a Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury and Uniformed Services University of the Health Sciences.
b Deployment Health Clinical Center, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury.
Am J Bioeth. 2016 Aug;16(8):30-7. doi: 10.1080/15265161.2016.1187212.
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.
机构审查委员会 (IRB) 的延迟可能会阻碍美国军方获得联邦资金的研究的成功完成。当这种情况发生时，与时间敏感、任务相关的问题得不到解答。如果延迟挤压了招募时间表，导致没有足够的样本量进行明确的分析，研究参与者将面临不必要的负担和风险。更广泛地说，军事人员会接触到未经测试或测试不足的干预措施，这些措施是由善意的领导人实施的，他们完全绕过了研究过程。为了说明这一点，我们提供了两个案例示例。我们假设 IRB 延迟通常是为了管理机构风险，而不是保护研究参与者。监管机构可能认为快速行动的风险大于延迟的风险，因此选择在官僚主义方面犯错。本文的作者都是军方资助的研究人员、政府利益相关者和/或人体研究保护专家，他们提出了切实可行的建议来改进 IRB 系统，并最终改善军队、退伍军人和平民群体内的研究。
