Few IRBs are inspected by federal agencies to ensure regulatory compliance, according to a report from the Government Accountability Office.1
About 2,300 IRBs are overseen by the Office for Human Research Protections (OHRP) and the FDA. OHRP conducts only three or four routine inspections annually. The FDA conducted 133 inspections, on average, from 2010 through 2021.
A consensus is needed for how to measure IRB quality or effectiveness, and more inspections are needed to ensure instances of IRB noncompliance are identified, according to the report’s authors.
Jonathan Green, MD, MBA, sees a larger issue with how IRBs work currently: An incentive structure that is not aligned with the IRBs’ primary mission to protect human research participants. “The way the IRB system is set up, and the way incentives are aligned, can create conflicts,” says Green, director of the Office of Human Subjects Research Protections at the National Institutes of Health (NIH).
Green recently co-authored a paper on this topic.2 Inherent conflicts of interest in all IRBs (whether the IRB is embedded in an academic medical center or an independent for-profit IRB) are a threat to ethical research, according to Green and a co-author.
The concern is IRBs’ relationships to their major stakeholders are not aligned with the IRBs’ primary obligation — to act in the best interest of research participants. For example, the interests of investigators, research institutions, and industry sponsors of research are for a rapid and minimally burdensome review. Those stakeholders want the study to be initiated in a timely manner.
Research participants’ interests differ. For people who are participating in the clinical trial, a thoughtful, thorough review is best. “This may be more time-consuming and increase burden on the investigator,” Green notes.
Most study participants are not even aware of the IRB’s existence. Even if they were, participants really have no mechanism to hold IRBs accountable, or to advocate on their own behalf when the IRB is reviewing a study protocol.
In contrast, investigators and research institutions can hold IRBs accountable in multiple ways. Institutions control the resources allocated to the IRB office, which influences how the group functions and what the board reviews. Researchers can complain to institutional leadership if they believe the IRB is problematic. “Investigators can take their research and funding to other institutions if they feel their concerns are not addressed,” Green adds.
IRBs should be not-for-profit, funded by the government, and independent of institutions, Green and his colleague wrote. This would remove the financial incentive that conflicts with the IRB’s primary obligation to research participants.
The authors also suggested creating a process to adjudicate claims that allege study participants were harmed by the IRB. A transparent public IRB system could improve the efficiency of ethical review, with a single set of policies and procedures, and might strengthen public trust, according to the authors.
“The concerns that we raise in the paper are ‘open secrets’ in the IRB community. We need a dialogue so that we can find ways to address and mitigate the concerns,” Green says.
Individual IRB members’ conflicts of interest is another factor that can stand in the way of ethical research. For instance, an IRB member might own stock in a company that is sponsoring a study for a new drug. A positive outcome likely will increase the value of that company’s stock. However, this generally is not a major concern, as IRB review rarely affects study outcomes. “This is relatively easy to identify and mitigate, as members should identify that interest and recuse themselves,” Green says.
At some institutions, IRB members file financial disclosures that would identify this kind of conflict. Harder-to-detect conflicts involve IRB members who are colleagues of investigators whose study protocols are under review.
“Members should be honest with themselves and the IRB if they feel that they cannot fairly review a study for any reason, and recuse themselves,” Green says.
An IRB member would have a conflict of interest (COI) if they or their spouse, partner, or children or dependents were involved in any way in a research protocol that they are asked to review, says Barbara DeCausey, MPH, MBA, director of Virginia Tech’s human research protection program.
IRB members also could have a COI if they (or a family member) could benefit from the product or service tested based on their involvement with the research or their relationship or affiliation with the sponsor.
“Most institutions have guidance and policies for IRB members to disclose and manage their COIs,” DeCausey notes.
Before participating in the review of a research protocol, IRB members should be asked explicitly if they have a COI. Because some COIs are not obvious, IRB members also are provided with training to help them identify potential conflicts. “IRB members should recuse themselves from reviewing research protocols when they have a COI as defined by their institution or when they believe they cannot give an independent review,” DeCausey says.
(Editor’s Note: Green is employed by the NIH, but the views expressed in the paper and this interview are submitted in his personal capacity and not his official capacity.)
REFERENCES
1. U.S. Government Accountability Office. Institutional Review Boards: Actions needed to improve federal oversight and examine effectiveness. GAO-23-104721. Published Jan. 17, 2023.
2. Green JM, Rosenfeld S. Conflicts of interest in institutional review boards are a threat to ethical research. Nat Med 2023; Jul 24. doi: 10.1038/s41591-023-02442-0. [Online ahead of print].
A consensus is needed for how to measure IRB quality or effectiveness, and more inspections are needed to ensure instances of IRB noncompliance are identified, according to the authors of a recent report.
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