Protecting and respecting the vulnerable: existing regulations or further protections?
- 582 Downloads
Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research.
KeywordsVulnerable populations Federal regulations Economically vulnerable Cognitive impairment Mission creep Research ethics
The author would like to thank Ann Jeschke for her tireless editing and formatting assistance. The author also acknowledges the financial support from grant UL1 RR024992 from the NIH National Center for Research Resources.
- 3.McGee, Glen, ed. 2004. American Journal of Bioethics 4(3).Google Scholar
- 6.Stineman, Margaret G., and David W. Musick. 2001. Protection of human subjects with disability: Guidelines for research. Archives of Physical Medicine and Rehabilitation 82(12S): 9–14.Google Scholar
- 7.National Commission for the Protection of Human Subjects of Biomedical Research. 1978. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington: US Government Printing Office.Google Scholar
- 8.White, Ronald F. 2007. Institutional Review Board mission creep: The Common Rule, social science, and the nanny state. Independent Review 11(4): 547–564.Google Scholar
- 9.U.S. Code of Federal Regulations. 2009. Protection of human subjects. 45 CFR 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed Jan 9, 2013.
- 11.Epstein, Steven. 2007. Inclusion: The politics of difference in medical research. Chicago: University of Chicago Press.Google Scholar
- 18.Kipnis, Kenneth. 2001. Vulnerability in research subjects: A bioethical taxonomy. In Ethical and policy issues in research involving human participants, vol. 2, G-1. Bethesda: National Bioethics Advisory Council.Google Scholar
- 23.DuBois, James M., Laura Beskow, Jean Campbell, Karen Dugosh, David Festinger, Sarah Hartz, Rosalina Hartz, and Charles Lidz. 2012. Restoring balance: A consensus statement on the protection of vulnerable research participants. American Journal of Public Health 102(12): 2220–2225.CrossRefGoogle Scholar
- 24.Jeste, Dilip V., ed. 2002. American Journal of Geriatric Psychiatry 10(2).Google Scholar
- 25.Denny, Colleen C., and Christine Grady. 2007. Clinical research with economically disadvantaged populations. British Medical Journal 33(7): 382–385.Google Scholar
- 31.Wertheimer, Allen. 1999. Exploitation. Princeton: Princeton University Press.Google Scholar
- 32.Varmus, Harold. 1994. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 59(59): 14508–14513.Google Scholar