The U.S. Department of Health and Human Services Office of Human Research Protection (OHRP) has mandated that all research sites outside the United States that participate in research funded by the U.S. Government must file documentation certifying that each research site observes the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and has an independent ethics committee. Sites participating in trials sponsored by the U.S. National Cancer Institute (NCI) must also undergo regular on-site audits.
OHRP International Issues
OHRP provides services to help ensure that recognized ethical protections are afforded to persons participating in research conducted in countries outside the United States.
Declaration of Helsinki
This declaration, last amended in October 2008, is a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
This report outlines ethical principles and guidelines for the protection of human subjects of research
Establishing an Independent Ethics Committee
An independent ethics committee, also known as an Institutional Review Board (IRB), must be set up to comply with U.S. NCI policy. Policies and procedures for establishing an IRB vary by region and country. All institutions collaborating in clinical trials with the U.S. NCI must register their IRB and file a Federalwide Assurance (FWA).
Here are some resources for establishing an ethics committee or IRB:
Central Institutional Review Board (CIRB)
The Central IRB (CIRB) Initiative is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants.
U.S. Department of Health and Human Services IRB Guidebook
This guidebook provides help in understanding policies governing human research and in identifying sensitive issues in designing research proposals.
OHRP IRB Registration and Assurances
This site provides guidance in registering an IRB.