A group of researchers was examining IRB member attitudes toward protecting participants and including participants. “In our discussions, we noticed that these two goals are often in conflict in IRB reasoning and decision-making,” says Phoebe Friesen, PhD, assistant professor at McGill University’s biomedical ethics unit.
Friesen and colleagues decided to write a paper on this topic.1 IRB members are faced with what the authors called the “protection-inclusion dilemma.” IRBs are responsible for protecting research participants from harm.
However, IRBs also must encourage inclusion of underrepresented populations in studies.
These two responsibilities pull IRBs in competing directions. “IRB members tend to err toward protection over inclusion,” Friesen asserts.
Friesen and colleagues encouraged fellow researchers to ask several questions when they are designing study protocols:
• Does this research exploit certain forms of vulnerability or exacerbate risk?
• What protections/safeguards would be most appropriate to mitigate the risks present in this research?
• Is there a way to ensure necessary protections and reduce risks without excluding certain groups or individuals?
• Are excluded groups unnecessarily denied benefits associated with the research?
• Which populations are excluded from this research, and are those exclusions justified?
• Which populations are included in this research, and are those inclusions justified?
Researchers must strike a balance between protecting and including participants in their protocol design. Friesen and colleagues suggested building in additional safeguards for those deemed vulnerable.
“We also acknowledge, however, that the federal regulations offer little clarity when it comes to such additional safeguards,” Friesen reports.
REFERENCE
1. Friesen P, Gelinas L, Kirby A, et al. IRBs and the protection-inclusion dilemma: Finding a balance. Am J Bioeth 2022 Apr 28;1-14. doi: 10.1080/15265161.2022.2063434. [Online ahead of print].
Researchers must strike a balance between protecting and including participants in their protocol design. Building in additional safeguards for those deemed vulnerable could help.
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