Nondiscrimination in Selection of Research Subjects

Pages169-170

Page 169

The Issue

To avoid discrimination, selection of subjects for participation in HIV/AIDS research must conform to legal and ethical principles of justice. These principles typically require that benefits and burdens of research be distributed in equitable ways. HIV/AIDS research findings may vary with factors such as race, genetics, gender, age, social status, or other sensitive individual characteristics. HIV tends to burden vulnerable populations disproportionately because of social, economic, or other factors.

Under principles of justice, researchers must strike a balance between (1) over-burdening vulnerable populations with the risks of research and (2) under representing such populations in the findings and benefits of research.

Research participants should not be selected on the basis of judgments of social worth, potential contribution to society, or lifestyle. Researchers must also be careful to avoid selecting subjects in a way that leads to under-representation of vulnerable populations (such as pregnant women or children) in research results.

Legal and Policy Considerations

Distinctions in the selection of research participants should be driven by substantive scientific research questions. For example, enrollment of participants should not be affected by their injecting drug use (IDU) unless the protocol addresses an HIV prevention issue that is specific to IDU. Research participants should not be selected because of easy availability or manipulability, nor should they be systematically excluded because of their vulnerable status. Research findings and other preventive or treatment benefits provided should potentially benefit the participant population.

All research protocols should be submitted to external ethical review boards for evaluation and approval (see Topic 9.5). To gain approval, a research protocol must (1) justify the selection criteria for subjects; (2) outline the anticipated benefits that will accrue to the participants and the population or community from which they are drawn; and (3) justify the exclusion of members of a group that may benefit from the research.

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Practice Example

The UNAIDS Ethical Considerations in HIV Preventive Vaccine Research (2000) offers this advice:

* Guidance Point 4: "In order to conduct HIV vaccine research in an ethically acceptable manner, the research protocol...

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