IRB and Research Regulatory Delays Within the Military Health System

Do They Really Matter? And If So, Why and for Whom?

Published in: The American Journal of Bioethics, v. 16, no. 8, Aug. 2016, p. 30-37

Posted on RAND.org on July 19, 2016

by Michael C. Freed, Laura A. Novak, William D. Killgore, Sheila A. Rauch, Tracey Perez Koehlmoos, J. P. Ginsberg, Janice L. Krupnick, Albert Skip Rizzo, Anne Andrews, Charles C. Engel

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Research Questions

  1. In what ways do delays to studies within the military's research regulatory system affect servicemembers and their families?
  2. How can processes be improved to reduce delays?

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations.

Key Findings

  • Administrative processes that do not factor risk to potential participants (e.g., obtaining signatures for institutional review or publication approval) can delay the start of data collection, delay the dissemination of results, and lead to dissemination of outdated findings.
  • Unclear timelines and requirements can hamper the progress of a study and create unnecessary costs.
  • Delays to study start times can reduce the number of participants and affect the collection of an adequate sample size, leading to lack of study power, non-definitive results, and potentially misleading type two (false negative) results.
  • IRB approval delays to time-sensitive studies can create missed opportunities to collect data on devices or processes that may harm or benefit service members or the military mission.
  • Delays can also push commanders to make decisions regarding the use of untested devices or processes without data regarding relative benefit versus harm to servicemembers and effects on the military mission.

Recommendations

  • Institutional review board (IRB) practices should be standardized across the Department of Defense to allow for more efficient coordination of multisite studies and reduce researchers' time spent on multiple, redundant processes.
  • Large, multisite federally funded studies should be prioritized for IRB review to help ensure timely research on issues with the greatest potential impact on servicemembers and their families.
  • Administrative and measurement collection processes should be made transparent to help researchers navigate the review process and help military sites anticipate staffing needs.
  • Waivers of scientific review should be granted for protocols that have already undergone scientific review.

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