The History of Human Subjects Research and Rationale for Institutional Review Board Oversight.
ethics
institutional review board
research
research ethics committees
Journal
Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition
ISSN: 1941-2452
Titre abrégé: Nutr Clin Pract
Pays: United States
ID NLM: 8606733
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
08
10
2020
accepted:
01
12
2020
pubmed:
14
1
2021
medline:
1
9
2021
entrez:
13
1
2021
Statut:
ppublish
Résumé
The history of human subjects research and the abuses that led to the creation of the United States' (US) regulatory schema for research, which includes institutional review boards (IRBs), is long and complex. However, when one understands the history, one can see direct links between those abuses and the regulations, as well as the ethical principles, contained in the Belmont Report. To that end, we provide a brief analysis of the history of human subjects research and its abuses, including a lesser known case (the atrocities committed by Nazi scientists and physicians during World War II) and infamous cases in the US (including the Tuskegee Syphilis Study and Willowbrook). With that history in hand, we will then seek to understand the regulations that govern human subjects research and the IRB by grounding them both in the ethical principles in the Belmont Report.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
560-567Informations de copyright
© 2021 American Society for Parenteral and Enteral Nutrition.
Références
Eschner K. This Man's Gunshot Wound Gave Scientists a Window Into Digestion. Smithsonian Magazine. Accessed September 8, 2021. https://www.smithsonianmag.com/smart-news/grisly-story-human-guinea-pig-alexis-st-martin-180963520/
William Beaumont And Alexis St. Martin JAMA. 1962;182(8):863-865.
Spitz V. Doctors from Hell: The Horrific Account of Nazi Experiments on Humans. Illustrated Edition. Sentient Publications; 2005.
NOVA Online. The experiments. Accessed September 18, 2020. https://www.pbs.org/wgbh/nova/holocaust/experiside.html
Holocaust Encyclopedia. Nazi Medical Experiments. Accessed September 18, 2020. https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments
Annas GJ, Grodin MA. Reflections on the 70th anniversary of the nuremberg doctors’ trial. Am J Public Health. 2017;108(1):10-12.
Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust the fragile foundation of contemporary biomedical research. Hastings Cent Rep. 1996;26(5):25-29.
Krugman S. The willowbrook hepatitis studies revisited: ethical aspects. Rev Infect Dis. 1986;8(1):157-162.
Yoeli M, Most H, Hammond J, Scheinesson GP. Parasitic infections in a closed community: Results of a 10-year survey in Willowbrook State School. Trans R Soc Trop Med Hyg. 1972;66(5):764-776.
Krugman S, Ward R, Giles JP, Bodansky O, Jacobs AM. Infectious Hepatitis. N Engl J Med. 1959;261(15):729-734.
The U.S. National Archives and Records Administration. eCFR :: Title 45. Accessed October 4, 2020. https://ecfr.federalregister.gov/current/title-45/subtitle-A/subchapter-A/part-46
U.S. Food and Drug Administration. Exception from informed consent requirements for emergency research. Published April 21, 2020. Accessed October 7, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
U.S. Department of Health and Human Services. January 31, 2008 SACHRP letter to HHS Secretary: recommendations related to waiver of informed consent and interpretation of “minimal risk”. Published March 24, 2016. Accessed November 18, 2020. https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2008-january-31-letter/index.html
Rothman DJ. Were Tuskegee & Willowbrook ‘Studies in Nature’? Hastings Cent Rep. 1982;12(2):5-7.
Tuskegee University. About the USPHS syphilis study. Accessed September 21, 2020. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study
Centers for Disease Control and Prevention. The Tuskegee timeline. Published July 16, 2020. Accessed September 21, 2020. https://www.cdc.gov/tuskegee/timeline.htm
Jones JH. Bad Blood: The Tuskegee Syphilis Experiment, New and Expanded Edition. Illustrated Edition. Free Press; 1993.
U.S. Department of Health and Human Services. The Belmont Report. Published January 28, 2010. Accessed September 30, 2020. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
London AJ, Jr DAB, Bhan A. Network for the EWG of the HPT. Improving ethical review of research involving incentives for health promotion. PLOS Med. 2012;9(3):e1001193.
Kight CE, Bouche JM, Curry A, et al. Consensus recommendations for optimizing electronic health records for nutrition care. Nutr Clin Pract. 2020;35(1):12-23.