Focus on Clinical Research. Entities With Limited Resources. RESPONSIBILITIES 1) Ensure the research responds to the health needs and priorities of the target community 2) Ensure any product or benefit developed will be made available to the community.
Successful interventions that result from the research must be made available to the community.
If this is not done, the research is exploitative.
Should investigators ever use the standards of care/ethics of a developing countries vs. developed countries in comparisons?
Are investigators responsible for the health of their participants?
Can participants in developing countries understand informed consent (e.g., is there an expectancy of benefit or treatment even if not stated in the informed consent)?
Is it ethical to do research in developing countries on issues relevant to developed countries but not relevant to developing countries?
3. Potential risks and discomforts
4. Anticipated benefits to subjects
5. Anticipated benefits to society
6. Alternatives to participation
7. Payment for participation
8. Possible commercial products
9. Sample remaining at the end of the study
10 Financial obligation
11. Emergency care and compensation for injury
12. Privacy and confidentiality
13. Participation and withdrawal
14. Consequences of withdrawal
15. Withdrawal of participation by the investigator
16. New findings
17. Identification of investigators
18. Rights of research subjects
19. Adherence to HIPAAHuman Subjects Consent Form