Human Subjects & IRBs

Policies and Guidance

Human subjects research comprises a broad spectrum, from testing of new drugs and therapeutics to surveys and questionnaires (in person or online), observation studies, and research with human tissues or data about human beings. It may or may not include direct contact with people.

Anyone performing human subjects research at Harvard, including faculty, staff, and students, must obtain the requisite approvals prior to beginning the project, regardless of funding source.

Harvard has two IRB offices that oversee human research activities:

Harvard’s IRBs are governed by the Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University.

The Harvard IRBs share a common Electronic Submission, Tracking and Reporting ESTR which is a web-based system where all researchers submit their applications including completed forms and sample documents.    

While the IRBs are the first line of contact for any human-research-related question, human subjects research may require approvals beyond that given by the IRB:

Multi-center research may be eligible for the Common Reciprocal Reliance Agreement, which can allow investigators who are conducting a mutli-center clinical study to request that participating IRBs rely on the review of one center's IRB. Please see the Harvard Catalyst’s cede review website for more information.

Researchers should be aware of the Financial Policy on Human Subjects Payments.