Institutional Review Boards in Developing Countries
Author Information
Author(s): Jean William Pape
Primary Institution: Cornell University Medical College
Hypothesis
Can IRBs in the United States guarantee the protection of human subjects involved in research projects in developing countries?
Conclusion
The IRB process is complex and may not effectively protect volunteers in developing countries due to lengthy consent forms and lack of understanding.
Supporting Evidence
- IRBs have no effective way of controlling what goes on in the field.
- U.S. consent forms are too long and complicated for participants to fully understand.
- Only half of volunteers in a phase-II HIV vaccine trial answered all questions correctly after counseling.
Takeaway
This study looks at how well U.S. review boards protect people in other countries who are part of research studies, and it finds that they often don't do a good job.
Methodology
The study proposes using a simple questionnaire to evaluate volunteers' understanding of research studies.
Potential Biases
The IRB process may favor legal protection over volunteer welfare.
Limitations
The study does not provide specific data on the number of participants or the effectiveness of the proposed questionnaire.
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