The Inalienable Right to Withdraw from Research

UNCG Author/Contributor (non-UNCG co-authors, if there are any, appear on document)
Terrance C. McConnell, Professor (Creator)
The University of North Carolina at Greensboro (UNCG )
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Abstract: 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." (1) In each of these cases, there is no indication that the right is qualified in any way. There does appear to be a qualification in the first code of ethics for researchers, the Nuremberg Code, which says: "During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible." (2) It is important to note, however, that the Code says that this is a reason to allow subjects to withdraw; it does not imply that this is the only reason.

Additional Information

Language: English
Date: 2010
ethics, medicine, academic research, research ethics, research consent, informed consent, research methods

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