Friday, May 13, 2016

Medical researchers call for IRB clarity

Two medical researchers and a bioethicist, all affiliated with the UC Davis Center for Healthcare Policy and Research, call for IRBs to “reduce researchers’ frustrations and foster greater trust” by offering “transparency and accountability around IRB decisions.”

[Stephen G. Henry, Patrick S. Romano, and Mark Yarborough, “Building Trust Between Institutional Review Boards and Researchers,” Journal of General Internal Medicine, May 2, 2016, 1–3, doi:10.1007/s11606–016–3721–3.

Citing Abbott and Grady, Schneider, and Stark, the authors lament that “Many IRBs deliberate in isolation and either lack access to or do not make use of sufficient scientific, clinical, or ethical expertise relevant to the protocols they review. Research shows that IRBs tend to adjudicate protocols in a disjointed, ad hoc manner rather than proactively developing and promulgating policies that they then apply to protocols that involve substantive ethical concerns in regulatory gray zones.”

They call for IRBs and the institutions they serve to:

  • “acknowledge [the broad discretion they possess] and then be willing to be held accountable for the manner in which they exercise it.”
  • “cite the specific sources that support their decisions, such as the Common Rule, written institutional policies, and/or IRB discretion.”
  • “specify whether decisions are driven by concerns for research participants or for institutions.”
  • “be explicit about the extent to which they used empirical evidence, if at all, to guide their decisions.”
  • establish “an organized appeals process … to mitigate the inherent power imbalance between researchers and IRBs.”

“Widespread implementation of these recommendations,” they hope, “will promote productive dialogue about research ethics within research institutions, and help to guard against the current prevailing focus on compliance. Implementation will also promote more consistent and defensible decisions from IRBs and greater trust between IRBs and researchers, both of which will strengthen public confidence in biomedical research.”

Sounds good, but I must note that since 1981 IRBs have been required to write minutes that show “the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.” Henry et al. are asking IRBs to obey the regulations they have been flouting for 35 years.

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