期刊
HASTINGS CENTER REPORT
卷 52, 期 3, 页码 9-17出版社
WILEY
DOI: 10.1002/hast.1391
关键词
consent; pragmatic clinical trials; PCT; respect; clinical ethics; research ethics; bioethics
This article proposes eight dimensions for demonstrating respect in pragmatic clinical trials, including engaging patients and communities in research design and execution, promoting transparency, maximizing agency, minimizing burdens, protecting privacy, valuing interpersonal interactions, providing compensation, and maximizing social value.
Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据