{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:16:38Z","timestamp":1788221798702,"version":"build-2803163510"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,1,13]],"date-time":"2021-01-13T00:00:00Z","timestamp":1610496000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["aspenjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Nut in Clin Prac"],"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The history of human subjects research and the abuses that led to the creation of the United States\u2019 (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\n                    <jats:italic>Belmont Report<\/jats:italic>\n                    . 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\n                    <jats:italic>Belmont Report<\/jats:italic>\n                    .\n                  <\/jats:p>","DOI":"10.1002\/ncp.10623","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T07:51:36Z","timestamp":1610697096000},"page":"560-567","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["The History of Human Subjects Research and Rationale for Institutional Review Board Oversight"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4780-7595","authenticated-orcid":false,"given":"Ryan","family":"Spellecy","sequence":"first","affiliation":[{"name":"Center for Bioethics and Medical Humanities and Office of Research Medical College of Wisconsin  Milwaukee Wisconsin USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Busse","sequence":"additional","affiliation":[{"name":"School of Pharmacy Office of Research Medical College of Wisconsin  Milwaukee Wisconsin USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,1,13]]},"reference":[{"key":"e_1_2_11_2_1","article-title":"This Man's Gunshot Wound Gave Scientists a Window Into Digestion","author":"Eschner K.","year":"2021","journal-title":"Smithsonian Magazine. 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Accessed September 18 2020.https:\/\/encyclopedia.ushmm.org\/content\/en\/article\/nazi-medical-experiments"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.2105\/AJPH.2017.304203"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.2307\/3528467"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinids\/8.1.157"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/0035-9203(72)90091-0"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM195910082611501"},{"key":"e_1_2_11_12_1","unstructured":"The U.S. National Archives and Records Administration. eCFR\u202f:: Title 45. Accessed October 4 2020.https:\/\/ecfr.federalregister.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46"},{"key":"e_1_2_11_13_1","unstructured":"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"},{"key":"e_1_2_11_14_1","unstructured":"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 \u201cminimal risk\u201d. Published March 24 2016. Accessed November 18 2020.https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/2008-january-31-letter\/index.html"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.2307\/3561798"},{"key":"e_1_2_11_16_1","unstructured":"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"},{"key":"e_1_2_11_17_1","unstructured":"Centers for Disease Control and Prevention. TheTuskegee timeline. Published July 16 2020. Accessed September 21 2020.https:\/\/www.cdc.gov\/tuskegee\/timeline.htm"},{"key":"e_1_2_11_18_1","volume-title":"Bad Blood: The Tuskegee Syphilis Experiment, New and Expanded Edition","author":"Jones JH.","year":"1993"},{"key":"e_1_2_11_19_1","unstructured":"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"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001193"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/ncp.10433"}],"container-title":["Nutrition in Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ncp.10623","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ncp.10623","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ncp.10623","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,20]],"date-time":"2025-10-20T12:13:04Z","timestamp":1760962384000},"score":1,"resource":{"primary":{"URL":"https:\/\/aspenjournals.onlinelibrary.wiley.com\/doi\/10.1002\/ncp.10623"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,13]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1002\/ncp.10623"],"URL":"https:\/\/doi.org\/10.1002\/ncp.10623","archive":["Portico"],"relation":{},"ISSN":["0884-5336","1941-2452"],"issn-type":[{"value":"0884-5336","type":"print"},{"value":"1941-2452","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,13]]},"assertion":[{"value":"2020-10-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-12-01","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-13","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}