Tsan Min-Fu, Nguyen Yen
1 McGuire Research Institute, Richmond, VA, USA.
2 U.S. Department of Veterans Affairs, Washington, DC, USA.
J Empir Res Hum Res Ethics. 2018 Jul;13(3):270-275. doi: 10.1177/1556264618776460. Epub 2018 May 18.
Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% ( M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.
常规现场审查应主要关注那些有伤害人类受试者风险的机构。利用来自107个机构的人类研究保护计划绩效指标数据，当某个机构的违规/事件发生率在该绩效指标的最高三项发生率之中时，我们将其定义为有风险的机构。基于2017年14项存在违规和事件的绩效指标，确定了27个有风险的机构。这27个有风险的机构虽仅占所有机构的25%，却导致了所有报告的违规/事件的70%±25%（均值±标准差；范围=32%-100%）。因此，绩效指标数据可用于指导合规监督活动。
