Ethical Challenges and Strategies in Conducting Research with Vulnerable Populations in Low- and Middle-Income Countries

Ethical Challenges and Strategies in Conducting Research with Vulnerable Populations in Low- and Middle-Income Countries

Authors

  • Farooq Azam Rathore Department of Rehabilitation Medicine, Quetta Institute of Medical Sciences, Quetta
  • Fareeha Farooq Department of Biochemistry, Quetta Institute of Medical Sciences, Quetta
  • Teresia Wamuyu Maina Heidelberg Institute of Global Health, Heidelberg University, Germany

DOI:

https://doi.org/10.21649/akemu.v31i1.5775

Keywords:

Biomedical research; vulnerable population; bioethics; research integrity; exploitation; Institutional Review Boards; ethical guidelines

Abstract

There is evidence that vulnerable populations (children, prisoners, pregnant women, elderly individuals, and individuals with mental or physical disabilities) have been exploited in the past in the name of medical research. These exploitations were carried out by individuals, institutions and even governments. It highlights the need for mechanisms to protect their rights and well-being. This mini review highlights the landmark events of exploiting vulnerable populations in medical research and outlines measures for their protection. These include the Tuskegee Syphilis Study, the Guatemala Syphilis Experiment, and the Holmesburg Prison Experiment. These well documented examples from the past suggest that there is a need for establishing and following a framework ethical guideline, obtaining informed consent, and reducing risks to the research participants. Protection of the vulnerable populations require that researchers must follow ethical standards, such as those recommended in the 1979, Belmont Report. These principles include respect for persons, beneficence, and Justice. An appropriate mechanism for a formal and truly Informed consent from the research participants and appropriate approval and oversight of Institutional Review Boards/ Ethical Review Committee (IRBs/ERC) are necessary to ensure that the research is being conducted in an ethical manner. Individual researchers and medical institutions should also consider the potential exploitation of the vulnerable populations during the research process. They must consider additional safeguards while conducting research into populations that are considered vulnerable. These steps are an ethical and moral obligation for the researchers to avoid exploitation of vulnerable populations in the name of scientific research and to safeguard their interest. These steps can ensure that the medical research is being conducted in an ethical manner and is likely free from exploitation of the research participants. As a result, the outcomes of such research can be trusted to make correct medical practices and policies.

References

1. Council for International Organizations of Medical Sciences (CIOMS). International guidelines on good governance practice for research institutions. Geneva, Switzerland: CIOMS; 2023. Available at https://cioms.ch/publications/product/international-guidelines-on-good-governance-practice-for-research-institutions Accessed on 10th April 2025

2. Hurst SA. Vulnerability in research and health care; describing the elephant in the room? Bioethics. 2008; 22(4):191–202.

3. US Department of Health and Human Services. eCFR : 45 CFR Part 46 (2018-07-19) -- Protection of Human Subjects. 2023. Available at: https://www.ecfr.gov/on/2018-07-19/title-45/subtitle-A/subchapter-A/part-46. Accessed 10th April 2025.

4. National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants: CreateSpace Independent Publishing Platform; 2015. Available at https://bioethicsarchive.georgetown.edu/nbac/human/oversumm.html Accessed 11th April 2025

5. Gordon BG. Vulnerability in Research: Basic Ethical Concepts and General Approach to Review. Ochsner J. 2020;20(1):34-8.

6. Vulnerable Participants | Research. 2023. Available at: https://research.virginia.edu/irb-sbs/vulnerable-participants. Accessed January 10, 2023.

7. Wall LL. The controversial Dr. J. Marion Sims (1813-1883). Int Urogynecol J. 2020;31(7):1299-303.

8. Park J. Historical Origins of the Tuskegee Experiment: The Dilemma of Public Health in the United States. Uisahak. 2017;26(3):545-78.

9. Paul C, Brookes B. The Rationalization of Unethical Research: Revisionist Accounts of the Tuskegee Syphilis Study and the New Zealand "Unfortunate Experiment". Am J Public Health. 2015;105(10):12-9.

10. Zenilman JM. Ethics gone awry: the US Public Health Service studies in Guatemala; 1946-1948. Sex Transm Infect. 2013;89(4):295-300.

11. Sub Committee on Energy Conservation and Power. American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens: Report. Available at https://www.howardnema.com/wp-content/uploads/2021/02/American_Nuclear_Guinea_Pigs_Three_Decades_of_Radiation_Experiments_on_U.S_Citizens86.pdf . Accessed 11th April 2025

12. McCally M, Cassel C, Kimball DG. U.S. government-sponsored radiation research on humans 1945-1975. Med. Glob. Surviv. 1994;1(1):4-17.

13. MacLure J. Unnatural Resources: The Colonial Logic of the Holmesburg Prison Experiments. J Med Humanit. 2021;42(3):423-33.

14. Bruce AA, Umesi AO, Bashorun A, Ochoge M, Yisa M, Obayemi-Ajiboye D, et al. Collecting and reporting adverse events in low-income settings-perspectives from vaccine trials in the Gambia. Trials. 2024 2;25(1):579.

15. Ahmed A, Daily JP, Lescano AG, Golightly LM, Fasina A. Challenges and Strategies for Biomedical Researchers Returning to Low- and Middle-Income Countries after Training. Am J Trop Med Hyg. 2020 ;102(3):494-6.

16. Victor E, Luna F, Guidry-Grimes L, Reiheld A. Vulnerability in practice: Peeling back the layers, avoiding triggers, and preventing cascading effects. Bioethics. 2022;36(5):587-96.

17. Imam A, Wariri O, Dibbasey T, Camara A, Mendy A, Sanyang AN, et al. Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia. BMJ Glob Health. 2021;6(8):006419.

18. Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017;15(1):8. https://doi.org/10.1186/s12961-016-0164-6

19. Memon R, Asif M, Khoso AB, Tofique S, Kiran T, Chaudhry N, et al.Pakistan Institute of Living and Learning (PILL). Recognizing values and engaging communities across cultures: towards developing a cultural protocol for researchers. BMC Med Ethics. 2021;22(1):47

20. Jafarey AM, Iqbal SP, Hassan M. Ethical review in Pakistan: the credibility gap. J Pak Med Assoc. 2012;62(12):1354-7.

21. Grady C. Institutional Review Boards: Purpose and Challenges. Chest. 2015;148(5):1148-55.

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Published

03/31/2025

How to Cite

Farooq Azam Rathore, Farooq, F., & Maina, T. W. (2025). Ethical Challenges and Strategies in Conducting Research with Vulnerable Populations in Low- and Middle-Income Countries. Annals of King Edward Medical University, 31(1). https://doi.org/10.21649/akemu.v31i1.5775

Issue

Section

Narrative Review

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