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

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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.

Department of Health and Human Services, “Federal Policy for the Protection of Human Subjects,” Federal Register 80, no. 173 (2015): 53933-4061.

Id., at 53938.

H. K. Beecher , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354-1360.

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E. W. Clayton , “Incidental Findings in Genetics Research Using Archived DNA,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 286-291.

D. M. Roden 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.

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).

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See E. W. Clayton, supra note 9; W. Burke , B. J. Evans , and G. P. Jarvik , “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.

L. M. Beskow and W. Burke , “Offering Individual Genetic Research Results: Context Matters,” Science Translational Medicine 2, no. 38 (2010): 38cm20.

D. I. Shalowitz and F. G. Miller , “Disclosing Individual Results of Clinical Research: Implications of Respect for Participants,” Journal of the American Medical Association 294, no. 6 (2005): 737-740.

S. M. Wolf , “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.

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C. Grady et al ., “Broad Consent for Research with Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42.

See R. J. Cadigan et al., supra note 1.

K. B. Brothers 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.

T. L. Beauchamp and J. F. Childress , Principles of Biomedical Ethics (New York: Oxford University Press, 1979).

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.

H. Y. Vanderpool , The Ethics of Research Involving Human Subjects: Facing the 21st Century (Frederick, MD: University Publishing Group, Inc., 1996).

L. R. Churchill , J. B. Fanning , and D. Schenck , What Patients Teach: The Everyday Ethics of Health Care (New York: Oxford University Press, 2016).

Id.

J. Vitak , K. Shilton , and Z. Ashktorab , “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.

See N. Shore, supra note 18.

J. Elster , Deliberative Democracy, vol. 1 (New York: Cambridge University Press, 1998); H. A. Linstone and M. Turoff, The Delphi Method (Reading, MA: Addison-Wesley, 1975).

S. M. Rivera 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.

N. M. King , G. Henderson , and J. Stein , Beyond Regulations: Ethics in Human Subjects Research (Chapel Hill, NC: UNC Press Books, 1999).

P. Friesen 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.