During its meeting on July 19-20, 2023, SACHRP advanced its work toward completing one of the recommendations contained in this year’s Government Accountability Office (GAO) report. The report produced by the independent, non-partisan agency calls for actions needed to improve federal oversight and examine the effectiveness of IRBs.
On the first day of the meeting, Douglas Diekema, MD, MPH (SACHRP Chair), Julie Kaneshiro (Acting Director, OHRP), David Forster, JD (Co-chair), and Susan Kornetsky, MPH, CIP (Subpart A subcommittee member), helped SACHRP members navigate the challenging task of drafting and revising recommendations to measure IRB effectiveness in protecting human subjects.
In March, SACHRP began its charge on one of the four recommendations of the 2023 GAO report: That OHRP and FDA launch a renewed effort to convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects. Given there are currently no established standards for evaluating the effectiveness of IRBs, the GAO report proposes several potential strategies, including “peer audits of IRB meetings and decisions; mock protocols; surveys of IRB members, investigators, and human research participants; or other approaches.”
SACHRP’s current draft on how to examine the effectiveness of IRBs concludes:
SACHRP met virtually on July 19-20. Part of the discussion focused on how to improve federal oversight and examine the effectiveness of IRBs.
Specifically, OHRP asked SACHRP to consider the following points to support convening HHS stakeholders, as recommended by GAO:
- What constitutes effectiveness in protecting research participants? This could be defined in terms of avoiding harms, ensuring subjects exercise informed consent, protecting subjects’ rights and welfare, treating subjects equitably or fairly, or achieving greater consistency in applying the regulation, or something else. Depending on what is being protected, the IRB’s actions could differ and measures of effectiveness would vary accordingly. What definition of IRB effectiveness is the most important to focus on and measure?
- SACHRP is one HHS “stakeholder.” What other stakeholder groups should HHS convene as part of examining approaches for measuring IRB effectiveness? What factors make an entity an appropriate stakeholder?
- GAO provides several potential effectiveness measures. How do these approaches differ, and what are their benefits and limitations? What approaches should HHS and stakeholders prioritize?
Criteria to Determine IRB Effectiveness
During its July meeting, SACHRP members discussed a range of criteria of how IRBs could be effectively evaluated.
For each of the proposed standards of measuring IRB effectiveness, SACHRP evaluated the pros and cons; feasibility of implementation; measurability; and assessment of whether something is more administrative/procedural or more substantive in terms of ethics. SACHRP also considered whether something was IRB-focused or broader.
When considering “Compliance with the Belmont Principles” and “Ensuring Subjects Exercise Informed Consent–Based on the Principle of Respect for Persons,” SACHRP noted, “If this standard were adopted, it would be important to assess whether the consent forms consistently include the elements of consent and that the consent process was conducted with sufficient opportunity for consideration, free from undue influence or coercion.”
SACHRP’s draft recommendations also mentioned a possible IRB assessment that could include “Certified IRB Professional (CIP) IRB Staff/Board Members” as a data point.
“The CIP is an intense, lengthy test of an individual’s knowledge of the IRB’s purpose and the regulatory requirements. Thus, another possible standard based on training could be a requirement that an IRB have a certain number or percentage of IRB staff members or board members who have obtained the CIP certification.”
SACHRP also addressed the goal for “Public Knowledge of and Trust in the IRB System,” noting that, “The goal of having an IRB is to establish public trust in the research enterprise, which provides value to society by producing new scientific knowledge. The research enterprise needs to meet public expectations of research.”
A pro of this item was that “The IRB system was created to help correct the public impression that research was being conducted inappropriately and causing harm, particularly to vulnerable subjects…” But, a con for the same item was that, “Unfortunately, many members of the public are unaware of the existence of IRBs or how they operate. The public face of research to many members of the public is the investigators they interact with, or government or commercial sponsors rather than IRBs.”
Introducing the idea of the stakeholders in this conversation, SACHRP noted that many operating within the research enterprise have responsibility for protecting the rights and welfare of human subjects. SACHRP’s draft recommendation document identified: individuals who volunteer to participate in research; communities where research activities take place; patient advocacy groups; institutions that conduct research; institutional officials; IRB affiliated and unaffiliated members; IRB staff; investigators; research staff; Common Rule agencies, including FDA; SACHRP; commercial research funders; bioethicists; PRIM&R, AAHRPP, Inc.; The Consortium to Advance Effective Research Ethics Oversight; and others, including consultants.
- Learn about the background of the GAO Report.
- Learn more about SACHRP.
- View the agenda for the July 2023 meeting.
- Read the minutes of SACHRPs March 22-23 meeting.
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This article was originally published in the July 2023 PRIM&R Member Newsletter. Click here to become a PRIM&R member and join our supportive membership community that provides resources and connections with colleagues from more than 1,000 institutions in more than 40 countries.