{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,6]],"date-time":"2024-09-06T17:47:34Z","timestamp":1725644854790},"reference-count":59,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,12,19]],"date-time":"2014-12-19T00:00:00Z","timestamp":1418947200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hastings Center Report"],"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:italic>SUPPORT, a study involving approximately 1,300 premature infants who were randomly assigned to treatment protocols that differed in whether they offered higher or lower levels of oxygen saturation, was purportedly an example of comparative effectiveness research performed in the intensive care unit. However, SUPPORT became highly controversial. One source of controversy involved the proper determination of \u201creasonably foreseeable risks.\u201d Commentators debated whether randomization to contrasting restrictive strategies that are within existing standard\u2010of\u2010care treatments imposed additional \u201creasonably foreseeable risks\u201d greater than what study participants would have received outside of the research. A second controversial issue had to do with disclosures in informed consent documents. This article explores these issues<\/jats:italic>.<\/jats:p><jats:p><jats:italic>We argue that randomization to contrasting restrictive interventions lying at the outer ends of \u201cstandard\u2010of\u2010care\u201d practices differs in important ways from unrestricted \u201cstandard\u2010of\u2010care\u201d practices available outside of a proposed study; that research involving such randomization might pose additional \u201creasonably foreseeable risks\u201d from what occurs in \u201cstandard\u2010of\u2010care\u201d practices; and that for trials whose study designs are similar to the SUPPORT study, respect for persons requires the disclosure of information about the nature of the experimental procedures and their risks<\/jats:italic>.<\/jats:p>","DOI":"10.1002\/hast.403","type":"journal-article","created":{"date-parts":[[2014,12,20]],"date-time":"2014-12-20T04:26:52Z","timestamp":1419049612000},"page":"21-29","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Were There \u201cAdditional Foreseeable Risks\u201d in the SUPPORT Study? <i>Lessons Not Learned from the ARDSnet Clinical Trials<\/i>"],"prefix":"10.1002","volume":"45","author":[{"given":"Henry J.","family":"Silverman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Didier","family":"Dreyfuss","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,12,19]]},"reference":[{"key":"e_1_2_8_2_1","first-page":"1959","article-title":"Target Ranges of Oxygen Saturation in Extremely Preterm Infants","author":"Carlo W. 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D.","year":"2013","journal-title":"Bioethics Forum"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000111"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.CCM.0000114814.62759.06"},{"key":"e_1_2_8_13_1","unstructured":"M.Carome S.Wolfe andR.Macklin \u201cAnalysis of the Complete Protocol and Consent Form for the SUPPORT Study: Lack of Informed Consent and a Failure to Ensure That Risks Were Minimized \u201d a report prepared for Secretary of Health and Human Services Kathleen Sebelius May 8 2013 athttp:\/\/www.citizen.org\/documents\/2124.pdf."},{"key":"e_1_2_8_14_1","unstructured":"Lantos \u201cOHRP and Public Citizen Are Wrong about Neonatal Research on Oxygen Therapy.\u201d"},{"key":"e_1_2_8_15_1","article-title":"The SUPPORT Study and the Standard of Care","author":"Shepherd L.","year":"2013","journal-title":"Bioethics Forum"},{"key":"e_1_2_8_16_1","unstructured":"Ibid."},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jp.7211067"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.849303"},{"key":"e_1_2_8_19_1","unstructured":"Office for Human Research Protections letter to the University of Alabama March 7 2013 at p. 9\u201010."},{"key":"e_1_2_8_20_1","unstructured":"Office for Human Research Protections letter to the ARDSNetwork October 7 2002 http:\/\/medschool.umaryland.edu\/geei\/docs\/OHRP_letter.pdf at p. 4."},{"key":"e_1_2_8_21_1","unstructured":"Office for Human Research Protections letter to the University of Alabama at Birmingham June 4 2013."},{"key":"e_1_2_8_22_1","unstructured":"Office for Human Research Protections letter to the ARDSNetwork October 7 2002 at p. 5."},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.CCM.0000162384.71993.A3"},{"key":"e_1_2_8_24_1","unstructured":"ARDSNetwork ARDSNetwork Investigators\u2019 Response to the October 7 2002 OHRP letter March 12 2003 http:\/\/medschool.umaryland.edu\/geei\/docs\/ardsnet_response.pdf."},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.851582"},{"key":"e_1_2_8_26_1","unstructured":"Macklin and Shepherd \u201cInformed Consent and Standard of Care.\u201d"},{"key":"e_1_2_8_27_1","unstructured":"Office for Human Research Protections letter to the University of Alabama March 7 2013 p. 5."},{"key":"e_1_2_8_28_1","unstructured":"Office for Human Research Protections letter to the ARDSNetwork October 7 2002 \u201d at p. 20."},{"key":"e_1_2_8_29_1","unstructured":"Wilfond \u201cQuality Improvement Ethics.\u201d"},{"key":"e_1_2_8_30_1","unstructured":"U.S. Department of Health and Human Services public meeting August 28 2013 p. 57."},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.849311"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.166.11.340"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200311-1577CP"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1401602"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-008-0999-6"},{"key":"e_1_2_8_36_1","unstructured":"U.S. Department of Health and Human Services public meeting August 28 2013 p. 68."},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.849312"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-004-2493-0"},{"key":"e_1_2_8_39_1","unstructured":"NICHD Neonatal Research Network \u201cThe Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants: The SUPPORT Trial \u201d August 28 2004 (revised September 16 2004; updated March 28 2005) athttp:\/\/www.nih.gov\/icd\/od\/foia\/library\/Protocol.pdf."},{"key":"e_1_2_8_40_1","unstructured":"Carome Wolfe and Macklin \u201cAnalysis of the Complete Protocol and Consent Form for the SUPPORT Study.\u201d"},{"key":"e_1_2_8_41_1","unstructured":"45 C.F.R. 46.111(a) (1) \u201cProtection of Human Subjects \u201d revised June 18 1991."},{"key":"e_1_2_8_42_1","unstructured":"ARDSNetwork \u201cResponse to the October 7 2002 OHRP Letter \u201d at p. 19\u201020."},{"key":"e_1_2_8_43_1","unstructured":"ARDSNetwork \u201cResponse to the October 7 2002 OHRP Letter \u201d p. 11."},{"key":"e_1_2_8_44_1","unstructured":"NICHD Neonatal Research Network \u201cThe Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants.\u201d"},{"key":"e_1_2_8_45_1","unstructured":"45 C.F.R. 46. 111 Protection of Human Subjects Rev. June 18 (1991)."},{"key":"e_1_2_8_46_1","doi-asserted-by":"crossref","first-page":"766","DOI":"10.1056\/NEJMhle1313674","article-title":"Informed Consent, Comparative Effectiveness, and Learning Health Care","author":"Faden R. R.","year":"2014","journal-title":"New England Journal of Medicine"},{"key":"e_1_2_8_46_2","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1056\/NEJMhle1312508","article-title":"Informed Consent for Pragmatic Trials\u2014The Integrated Consent Model","author":"Kim S. 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