Evidence map›Paper›PMID 35218602›Full record

ArticleEthics & human research2022

Evaluating the Ability to Consent to Research: A Twenty-Year Track Record.

Mikaela Matera-Vatnick, Katherine W Todman, Paul G Wakim, Haley K Sullivan, Carol Squires, Julie Brintnall-Karabelas, Samuel N Doernberg, Marion Danis

Erratum issuedOpen access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ethics & human research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 98% of its field
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

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 2 countries.

Mikaela Matera-VatnickPostbaccalaureate fellow at the National Cancer Institute.
Katherine W TodmanClinical social worker at the National Institute of Mental Health (NIMH).
Paul G WakimChief of the biostatistics and clinical epidemiology service at the National Institutes of Health Clinical Center (NIH CC).
Haley K SullivanPhD student in health policy at Harvard University and was a fellow in the Department of Bioethics at the NIH CC at the time of participating in this research.
Carol SquiresLicensed certified social worker at the NIMH.
Julie Brintnall-KarabelasLicensed clinical social worker at the NIMH.
Samuel N DoernbergFourth-year medical student at Harvard Medical School and was a fellow in the Department of Bioethics at the NIH CC at the time of participating in this research.
Marion DanisChief of the Bioethics Consultation Service at the NIH CC.
Harvard University · USNational Cancer Institute · MYNational Institutes of Health Clinical Center · USNew York Times · US

Funding

Office of the Clinical Director-Core ActivitiesZIDMH002912 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI PAO, MARYLAND · 2009 to 2025
$89.5M
Psychiatry Consultation Liaison Service ResearchZIAMH002922 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI PAO, MARYLAND · 2009 to 2025
$11.5M
Office of the Clinical Director Z01MH002912 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI PAO, MARYLAND · 2008 to 2008
$4.4M
Intramural NIH HHS Z01 MH002912Intramural NIH HHS Z99 MH999999Intramural NIH HHS ZID MH002912
6 · The paper itself

Abstract

Occasionally, the ability of prospective research participants to consent may be uncertain. Yet standardized capacity-assessment tools may not suffice to determine the ability to consent to a particular research protocol. This study consisted of a retrospective review of the outcomes of an alternative approach used by the Ability to Consent Assessment Team at the National Institutes of Health. Of 944 individuals evaluated over 20 years (1999-2019), 70.1% were determined to have capacity to consent to participate in research. Of those who lacked capacity to consent and were subsequently evaluated for their ability to assign a surrogate, 86.0% had the ability to do so. The findings demonstrate that establishing a task-specific approach for assessing the capacity of potential participants to consent to a variety of research protocols can facilitate safe and ethically justifiable inclusion of individuals whose ability to consent is initially uncertain.

Indexed as

Decision MakingInformed ConsentHumansProspective StudiesRetrospective Studiesdecision-making capacityhuman subjects researchinformed consentneurocognitive disorderssurrogate decision-making

Identifiers

PMID35218602
PMCPMC11017231
OpenAlexW4214542318

What OpenQuestion holds

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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.