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 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 Citations (Scopus)

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

Fingerprint

Research Ethics Committees
Health
Research
Veterans
Sample Size
Research Personnel
Population

Keywords

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

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

Cite this

IRB and Research Regulatory Delays Within the Military Health System : Do They Really Matter? And If So, Why and for Whom? / Freed, Michael C.; Novak, Laura A.; Killgore, William; Rauch, Sheila A M; Koehlmoos, Tracey P.; Ginsberg, J. P.; Krupnick, Janice L.; Rizzo, Albert Skip; Andrews, Anne; Engel, Charles C.

In: American Journal of Bioethics, Vol. 16, No. 8, 02.08.2016, p. 30-37.

Research output: Contribution to journalArticle

Freed, MC, Novak, LA, Killgore, W, Rauch, SAM, Koehlmoos, TP, Ginsberg, JP, Krupnick, JL, Rizzo, AS, Andrews, A & Engel, CC 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, vol. 16, no. 8, pp. 30-37. https://doi.org/10.1080/15265161.2016.1187212
Freed, Michael C. ; Novak, Laura A. ; Killgore, William ; Rauch, Sheila A M ; Koehlmoos, Tracey P. ; Ginsberg, J. P. ; Krupnick, Janice L. ; Rizzo, Albert Skip ; Andrews, Anne ; Engel, Charles C. / IRB and Research Regulatory Delays Within the Military Health System : Do They Really Matter? And If So, Why and for Whom?. In: American Journal of Bioethics. 2016 ; Vol. 16, No. 8. pp. 30-37.
@article{83443e5a55614498abb103765eb7ba8f,
title = "IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?",
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.",
keywords = "human subjects research, IRB (institutional review board), Keywords, regulatory issues, research ethics",
author = "Freed, {Michael C.} and Novak, {Laura A.} and William Killgore and Rauch, {Sheila A M} and Koehlmoos, {Tracey P.} and Ginsberg, {J. P.} and Krupnick, {Janice L.} and Rizzo, {Albert Skip} and Anne Andrews and Engel, {Charles C.}",
year = "2016",
month = "8",
day = "2",
doi = "10.1080/15265161.2016.1187212",
language = "English (US)",
volume = "16",
pages = "30--37",
journal = "American Journal of Bioethics",
issn = "1526-5161",
publisher = "Routledge",
number = "8",

}

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

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.

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 - human subjects research

KW - IRB (institutional review board)

KW - Keywords

KW - regulatory issues

KW - research ethics

UR - http://www.scopus.com/inward/record.url?scp=84983087343&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84983087343&partnerID=8YFLogxK

U2 - 10.1080/15265161.2016.1187212

DO - 10.1080/15265161.2016.1187212

M3 - Article

C2 - 27366845

AN - SCOPUS:84983087343

VL - 16

SP - 30

EP - 37

JO - American Journal of Bioethics

JF - American Journal of Bioethics

SN - 1526-5161

IS - 8

ER -