Hastings Cent Rep. 2022 May;52(3):9-17. doi: 10.1002/hast.1391.
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.
研究伦理监督系统传统上强调知情同意过程是展示对潜在研究对象尊重的主要手段。然而，研究人员如何在实用临床试验（PCTs）中最好地履行尊重人的伦理义务——特别是那些可能改变或放弃知情同意的试验——仍然未知。我们提出了在 PCTs 中展示尊重的八个方面：（1）让患者和社区参与研究设计和执行，（2）促进透明度和开放沟通，（3）最大限度地发挥能动性，（4）最小化负担并促进可及性，（5）保护隐私和机密性，（6）重视与临床医生和研究团队成员的人际互动，（7）提供补偿，（8）最大限度地提高社会价值。虽然在 PCT 背景下尊重需要什么将取决于具体 PCT 的性质，但这些方面的广泛程度表明，尊重义务超出了知情同意过程。
