Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-26T09:21:16.864Z Has data issue: false hasContentIssue false
  • English
  • Français

The Inalienable Right to Withdraw from Research

Published online by Cambridge University Press:  01 January 2021

Terrance McConnell
Get access Rights & Permissions [Opens in a new window]

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.”

Type
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

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

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
Id., at 29.Google Scholar
Chwang, E., “Against the Inalienable Right to Withdraw from Research,” Bioethics 22, no. 7 (2008): 370–378.CrossRefGoogle Scholar
Spillman, M. A. and Sade, R. M., “Clinical Trials of Xenotransplantation: Waiver of the Right to Withdraw from a Clinical Trial Should Be Required,” Journal of Law, Medicine & Ethics 35, no. 2 (2007): 265–272.CrossRefGoogle Scholar
See Chwang, , supra note 3, at 370.Google Scholar
See Spillman, and Sade, , supra note 4, at 266–268.Google Scholar
Sumner, L. W., The Moral Foundation of Rights (New York: Oxford University Press, 1987): At Chapter 2.Google Scholar
McConnell, T., Inalienable Rights: The Limits of Consent in Medicine and the Law (New York: Oxford University Press, 2000): at 5–7Google Scholar
Id., at 8–11.Google Scholar
This account is not stipulative. For a defense, see id., at 12–14 and 18–19. See also, Black's Law Dictionary, 8th ed. (St. Paul, MN: West Publishing, 2004): At 1348; Kronman, A. T., “Paternalism and the Law of Contracts,” Yale Law Journal 92, no. 5 (1983): At 775; and Rose-Ackerman, S., “Inalienability and the Theory of Property Rights,” Columbia Law Review 85, no. 5 (1985): at 931.CrossRefGoogle Scholar
See McConnell, , supra note 8, at 24–31.Google Scholar
See Chwang, , supra note 3, at 374.Google Scholar
Id., at 375.Google Scholar
Id., at 371–372.Google Scholar
See Spillman, and Sade, , supra note 4, at 266–267.Google Scholar
Once a survey has been completed, one might wonder what further interests of subjects could be implicated. To cite just one possibility, subjects may have developed moral objections to the study and not wish to be complicit in any way with such a project.Google Scholar
See Spillman, and Sade, , supra note 4, at 269.Google Scholar
Id., at 269. See also, Florencio, P. S. and Ramanathan, E. D., “Legal Enforcement of Xenotransplantation Public Health Safeguards,” Journal of Law, Medicine & Ethics 32, no. 1 (2004): 117–123.CrossRefGoogle Scholar
Id., at 270.Google Scholar
There may be reason to doubt this, however. See Gostin, L. O., Public Health Law, 2nd ed. (Berkeley, CA: University of California Press, 2008): at 400–404, for a discussion of when compulsory screening and conditional screening are justified.Google Scholar
See Chwang, , supra note 3, at 371.Google Scholar
See McConnell, , supra note 8, at 83–85.Google Scholar
Id., at 12 and 52.Google Scholar
Menikok, E. and Richards, E. P., What the Doctor Didn't Say: The Hidden Truth about Medical Research (New York: Oxford University Press, 2006): At 45, arguing that a patient's waiver of the right not to sue for malpractice is not recognized by the law because it is “against public policy.”
See Kronman, , supra note 10, at 778–779.Google Scholar