Article Text

other Versions

PDF
Paper
Participants’ responsibilities in clinical research
  1. David B Resnik1,
  2. Elizabeth Ness2
  1. 1National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Research Triangle Park, North Carolina, USA
  2. 2National Cancer Institute (NCI), National Institutes of Health (NIH), Bethesda, Maryland, USA
  1. Correspondence to
    Dr David B Resnik, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), 111 Alexander Drive, PO Box 12233, CU 03, Mail Drop CU 108, Research Triangle Park, NC 27709, USA; resnikd{at}niehs.nih.gov

Discussions on 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 enrol 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.

Statistics from Altmetric.com

Footnotes

  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles

  • The concise argument
    Bennett Foddy