Maximizing IRB Contributions from Non-Scientist and Non-affiliated Members

Stephen Poppel  and Nathalia Henry

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Content Copyright

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Conflict-of-Interest DisclosureNathalia Henry and Stephen Poppel:

We have no relevant personal/professional/financial relationships with respect to this educational

activity

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1. Identify strategies for the effective framing of IRB members’ roles and responsibilities

2. Discuss approaches for non-scientist and nonaffiliated members to communicate more effectively within their IRBs

3. Explore opportunities to overcome structural and cultural challenges that may impact the non-scientist/nonaffiliated members’ positions

Learning Objectives

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Stakeholders Roles/FunctionsEntity/Institution/HRPP Oversee Human Research Protection Program 

(HRPP) in accordance with Federalwide Assurance (FWA) and a statement of principles such as the Belmont Report

Non-Scientific IRB Members Serve on IRB* Unaffiliated IRB Members Serve on IRB* IRB Office Staff Provide administrative, operational and 

regulatory support to the IRB. Serve on IRB**IRB Chairs and Vice Chairs Serve on IRB Other IRB Panel Members Serve on IRB* 

Who We Are; Why We’re Here

*As a voting member, alternate and/or designated reviewer**At some institutions the IRB operational/administrative support staff also serve as IRB members

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§ “Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities…..”

§ “The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of its members including consideration of race, gender and cultural backgrounds and sensitivity to such issues such as community attitudes to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects”. 45 CFR 46.107 (a)

Regulatory Requirements for IRB Membership

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§ “Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.” 45 CFR 46.107(b)

§ “Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.” 45 CFR 46.107(c)

Regulatory Requirements for IRB Membership (continued)

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“SACHRP believes the scientist/non-scientist distinction was designed to ensure a range of intellectual and philosophical perspectives among IRB members. By use of the term “primary concerns”, both OHRP and FDA regulations acknowledge that the concerns of an IRB member are unlikely to lie solely in scientific, or solely in non-scientific, areas.”Attachment B: Recommendation on IRB Membership and Definition of Non-scientist under 45 CFR 46 and 21 CFR 56, https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2011-january-24-letter-attachment-b/index.html

Why do IRBs have Community Members?

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§ Why do individuals generally desire to serve on the IRB?

§ How do non-scientific and unaffiliated IRB members often view themselves?o Personal/professional intentionso Desired contributions

Common Characteristics of IRB Members

All Stakeholders have a role in contributing to the effective engagement of non-scientific and unaffiliated IRB members

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Non-Scientist = ?Non-Affiliated = ?

= What?

What is a “non”?

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What community?What representation?

Community Representative?

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o Non-Non• Information + Enthusiasm

o Non (the opposite)• Lack of Information + Uncertainty

? !

“Non” vs “Non-Non”

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Focus on Informed Consent

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Potential Challenges to Nonscientist or Unaffiliated IRB Member Engagement

§ Varying degrees of expertise (That non-scientists aren’t experts is a misconception and a misunderstanding of their role as IRB members)

§ Language (IRB lingo/regulatory jargon)

§ Unclear/undefined expectations

§ Structural issues

§ Cultural issues

§ The framing of IRB roles [The tone from the top (IRB Chairs)]

These challenges can be also viewed as opportunities

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§ Belmont Principles (Respect for persons. Beneficence. Justice.)

§ 45 CFR 46.111 Criteria for IRB Approval

§ Elements of Informed Consent (Basic and Additional Elements)

§ Non-scientist/Unaffiliated member “gut check”     (Risk to benefit, Costs, Participant community perspective (lay point of view),      Consent form readability…etc.)

Setting Expectations for IRB Review and Approval

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Communication and engagement strategies§ Define roles & responsibilities

§ Ongoing support: o Education/Trainingo Resources and toolso Coaching and mentorship (the “human touch” and a sense of belonging)

§ IRB member evaluation and feedback processes (360 feedback; “performance review”)

§ All parties establish clear expectations

§ Refine IRB submission assignment process

§ Refine meeting conduct/management

§ Allow the non-scientist to remain a non-scientist

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Com.mu.ni.ca.tion

synonyms: transmission, conveyance, divulgence, disclosure

kəˌmyo͞onəˈkāSH(ə)n/Noun

1. the imparting or exchanging of information or news.

2. means of connection between people or places, in particular.

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Re.spect

verb1. admire (someone or something) deeply, as a result of their abilities, qualities, or achievements.

synonyms: esteem, admire, think highly of, have a high opinion of, hold in high regard, hold in (high) esteem, look up to, revere, reverence, honor

rəˈspekt/noun1. a feeling of deep admiration for someone or something elicited by their abilities, qualities, or achievements.

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§ ... a good thing!§ Shared Goals§ Long-term Benefit§ Constructive, not Adversarial

Strategy: Quality Control

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CollaboratePrepareRespectContributeAssertBefriendRemember

Tactics

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1. Wenner, D.M. (2015). “Barriers to Effective Deliberation in Clinical Research Oversight”, HEC Forum

2. Allison, R., et al. (2008). “Roles and Experiences of Non-Scientist Institutional Review Board Members at the National Institutes of Health”, IRB 

3. Porter, J.P. (1986), “What Are the Ideal Characteristics of Unaffiliated/Nonscientist IRB Members?” IRB Ethics and Human Research, Vol 8, No. 3.

4. Klitzman, R (2012), “Institutional Review Board Community Members: Who Are They, What Do They Do, and Whom Do They Represent?” Acad Med. 2012 July ; 87(7): 975–981.

5. Lidz, C.W., et al. (2012): “The Participation of Community Members on Medical         Institutional Review Boards”, J Empir Res Hum Res Ethics. 2012 February; 7(1):1-6.

References/Additional Reading Material

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Questions?

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Thank You