IRBs May Need to Seek Outside Expertise; More Data Are Needed
When reviewing study protocols, IRBs might need to call on outside expertise. “Lack of appropriate expertise among IRB members has significant potential to negatively affect IRB effectiveness and quality,” says Kimberley Serpico, MEd, CIP, associate director of IRB operations at the Harvard T.H. Chan School of Public Health.
Serpico and colleagues identified gaps in the published literature on when, why, and how IRBs consult with outside experts.1 “There is limited understanding of how IRBs obtain assistance with review, when needed,” Serpico says.
The HHS Common Rule allows IRBs to obtain assistance from outside individuals to review protocols that require expertise beyond what is available on the IRB.2 However, Serpico and colleagues found almost no data on the extent to which IRBs use outside experts, or why they use them (for what types of topics, designs, or populations). “We already knew going into the project that there was a very limited body of research on this topic. But once we got further into writing this paper, we understood how truly incomplete it was — and is,” Serpico says. “There are no empirical data on this topic.”
IRBs review all kinds of study protocols involving vulnerable populations; legal issues; drugs, devices, and biologics; technology; and cultural context, both domestic and international. “It’s impossible for any IRB to claim an exhaustive range of methodological and disciplinary expertise within their membership,” Serpico says.
Without the right expertise, the quality of IRB review comes into question. “But for a variety of reasons, IRBs may not be taking advantage of the option to use outside experts,” Serpico says.
IRB members may struggle to find a consultant with the risk expertise. IRBs also might be concerned that acknowledging the need for outside expertise could lead to the perception the IRB is not adequately composed.
Serpico and colleagues outlined a research agenda on what is needed to meaningfully study how, when, and why IRBs use outside experts. “With this paper, we begin to expand what is known on this topic. But this is just the start,” Serpico says.
Learning from IRBs with strong processes for consulting with outside experts could benefit the research community in many ways. “A deeper study of IRB engagement with outside experts could help address knowledge gaps, identify strengths and weaknesses of existing practices, facilitate learning from the experiences of other IRBs, and indicate areas where further guidance may be needed,” Serpico offers.
Rodney Hicks, PhD, APRN, FAANP, FAAN, associate dean for research and administration at Western University, says, “my institution has 400 scientists and 11 IRB members. Obviously, 11 people cannot represent all those scientific backgrounds.”
Recently, the IRB consulted outside experts after multiple researchers asked for permission to use leftover biobank samples collected from previous research projects (either their own or others). The ethical dilemma for the IRB was the people represented by those specimens never gave permission for retaining the sample or releasing the sample for other studies. “Just because you saved it, does it make it yours? The answer is, really, it doesn’t,” Hicks says.
To prepare for cases like this, Hicks recommends IRB chairs review what is included in their policy manuals. “Verify that it has the verbiage from the federal regulations stating that outside experts can be consulted,” Hicks says.
REFERENCES
- Serpico K, Rahimzadeh V, Anderson EE, et al. Institutional review board use of outside experts: What do we know? Ethics Hum Res 2022;44:26-32.
- §45 CFR 46.107(e).
It is impossible for any IRB to claim an exhaustive range of methodological and disciplinary expertise within their membership. Without the right expertise, the quality of IRB review comes into question. But for a variety of reasons, IRBs may not be taking advantage of the option to use outside experts.
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