3. Institutional Authority

3 Institutional Authority

3.1 Assurance of Compliance

3.2 Committee on the Use of Human Subjects (CUHS) Office

3.3 Massachusetts Law

3 Institutional Authority 

The President and Provost of Harvard University have designated the Associate Provost for Research Policy and Institutional Compliance as the officer who coordinates the University’s human research protections programs, reporting to the Provost, who serves as Institutional Official for the CUHS. 

In accordance with the September 22, 2003 vote of the President and Fellows of Harvard College, the jurisdiction of the CUHS extends to ALL research (whether funded or not, and regardless of funding source) involving human subjects conducted by investigators under the auspices of the University-Area Institutions. Research under the auspices of the University-Area institutions includes research conducted by or under the direction of any employee or agent of the University-Area institutions (including students) in connection with his or her institutional responsibilities, conducted by or under the direction of any employee or agent of the University-Area institutions using any of their property or facilities or involving the use of these institutions’ non-public information to identify or contact human subjects for research purposes. 

3.1 Assurance of Compliance

Harvard University holds a Federalwide Assurance (FWA), [FWA #00004837], applicable to all of the University-Area Institutions. 

3.2 Committee on the Use of Human Subjects (CUHS) Office 

The CUHS Office reports to the Dean of the Faculty of Arts and Sciences (since the CUHS is a Faculty of Arts and Sciences Standing Committee) and to the Harvard University Provost (who also serves as the Institutional Official and the Signatory Official on the Federalwide Assurance). The CUHS office is supervised by the Executive Officer of the CUHS. The Executive Officer has expert knowledge in regulatory issues regarding human subjects and, as the Human Protections Administrator, is the sole point of contact between the University-Area institutions and the Office for Human Research Protections, Department of Health and Human Services. 

The CUHS is staffed by a sufficient number of administrative positions, including Research Officers and support staff, to perform its functions. The duties and responsibilities for all staff are found in their respective job descriptions, and their performance is evaluated on an annual basis, or more frequently as required, in accordance with the human resources policies and procedures of the Faculty of Arts and Sciences. CUHS Office Staff attend local and national conferences on human research protection issues and are expected to remain current on emerging issues regarding the use of human subjects in research. 

3.3 Massachusetts Law 

Harvard University and the CUHS rely on the Office of the General Counsel of the University to interpret and help apply Massachusetts law, where applicable to human subjects research.