2024 Webinars

What IACUCs Need to Know About Working with IBCs Webinar

Thursday, April 11, 2024
1:00–2:30 PM ET

Contributor: 
Jacqueline Hoats Shields, BFA, CPBCA Associate Director of Research Safety Compliance under the Office of the Vice President for Research at the University of Michigan. 

This webinar will explore the similarities and differences between IACUC and IBC programs and how the two oversight models can work together effectively. What are the key connection points and where are the potential missed signals when projects require review by both committees?

We'll aim to generate practical ideas for achieving productive partnerships between these two compliance areas at your institution. 

After participating in this webinar, attendees will be able to: 

• Review what IBCs oversee, how they function, and how this compares to the IACUC. 
• Outline what needs to happen when a project under IACUC review also involves IBC oversight. 
• The big stuff: Similarities and differences between IBCs and IACUCs. 
  • Emphasis points for IBCs compared to IACUCs 
  • Regulations and guidelines 
  • Institutional rules and policies 
• The nitty gritty: Working together when you are so different. 
  • Connection points between the programs 
  • Timing can be everything 
  • Mind the gap(s) 
  • Technical issues 
  • Cases and examples 

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

Cost
Members: $100
Nonmembers: $190

Meeting Challenges of IACUC Administration: Case Studies in Handling Complex Protocol Issues Webinar

Tuesday, May 21, 2024
1:00–2:30 PM ET

Contributors:
Louis DiVincenti, DVM, MS, DACLAM, DACAW, Senior Veterinary Medical Officer for Research with the United States Department of Agriculture (USDA) Animal Care National Policy Staff

Neera V. Gopee, DVM., PhD, DACLAM, DABT, Associate Director, Animal Welfare Policy, in the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health 

Many IACUC administrators, members, and staff struggle with protocol questions and what the IACUC should consider in reviewing protocols. During this webinar, speakers and attendees will work through case studies on protocol review issues and discuss possible ways to handle these complex situations.

Before attending the webinar, attendees should have a sound working knowledge of the IACUC and the regulations that provide guidance. Important to the session are well-versed IACUC administrators who can share their experiences with protocol challenges. Participants will engage in this interactive session by responding to case studies and scenarios using the Zoom polls, chat, QAs and/or raise hand features.

After participating in this webinar, attendees will be able to: 

• Evaluate various approaches to resolving complex protocol review issues, considering regulatory requirements and ethical implications.

• Analyze the potential consequences of different actions in response to challenging protocol scenarios.

• Develop strategies for collaborating effectively with stakeholders (investigators, veterinarians, other IACUC members) to optimize protocol outcomes and enhance animal welfare.

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

Cost
Members: $100
Nonmembers: $190

IRBs and Expanded Access Webinar

Tuesday, June 18, 2024
1:00–2:30 PM ET

Contributors
Holly Fernandez Lynch, JD, MBE, Assistant Professor of Medical Ethics and Law at the University of Pennsylvania

Megan Kasimatis Singleton, JD, MBE, CIP, Associate Dean for Human Research Protection and Director of the Human Research Protection Program at Johns Hopkins University School of Medicine

Join this panel discussion to gain an understanding of expanded access (sometimes called “compassionate use”), the ethical issues involved, and an overview of recent regulatory and policy developments. With a panel of individuals including representatives from the FDA, industry, and academia, this educational opportunity will discuss the FDA’s new guidance on IRB Review of Individual Patient Expanded Access Submissions and provide considerations for implementation.

What practical considerations are IRBs and HRPPs making for expedited review? How should oversight bodies be thinking about data collection from expanded access patients? What are the FDA expectations? Who are the stakeholders involved in this process and how can they most effectively engage?

After this webinar, you will be able to: 

• Define expanded access and identify relevant stakeholders.
• Understand the key components of the new FDA Guidance related to IRB review of Individual Patient Expanded Access Requests.
• Examine different perspectives about implementation of the guidance to help inform practice.

CE Credit

Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

CIP Credit
Course participants who hold the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.

Cost
Members: $100
Nonmembers: $190

The Documents Side of an Animal Care and Use Program Webinar

Thursday, June 27, 2024
1:00–2:15 PM EST 

Contributor
Bill Greer, Assistant Vice President for Research, University of Michigan 

The intricacies of a complex Animal Care and Use Program (ACUP) are interwoven with a collection of policies, guidelines, and standard operating procedures (SOPs), forming the backbone of its operational framework.

Together, these elements create a cohesive structure that governs the program's activities, enhances accountability, and fosters organizational alignment, thereby facilitating the successful execution of the program. 

What Will I Learn?

• Identify the primary differences between policies, guidelines, and standard operating procedures (SOPs) within an Animal Care and Use Program (ACUP). 

• Explain the distinct purposes served by policies, guidelines, and SOPs in governing the activities of an ACUP. 

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
 

CPIA Credit
Course participants who hold the Certified Professional in IACUC Administration (CPIA®) credential may apply 1.25 continuing education credits towards CPIA® recertification credit for this PRIM&R webinar. Please refer to the CPIA® recertification guidelines for additional information.

Cost
Members: $100
Nonmembers: $190

Resources for IRBs: Challenges with Reproductive Applications of Genomics Research

Tuesday, July 16, 2024  
1:00–2:30 PM ET

Contributors
Marsha Michie, PhD, Associate Professor of Bioethics at the Case Western Reserve University School of Medicine
Ruth M. Farrell, MD, MA, FACOG, Physician-scientist, Cleveland Clinic

As the field of genomic science advances, there is growing interest in applications of genomic interventions in the reproductive context. This includes genomic modification of embryos, fetuses, and gametes with the goal of avoiding serious disease in offspring. Germline modifications, including possible unintended effects of somatic interventions, are of particular interest as changes induced in the present will have implications for future generations. 

The design and review of these studies entails considering risks and potential benefits not just for the offspring but also the pregnant person who will carry the genomically modified embryo within their body. Given the unique aspects of trials genomic interventions, it will be critical for IRBs to provide guidance regarding the conduct of these studies and the protections that must be in place for both pregnant individuals (during and after the pregnancy) and offspring.  

After this webinar, you will be able to: 

• Identify the unique ethical considerations associated with reproductive applications of genomic interventions.  
• Explain the risk/benefit considerations for pregnant persons participating in trials of genomic modification and offspring that result from genomic modification in vitro or in utero. 
• Assess current IRB practices to regulate reproductive applications of genomic interventions and the role of novel resources to support those efforts.  

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

CIP Credit
Course participants who hold the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.

Cost
Members: $100
Nonmembers: $190

Defining and Navigating Risk in Exempt Research Webinar

Tuesday, October 29, 2024 
1:00-2:30 PM ET

Contributors: 
David Comalli, PhD, IRB Director, Temple University

Justin Snyder, PhD, HRP Education Coordinator, University of Pittsburgh

Survey IRB websites, presentations on Exempt research, or review the preamble to the revised Common Rule, and it becomes apparent that Exempt research is often approached as no risk or the least risky human subject research. 

At the same time, the regulations are silent on risk and the Exemptions except for the determining if Limited Review is required for certain categories. Does this provide sufficient protection for subjects?  How should IRB’s address the risks of Exempt research? 

What are the greatest allowable risks for an Exempt study, and how should IRB’s handle studies that exceed that threshold but otherwise meet an Exempt category?  How might we improve subject protections by reviewing Exempt research from a perspective that is not restricted to traditional risk concerns? 

This webinar will address these and related ethical questions with an emphasis on SBER. The webinar will provide a basic overview of Exemptions followed by an intermediate to advanced discussion of risk and the application of the Exemption categories. 

After participating in this webinar, attendees will be able to: 

• List and describe the Exemption categories and prevailing wisdom on Exempt research 
• Analyze the ethical considerations associated with Exempt research and how IRB’s might approach those considerations 

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.

​Cost

Members: $100
Nonmembers: $190

Doing it Right: Consent and Compensation in Crowdsourced Data Collection Webinar

Contributor: 
Mary L. Gray, PhD, Senior Principal Researcher at Microsoft Research and Faculty Associate at Harvard University’s Berkman Klein Center for Internet and Society.

After the introduction of Mechanical Turk (MTurk) as a human computation work platform, the use of crowdsourcing for data collection in research rose significantly, especially in the psychological sciences.

With the increased use of platforms such as MTurk came questions regarding the price of human labor vis-à-vis compensation to research subjects and implications for “voluntary informed consent.” In both preparatory work and research participation, does incomplete disclosure meet the requirements and standards for informed consent?

This webinar provides an overview of the history of the use of crowdsourcing for research data collection, addresses issues of identifiability and representativeness of MTurk workers, and describes techniques that have been developed to ensure both meaningful consent as well as mechanisms for ensuring that MTurk workers get compensated for their participation even if they were to withdraw from the study. 

Cost
Members: $100
Nonmembers: $190

Considering the Ethical, Legal and Social Implications of Digital Health Research

The use of digital strategies and tools is on the rise in health research. While technologies like wearable sensors and social network platforms hold promise for understanding health behaviors, these strategies for gathering data include ethical, legal, and social implications (ELSIs) that must be considered.

This webinar provides an overview of how digital tools/strategies, including machine learning and artificial intelligence, are used in health research. It will highlight novel strategies for identifying possible unintended ELSIs when developing and evaluating digital health studies.

You will be introduced to the Digital Health Checklist (DHC) and framework. With the use of case studies, attendees will apply the DHC with a goal of improving awareness of issues related to privacy, risk/benefit assessment and data management that can be used when developing or reviewing a research protocol and consent form. In addition, learn to apply a more structured approach to assessing digital health research risks.

Recognizing, Investigating and Reporting Noncompliance and Adverse Events

This interactive webinar will use a mix of lecture, scenarios, and Q&A to examine the IACUC’s role in identifying noncompliance and other adverse events in the animal care and use program.

Amidst the increasing complexity of research, heightened institutional and public scrutiny, and evolving regulations, maintaining meticulous oversight of animal care and use programs remains a steadfast obligation of every Institutional Animal Care and Use Committee (IACUC). A critical part of IACUC oversight involves identifying when things go wrong, implementing corrective actions, and, in some cases, reporting to regulatory and oversight bodies.
 

 1.5 Continuing Education credits towards CPIA Recertification.