ArticleCritical care medicine2010
Surrogate consent for research involving adults with impaired decision making: survey of Institutional Review Board practices.
Article in Critical care medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.
- Pooled it
- Designing Consent Processes for Research With Older Adults Who May Lack Decisional Capacity: A Guide for Investigators.Journal of the American Geriatrics Society · 2026Article
- Recruiting People With Dementia in Emergency Research: Insights From Geriatric Emergency Care Applied Research 2.0 Network (GEAR 2.0) Pilot Studies.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2026Article
- The authors reply.Critical care medicine · 2025Article
- Vulnerable Research Participant Policies at U.S. Academic Institutions.Journal of empirical research on human research ethics : JERHRE · 2024Article
- Expanding the ethnographic toolkit: Using medical documents to include kinless older adults living with dementia in qualitative research.Journal of aging studies · 2023Article
- Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults.Journal of Alzheimer's disease reports · 2023Article
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
- Medical Decision-Making in Oncology for Patients Lacking Capacity.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2020Review
- Research approvals iceberg: how a 'low-key' study in England needed 89 professionals to approve it and how we can do better.BMC medical ethics · 2019Article
- Procedural Framework to Facilitate Hospital-Based Informed Consent for Dementia Research.Journal of the American Geriatrics Society · 2018Article
- Perspectives of Decisional Surrogates and Patients Regarding Critical Illness Genetic Research.AJOB empirical bioethics · 2016Article
- Article
- Addressing risks to advance mental health research.JAMA psychiatry · 2013Article
- Research to inform the consent-to-research process.Intensive care medicine · 2013Article
- Critical illness research involving collection of genomic data: the conundrum posed by low levels of genomic literacy among surrogate decision makers for critically ill patients.Journal of empirical research on human research ethics : JERHRE · 2013Article
- Public's approach to surrogate consent for dementia research: cautious pragmatism.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2013Article
- Article
- Surrogate and patient discrepancy regarding consent for critical care research.Critical care medicine · 2012Article
- What is the evidence to support the use of therapeutic gardens for the elderly?Psychiatry investigation · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
objectivesMost critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research. DESIGN, SETTINGS, AND
participantsA cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.
interventionsNone. MEASUREMENTS: Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults. MAIN
resultsInstitutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.
conclusionsMuch variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.