The Harvard Faculty of Medicine (comprised of Harvard Medical School [HMS] and the Harvard School of Dental Medicine [HSDM] established the Committee on Human Studies (also referred to as the CHS or IRB) to review research projects and activities that involve human participants, and which oversees the implementation of all policies and procedures for human studies research.

The mission of the CHS is to insure that all participants are protected from any unnecessary risk while involved in a research project, that they make an informed decision to participate, and whenever possible, that there is a benefit to the participant or to society from the research. The goal of CHS is to assist Investigators in developing appropriate research protocols in accordance with federal, and University policies, and within accepted ethical guidelines.

The CHS complies with the Department of Health and Human Services (DHHS) policies for the protection of human participants in research as administered through the DHHS regulatory arm, the Office for Human Research Protection (OHRP), and the requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR § 46) including its subparts A, B, C, and D. Additionally, the CHS complies with the Federal Drug Administration’s Code of Federal Regulations at 21 CFR § 50 and 21 CFR § 56, as well as applicable Commonwealth of Massachusetts regulations governing human studies research.

The CHS is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, entitled, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (also referred to as the Belmont Report).

In addition to the above Federal and Commonwealth regulations and the Belmont Report, HMS/HSDM faculty, staff and students are expected to comply with all applicable provisions of the HMS Faculty Policies on Integrity in Science, as well as Harvard University’s Statement of Policies and Procedures Governing the Use of Human Subjects in Research, its Information Security and Privacy policies, and Statement of Values and the policies and procedures of the CHS.

Updated: 23-Nov-2009