The IRB is a federally mandated committee of scientific and non-scientific people who are responsible to review, approve, and monitor biomedical and behavioral research involving humans to protect participants’ rights, safety, and welfare.
In accordance with US Food and Drug Administration, Department of Health and Human Services, and Massachusetts regulations, anyone at CHA who conducts or participates in research involving humans must submit the study for IRB review and receive approval before initiating the research. The IRB must also review and approve the research at least annually to make certain that the research does not expose study participants to unreasonable or unnecessary risk.
The CHA IRB meets monthly, or as needed. In its deliberations, the IRB will use the ethical principles of beneficence, respect for persons, and justice that are established in the 1979 Belmont Report to make its determination. With representation from a wide range of scientific disciplines and from outside the academic community, the IRB gives rapid, but individualized, attention to the numerous and diverse research projects at CHA.
The IRB Chair and IRB office members are available to help investigators develop a protocol or informed consent form, provide research education and training, help interpret how certain regulations apply to a specific research study, or answer questions about the IRB forms. As a member of the Harvard Catalyst, additional resources are available to CHA personnel, including the Catalyst Research Resources. Help is also available to researchers to develop and conduct study monitoring, prepare for a sponsor’s or a federal site visit, or train and orient new investigators and/or coordinators.
Please call the IRB office at 617-806-8702 with questions or for assistance; our office staff is readily available.