Clinical Trial Ethical Challenges in Low- and Middle-Income Countries: A Review of Systematic Review

TL;DR

This paper reviews ethical challenges in clinical trials conducted in low- and middle-income countries, highlighting issues like informed consent and vulnerable populations.

Contribution

The study provides a comprehensive umbrella review of ethical considerations in clinical trials in LMICs using PRISMA and AMSTAR 2 guidelines.

Findings

Informed consent is the most reported ethical issue in clinical trials in low- and middle-income countries.

Vulnerable populations and underreporting are significant ethical concerns that require attention.

Communities in LMICs may be more prone to ethical issues due to lack of awareness and historical exploitation.

Abstract

Clinical trials are increasingly being conducted in low- and middle-income countries (LMICs) for many reasons. However, there are many ethical implications of conduction clinical trials in LMICs. Henceforth, we performed an umbrella review to delineate the evidences regarding the ethical considerations of clinical trial in LMICs. This review followed the PRISMA guideline for the search strategy and used AMSTAR 2 for literature appraisal. This study was registered in PROSPERO (CRD42022325204) to promote transparency and prevent unintended duplication. The search retrieved 18,348 records in stage 1 (16,383 after deduplication); 299 articles were screened for eligibility in stage 2, and eight systematic reviews met inclusion criteria and were included in the umbrella review. AMSTAR-2 appraisal rated three reviews as high confidence, one as low confidence, and four as critically low confidence. Our result shows that informed consent was the most reported ethical issue, and other concerns such as inclusion of vulnerable population, responsible conduct of research and underreporting ought not to be overlooked as well. The communities in LMIC, not being fully aware of their rights, and considering they may lack knowledge of the history of frequent exploitation and bigotry, are more likely to have ethical concerns than wealthy nations. To attain health justice, ethical standards now in place must be upheld and implemented.

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