title: The need for reform of human subjects protections in military health research.
abstract: 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.
authors.affiliation: School of Nursing and Psychiatry, Medical School, University of Michigan, 400 North Ingalls Building, Ann Arbor, MI 48109, USA.
authors.forename: Reg Arthur
authors.initials: RA
authors.lastname: Williams
authors.forename: Gary
authors.initials: G
authors.lastname: Gatien
authors.forename: Bonnie M
authors.initials: BM
authors.lastname: Hagerty
mesh_terms: D035841:Behavioral Research; D028744:Ethics Committees, Research / Q000458:organization & administration*; D019317:Evidence-Based Medicine; D018166:Health Care Reform; D006805:Human Experimentation / Q000941:ethics; D006801:Humans; D008887:Military Medicine; D008889:Military Personnel; D012106:Research; D035842:Research Subjects