International Research with Human Subjects and Clinical Trials

International research involving human subjects often presents unique challenges. To help guide you through the IRB submission process, the Human Research Protection Office offers a number of useful resources.

Human subjects research guidance

Guidance materials

The International Human Subjects Research Guidance materials, developed by the Washington University International Research with Human Subjects Committee provide detailed instructions on the human subjects requirements for conducting international research.

Additionally, prior to submitting to WashU’s IRB, the WashU PI (and local informed partner) should review the International Compilation of Human Research Standards, published by the Office for Human Research Protections (OHRP). This is a listing of over 1,000 laws, regulations, and guidelines on human subject protections in over 100 countries from several international organizations.  This document can be a resource to consult in determining country level guidelines on international human subjects research.

The Office for Human Research Protections (OHRP) is the federal agency that oversees IRBs. WashU’s expectations are compiled from federal OHRP.

Pre-submission resources

International Prep Work Checklists

International Research Prep Work Checklists provide valuable information on the requirements that must be completed PRIOR to submitting the study to WashU IRB. Completing these tasks prior to WashU IRB submission will avoid delays with IRB review and approval.

Pre-submission consultation

Cindy Brantmeier, PhD is faculty fellow, International Research within the Office of Vice Chancellor for Research. She has extensive experience conducting international research on human subjects.  In her role as faculty fellow, she is available to provide a consultation regarding requirements when conducting human subjects research outside the US PRIOR to submitting to WashU IRB.

International clinical trials

Special considerations for international clinical trials

Definition of a clinical trial

Studies that are defined as “clinical trials” may have special compliance requirements.  A number of federal agencies, including the NIH, share a definition of “clinical trial” that is codified in federal regulations: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”  NIH policy has additional requirements for clinical trials, including Good Clinical Practice (GCP) training and clinicaltrials.gov registration.  Clinical trials are generally defined more broadly by the U.S. federal government than by other organizations so investigators are encouraged to review the proposed research carefully to determine whether or not it is a clinical trial. The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices, and biologics. The FDA defines a clinical investigation as “any experiment that involves a test article and one or more human subjects” when the test article is or would be FDA-regulated. Laws and regulations outside the United States may have differing definitions of a clinical trial. 

Sponsorship and CROs

ICH-GCP E6(R2) defines a sponsor as an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Some international clinical trials will require assigning a local sponsor/legal representative within the jurisdiction you plan to conduct your trial in. This is dependent on the relevant regulations within the country and whether your research is subjected to those regulations. For trials where it is determined that a local sponsor/legal representative is required, appropriate contracts must be executed between WashU and the local sponsor/legal representative. A contract research organization (CRO) that is experienced in managing international clinical trials may be hired to provide services including regulatory documentation, data management, trial logistics, and project management. 

Insurance

Many countries require that a clinical trial sponsor maintain specific clinical trial insurance policies.  It is important to account for the cost of such a policy in your pre-trial planning. WashU’s Office of Risk Management can facilitate securing a clinical trial policy. 

Ex-U.S. laws and regulations

Clinical trials in other countries are often subject to a variety of laws and regulations, including laws related to coverage for trial participant injuries and data privacy laws. It is important to consult with experts that can advise on the laws applicable in that country.