8.1 Research Involving Vulnerable Populations
Cheryl Mack, MD, MA, FRCPC
Learning Objectives
- To be able to define and identify vulnerable populations as they pertain to medical research
- To understand why populations within developing countries should be considered vulnerable as test populations
- To highlight the ethical concerns that arise specifically when engaging in medical research in developing countries
- To understand the safeguards that are typically implemented to decrease the incidence of exploitation
- To be made aware of the ongoing debate that arises when we discuss ethical universalism, ethical imperialism and ethical relativism
Case
ABC Pharmaceuticals has discovered what it hopes to be the next generation of antiretroviral drugs. Animal studies have been promising and demonstrate an ability to prevent the transfer of HIV through vertical transmission. Phase II human clinical trials have been completed, and researchers are hoping to test this drug in a high-risk population in an economically depressed region of Africa that has been suffering through both drought and political unrest. It is hoped that this drug will be shown to be at least as effective as present therapies but with less toxicity and simpler dosing. You represent the research ethics board that, along with the local African review board, is assessing the adherence to ethical guidelines prior to giving approval. The population the researchers are seeking to study has a high prevalence of HIV infection, and the predominant strain of HIV seems to be unique to that area of Africa. Vertical transmission has been identified as a grave concern in the area, with numerous infants testing positive. Presently, the proposed test population does not have a reliable source from which to obtain antiretroviral medications. As a member of the research ethics board, you have concerns regarding the test population.
Questions
- What is the definition of a vulnerable population, and does the test population in question qualify as one?
- When engaging in multinational research, what can emerge as a source of conflict when assessing protocols for their adherence to ethical standards of care?
- Given that research ethics committees reviewing multinational research protocols are often confronted by variable ethical standards that can conflict with international standards emphasizing Western-based ethical viewpoints, the universality of these viewpoints is often questioned when dealing with other cultures. How should these differences be resolved?
- Why is the relevancy of research to the population involved in the study such a concern, and does the study design in the illustrated case satisfy the ethical guideline of relevancy in the test population?
- Does the study design address the long-term interests of both the test population and the wider community? Name a primary component of post-study design.
- Should the study design be allowed to include a placebo control group?
Discussion
References
- Weijer C. Protecting communities in research: philosophical and pragmatic challenges. Cambridge Quarterly of Healthcare Ethics 1999; 8: 501–13.
- Benatar S. Towards progress in resolving dilemmas in international research ethics. Journal of Law, Medicine & Ethics Winter 2004; 32(4): 574–82.
- Benatar S. Reflections and recommendations on research ethics in developing countries. Social Science and Medicine 2002; 54: 1131–41.
- Dickens BM, Cook RJ. Ethical and legal issues in reproductive health: challenges of ethical research in resource-poor settings. International Journal of Gynecology and Obstetrics 2003; 80: 79–86.
- Benatar S. Avoiding exploitation in clinical research. Cambridge Quarterly of Healthcare Ethics 2000; 9: 562–5.
- Dowdy DW. Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial." Journal of Medical Ethics 2006; 32: 357–60.
- World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. World Medical Association [adopted 1964; last updated 2004]. Available from: http://www.wma.net/e/policy/b3.htm
Resources
- Angell M. Ethical imperialism? Ethics in international collaborative clinical research. New England Journal of Medicine 1988; 319: 1081–3.
- Angell M. The ethics of clinical research in the Third World. New England Journal of Medicine 1997; 337: 847–9.
- Benatar SR. Commentary: justice and medical research: a global perspective. Bioethics 2001; 15: 333–40.
- Lurie P, Wolfe S. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine 1997; 337: 853–5.
- Macklin R. Against relativism: cultural diversity and the search for ethical universals in medicine. Oxford: Oxford University Press; 1999