These guidance materials were created by the Washington University International Research with Human Subjects Committee and provide detailed instructions on the human subjects requirements for conducting international research.
This document provides comprehensive guidance on the IRB review requirements for international research and outlines the responsibilities of the researchers.
This flow chart outlines when a local context advisor review or foreign IRB/Ethics Committee review is required. This decision point hinges on the requirements of the country in which the research will be conducted, the type of research and funding source, if any.
There may be times when certain language must be included in the consent form even if a foreign IRB is responsible for the review of the consent form.
- Certificate of Confidentiality (COC)
– If your study is funded by one of the federal Public Health Services Agencies (PHS), the COC requirements apply and language describing the protections of a COC must be included in the consent form.
– Template consent language to describe the COC protections is found in the consent template that is available as part of your draft myIRB application.
– The use of a document separate from the consent form is also an option. Contact your International Research HRPO Partner: Erin Higgs (firstname.lastname@example.org) or Mitchell Saulisbury-Robertson (email@example.com) to obtain a copy of the COC separate document.
– For more information on the applicability of a COC to your study see: https://research.wustl.edu/cocs/
- General Data Protection Regulation (GDPR)
– Language about GDPR protections should be in the consent when there is a transfer of personal data collected from citizens of the EEA (most countries in Europe including the United Kingdom) and transferred outside of Europe.
– The template consent language can be found in the suggested language for biomedical or behavioral research documents linked on the attachments page of your draft myIRB application.
– See the International Human Subjects Research guidance document for more information on GDPR.
- Key Information
A key information section in the consent form is required when a study receives federal funds and the study is NOT exempt.
The research guide includes instructions on how to write a key information section.
International Compilation of Human Research Standards
The International Compilation of Human Research Standards is a listing of over 1,000 standards on human subjects protections offered by the DHHS, Office of Human Research Protection Office. These standards may include laws, regulations, and/or guidelines.
Content current as of 10/5/2022