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ABSTRACT. The right to withdraw from participation in research is recognized in virtually all national and international guidelines for research on human subjects. It is therefore surprising that there has been little justification for that right in the literature. We argue that the right to withdraw should protect research participants from information imbalance, inability to hedge, inherent uncertainty, and untoward bodily invasion, and it serves to bolster public trust in the research enterprise. Although this argument is not radical, it provides a useful way to determine how the right should be applied in various cases.
It is universally accepted that participants in biomedical research have the right to withdraw from participation at any time, except, perhaps, when withdrawal would constitute a threat to their health or the health of others. The right to withdraw is encoded in nearly every document on the requirements for ethical conduct of research on humans, including the U.S. Code of Federal Regulations governing all federallyfunded research, the Common Rule (45 CFR 46); the Declaration of Helsinki (WMA 2008); the 2002 research guidelines of the Council for International Organizations of Medical Sciences (CIOMS 2002); and the Belmont Report (National Commission 1979). Presumably, if codification of the right in these guidelines were meant merely to prevent investigators from physically compelling subjects to remain in a trial, they would be unnecessary as such protections are already afforded in common law. After all, even if consent to participate in a trial constituted a promise or contract to complete the trial (barring unforeseen adverse events), the U.S. legal system does not ordinarily require a party to perform a specific act ("specific performance"), although one can be required to compensate another party for breach of contract (American Law Institute 1981). So the crucial issue is not whether subjects can be physically coerced into completing a trial. They cannot. To use the language of CIOMS as a framework, the question is whether and why subjects have the right to withdraw without penalty or the loss of benefits to which the subject is otherwise entitled. (We often use "right to withdraw" as shorthand for this more elaborate formulation).
Despite its near universal acceptance, it is not clear how the right to withdraw is best understood. Is it...