A new National Institutes of Health (NIH) policy mandates that all domestic sites participating in multicenter research studies use a single institutional review board (IRB).1 Eric Juengst, PhD, director of the University of North Carolina (UNC) Center for Bioethics in Chapel Hill, has some ethical concerns about this requirement.
“The main ethical concern that challenges all efforts at centralized review for multicenter studies is the loss of local perspectives on the issues involved in recruiting, informing, and respecting human research participants,” he explains.
Different sites draw from populations in different socioeconomic and environmental conditions, and with different relationships between the community and the biomedical research enterprise.
“The de-centralized approach, for all its inefficiency, allowed reviewers with local knowledge to take these differences into account,” says Juengst. This ensured “precision protection” for research participants, he adds, just as “precision medicine” aspires to use individualized data to tailor clinical interventions.
Another ethical concern: When the centralized review is undertaken by for-profit IRBs, the profit motive inevitably introduces risks of bias and conflict of interest. “It is a little ironic that NIH is advocating a one-size-fits-all approach to protecting human participants in research, just as that research is turning increasingly to the search of precision approaches that are dedicated to individualizing factors in healthcare,” says Juengst.
The rationale for the new NIH policy prescribing the use of single IRBs for multicenter trials is the need to increase the speed and efficiency of the research review process. The aim is to expedite research that might benefit patients and the public, says Juengst. However, he says, this comes at the expense of just the sort of “precision ethics” that the localized IRB system was designed to facilitate.
“This puts the research imperative in direct tension with the commitment to earning public trust that has enabled biomedical research to flourish as it has in the last decades,” Juengst concludes.
REFERENCE
- Final NIH policy on the use of a single institutional review board for multisite research. Federal Register 2016; 81(119): 40325-40331.
SOURCE
- Eric Juengst, PhD, Director, UNC Center for Bioethics, University of North Carolina, Chapel Hill. Phone: (919) 962-4340. Email: [email protected].
A new National Institutes of Health policy mandates that all domestic sites participating in multicenter research studies use a single institutional review board.
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