From Decision Supporter to Informed Surrogate: An Improved Approach to Enrolling Cognitively Impaired Subjects in Clinical Research.
While supported decision-making for persons with dynamic cognitive impairment has been considered in the context of medical treatment, there has been little attention to its application in the context of enrolling cognitively impaired subjects in clinical research. The Common Rule allows enrollment...
| Publicado en: | Journal of Law, Medicine & Ethics Vol. 54; no. 2; pp. 67 - 74 |
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| Autores principales: | , |
| Formato: | Journal Article |
| Publicado: |
Cambridge University Press
Summer2026
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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=194133293&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 194133293 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10731105 JME jtl: Journal of Law, Medicine & Ethics issn: 10731105 maglogo: N pubinfo: dt: Summer2026 vid: 54 iid: 2 pid: 15979 pub: Cambridge University Press artinfo: ui: 194133293 10.1017/jme.2025.10197 194133293 ppf: 67 ppct: 7 formats: tig: atl: From Decision Supporter to Informed Surrogate: An Improved Approach to Enrolling Cognitively Impaired Subjects in Clinical Research. aug: au: Harrison, Robert Randolph Trombetta, Alannah affil: S J Quinney College of Law, University of Utah, United States sug: subj: Research, Medical Research Subject Recruitment Research Subjects Decision Making Persons with Intellectual Disabilities Psychosocial Factors Consent (Research) Research Ethics Patient Rights Legislation, Medical Patient Autonomy Special Populations Patient Participation Personal Values Support, Psychosocial Advance Directives Organizational Policies Trust Research Subject Retention Conflict of Interest (Research) Altruism ab: While supported decision-making for persons with dynamic cognitive impairment has been considered in the context of medical treatment, there has been little attention to its application in the context of enrolling cognitively impaired subjects in clinical research. The Common Rule allows enrollment permission from a Legally Authorized Representative, one empowered under institutional policy to provide consent for subjects lacking decision-making capacity, but many Legally Authorized Representatives lack knowledge of the person's values and preferences adequate to an ethically valid judgement about research enrollment. Supported decision-making and surrogate decision-making can be complementary as subjects transition between impairment stages, providing an opportunity to address ethical problems with the current practice of reliance on uninformed surrogates. Through designation of a supporter who is willing to serve through the progression of impairment, dementia patients choose their supporter and ultimate surrogate, engage with them on the issues that later give rise to requests to enroll the subject in research, and ensure that the surrogate will have knowledge of the values and preferences of the subject necessary to an ethically defensible substituted judgement. Legal frameworks can be adapted to provide recognition of research enrollment as an area of valid decision by supporters on behalf of beneficiaries. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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