Fall 2011, Issue 13
Tips for International Human Subject Research
Human subject research performed outside of the U.S. requires more knowledge and more time than that performed entirely within the U.S. In order to develop appropriate protocols, researchers need to be familiar with the host country’s laws, as well as the local culture and norms. Without this knowledge, researchers may inadvertently put their subjects and research team members at risk. For example, there are places where a researcher should not speak with a married woman unless her husband is present, and in some tribal villages a researcher may need a chief's approval before talking to a potential subject. Research team members asking questions about illegal activities could also inadvertently put subjects and themselves at risk.
Ethical guidelines and laws regarding human subject research in over 100 countries and from several international organizations can be found in the Office for Human Research Protections (OHRP) International Compilation of Human Subject Protections, which is updated annually. One of the best ways for a researcher to obtain needed information about a local culture is to contact a nongovernmental organization (NGO) working in the area. A collaborating foreign institution is also able to provide the principal investigator (PI) with needed information. Other sources of help include the country’s health ministry and consulate. Some PIs rely on other Tufts faculty with experience in the country, or they contact the authors of publications of research conducted in the country.
International research is subject to the same rules and regulations as national research. The CITI training module on international research is recommended for PIs and research team members. Those aspects of the human subject research that are carried out at Tufts are under the purview of Tufts’ Institutional Review Boards (IRBs), and those aspects of the research that are carried out in the participating country are under the purview of that country’s IRB or ethics committee. The OHRP provides a database (searchable by country) of registered IRBs and of institutions that hold a federalwide assurance (FWA), which is required for any institution that is engaged in human subject research that is conducted or supported by any agency of the U.S. Department of Health and Human Services.
The research protocol submitted to a Tufts IRB should clearly specify which aspects of the research will be carried out in each country. The protocol should include information that shows the PI is familiar with the proposed research area and is qualified to do the study at the foreign site. Suggested supplemental information includes local laws, languages, the age of majority, cultural sensitivities, who is responsible for providing consent, and whether written or oral consent is customary. Tufts IRB offices have created a reference sheet to guide PIs in compiling this information. The Social, Behavioral & Educational Research (SBER) IRB application form has a section for international research; the Health Sciences Campus and Tufts Medical Center IRB form does not have a separate section, but requests the information be provided in the protocol.
International research tends to demand more time than national research to develop protocols and receive all needed authorizations. Some IRBs at certain institutions in other countries only meet once a year, so it is important to know the schedule and requirements well in advance of the anticipated research start date.
Tufts’ IRB administrators advise PIs to contact their IRB office as soon as they begin planning an international research project. IRB staff will help direct PIs to where they may obtain more information to develop solid protocols that comply with all Tufts, U.S., and participating country requirements.
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