Evidence map›Paper›PMID 34006518›Full record

ArticleBMJ global health2021

What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis.

Sangeetha Paramasivan, Philippa Davies, Alison Richards, Julia Wade, Leila Rooshenas, Nicola Mills, Alba Realpe, Jeffrey Pradeep Raj, Supriya Subramani, Jonathan Ives and 3 more

Abstract readScoping Review
In one paragraph

Article in BMJ global health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Trials Methodology Research: what is it and why should India invest in it?The Lancet regional health. Southeast Asia · 2024
    Review
  5. 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

13 authors.

Sangeetha ParamasivanPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK sangeetha.paramasivan@bristol.ac.uk.ORCID 0000-0001-7329-9574
Philippa DaviesPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Alison RichardsPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Julia WadePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Leila RooshenasPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Nicola MillsPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Alba RealpePopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Jeffrey Pradeep RajDepartment of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Supriya SubramaniInstitute of Biomedical Ethics and History of Medicine, University of Zurich, Zurich, Switzerland.
Jonathan IvesCentre for Ethics in Medicine, University of Bristol, Bristol, UK.
Richard HuxtableCentre for Ethics in Medicine, University of Bristol, Bristol, UK.
Jane M BlazebyUniversity Hospitals Bristol NHS Foundation Trust, NIHR ARC West, Bristol, UK.
Jenny L DonovanPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Funding

Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

introductionThe post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.

methodsOur search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.

resultsTitles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.

conclusionThe review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.

Indexed as

EcosystemInformed ConsentEmpirical ResearchHealth PersonnelHumansIndiasystematic review

Identifiers

PMID34006518
PMCPMC8137180

What OpenQuestion holds

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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.