IRB Policies and Procedures

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 Institutional Review Board (IRB) or Exempt Review Committee (ERC). They are 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 socio-economic, 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 undue influence or coercion.

When engaging in international research, investigators must consider local laws and customs, local IRBs, agencies or "gatekeeper" organizations, and informed consent alternatives. 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 hundreds of 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, and to assure these standards are followed appropriately. OHRP has also published two documents concerning Social and Behavioral Research: (1) International Social/Behavioral Research Standards - Description and (2) International Social/Behavioral Research Standards - Analysis.

Requirements

Researchers proposing to conduct international research must:

  • Provide a statement asserting that s/he has reviewed The International Compilation of Human Research Standards and/or the (1) International Social/Behavioral Research Standards - Description and (2) International Social/Behavioral Research Standards - Analysis 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
  • For non-English speaking participants, 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

For research involving European Union (EU) or European Economic Area nationals, additional elements may be required in the application and informed consent form. Please refer to the European Union's General Data Protection Regulation policy.

All investigators conducting research internationally must complete CITI's international module as part of their human research course training.

Procedures

  1. If not completed initially, the Principal Investigator (PI), co-investigators and research assistants complete the international module as part of the required human research course training via CITI.
  2. With an IRB or ERC submission, the Principal Investigator (PI) includes a statement about having reviewed the Office of Human Research Protections' International Compilation of Human Research Standards, and/or its Social/Behavioral Standards and adheres to what is described for the specific country. If the country's standards require additional information, the PI provides it.
  3. The PI addresses other requirements about the location and its conditions, any additional risks for this population, the appropriate method of obtaining informed consent, the language being used, and any foreign IRB or equivalent approvals.
  4. If EU or EEA nationals are involved, the PI includes required information from the European Union's General Data Protection Regulation in the application and informed consent form.

Related Policies

  • European Union's General Data Protection Regulation
  • Non-English Speaking Participants

History

11/02/2017 - Updated OHRP's International Compilation for 2018; provided a definition and adjusted formatting
05/25/2018 - Updated with OHRP's Social/Behavioral standards and EU requirements; added procedures
07/24/2018 - Updated links to the current International Compilation.