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Participants' responsibilities in clinical research
David B Resnik1, Elizabeth Ness
1National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Research Triangle Park, NC 27709, USA. resnikd@niehs.nih.gov
Journal of Medical Ethics
|July 24, 2012
Summary
Competent adult participants in clinical research have ethical responsibilities, including compliance with study protocols. Researchers must inform participants of these duties and support their fulfillment for ethical research conduct.
Area of Science:
- Bioethics
- Clinical Research Ethics
Background:
- Ethical and regulatory discussions in clinical research predominantly focus on researchers and institutions.
- The responsibilities of research participants are often overlooked in these discourse.
Purpose of the Study:
- To delineate the ethical responsibilities of participants in clinical research.
- To establish a framework for participant duties based on ethical principles.
Main Methods:
- Conceptual analysis of ethical duties in clinical research.
- Argumentation based on principles of promise-keeping, non-maleficence, beneficence, and reciprocity.
Main Results:
- Competent adult participants have obligations to comply with study requirements and agreed-upon terms.
- These responsibilities stem from ethical duties including promise-keeping and avoiding harm.
Conclusions:
- Investigators should clearly communicate participant responsibilities during the informed consent process.
- Addressing compliance barriers and offering incentives can support participant adherence; coercive measures are rarely justified.
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