Evidence map›Paper›PMID 33349794›Full record

ArticleEthics, medicine, and public health2021

Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19.

C Bahans, S Leymarie, D Malauzat, M Girard, C Demiot

Abstract read
In one paragraph

Article in Ethics, medicine, and public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. How COVID-19 changed clinical research strategies: a global survey.The Journal of international medical research · 2022
    Article
  8. Article
  9. Article
  10. Review
  11. The landscape of COVID-19 trials in Australia.The Medical journal of Australia · 2021
    Article
  12. 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

5 authors.

C BahansComité de Protection des Personnes Sud-Ouest et Outre-Mer IV- Centre Hospitalier Esquirol, Cabanis Haut, 15, rue du Docteur-Marcland - BP 61730, 87025 Limoges Cedex, France.
S LeymarieComité de Protection des Personnes Sud-Ouest et Outre-Mer IV- Centre Hospitalier Esquirol, Cabanis Haut, 15, rue du Docteur-Marcland - BP 61730, 87025 Limoges Cedex, France.
D MalauzatComité de Protection des Personnes Sud-Ouest et Outre-Mer IV- Centre Hospitalier Esquirol, Cabanis Haut, 15, rue du Docteur-Marcland - BP 61730, 87025 Limoges Cedex, France.
M GirardComité de Protection des Personnes Sud-Ouest et Outre-Mer IV- Centre Hospitalier Esquirol, Cabanis Haut, 15, rue du Docteur-Marcland - BP 61730, 87025 Limoges Cedex, France.
C DemiotComité de Protection des Personnes Sud-Ouest et Outre-Mer IV- Centre Hospitalier Esquirol, Cabanis Haut, 15, rue du Docteur-Marcland - BP 61730, 87025 Limoges Cedex, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 epidemic has led to the intense mobilization of all health professionals, including those involved in research. From the very beginning, research ethics committees (RECs) have been called upon and mobilized to carry out the scientific and ethical evaluations of research projects to achieve a sound analysis of their risk/benefit balance. The aim of this article is to present an ethical reflection on the challenges and consequences of the fast-track procedure for the evaluation of COVID-19 research projects in the context of a public health emergency. Indeed, a large number of protocols of reduced rigor were hastily prepared without collaboration between researchers and in the absence of national regulation. As a result, a number of ethical dilemmas have emerged concerning the opposing needs of pragmatism imposed by the emergency context and the ethical principles that should govern the conduct of research. Moreover, the dispersion of these individual projects, aggravated by excessive media coverage of specific treatments, has resulted in a weakened impact of the research in the epidemic context. This article provides suggestions for the ethical management of ongoing and upcoming research, giving RECs the opportunity to adapt their evaluations to avoid allowing the pragmatism of the emergency context to subvert the inviolability of the epistemological and ethical principles of research on humans. This reflection may strengthen the ethical basis for the formulation of their decisions.

Indexed as

Clinical trialCOVID-19EmergencyEthicsResearch ethics committee

Identifiers

PMID33349794
PMCPMC7744003

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.