IRB Administration

Webinar Bundle: IRB Administration

The IRB Administration webinar bundle is made up of a curated selection of PRIM&R's recorded webinars, hand-picked to provide in-depth instruction. Developed and presented by experts, the webinars in this bundle offer insight into some of the fundamental concepts and challenges in IRB administration, including the development of tools to streamline IRB protocol review, effective training and retention of IRB staff, and how to run a good committee meeting.

Continuing Education

Certificates of attendance are available for webinars recorded in 2014 or later, and can be used to obtain continuing education credit from professional organizations. If you are looking for credits to specifically recertify your PRIM&R credential, please refer to our lists of CIP-eligible PRIM&R programs and CPIA-eligible PRIM&R programs.

Included Webinars

Complex Protocols: Digging Deeper to Better Protect Human Subjects

2014

Speaker: Lori Roesch, CIM, CIP

As research and clinical trials evolve, IRBs face challenges in reviewing increasingly complex protocols. Complications that may be presented by sponsors include additional optional components, sub-studies that are tied to the main study but are not part of the main study objectives, and third party involvement in the conduct of the sub-study. Protocols from certain larger sponsors usually contain the information that the IRB needs in order to properly review the study and any additional components. However, some sponsors are less attuned to the intricacies of IRB review, and may fail to provide the level of information an IRB requires when reviewing these activities.

Without sufficient information in the protocol, IRBs cannot adequately assess reasonableness of risks or evaluate whether they have been minimized. Furthermore, incomplete information makes it challenging to establish whether there are adequate provisions in place to protect the confidentiality of study data. This webinar will help IRBs determine whether protocols submitted for review contain incomplete information and will provide guidance on requesting additional information from the sponsor to better protect human subjects.

The webinar speaker addresses the following examples of complex protocol scenarios:

  • Studies with optional health, economic, or tissue-banking activities
  • Studies with pregnancy surveillance data requested
  • Studies with a washout period as either part of the protocol or an eligibility criterion

Participation in this 60-minute webinar counts as 1 CE credit hour.

Identify, Recruit, Train, Retain: Building a Diverse, Qualified IRB

2016

Speakers: Courtney Jarboe, MA, MS, CIP and Ann Morrison, MA, PhD

IRBs should be diverse, skilled, knowledgeable, and committed to the common goal of protecting human subjects. Identifying and retaining skilled, motivated IRB members, is a perennial challenge. How do HRPP and IRB leaders navigate the various challenges of maintaining a skilled, knowledgeable, and diverse committee? During this advanced-level webinar, presenters provide approaches for strategically identifying, recruiting, training, and retaining IRB members to create a healthy and qualified board.

After attending this webinar, attendees will be able to:

  • Identify board member candidates:
    • Assess the IRB's strengths and identify gaps in skills, perspectives, and knowledge
    • Develop strategic and diverse recruitment strategies
    • Develop selection criteria for leadership roles (i.e. Chair)
  • Recruit board members:
    • Provide candidates clear expectations for commitment and accountability to the IRB
    • Evaluate each candidate's expertise and experience
  • Train board members:
    • Deliver educational opportunities that result in board member engagement and learning
    • Develop a foundation of common understanding of the ethical and regulatory concepts for IRB review while preserving individual perspectives
    • Create a comprehensive educational plan that includes continuing education, engagement, and feedback
  • Retain board members:
    • Identify your IRB's unique challenges that may impact a member's continued service
    • Develop strategies to promote the institution's investment in the IRB

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

IRB Administration: Providing Stellar Support to your IRB

2014

Speakers: Maria Arnold, CIP and Megan Kasimatis Singleton, JD, MBE, CIP

IRB administrators serve as facilitators of the human subjects research review process. They are tasked with carrying out a variety of organizational and administrative responsibilities. This webinar focuses on some of the core responsibilities of IRB administrators and provides insight into best practices across a range of institutional sizes and structures. Specific topics for discussion include:

  • IRB recordkeeping, including meeting minutes, membership, correspondence with investigators, and records of actions reviewed by the IRB
  • Facilitation of the application and review process, including pre-screening submissions for completeness
  • Generation of IRB correspondence including actions taken by the convened IRB
  • Production and maintenance of standard operating procedures

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Making Good Meetings Happen for IACUCs and IRBs

2016

Speakers: Melissa Frumin, MD, MS and Rachel Murray, MS, CPIA, RLATG

Whether you're involved in the ethical oversight of research involving animals or human subjects, committee meetings are part of the job. IACUC and IRB staff and chairs are tasked with ensuring that meetings run well and are conducted in accordance with federal regulations. 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 committee meetings.

During this webinar, an experienced IACUC compliance specialist and an IRB chair share best practices for meeting management. Through discussion of common IACUC and IRB meeting scenarios, speakers address the following topics:

  • Stimulating discussion when members are quiet, and staying on track when they're not
  • Mediating conflict during protocol review
  • Preparing so that federal and institutional regulations are clear and understandable
  • Avoiding meeting fatigue
  • Clarifying the roles of the administrator, chair, the unaffiliated/nonscientist, and other members in meetings
Navigating the New Reliance Agreement Landscape

2016

Speakers: Emily Chi Fogler, Esp. and Tracy Ziolek, MS, CIP

Recent regulatory updates signal a shift to a research landscape requiring single IRB review of multi-site research. Institutions are entering into IRB reliance agreements with other institutions, serving themselves as a relying institution, or becoming the IRB of record. Increasingly complex multi-site arrangements or "master" agreements—involving more than two institutions, multiple protocols, or institutions serving alternately in both relying and reviewing roles—are becoming more common. How can institutions and IRBs prevent problems and address the challenges that may arise from reliance arrangements? During this intermediate-level webinar, an IRB director and a research attorney review the 2016 NIH funding environment. The speakers identify and provide strategies for navigating common areas of uncertainty and for addressing key implementation challenges, including:

  • Maintaining transparent communication pathways and exchange of information among relying institutions and their IRBs, investigators, and the IRB of record
  • Defining the relying institution's reporting obligations to the IRB of record and vice versa
  • Identifying responsibilities with respect to externally reportable events
  • Engaging and educating investigators and research teams on their role in the reliance arrangement

Commentary is provided from the perspective of the relying institution as well as the IRB of record, and is relevant to reliance arrangements with fellow research institutions as well as with independent IRBs.

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Practical and Effective Approaches To Educate IRB Members

2015

Speakers: Mina P. Busch, MSS, CCRP, CIP and Scott Lipkin, DPM, CIP

Providing IRB members with a solid knowledge base through proper training and education is vital to ensure they can perform the tasks associated with their roles in human subjects protections. How do you balance finding effective ways to deliver relevant and valuable information with limited time and resources? What are the best methodologies to evaluate the impact of your educational plan? This webinar helps to explore these questions and develop a successful IRB member education program.

During this webinar, presenters:

  • Discuss challenges faced in building an education plan for IRB members
  • Explore opportunities to educate IRB members when internal resources are limited
  • Recommend methodologies to evaluate the effectiveness of an IRB member education program
Tools, Templates, and Checklists for Streamlining IRB Protocol Review

2016

Speakers: Sharon Freitag and Megan Kasimatis Singleton, JD, MBE, CIP

One of the primary responsibilities of the IRB administrator is to facilitate and streamline protocol review. With the right tools, templates, and checklists, administrators can do so efficiently and in compliance with applicable regulatory requirements. Using examples from typically challenging areas of protocol review, the presenters of this webinar will demonstrate how to identify, develop, and successfully implement your own tools, templates, and checklists. Areas covered include:

  • Screening of protocols upon receipt to determine submission completeness and the level of review required
  • Facilitating IRB member reviews
  • Using meeting minutes to document IRB determinations
  • Developing IRB correspondence to communicate IRB inquiries or determinations

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Working through Conflict: Helping IRB Staff Communicate Effectively with Investigators

2014

Speakers: Helen Panageas, CIP and Suzanne Rivera, PhD, MSW

IRB personnel are responsible for ensuring the committee functions smoothly. Excellent communication and interpersonal skills are vital for effective collaboration with investigators. Friction between researchers and the IRB can be challenging. Some investigators view IRBs as obstacles, and some IRB staff take on the role of the gatekeeper; these approaches can create tension and conflict. Through the use of concrete examples, presenters provide strategies for effective verbal and written communication between IRBs and investigators. In this session, faculty and attendees:

  • Review clear, concise, and tactful strategies for delivering information to investigators
  • Explore the skills needed to diffuse frustration and resolve conflicts in a professional manner
  • Identify mistakes commonly made in communication on sensitive matters
  • Discuss strategies for using email more effectively to transmit IRB findings and stipulations
  • Focus on the common goals of IRBs and investigators to increase cooperation

Participation in this 90-minute webinar counts as 1.5 CE credit hours.

Access Webinar Bundles

Webinar bundles are available to individual PRIM&R members at no cost. For a fraction of the cost of this bundle, become a member to watch the included webinars and gain dozens of other member benefits. 

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Nonmembers can purchase individual or group access to this webinar bundle using the order form below. Each webinar is also availalbe individually. 

Individual nonmember rate: $1,470

Group nonmember rate: $3,000