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The Inalienable Right to Withdraw from Research

Published online by Cambridge University Press:  01 January 2021

Terrance McConnell
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Extract

Consent forms given to potential subjects in research protocols typically contain a sentence like this: “You have a right to withdraw from this study at any time without penalty.” If you have ever served on an institutional review board (IRB) or a research ethics committee, you have no doubt read such a sentence often. Moreover, codes of ethics governing medical research endorse such a right. For example, paragraph 24 of the Declaration of Helsinki says, “The subject should be informed of the right… to withdraw consent to participate at any time without reprisal.” Similarly, section C of the Belmont Report says that subjects must be informed that they have the right “to withdraw at any time from the research.” And in section 46.116 of the Common Rule (issued by the United States Department of Health and Human Services), it says that one of the elements of informed consent must include a statement that “the subject may discontinue participation at any time without penalty or loss of benefit to which the subject is otherwise entitled.”

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 4 , Winter 2010 , pp. 840 - 846
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

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References

These documents are reprinted in Emanuel, E. J. et al., eds., Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary (Baltimore: Johns Hopkins University Press, 2003): At 31, 36, and 46, respectively.Google Scholar
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