abstracts

Social Mobilization and Communication: An Essential Component of Success of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) I Ebola Vaccine Study Conducted During the Ebola Outbreak

Authors: Barthalomew Wilson; Joseph Boye Cooper; and Julia Lysander, PREVAIL, US Joint Clinical Research Partnership; Khalipha Bility, Leidos Biomedical Research, Inc.; Jestina Doe Anderson, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.; Hassan Kiawu, PREVAIL; Laurie Doepel and Elizabeth Higgs, National Institute of Allergy and Infectious Diseases, NIH; Juli Endee, Liberia Crusaders for Peace
Programmatic Submission
Category: 2016 AER Conference

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Public Perspectives on Use of De-Identified Health Information for Private Sector or Commercial Uses
Poster Abstracts

Public Perspectives on Use of De-Identified Health Information for Private Sector or Commercial Uses

Authors: Donald J. Willison, ScD, University of Toronto; Kieran O'Doherty, PhD. University of Guelph; Ana Komparic, BSc, University of Toronto
Scientific Submission
Category: 2016 AER Conference

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What Children and Adolescents Value in Research and the Assent Process: A Pediatric Hospital's Exper
Poster Abstracts

What Children and Adolescents Value in Research and the Assent Process: A Pediatric Hospital's Experience

Authors: Rose Singh, MPH; Jessica Macha, BA, CIP; Eriika Etshokin, MA; and Susanna McColley, MD
Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago
Programmatic Submission
Category: 2016 AER Conference

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