Evidence map›Paper›PMID 32461225›Full record

ReviewBMJ global health2020

Regulating international clinical research: an ethical framework for policy-makers.

Bernardo Aguilera, David DeGrazia, Annette Rid

Abstract readReview
In one paragraph

Review in BMJ global health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
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.

Bernardo AguileraDepartment of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-9138-5003
David DeGraziaDepartment of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Annette RidDepartment of Bioethics, The Clinical Center, National Institutes of Health, Bethesda, Maryland, USA annette.rid@nih.gov.ORCID 0000-0003-1117-1975

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

Indexed as

PolicyHumansclinical trialhealth policyhealth services research

Identifiers

PMID32461225
PMCPMC7259867

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.