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A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century

Published online by Cambridge University Press:  01 January 2021

Kyle B. Brothers ,
Suzanne M. Rivera ,
R. Jean Cadigan ,
Richard R. Sharp  and
Aaron J. Goldenberg
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Abstract

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Type
Columns: Currents in Contemporary Bioethics
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 1: Sharing Data in a Medical Information Commons , Spring 2019 , pp. 165 - 172
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Cadigan, R. J. et al., “Public Comments on Proposed Regulatory Reforms That Would Impact Biospecimen Research: The Good, the Bad, and the Puzzling,” IRB 37, no. 5 (2015): 1-10; S. M. Rivera et al., “CTSA Institution Responses to Proposed Common Rule Changes: Did They Get What They Wanted?” Journal of Empirical Research on Human Research Ethics 12, no. 2 (2017): 79-86.Google Scholar
Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” Federal Register 76, no. 143 (2011): 44512-44531.Google Scholar
Department of Health and Human Services, “Federal Policy for the Protection of Human Subjects,” Federal Register 80, no. 173 (2015): 53933-4061.Google Scholar
Id., at 53938.Google Scholar
Beecher, H. K., “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354-1360.Google Scholar
Lillie, E. O. et al., “The N-of-1 Clinical Trial: The Ultimate Strategy for Individualizing Medicine?” Personalized Medicine 8, no. 2 (2011): 161-173.CrossRefGoogle Scholar
Glasgow, R. E. et al., “National Institutes of Health Approaches to Dissemination and Implementation Science: Current and Future Directions,” American Journal of Public Health 102, no. 7 (2012): 1274-1281.CrossRefGoogle Scholar
Wolf, S. M. et al., “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361-384.CrossRefGoogle Scholar
Clayton, E. W., “Incidental Findings in Genetics Research Using Archived DNA,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 286-291.Google Scholar
Roden, D. M. et al., “Development of a Large-Scale De-Identified DNA Bio-bank to Enable Personalized Medicine,” Clinical Pharmacology and Therapeutics 84, no. 3 (2008): 362-369.CrossRefGoogle Scholar
Nuremburg Code, “Trials of War Criminals before the Nuernburg Miltary Tribunals under Control Council Law No. 10: Nuernburg, October 1946-April 1949,” (1947); World Medical Association, “WMA Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects” (1964).Google Scholar
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research” (1979).Google Scholar
Richardson, H. S. and Belsky, L., “The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking About the Clinical Care That Researchers Owe Their Subjects,” Hastings Center Report 34, no. 1 (2004): 25-33.CrossRefGoogle Scholar
See E. W. Clayton, supra note 9; Burke, W., Evans, B. J., and Jarvik, G. P., “Return of Results: Ethical and Legal Distinctions between Research and Clinical Care,” American Journal of Medical Genetics Part C: Seminars in Medical Genetics 166, no. 1 (2014): 105-111.Google Scholar
Beskow, L. M. and Burke, W., “Offering Individual Genetic Research Results: Context Matters,” Science Translational Medicine 2, no. 38 (2010): 38cm20.Google Scholar
Shalowitz, D. I. and Miller, F. G., “Disclosing Individual Results of Clinical Research: Implications of Respect for Participants,” Journal of the American Medical Association 294, no. 6 (2005): 737-740.CrossRefGoogle Scholar
Wolf, S. M., “Return of Individual Research Results and Incidental Findings: Facing the Challenges of Translational Science,” Annual Review of Genomics and Human Genetics 14 (2013): 557-577.CrossRefGoogle Scholar
Shore, N., “Re-Conceptualizing the Belmont Report,” Journal of Community Practice 14, no. 4 (2006): 5-26.CrossRefGoogle Scholar
Grady, C. et al., “Broad Consent for Research with Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42.CrossRefGoogle Scholar
See R. J. Cadigan et al., supra note 1.Google Scholar
Brothers, K. B. et al., “When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority,” The Journal of Pediatrics 168 (2016): 226-31.e1.Google Scholar
Beauchamp, T. L. and Childress, J. F., Principles of Biomedical Ethics (New York: Oxford University Press, 1979).Google Scholar
Beauchamp and Childress proposed autonomy, beneficence, non-maleficence, and justice as the four primary principles for bioethics. The Belmont Report proposes respect for persons, beneficence, and justice as the three principles that should ground human research ethics. There is significant overlap in these accounts, however. The discussion of respect for persons in the Belmont Report highlights that this principle encompasses autonomy. Similarly, non-maleficence can also be understood as a dimension of the principle of beneficence.Google Scholar
Vanderpool, H. Y., The Ethics of Research Involving Human Subjects: Facing the 21st Century (Frederick, MD: University Publishing Group, Inc., 1996).Google Scholar
Churchill, L. R., Fanning, J. B., and Schenck, D., What Patients Teach: The Everyday Ethics of Health Care (New York: Oxford University Press, 2016).Google Scholar
Id.Google Scholar
Vitak, J., Shilton, K., and Ashktorab, Z., “Beyond the Belmont Principles: Ethical Challenges, Practices, and Beliefs in the Online Data Research Community,” abstract from presentation at 19th ACM Conference on Computer-Supported Cooperative Work & Social Computing, printed in Proceedings of the 19th ACM Conference on Computer-Supported Cooperative Work & Social Computing (2016): 941-953.Google Scholar
See N. Shore, supra note 18.Google Scholar
Elster, J., Deliberative Democracy, vol. 1 (New York: Cambridge University Press, 1998); H. A. Linstone and M. Turoff, The Delphi Method (Reading, MA: Addison-Wesley, 1975).Google Scholar
Rivera, S. M. et al., “Modernizing Research Regulations Is Not Enough: It's Time to Think Outside the Regulatory Box,” American Journal of Bioethics 17, no. 7 (2017): 1-3.CrossRefGoogle Scholar
King, N. M., Henderson, G., and Stein, J., Beyond Regulations: Ethics in Human Subjects Research (Chapel Hill, NC: UNC Press Books, 1999).Google Scholar
Friesen, P. et al., “Rethinking the Belmont Report?” American Journal of Bioethics 17, no. 7 (2017): 15-21; E. Y. Adashi, L. B. Walters, and J. A. Menikoff, “The Belmont Report at 40: Reckoning with Time,” American Journal of Public Health 108, no. 10 (2018): 1345-1348.CrossRefGoogle Scholar