1. IRB-Investigator/ Research Coordinator Mtg. Conducting Research at Non-Columbia Sites Including International Research September 14, 2004 George Gasparis Brenda Ruotolo Columbia University Medical Center IRB

2. Objectives 1)Present an understanding of regulatory requirements and ethical considerations. 2)Overview of International Standards. 3)Effective Negotiation Strategies toResolve Regulatory Differences.

3. International Standards for the Protection of Human Subjects: Ethical Standards 1. Nuremberg Code – 1947 2. Declaration of Helsinki – Revised 8 times between 1964 and 2000 3. Belmont Report – U.S. - 1979 4. Australian National Statement on Ethical Conduct in Research Involving Humans - 1992

4. International Standards for the Protection of Human Subjects: Procedural Standards 1. Council for International Organizations of Medical Sciences (CIOMS) – 1993, 2002 2. International Conference on Harmonization – 1987 3. Canadian Tri-Council Policy Statement - 1998 4. Ethical Guidelines for Biomedical Research on Human Subjects - 2000

5. OHRP Office For Human Research Protections ( formerly OPRR )

6. ABCs of 45 CFR 46 Every institution engaged in DHHS supported or conducted human subjects research needs: Every institution engaged in DHHS supported or conducted human subjects research needs: A. Assurance of Compliance Approved by OHRP B. Board Approval (i.e., IRB, REB, ethics cmte.) C. Consent Obtained from Each Subject, Unless Waived by the IRB Waived by the IRB

7. Federal Wide Assurance (FWA) Revised Version Released Revised Version Released March 20, 2002 On OHRP Website

8. International Assurance Can adhere to: CIOMS www.cioms.ch www.cioms.ch Declaration of Helsinki www/wma.net

9. IRB Registration System Implemented December 3, 2000 Implemented December 3, 2000 Joint Effort with FDA Joint Effort with FDA No requirement for review of Federally funded research No requirement for review of Federally funded research

10. IRB Registration System - cont’d. n Simple 3 Page Form n All Registered IRBs will be Informed of New Guidance/Updates/Regs. n Can Track Registered IRBs on OHRP Website

11. Challenging Issues Challenging Issues Research that will be Conducted at Distant Site Research that will be Conducted at Distant Site OHRP Guidance OHRP Guidance IRB Knowledge of Local Research Setting http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm Provides guidance on the necessary information that should be obtained about local research context.

12. Challenging Issues Challenging Issues Informed consent -cultural differences -regulatory differences IRB composition -lack of gender representation IRB Review -easy to find for biomedical research, but not always for behavioral studies but not always for behavioral studies

13. Challenging Issues Challenging Issues Clinical Research -will the research benefit the local community? -will the results be provided to the local community? -are local officials involved in the design of the study? -selection of test article; equivalent to std. therapy in developed country? -use of placebo-controlled studies?

14. Challenging Issues Challenging Issues -Capacity Building -Stigmitization of subjects

15. International Research WHO - Spring 2000 Operational Guidelines for Ethics Committees That Review Biomedical Research http://www.who.int/tdr/publications/ publications/ethics.htm

16. OHRP on the World Wide Web http://dhhs.gov/ohrp/