Equitable Access to Information and Benefits

• Pages: 175-176

Contenidos

• The Issue.
• Legal and Policy Considerations.
• Practice Example.
• References.

Page 175

The Issue

Principles of justice and international human rights require equitable access to information and benefits of HIV research. Participants in research, whether in the experimental or control arm, must have equal access to treatments demonstrated by the research as beneficial. A more difficult issue is the extent to which such treatments must be made more widely available in the host country. Failing to make such benefits available to the population that bore the risks of research is considered exploitive and inequitable. Whether the responsibility to provide interventions falls on the research sponsor or host country's national government, or both, is less clear.

Another issue stemming from the principle of justice is whether participants in international research should be treated similarly regardless of where the research is conducted or whether it is sufficient that participants be treated similarly to others in their country. Ideally, participants would be given access to the best care available anywhere in the world whether they are in developing or developed countries. Though recognized in leading international ethical guidelines, this high standard of care is not required. Instead, some recommend a middle standard: the highest level of care available in the host country. Others recognize a lower standard: the level of care currently provided by the public health system in the host country. Debate continues about what standard of care is ethically required.

Legal and Policy Considerations

Because many of the concerns about equitable access to benefits and information involve international HIV research, policy recommendations often emphasize capacity building in the host country. The host country must have a system to conduct independent ethical review of research. Proposed research should be separately reviewed and approved by both the sponsor's and host country's ethics boards, consistent with the following considerations:

Researchers must evaluate a host country's capacity to provide interventions shown to be beneficial by the research, evaluate the possibility of providing interventions to a broader population, and provide justification for conducting research in a host country that cannot provide proven therapeutic benefits to a wider population; Researchers must propose how the research will improve the local...