September 2004, Issue 3

Institutional Review Board Approval for International Human Subjects Research

Besides the normal challenges of developing an ethical protocol for human subjects research, investigators working in foreign countries have the additional challenge of learning about the local culture and norms and developing their protocol with these norms in mind. Without this knowledge, researchers may inadvertently put their subjects at risk. For instance, in some countries people aren't allowed to talk about their government, either positively or negatively. Asking inappropriate questions could put the subjects at risk. There are places where you cannot talk to a woman unless her husband is present, and in some tribal villages you may need a chief's approval before you talk to anybody. So a primary responsibility of the researcher is to know the population under study and to ensure that the Institutional Review Board (IRB) is provided with information about the local context from an authority who is not affiliated with the researcher's project. This information should include such things as potential risks, whether the research topic is of a sensitive nature, what local laws must be followed, and what methods for collecting data and ensuring confidentiality are appropriate for the area.

International research is subject to the same rules and regulations as national research. The principal investigators (PIs) must get human research protocols approved by an IRB. If the country of interest has an IRB that has been approved by the Office of Human Research Protection (OHRP, a division of the US Department of Health and Human Services), the PI can submit a request to the Vice Provost to have that IRB serve in lieu of the Tufts IRB. The Tufts IRB can assist the PI in this endeavor. A list of international IRBs can be found at http://ohrp.cit.nih.gov/search/irctrypck.asp.

Not all countries have IRBs, however, and some international IRBs will not sign US government documents. If working with an IRB operating in the country of interest under an agreement with the OHRP is not possible, the protocol must be submitted to the Tufts IRB for review. The PIs may be required to have any organizations or institutions with which they are collaborating sign an "IRB Authorization Form" and have all personnel from the foreign country sign an "Unaffiliated Investigator Agreement." The PIs should check with the Tufts IRB for any agreements that must be signed.

Just as in the United States, the fully informed consent of all human subjects must be documented. Consent forms may need to be translated into the local language. In countries where many people are illiterate, or where it is against one's culture to sign one's name to a document, the IRB may decide to waive the signed consent form and allow documentation of verbal consent. If verbal consent is allowed, a script must be used that is easily understood by the local people. The criteria for waiving signed consent are governed by regulations stipulated in 45CFR 46.116 and 46.117 (Code of Federal Regulations).

Besides being responsible for the safety of study participants, PIs are also responsible for the appropriate education and conduct of all those involved in the research, both paid personnel and volunteers, within both the US and the country of interest. Educational requirements for key personnel are the same as for national studies, and certificates of education may require translation.

Another consideration for international researchers is the secure maintenance, storage, and transportation of data. In the US, acceptable standards of data safety include password protection, locked filing cabinets, and/or removal of identifiers. In a foreign country, you have to consider the available facilities and technologies for the security of the data while it is in that country, and whether the data could put someone at risk if it fell into the wrong hands. You also have to consider the best mode of transport back to the United States. Locked containers are no longer allowed on airlines, so you have to decide whether it is safer to send the data by mail or with a person. PIs must advise about what is practical in each case, but it is the IRB's decision as to the approved methods that best protect the confidentiality of the subjects.

If all the forms have been filled out properly, and the IRB has adequate expertise on the country of interest, review of an international protocol should not take any longer than review of a national protocol — four to six weeks. The IRB must have local context information about the area in which the research is to take place; so providing this information is essential if the board does not have a member familiar with the country of interest. Some forms of research and some countries (i.e., national security risks) require approvals from agencies in addition to the DHHS's OHRP. They will therefore require more review time.

For more information, go to the OHRP homepage at http://www.hhs.gov/ohrp/

If you have any questions please contact the Office of the Vice Provost at (617) 627-3417.