Evidence map›Paper›PMID 22313664›Full record

ReviewJournal of medical ethics2012

The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries.

Amulya Mandava, Christine Pace, Benjamin Campbell, Ezekiel Emanuel, Christine Grady

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of medical ethics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 4 pooled it
–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

81 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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21 more citing papers are in PubMed but not listed here.

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

5 authors.

Amulya MandavaDepartment of Bioethics, National Institutes of Health, Bethesda, MD 20892, USA.
Christine Pace
Benjamin Campbell
Ezekiel Emanuel
Christine Grady

Funding

Randomized informed consentZIACL010531 · CLC · CLINICAL CENTER · PI GRADY, CHRISTINE P · 2009 to 2022
$0k
Intramural NIH HHS ZIA CL010531
6 · The paper itself

Abstract

objectiveSome researchers claim that the quality of informed consent of clinical research participants in developing countries is worse than in developed countries. To evaluate this assumption, we reviewed the available data on the quality of consent in both settings.

methodsWe conducted a comprehensive PubMed search, examined bibliographies and literature reviews, and consulted with international experts on informed consent in order to identify studies published from 1966 to 2010 that used quantitative methods, surveyed participants or parents of paediatric participants in actual trials, assessed comprehension and/or voluntariness, and did not involve testing particular consent interventions. Forty-seven studies met these criteria. We compared data about participant comprehension and voluntariness. The paucity of data and variation in study methodology limit comparison and preclude statistical aggregation of the data. RESULTS AND DISCUSSION: This review shows that the assertion that informed consent is worse in developing countries than in developed countries is a simplification of a complex picture. Despite the limitations of comparison, the data suggest that: (1) comprehension of study information varies among participants in both developed and developing countries, and comprehension of randomisation and placebo controlled designs is poorer than comprehension of other aspects of trials in both settings; and (2) participants in developing countries appear to be less likely than those in developed countries to say they can refuse participation in or withdraw from a trial, and are more likely to worry about the consequences of refusal or withdrawal.

Indexed as

Biomedical ResearchDeveloped CountriesDeveloping CountriesHumansInformed ConsentPatient SelectionResearch PersonnelResearch Subjects

Identifiers

PMID22313664
PMCPMC4825806

What OpenQuestion holds

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Read underepoch 390

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.