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.
authors.affiliation: a Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury and Uniformed Services University of the Health Sciences.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Freed
authors.affiliation: b Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury.
authors.forename: Laura A
authors.initials: LA
authors.lastname: Novak
authors.affiliation: c University of Arizona, McLean Hospital, and Harvard Medical School.
authors.forename: William D S
authors.initials: WD
authors.lastname: Killgore
authors.affiliation: d Emory University School of Medicine and Atlanta VA Medical Center.
authors.forename: Sheila A M
authors.initials: SA
authors.lastname: Rauch
authors.affiliation: e Headquarters, U.S. Marine Corps and Uniformed Services University of the Health Sciences.
authors.forename: Tracey P
authors.initials: TP
authors.lastname: Koehlmoos
authors.affiliation: f William Jennings Bryan Dorn VA Medical Center and University of South Carolina School of Medicine.
authors.forename: J P
authors.initials: JP
authors.lastname: Ginsberg
authors.affiliation: g Georgetown University School of Medicine.
authors.forename: Janice L
authors.initials: JL
authors.lastname: Krupnick
authors.affiliation: h University of Southern California Institute for Creative Technologies.
authors.forename: Albert Skip
authors.initials: AS
authors.lastname: Rizzo
authors.affiliation: i Headquarters, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury and National Institute of Standards and Technology.
authors.forename: Anne
authors.initials: A
authors.lastname: Andrews
authors.affiliation: j Uniformed Services University of the Health Sciences and RAND Corporation.
authors.forename: Charles C
authors.initials: CC
authors.lastname: Engel
mesh_terms: D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D008887:Military Medicine; D008889:Military Personnel; D012108:Research Personnel; D012306:Risk
keywords: IRB (institutional review board); Keywords; human subjects research; regulatory issues; research ethics