IRB Review of International Research
Research conducted by Northwestern University investigators in foreign countries remains under University purview and guidelines. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or for a meaningful consent and/or assent process.
Special attention should be given to local customs and to local cultural and religious norms in developing research, drafting recruitment material as well as written consent documents and data collection instruments. When it is appropriate the IRB will consider alternative consent formats if culturally appropriate. In some instances, it may be appropriate for the IRB to waive some or all requirements for written consent in favor of a verbal consent for cultural, religious or literacy reasons. Research proposals for which this may be reasonable should include explanations of cultural norms or conditions requiring such as waiver. (E.g. societies where no written language is used, or societies where signatures represent the surrender of spirit or soul to the researcher)
Where appropriate, research projects must have been approved by the local equivalent of an IRB before they are presented to the University IRB. Where there is no equivalent board or group, investigators are expected to consult with local experts or community leaders about the project and to secure their support for the conduct of the research. The IRB does require that there be good faith effort applied to secure local cooperation for the research and to document those efforts as part of the application.
In addition, the OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by HHS receive an equal level of protection as research participants inside the United States. To that end, the Institution’s human research activities, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), will be guided by an assurance of specific principles governing the institution in carrying out its responsibilities for protecting the rights and welfare of humans in research conducted at or sponsored by the institution. This requirement of an assurance applies to non-U.S. Institutions such that whenever non-U.S. institutions are engaged in non-exempt HHS-supported or -conducted human research, the HHS human subject protection regulations, 45 CFR part 46, apply.
This means that when appropriate the non-U.S. institution must obtain an FWA which is the only type of assurance of compliance accepted and approved by OHRP. There is a single version of the FWA and the Terms of Assurance for U.S. and non-U.S. institutions. For additional information see: (http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/fwa-protection-of-human-subjecct/index.html)
It should be noted that there when considering local cultural norms, equivalent protections are required (see OHRP guidance for equivalent protections: http://www.hhs.gov/ohrp/international/equivalent-protections/index.html). For example, with all due respect and sensitivity for local customs, minors who are treated as adults in their own country will be treated as minors for the purpose of protection in research. However, the definition of who may provide ‘parental permission’ to participate may appropriately be adjusted based on cultural norms. It is possible, that grandparents or even tribal leaders may be the cultural head of household and may ethically serve as the designated guardian for a minor participating in research. That said, the cultural norms in question must be identified in the research protocol and the exception to policy anticipated.
OHRP also publishes The International Compilation of Human Research Standards, a listing of over 1,000 laws, regulations, and guidelines on human subject protections in over 100 countries and from several international organizations. This document should be consulted to determine country level guidelines on human subject research. Many of the listings embed hyperlinks to the source document.