TY - JOUR
T1 - IRB and Research Regulatory Delays Within the Military Health System
T2 - Do They Really Matter? And If So, Why and for Whom?
AU - Freed, Michael C.
AU - Novak, Laura A.
AU - Killgore, William D.S.
AU - Rauch, Sheila A.M.
AU - Koehlmoos, Tracey P.
AU - Ginsberg, J. P.
AU - Krupnick, Janice L.
AU - Rizzo, Albert Skip
AU - Andrews, Anne
AU - Engel, Charles C.
N1 - Publisher Copyright:
© 2016, Copyright © Taylor & Francis Group, LLC.
PY - 2016/8/2
Y1 - 2016/8/2
N2 - 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.
AB - 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.
KW - IRB (institutional review board)
KW - Keywords
KW - human subjects research
KW - regulatory issues
KW - research ethics
UR - http://www.scopus.com/inward/record.url?scp=84983087343&partnerID=8YFLogxK
U2 - 10.1080/15265161.2016.1187212
DO - 10.1080/15265161.2016.1187212
M3 - Article
C2 - 27366845
AN - SCOPUS:84983087343
SN - 1526-5161
VL - 16
SP - 30
EP - 37
JO - American Journal of Bioethics
JF - American Journal of Bioethics
IS - 8
ER -