OHRP International Activities

1
OHRP International Activities

• Glen Drew
• Health Policy Analyst
• Office for Human Research Protections

2
Goals

• Overview of OHRP International Activities.
• Dueling IRBs Example.

3
International Activity Goals

• Build capacity for ethical review.
• Increase awareness of requirements.
• Increase compliance.
• Ensure all HHS research matches ethical
  principles.

4
OHRP International Activities

• Capacity Building.
• Organizational Cooperation.
• Workshops.
• Quality Improvement.

5
Organizational Cooperation

• Other HHS Agencies
• Other Federal Agencies
• World Health Organization
• Research Institutions

6
Organizational Cooperation (2)

• Regional fora of interest
• Pacific and South Asia
• Russia and Confederation of Independent States
• Africa
• Central and South America
• North America

7
Fora Contacts

• SIDCER
• Strategic Initiative to Develop Capacity for
  Ethical Review.
• Web Site - www.sidcer.net/.

8
Workshops

• One workshop annually in each forum.
• Presentations at other workshops and
  conferences.

9
Quality Improvement

• Visit to five institutions in South Africa
• Video conference.
• Open to additional International QI.

10
New Initiatives

• Voluntary international accreditation.
• Identify institutions with most international
  work.
• Research ethics courses in those countries.
• Network workshops and more.

11
Dueling IRBs

• U.S. sponsored trial in Malawi.
• IRBs differed on wording in consent.
• Mfutso-Bengu, JM, Taylor, TE. Ethical
  jurisdictions in biomedical research. Trends in
  Parasitology 2002 18(5) 231-234
• What can the researchers do?

12
Conclusion

• OHRP seeks to build capacity.
• Look for opportunities to cooperate, leverage
  resources.