{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T19:10:53Z","timestamp":1769973053367,"version":"3.49.0"},"reference-count":26,"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>The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) has been the focal point of many different criticisms regarding the ethics of the study ever since publication of the trial's findings in 2010 and 2012. In this article, we focus on a concern that the technical design and implementation details of the study were ethically flawed. While the federal Office Human Research Protections focused on the consent form, rather than on the study design and implementation, OHRP's critiques of the consent form reveal views about the study design and implementation that we believe are fundamentally flawed. These criticisms about the design and implementation of SUPPORT, if generalized, become relevant concerns about these aspects of many comparative effectiveness research studies<\/jats:italic>.<\/jats:p><jats:p><jats:italic>Our analytical approach will be to use SUPPORT as a prime example of comparative effectiveness research and show why it challenges some prevailing assumptions about the riskiness of research. We will address five aspects of the study design and implementation: 1) randomization, 2) treatment by protocol, 3) choice of endpoints, 4) lack of a \u201cstandard care\u201d control group, and 5) the use of altered oximeters. Examining these aspects will allow us to answer two specific central questions. The first is a methodological question with ethical implications: was the study designed in such a way as to answer the primary study question? The second question is whether the study design added or decreased risk to the babies enrolled in the study compared to babies who were not in the study<\/jats:italic>.<\/jats:p>","DOI":"10.1002\/hast.407","type":"journal-article","created":{"date-parts":[[2014,12,20]],"date-time":"2014-12-20T04:27:32Z","timestamp":1419049652000},"page":"30-40","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["SUPPORT and the Ethics of Study Implementation: <i>Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies<\/i>"],"prefix":"10.1002","volume":"45","author":[{"given":"John D.","family":"Lantos","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Feudtner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,12,19]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Office for Human Research Protection letter to University of Alabama at Birmingham October 12 2014 http:\/\/www.mazzaschi.com\/OHRP.6.4.2013.pdf."},{"key":"e_1_2_9_3_1","first-page":"297","article-title":"Questing for Grails: Duplicity, Betrayal and Self\u2010Deception in Postmodern Medical Research","author":"Annas G. J.","year":"1996","journal-title":"Journal of Contemporary Health Law and Policy"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e31829b1e4b"},{"key":"e_1_2_9_5_1","unstructured":"M. ACarome S. M.Wolfe letter to Secretary of Health and Human Services in re The Surfactant Positive Pressure and Oxygenation Randomized Trial (SUPPORT) April 2013 accessed November 20 2014 http:\/\/www.citizen.org\/documents\/2111.pdf."},{"key":"e_1_2_9_6_1","unstructured":"V.Sharav HHS public meeting August 2013 accessed February 8 2014 https:\/\/www.youtube.com\/watch?v=IAfBKgYmxtg&list=PLrl7E8KABz1Gc_ndt\u20109grGg8O_jE5G1RNC&index=8."},{"issue":"1","key":"e_1_2_9_7_1","first-page":"1","article-title":"Legally Blind: The Therapeutic Illusion in the SUPPORT Study of Extremely Premature Infants","author":"Annas G. J.","year":"2013","journal-title":"Journal of Contemporary Health Law and Policy"},{"issue":"12","key":"e_1_2_9_8_1","first-page":"8","article-title":"Informed Consent and Standard of Care: What Must Be Disclosed?","author":"Macklin R.","year":"2013","journal-title":"American Journal of Bioethics"},{"key":"e_1_2_9_9_1","first-page":"1855","article-title":"Of Mice but Not Men\u2014Problems of the Randomized Clinical Trial","author":"Hellman S.","year":"1991","journal-title":"New England Journal of Medicine"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsb030228"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.849310"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.CCM.0000257333.95528.B8"},{"issue":"8","key":"e_1_2_9_13_1","first-page":"1","article-title":"Lay Public's Understanding of Equipoise and Randomisation in Randomised Controlled Trials","author":"Robinson E. J.","year":"2005","journal-title":"Health Technology Assessment"},{"key":"e_1_2_9_14_1","doi-asserted-by":"crossref","unstructured":"L. M.Askie D. J.Henderson andH.Ko \u201cRestricted versus Liberal Oxygen Exposure for Preventing Morbidity and Mortality in Preterm or Low Birth Weight Infants \u201d Cochrane Database of Systematic Reviews 4 (2001) art. no. CD001077 doi:10.1002\/14651858.CD001077.","DOI":"10.1002\/14651858.CD001077"},{"key":"e_1_2_9_15_1","unstructured":"K.Barrington \u201cPre\u2010SUPPORT What Did We Really Know? \u201d September2013 accessed May 19 2014 http:\/\/neonatalresearch.org\/2013\/09\/07\/pre\u2010support\u2010what\u2010did\u2010we\u2010really\u2010know."},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2013-4176"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.849308"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2013.851300"},{"issue":"21","key":"e_1_2_9_19_1","first-page":"1959","article-title":"Target Ranges of Oxygen Saturation in Extremely Preterm Infants","author":"Carlo W. A.","year":"2010","journal-title":"New England Journal of Medicine"},{"issue":"22","key":"e_1_2_9_19_2","first-page":"2094","article-title":"Oxygen Saturation and Outcomes in Preterm Infants","author":"Stenson B. 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