The History and Policy Evolution of Waivers of Informed Consent in Research.
We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research...
| Publicado en: | Journal of Legal Medicine Vol. 41; no. 1/2; pp. 1 - 29 |
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| Autores principales: | , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Taylor & Francis Ltd
Jan-Jun2021
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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=151552534&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 151552534 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01947648 B9P jtl: Journal of Legal Medicine issn: 01947648 maglogo: N pubinfo: dt: Jan-Jun2021 vid: 41 iid: 1/2 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 151552534 151552534 151552534 10.1080/01947648.2021.1917464 151552534 ppf: 1 ppct: 28 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: The History and Policy Evolution of Waivers of Informed Consent in Research. aug: au: Kassels, Austin Connor Merz, Jon F. sug: subj: Policy Making Consent (Research) Legislation and Jurisprudence Research Ethics Legislation and Jurisprudence Rules and Regulations Research Protocols Research Subjects Research Subject Recruitment ab: We examine the evolution of policies permitting exceptions to or waivers of informed consent for research in the United States. This review reveals that (1) exceptions to the duty to secure informed consent were originally quite narrow; (2) there were two alternative approaches to allowing research on human subjects without their prospective consent: (i) exceptions in which individual capacity to consent is to be assessed and consent tailored to each person's abilities and (ii) waivers of the general requirement for a population of potential subjects, where securing prospective consent would "destroy or invalidate" critically important research; (3) waivers only appeared in the final rulemakings for research regulations issued by the National Institute of Education in 1974 and the Department of Health and Human Services in 1981, limiting the opportunity for the public to weigh in on the scope and use of waivers; and (4) rules adopted since 1981 have almost uniformly added extra requirements to justify waivers. Examples drawn from recent research show expansion of the use of waivers far beyond the bounds originally envisioned. Greater transparency about the use of waivers is needed for the public to weigh in on the standards for foregoing informed consent in human research. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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