Assessing the Remedy: The Case for Contracts in Clinical Trials.
Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that su...
| Publicado en: | American Journal of Bioethics Vol. 11; no. 4; pp. 3 - 13 |
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| Formato: | Journal Article |
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Taylor & Francis Ltd
Apr2011
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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=104868205&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104868205 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15265161 FKZ jtl: American Journal of Bioethics issn: 15265161 maglogo: N pubinfo: dt: Apr2011 vid: 11 iid: 4 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 104868205 2011002297 10.1080/15265161.2011.560340 NLM21480063 104868205 ppf: 3 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Assessing the Remedy: The Case for Contracts in Clinical Trials. aug: au: Edwards, Sarah J. L. affil: University College London, sug: subj: Protection of Human Subjects Ethical Issues Research Ethics Clinical Trials Ethical Issues Contracts Ethical Issues Decision Making, Patient Ethical Issues Research Subject Retention Ethical Issues Internal Validity Institutional Review Decision Making, Ethical Consent (Research) Ethical Issues Physician-Patient Relations Ethical Issues Contracts Economics Accountability ab: Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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