At Last! Aye, and There's the Rub.
Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects resear...
| Publicado en: | American Journal of Bioethics Vol. 17; no. 7; pp. 4 - 8 |
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| Formato: | Journal Article |
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Taylor & Francis Ltd
Jul2017
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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=ccm&AN=123848143&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 123848143 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15265161 FKZ jtl: American Journal of Bioethics issn: 15265161 maglogo: N pubinfo: dt: Jul2017 vid: 17 iid: 7 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 123848143 10.1080/15265161.2017.1329479 123848143 ppf: 4 ppct: 4 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: At Last! Aye, and There's the Rub. aug: au: Capron, Alexander M. affil: University of Southern California sug: subj: Research Ethics Research Subjects Ethical Issues Federal Government Government Agencies Research Legislation and Jurisprudence United States Time Factors Bioethics ab: Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt “as a common core” the HHS regulations, “while permitting additions needed by any department or agency that are not inconsistent with these core provisions.” The commission believed—rightly, I still think—that having uniformity would ease administration, reduce regulatory burdens, simplify oversight, and make research more efficient. Yet our naïve expectation the task could be accomplished in 180 days meant that we failed to anticipate that if it took much longer—namely, the 10 years that passed before the Common Rule was issued—federal officials would thereafter be reluctant to change the regulations and that when they tried to do so twenty years later, with the issuance of the ANPRM in 2011, they would propose comprehensive revisions. I argue that was the wrong conclusion to draw from the difficulties in issuing the first Common Rule, and that the process of producing the new “final rule” on January 19, 2017—during which many of the proposed changes were either dumped or promulgated without being adequately vetted—reinforces the conclusion that a more incremental process, with ongoing involvement of the public through an advisory body like the President's Commission, would be a much better way to proceed. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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