Special considerations apply when the proposed research will be at sites for which the CPHS does not regularly conduct review, such as research involving countries outside the U.S. and international populations.

As with other OHRP-approved Institutional Review Boards (IRBs), the CPHS is charged with ensuring that: selection of subjects is equitable; privacy of subjects is protected and confidentiality is maintained; informed consent is sought in language understandable to the subject and under conditions that minimize possibility of coercion or undue influence; and appropriate safeguards protect the rights and welfare of vulnerable subjects.

Local research context: A vital aspect of this responsibility is possessing sufficient knowledge of the “local research context” (e.g., applicable local laws and customs) to satisfy these requirements. OHRP outlines standards for IRBs to obtain and document local research context, based on the risk level and nature of the proposed research. Accordingly, in such cases, the CPHS often requires additional information from the investigator, and possibly from outside consultants if necessary.

Thus, if you propose to conduct research abroad, the following issues should be addressed in the Protocol Narrative:

1. Describe the expertise you have or have access to which prepares you to conduct research in this location and/or with this subject population, including specific qualifications (e.g., relevant coursework, background, experience, training). Also, explain your knowledge of local community attitudes and cultural norms, and cultural sensitivities necessary to carry out the research (e.g., differences with U.S. culture).
2. Do you speak, write, and/or read the primary language of prospective subjects?
3. Were you invited to conduct your research by members of the local community?
4. Discuss how you will assure the voluntary and fully informed participation of the research subjects.
5. Explain how you will identify and minimize any risks posed to subjects, including those of confidentiality (see below).
   
   Confidentiality: The political or social climate in a foreign country may be such that normal methods for protecting the confidentiality of research data and the identity of subjects are not adequate. Except under unusual circumstances, the procedures to be employed should not be less stringent than those required by the CPHS for research in the U.S., even if those customary in the foreign country are less restrictive.