Human Research Training

Human research training must be completed by anyone working directly with human subjects or with data or biospecimens when it can be linked back to individual subjects.  All Principal Investigators (PIs), Co-Investigators, and those meeting the NIH definition of “Key Personnel” must complete training regardless of whether or not they have access to identifiable data/biospecimens or direct contact with subjects. Human research training must be completed every three years.

Harvard recognizes the following options fulfill the human subjects training requirement.

Other Training & Requirements

Sponsors and/or funders may require investigators and study staff complete additional training.

The National Institutes of Health’s (NIH) “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” establishes the expectation that all NIH funded researchers, investigators, and/or study staff who are involved in the conduct, oversight,
or management of clinical trials should be trained in Good Clinical Practice (GCP). As such,
Office of Regulatory Affairs and Research Compliance requires all researchers involved in the
conduct, oversight, or management of an NIH-funded clinical trial to complete ICH-GCP
training (e.g., CITI “Good Clinical Practice” online course, NIH GCP online modules for Social Behavioral Research or Harvard’s GCP for Social and Behavioral Research Field Guide.)
These courses are separate from the “Human Research (Protection of Human Subjects)” course.
Completed ICH-GCP training certificates should be submitted to the IRB in the ESTR record.