Doerr Megan, Grayson Shira, Moore Sarah, Suver Christine, Wilbanks John, Wagner Jennifer
Sage Bionetworks, 2901 Third Avenue Seattle, WA 98121, USA,
Center for Translational Bioethics & Health Care Policy, Geisinger, 100 N. Academy Ave., MC 30-42, Danville, PA 17822, USA.
Pac Symp Biocomput. 2019;24:427-438.
The United States' Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants' rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program's informed consent processes.
美国的研究项目是一项纵向研究计划，有着宏伟的全国招募目标，包括招募生物医学研究中传统上代表性不足的人群，其中许多人地理流动性较高。该项目拥有分布式基础设施，关键的项目资源分布在美国各地。鉴于其计划持续时间以及在招募和项目资源方面的地理覆盖范围，随着时间推移，多种州和领地法律可能适用于该项目以及参与者权利的确定。在此，我们列出并讨论与该项目特别相关的州和领地指导意见及法规，以及我们将其纳入项目知情同意程序的方法。
