IRB delays in federally funded research in the U.S. military “often appear in the service of managing institutional risk, rather than protecting research participants,” researchers report.1 Military IRBs may thus “err on the side of bureaucracy,” but the delays can place unnecessary burdens and risks on human research subjects.

On the other extreme, “military members are exposed to untested or under-tested interventions, implemented by well-intentioned leaders who bypass the research process altogether,” study authors warn.

Overall, “the IRB review process within the military is viewed as more opaque, unpredictable, slow, and adversarial than what [we] have experienced in other U.S. government, public, and private settings, as well as in anecdotes presented in the literature,” the authors concluded. We asked the lead author to comment on the findings, and Michael C. Freed, PhD, EMT-B, of the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD, and licensed psychologist and owner of Capital Behavioral Health & Wellness, LLC, provided the following answers.

IRB Advisor: The delays described seem to be often bureaucratic, but could an argument be reasonably made that perhaps human research and ethical oversight involving military subjects should proceed at a slower pace than research in general? For example, trials may involve something like anthrax vaccine for this special population, or any research-supported intervention could be “mandated,” given the command structure of the military.

Freed: In the paper, we argued for an efficient administrative process to ensure research protocols receive timely reviews. Delays have adverse effects on studies and create unnecessary burden on study participants that are usually overlooked. Rigor in the review is important, as is timely return of review results. We did not argue for an expedient IRB review at the expense of thoughtfulness and rigor. While pace of review might be equated with rigor, one needs to be mindful to not conflate the two.

In our “Case Example 1,” [dealing with post-traumatic stress disorder in veterans] we took no issue with the review of the IRB itself. Rather, we experienced challenges with the administrative processes at the front and back end of the review process. To your point, yes, high-risk studies should receive increased scrutiny. IRBs do this already (e.g., expedited and exempt reviews). But again, increased rigor does not necessarily necessitate a slower pace of review.

IRB Advisor: That said, you clearly state that, “we accept the necessity of regulatory review and see its value in protecting human subjects from harm and ensuring quality of research.” Can you discuss a few of the practical solutions proposed to streamline the process without increasing risk to research subjects?

Freed: Sure. We make the case that more review is not necessarily better or safer review. We make a few pragmatic suggestions:

  • Standardization of IRB processes and forms across the Department of Defense.
  • Priorities for federally funded studies, rather than priority of protocol receipt.
  • Transparency of processes and the collection of metrics to help with accountability, identify bottlenecks, and create benchmarks which can be measured and improved.
  • Examination of the order and necessity of a science review, in places where this happens.

Of note, we were equivocal on a centralized IRB as a suggestion, as a centralized system would not necessarily guarantee a more efficient review, as bottlenecks could still occur.

IRB Advisor: In what seems to be analogous to the old “justice delayed is justice denied” adage, you and colleagues raise the point that a stalled review process may give rise to ethical questions about the research and human subjects. Can you please elaborate on this concern and the ways that IRBs should figure this into their overarching goal of ensuring safe, ethical research?

Freed: The adage is a nice analogy. If studies cannot be completed properly because of IRB-related administrative delays, then the burden to participants is, by definition, unnecessary. What we are talking about here is about protecting research participants from undue burden — harm. In our “Case Example #2” [in which a military commander decided to proceed with use of fatigue monitoring devices for helicopter pilots after prolonged IRB delay], military leaders who wanted to implement and use the device in the field were not required to follow IRB protocol. Presumably, there were other administrative controls in place, but I cannot speak to those. We attempted to highlight an issue, which speaks to scope of IRB influence and the challenges with trying to align a time-sensitive opportunity for research with a regulatory system charged with ensuring human subjects protection. To the extent the IRB delay here was administrative, then our suggestions above may have helped researchers secure a definitive answer sooner.

Editor’s note: Dr. Freed wishes to state the views expressed are those of the author(s) and not necessarily those of USUHS or any other organization, public or private.

REFERENCE

  1. Freed MC, Novak LA, Kilgore DS, et al. IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom? American Jrl Bioethics 2016;16(8):30–37.