So You Think You Know Who's the "Legally Authorized Representative": Clinical Research Hits a Snag.
When a prospective participant in clinical research appears perhaps to lack decision-making capacity, many investigators do a capacity evaluation themselves, and if the person lacks capacity, reach out to the next of kin, presuming them to be the legally authorized representative (LAR) to consent (o...
| Publicado en: | Journal of Law, Medicine & Ethics Vol. 54; no. 1; pp. 69 - 85 |
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| Autor principal: | |
| Formato: | review tables/charts Journal Article |
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Cambridge University Press
Spring2026
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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=192490663&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 192490663 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10731105 JME jtl: Journal of Law, Medicine & Ethics issn: 10731105 maglogo: N pubinfo: dt: Spring2026 vid: 54 iid: 1 pid: 15979 pub: Cambridge University Press artinfo: ui: 192490663 192490663 192490663 10.1017/jme.2026.10228 192490663 ppf: 69 ppct: 16 formats: tig: atl: So You Think You Know Who's the "Legally Authorized Representative": Clinical Research Hits a Snag. aug: au: Morreim, Haavi affil: Department of Internal Medicine, College of Medicine, UTHSC, United States sug: subj: Clinical Research Ethical Issues Research Subjects Legislation and Jurisprudence Competence (Legal) Evaluation Consent (Research) Legislation and Jurisprudence Institutional Review Legislation and Jurisprudence Clinical Research Legislation and Jurisprudence Proxy Legislation and Jurisprudence Research Ethics United States Clinical Research History Research Subjects Ethical Issues Health Policy Protection of Human Subjects Counseling Research, Medical Legislation and Jurisprudence Research Personnel Health Care Delivery Medical Staff, Hospital Supervisors and Supervision Decision Making Legislation and Jurisprudence Competence (Legal) Ethical Issues Special Populations Proxy Ethical Issues Health Insurance Portability and Accountability Act ab: When a prospective participant in clinical research appears perhaps to lack decision-making capacity, many investigators do a capacity evaluation themselves, and if the person lacks capacity, reach out to the next of kin, presuming them to be the legally authorized representative (LAR) to consent (or not) on that person's behalf. However, that approach often does not actually comport with applicable law. This article begins with some history, explaining how, if there is no state law specifically governing clinical research, Institutional Review Boards have been instructed to base their policies concerning capacity determination and surrogacy selection on that jurisdiction's laws governing ordinary healthcare. A deep dive into many states' statutes reveals a remarkable, hitherto largely unrecognized diversity of provisions that, in turn, create unexpected legal and ethical hazards for investigators whose research participants may lack capacity. Several potential resolutions are suggested. pubtype: Academic Journal doctype: review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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