Research Participant Bill of Rights: Clarifying the Role of Research Physicians

Abstract

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.