Evidence map›Paper›PMID 42095697›Full record

ArticleJournal of the American Geriatrics Society2026

Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for Investigators.

Emily A Largent, Stephanie R Morain, Jason Karlawish

Abstract read
In one paragraph

Article in Journal of the American Geriatrics Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Emily A LargentDepartment of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-7536-5077
Stephanie R MorainBerman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland, USA.
Jason KarlawishDepartment of Medicine, Department of Medical Ethics and Health Policy, Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

Funding

Training Core (I)U54AG063546 · NIA · BROWN UNIVERSITY · PI Andrea L Gilmore-Bykovskyi · 2019 to 2026
$125.9M
Adapting supported decision making to promote wellbeing and improve health outcomes for persons living with Alzheimer's disease and Alzheimer's disease related dementiasR01AG077111 · NIA · UNIVERSITY OF PENNSYLVANIA · PI Emily Largent · 2022 to 2026
$3.1M
NIA NIH HHS R01 AG077111NIA NIH HHS R01AG077111NIA NIH HHS U54 AG063546NIA NIH HHS U54AG063546
6 · The paper itself

Abstract

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.

Indexed as

Biomedical ResearchDecision MakingInformed ConsentMental CompetencyAgedHumansResearch Designcapacityinformed consentresearch ethics

Identifiers

PMID42095697
PMCPMC13155372

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.