Human Subjects in Research

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.

For more information please visit the OVPR site: Human Subjects & IRBs.

Typically, a sponsor requires that proposed studies with human subjects be approved by the requisite IRB at the time the award is made. Some require that this approval be in hand at the time a proposal is submitted or, at a minimum, in process. Prior to submitting a proposal one should review the sponsor's human subject requirements. This information is generally available on the sponsor's web site or in the RFP. Please note: Non-funded agreements such as DUAs and MTAs that include human subjects may also require IRB approval.