 Wednesday, September 14 , 2005
| Topic: |
IRB Review of Non DHHS-Funded Protocols Carried Out in Mexico |
| Presenter: |
Amy McDaniel, Regulatory Compliance Analyst, SDSU |
| Location: |
SDSU Foundation: Sky Park |
| Discussion: |
Here are some of the questions that IRB's must ask while reviewing protocols for research in other countries/cultures, and a few discussion prompts:
• Are there any unique risks that may present to the study population during the course of this study and after the results of the study are released?
• Are there relevant benefits of participation for this population?
• Are the protections the US requires enough and culturally appropriate?
One of the main issues to address is that IRB's rely heavily on the PI to provide the answers to these questions- the PI is the expert on the population and what is culturally appropriate, however, the PI has a vested interest in the research. It is important to note that as long as the research is not DHHS funded, the IRB/Investigator is not required to have the research reviewed by a board representative of the local population.
A case study (behavioral AIDS/HIV research in Mexico conducted by U.S. investigators) will be provided at the meeting. |
| Readings: |
OHRP: International Issues
http://www.hhs.gov/ohrp/international/
OPRR Reports: Guidance for Institutional Review Boards for AIDS Studies
http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc84dec.htm
Ethical Issues in Data Collection for HIV Programming and Evaluation
http://www.fhi.org/en/HIVAIDS/pub/fact/ethicaldatacol.htm | |
