8.1 Research Involving Vulnerable Populations
Cheryl Mack, MD, MA, FRCPC
- 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
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.
- 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?
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