Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for Investigators.
Securing a participant's voluntary, informed consent is widely acknowledged as a requirement of ethical research. Yet, challenges can arise, particularly when a researcher seeks to enroll older adults who may lack the capacity to consent to research participation due to cognitive impairment. To addr...
| Publicado en: | Journal of the American Geriatrics Society Vol. 74; no. 6; pp. 1715 - 1722 |
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| Autores principales: | , , |
| Formato: | Artículo |
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Wiley-Blackwell
Jun2026
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| Materias: | |
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ssf&AN=194580312&site=ehost-live header: @attributes: shortDbName: ssf uiTerm: 194580312 longDbName: Social Sciences Full Text (H.W. Wilson) uiTag: AN controlInfo: bkinfo: jinfo: jid: 00028614 20Q jtl: Journal of the American Geriatrics Society issn: 00028614 maglogo: Y pubinfo: dt: Jun2026 vid: 74 iid: 6 pid: 480 pub: Wiley-Blackwell artinfo: ui: 194580312 10.1111/jgs.70473 ppf: 1715 ppct: 7 formats: tig: atl: Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for Investigators. aug: au: Largent, Emily A. Morain, Stephanie R. Karlawish, Jason affil: Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia Pennsylvania,, USA Berman Institute of Bioethics, Johns Hopkins University, Baltimore Maryland,, USA Department of Medicine, Department of Medical Ethics and Health Policy, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia Pennsylvania,, USA su: Self-efficacy Human research subjects Interviewing Informed consent (Medical law) Medical research Research ethics Patient selection Medical logic Cognitive testing Decision making in old age Conceptual structures Research methodology sug: subj: Self-efficacy Human research subjects Interviewing Informed consent (Medical law) Medical research Research ethics Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) Patient selection Medical logic Cognitive testing Decision making in old age Conceptual structures Research methodology keyword: capacity informed consent research ethics capacity informed consent research ethics ab: Securing a participant's voluntary, informed consent is widely acknowledged as a requirement of ethical research. Yet, challenges can arise, particularly when a researcher seeks to enroll older adults who may lack the capacity to consent to research participation due to cognitive impairment. To address this challenge, this article outlines a nine‐step framework for designing consent processes: (1) identify the participants in the study and assess whether some or all might reasonably be expected to lack decisional capacity; (2) determine whether enrolling participants who lack decisional capacity is justifiable; (3) determine whether informed consent is needed for some or all research procedures; if consent is required, (4) prepare the information that will be provided to prospective participants; (5) make both the information and the consent process accessible; (6) specify how prospective participants' decisional capacity will be assessed; (7) specify how surrogates will be identified and contacted when prospective participants are determined to lack decisional capacity; (8) determine how to involve prospective participants who lack decisional capacity in the decision‐making process, such as through assent or dissent; and as appropriate, (9) consider how capacity and consent might change across the duration of the study. This framework can help researchers anticipate and address common challenges and ensure they fulfill ethical and regulatory obligations. Applications of this framework include writing the human subjects portion of grant applications, preparing protocols for submission to an Institutional Review Board, and informing research practice. pubtype: Academic Journal doctype: Article src: R language: English refInfo: copyright: @attributes: flag: N holdings: @attributes: islocal: N |
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