International Research

International research, or research proposed to take place at a foreign location, presents several challenges to the IRB. The IRB is required to have and document knowledge of the "local research context" and may require additional information from researchers before final approval of foreign site protocols may be granted.

Local research context involves knowledge about socioeconomic, political and cultural factors that influence every part of the research realm. Researchers must be aware that foreign cultures may have diverse authority structures. These structures may greatly influence the consent process and the identification and reduction of potential coercion.

Information about local laws and customs, local IRBs, agencies or "gatekeeper" organizations, and informed consent alternatives must usually be provided for international research. To aid researchers with this task, the Office of Human Research Protections (OHRP) has published The International Compilation of Human Research Standards. This compilation lists the approximately 1,100 laws, regulations, and guidelines that govern research involving human participants in 96 countries, as well as standards from a number of international and regional organizations. This Compilation was developed for IRBs/Research Ethics Committees, researchers, sponsors, and others who are involved in international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure these standards are followed appropriately.

Requirements

Researchers proposing to conduct international research must:

  • Provide detailed information about where the study will be conducted (geographic location, performance site, etc.)
  • Provide a statement asserting that s/he has reviewed The International Compilation of Human Research Standards and adheres to the respective country's laws, regulations or guidelines that govern research involving human participants
  • Submit a copy of the local IRB or equivalent ethics committee approval, where possible
  • Provide information about the current social, economic and political conditions
  • Provide information about whether there are any additional risks that participants might face as a result of participation
  • Consider the most appropriate method for obtaining informed consent, taking into account the literacy level of the subjects, confidentiality concerns and cultural climate
  • Review and adhere to the IRB's translation policy (refer to the policy on Non-English Speaking Participants)