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. Objectives.
Conducting Research at Non-Columbia Sites
September 14, 2004
Columbia University Medical Center IRB
1) Present an understanding of regulatory requirements and ethical considerations.
2) Overview of International Standards.
3) Effective Negotiation Strategies toResolve Regulatory Differences.
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
Revised Version Released
March 20, 2002
On OHRP Website
Can adhere to:
Declaration of Helsinki
Implemented December 3, 2000
Joint Effort with FDA
No requirement for review of Federally funded research
Research that will be Conducted at Distant Site
IRB Knowledge of Local Research Setting
Provides guidance on the necessary
information that should be obtained about
local research context.
-lack of gender representation
-easy to find for biomedical research,
but not always for behavioral studies
-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?
-Stigmitization of subjects
WHO - Spring 2000
Operational Guidelines for Ethics Committees That Review Biomedical