Jim Gearhart

by Jim Gearhart

One Protocol, Twenty-two IRB Reviews, How Many Differences?

NWABR 2016A packet of documents online recently showed how one study can produce a variety of IRB decisions. (IRB stands for “institutional review board,” the U.S. term for ethics committees that review medical research.) These documents included approvals or correspondence from 22 IRBs about iCOMPARE, a study of medical student work hours. A public advocacy group, Public Citizen, opposes the trial, and this packet of IRB correspondence appeared as part of the protest. (A New England Journal of Medicine article responded to Public Citizen complaints about a similar, earlier trial.)

The iCOMPARE study (clinicaltrials.gov trial #NCT02274818) examines any differences in quality of learning, work-life balance, and patient outcomes when comparing two types of work schedules for internal medicine interns.

In this study, 39 research sites agreed to use an IRB of Record to approve and oversee the research. For the remaining researchers, another 21 local IRBs had to consider the same study. The methods of review and the decisions for those 22 IRBs (half were accredited, half were not) broke down into seven categories.

  1. Exemption from IRB Review (eight local IRBs): These IRBs (or administrators working with the IRBs) determined the research did not require IRB review or oversight, because
    • (Exemption Category 1) The research was conducted in established or commonly accepted educational settings, involving normal educational practices; and/or
    • (Exemption Category 2) The research involved the use of educational tests, survey procedures, interview procedures, or the observation of public behavior.
  2. Not Research on Human Subjects (two local IRBs): Two of the IRBs, one accredited, one not, found that the study did not meet the formal definition of research involving human subjects.
  3. Expedited Review with a waiver of consent (two local IRBs, IRB of Record): Two of the local IRBs reached the same conclusion as the IRB of record, that (1) the study presented minimal risk and (2) that a complete, formal informed consent process was not necessary.
  4. Expedited Review without a waiver of consent (two local IRBs): These IRBs may have relied on their institutions’ own consent form language and requirements rather than accepting the waiver of consent.
  5. Convened Board with a waiver of informed consent (two local IRBs)
  6. Convened Board without a waiver of informed consent (three local IRBs): In cases 5 and 6, the study went through full IRB reviews involving all members of the committees. Three of those convened boards required consent, while two agreed with the waiver.
  7. Other (two local IRBs): Two organizations determined that an IRB review was unnecessary, even “inappropriate.”

What is notable in this collection of decisions? Firstly, the level of effort involved in reviewing the research varied widely. At one end, investigators under the single IRB of record applied that decision without much effort past the initial review. Further along the spectrum of effort appeared an email response that said, “We don’t need to review this,” followed by the formal determinations that the study was exempt from IRB review. The four convened-board reviews stood at the far end of the effort scale, with all members of a board considering and discussing the protocol formally.

Also, accreditation  did not seem to affect the decisions or method of review. Half of the 22 organizations were accredited, half were not, and the seven review/decision combinations had nearly equal shares of accredited versus non-accredited organizations.

Last year the NIH, the House of Representatives, and the signatories of the Common Rule endorsed policies that encouraged a single IRB of record instead of multiple reviews. How would iCOMPARE have fared under such a policy? Did the additional 21 reviews improve the protection of the study subjects? The answer here seems to be not really.  For all of the additional attention, and apparent variety in conclusions, the 22 decisions endorsed very similar approaches to informing and handling participants.

 

Tags: , , , ,