Participants’ Responsibilities in Clinical Research

Discussions of the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions, and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent, adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enroll in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one’s self or others, beneficence, and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process and should stress the importance of fulfilling study requirements. They should address any impediments to compliance and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements. Key words: clinical research, ethics, participants, responsibilities, compliance Introduction

Discussions of the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions, and institutional review boards (IRBs), but very little about the responsibilities of research participants. Investigators are responsible for protecting the rights and welfare of participants, for designing, executing and managing the study, for ensuring the integrity of the data, and for reporting adverse events and unanticipated problems. Sponsors are responsible for providing investigators with financial support, designing the study (except for investigator-initiated research), preparing regulatory and legal documents, monitoring and auditing...