Ten questions institutional review boards should ask when reviewing international clinical research protocols.

1) “Is there a viable ethics committee in the host country that will review the protocol and how can they be contacted?” 2) “What is the principal investigator’s relationship with the community from which research volunteers will be recruited?” 3) “Does the research protocol address the ethical challenges of conducting research in a developing country?” 4) “Is the purpose of the research responding to the health needs of the host country?” 5) “When negotiating informed consent, how will the investigators assure that the research volunteers understand the consent procedure?” 6) “What exactly is the local standard of medical care?” 7) “Are the risks to volunteers acceptable in the social context of the host country?” 8) “Does anyone else in the host country know about the research?” 9) “What public health action will result from the findings of the research study?” 10) “Is capacity building an essential element of the research protocol?”