IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?

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

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)30-37
Number of pages8
JournalAmerican Journal of Bioethics
Volume16
Issue number8
DOIs
StatePublished - Aug 2 2016

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Keywords

  • IRB (institutional review board)
  • Keywords
  • human subjects research
  • regulatory issues
  • research ethics

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

Cite this

Freed, M. C., Novak, L. A., Killgore, W. D. S., Rauch, S. A. M., Koehlmoos, T. P., Ginsberg, J. P., Krupnick, J. L., Rizzo, A. S., Andrews, A., & Engel, C. C. (2016). IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom? American Journal of Bioethics, 16(8), 30-37. https://doi.org/10.1080/15265161.2016.1187212