Rothstein Mark A
Director of translational bioethics at the Institute for Clinical and Translational Science at the University of California, Irvine.
Ethics Hum Res. 2025 Sep-Oct;47(5):29-36. doi: 10.1002/eahr.60035.
Physicians engaged in clinical research have dual roles as members of the research team and as physicians. Although various medical ethics codes and associated ethics opinions state that physicians have substantially similar obligations to research participants as they have to patients, the reality is different. Research physicians follow study protocols that often require practices that depart from the standard of care. The proposed Bill of Rights for Clinical Research Participants incorporates key ethics principles from the physician-patient relationship, some of which already are reflected in provisions of the ethics codes and opinions addressing nontraditional physician relationships. The Bill of Rights is intended to promote greater transparency and accountability in a frequently misunderstood relationship.
从事临床研究的医生兼具研究团队成员和医生这双重角色。尽管各种医学伦理准则及相关伦理意见表明,医生对研究参与者所负有的义务与对患者所负有的义务基本相似,但实际情况并非如此。参与研究的医生遵循的研究方案往往要求采取有别于医疗标准的做法。拟议的《临床研究参与者权利法案》纳入了医患关系中的关键伦理原则,其中一些原则已体现在涉及非传统医患关系的伦理准则及意见条款中。该《权利法案》旨在促进一种常被误解的关系中更高的透明度和问责制。