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 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, 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.”