International Research

Purpose

The purpose is to outline the policies and procedures for International research.

Definition

International research is research which is proposed to take place outside of the United States. It may involve activities which take place on foreign soil, which access foreign human subjects remotely (e.g., Internet), or which access data about human subjects from the foreign location.

Policy

International research 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 over 1000 laws, regulations, and guidelines that govern research involving human participants in 130 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 a statement asserting that s/he has reviewed The International Compilation of Human Research Standards for the country involved and adheres to the respective location's laws, regulations or guidelines that govern research involving human subjects
  • Provide detailed information about where the study will be conducted (geographic location, performance site, etc.)
  • Provide information about the current social, economic and political conditions
  • Provide information about whether there are any additional risks that subjects 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)
  • Submit a copy of the local IRB, ERB or equivalent ethics committee approval, where possible

History

11/02/2017 - Updated OHRP's International Compilation for 2018; provided a definition and adjusted formatting