Human Subjects Involved in Research

Does your research involve human subjects? 

  • If the research includes human subjects, ensure the IRB application has been fully approved, and for partner institutions as well. Human subjects review at international universities and governmental sign-offs are a long process. In general, Harvard does not allow Harvard projects to engage in direct clinical care of patients, as clinical care lies outside the core mission of the University.  Any such arrangement would require specific approval from the Provost and the pertinent Dean of Faculty.
    • Human Research regulations/laws abroad. The IRB applies the same ethical and regulatory standards to research conducted abroad as to domestic research and must also ensure that the protections in place are appropriate for the local research context in which the research will be conducted. It is also important to note that investigators must comply with the relevant laws protecting human subjects in the host country and any requirements for local ethical review. Investigators should consider partnering with local researchers in order to ensure understanding of local context and regulations. International regulations can also be found online by navigating to https://www.hhs.gov/ohrp/international/compilation-human-research-standards/ or https://catalyst.harvard.edu/programs/regulatory/internationalresearch.html. For Longwood area investigators, submit a Service Request to the Quality Improvement Program for IRB submission assistance, assistance connecting with a local researcher, and/or navigating local regulation(s).
    • Ensure you and all investigators have a clear understanding of cultural and societal norms in the region, ensuring adequate recruitment measures and consent process.
    • Consult with your local IRB representatives for more information and to determine next steps: