Were There 'Additional Foreseeable Risks' in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials.
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....
| Publicado en: | Hastings Center Report Vol. 45; no. 1; pp. 21 - 30 |
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| Autores principales: | , |
| Formato: | Artículo |
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Wiley-Blackwell
Jan2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=100491642&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 100491642 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 00930334 HCR jtl: Hastings Center Report issn: 00930334 maglogo: Y pubinfo: dt: Jan2015 vid: 45 iid: 1 pid: 480 pub: Wiley-Blackwell artinfo: ui: 100491642 10.1002/hast.403 ppf: 21 ppct: 9 formats: fmt: – @attributes: type: T – @attributes: type: P size: 193KB tig: atl: Were There 'Additional Foreseeable Risks' in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials. aug: au: Silverman, Henry J. Dreyfuss, Didier su: Human research subjects Randomized controlled trials Critical care medicine Premature infants Informed consent (Medical law) Disclosure Children Ethics Informed consent & ethics Genetic research Oxygen Pediatrics Risk management in business sug: subj: Human research subjects Randomized controlled trials Critical care medicine Premature infants Informed consent (Medical law) Disclosure Children Ethics Research and development in the physical, engineering and life sciences Industrial Gas Manufacturing Informed consent & ethics Genetic research Oxygen Pediatrics Risk management in business ab: 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 'reasonably foreseeable risks.' Commentators debated whether randomization to contrasting restrictive strategies that are within existing standard-of-care treatments imposed additional 'reasonably foreseeable risks' 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. We argue that randomization to contrasting restrictive interventions lying at the outer ends of 'standard-of-care' practices differs in important ways from unrestricted 'standard-of-care' practices available outside of a proposed study; that research involving such randomization might pose additional 'reasonably foreseeable risks' from what occurs in 'standard-of-care' 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. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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