Resnik David B, Parasidis Efthimios, Carroll Kelly, Evans Jennifer M, Pike Elizabeth R, Kissling Grace E
IRB. 2014 Jan-Feb;36(1):12-9.
Federal research regulations require participants to be informed about whether medical care or compensation for injury is available in more than minimal risk studies and prohibit language in informed consent documents that waives, or appears to waive, legal rights. The objectives of this study were to compare data collected in 2000 and 2012 to identify significant changes in types of institutional compensation policies at U.S. research institutions, and assess the relationship between institutional characteristics and different types of policies. We found that research-related injury compensation policies did not change substantially during the time period. A significant percentage of policies contain language that can be reasonably interpreted as waiving, or appearing to waive, legal rights. Level of funding, public vs. private status, and institutional involvement in clinical research were associated with different types of policies. The lack of substantial change in compensation policies supports arguments for a national policy.
联邦研究法规要求，在风险超过最低限度的研究中，需告知参与者是否可获得医疗护理或伤害赔偿，并且禁止在知情同意文件中出现放弃或看似放弃合法权利的措辞。本研究的目的是比较2000年和2012年收集的数据，以确定美国研究机构机构赔偿政策类型的重大变化，并评估机构特征与不同类型政策之间的关系。我们发现，在这一时期，与研究相关的伤害赔偿政策没有实质性变化。很大一部分政策包含的措辞可被合理地解释为放弃或看似放弃合法权利。资金水平、公立与私立性质以及机构参与临床研究的情况与不同类型的政策相关。赔偿政策缺乏实质性变化支持了制定国家政策的观点。
