Evidence map›Paper›PMID 26743927›Full record

ReviewBritish journal of clinical pharmacology2016

The potential exploitation of research participants in high income countries who lack access to health care.

Rafael Dal-Ré, Annette Rid, Ezekiel Emanuel, David Wendler

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
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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

4 authors.

Rafael Dal-RéClinical Research, BUC (Biosciences UAM + CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, Madrid, Spain.
Annette RidDepartment of Social Science, Health and Medicine, King's College, London, UK.
Ezekiel EmanuelDepartment of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, Pennsylvania,, USA.
David WendlerDepartment of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There are millions of individuals living in North America and the European Union who lack access to healthcare services. When these individuals participate in research, they are at increased risk of being exposed to the risks and burdens of clinical trials without realizing the benefits that result from them. The mechanisms that have been proposed to ensure that research participants in low- and middle-income countries are not exploited are unlikely to protect participants in high-income countries. The present manuscript argues that one way to address concerns about exploitation in high-income countries would be to require sponsors to provide targeted benefits such as medical treatment during the trial, or the study drug after the trial. The latter could be achieved through extension studies, expanded access programs, or named-patient programs. Sponsors also might provide non-medical benefits, such as education or social support. Ethical and regulatory guidance should be revised to ensure that research participants in high-income countries who lack access to healthcare services receive sufficient benefits.

Indexed as

Informed ConsentBiomedical ResearchClinical Trials as TopicDeveloped CountriesDeveloping CountriesGovernment RegulationHealth Services AccessibilityHumansIncomePatient SelectionPovertyclinical trials regulationdrug developmentethical trial conductexploitation of participantsfair benefits frameworkpoor trial participants

Identifiers

PMID26743927
PMCPMC4834591

What OpenQuestion holds

Textmetadata
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.