The need for reform of human subjects protections in military health research.

A number of factors currently hinder the ability of researchers to conduct military-funded research studies successfully in a timely fashion, including low-risk, psychosocial and behavioral, multisite studies. Our experiences and a review of the literature highlight examples of delays and wide varia...

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Bibliographic Details
Published in:Military Medicine Vol. 177; no. 2; pp. 204 - 209
Main Authors: Williams RA, Gatien G, Hagerty BM, Williams, Reg Arthur, Gatien, Gary, Hagerty, Bonnie M
Format: research Journal Article
Published: Oxford University Press / USA Feb2012
Online Access:View this record in EBSCOhost
Description
Summary:A number of factors currently hinder the ability of researchers to conduct military-funded research studies successfully in a timely fashion, including low-risk, psychosocial and behavioral, multisite studies. Our experiences and a review of the literature highlight examples of delays and wide variations in military and civilian Institutional Review Board (IRB) approvals. This article describes the specific experiences from a program of research over a 15-year period, required documents unrelated to protection of human subjects, onsite study principal investigators, examples from other research, and participant recruitment. Concern is raised about significant resources committed to nonstudy interventions, some described as "training," which fall outside of IRB review and its human subject protections. A broad initiative for evidenced-based research, particularly psychosocial and behavioral research, could become marginalized with limited resources redirected to technology-focused quick fixes and data collection during training. Possible solutions and initiatives are proposed that emphasize the need to reform IRB oversight and associated paperwork that is required to undertake military research.