The mission of the HRPP is to 

• promote the welfare and rights of human research participants, 
• facilitate excellence in human research, and 
• provide timely and high quality education, review and monitoring for human research projects.

To safeguard the rights and welfare of human research subjects, UCSF adheres unequivocally to the principles of The Belmont Report, as described in detail below.

Human research protection is a collaborative, ongoing enterprise involving multiple groups at UCSF: high-level administrators, the pharmacy staff, researchers and their staff, the HRPP staff, IRB chairs and members, sponsors and funding agencies, the Office of Sponsored Projects, hospital and campus risk management, legal counsel, staff who provide support services provided to researchers, research institutes, and the research participants themselves. These groups work closely together to ensure the ethical, safe and legal conduct of the research enterprise.

The HRPP offers outreach and education, including the required online human subjects training for research key personnel, IRB members and HRPP staff. Researchers are asked to fill out complex applications, which are then carefully screened by HRPP staff and reviewed by the IRB, in order to ensure awareness of and compliance with regulations.

Primarily through the QIU, the HRPP performs post-approval monitoring, including screening of post-approval events and on-site monitoring of the conduct of research. Other units at UCSF that also monitor research conduct include, but are not limited to, the Comprehensive Cancer Center, the Clinical and Translational Sciences Institute and its Clinical Research Centers, and the SF VAMC Clinical Research Office. Research sponsors and cooperative groups also monitor compliance on a regular basis, and their findings are communicated to the HRPP.

Particular goals of the education and monitoring include ensuring that

• All key personnel engaged in human research have sufficient training in their ethical and regulatory responsibilities,
• No research activities begin until all required approvals are in place, and
• Researchers do not implement changes in a human research study without first obtaining approval for the amendments from the IRB.

Taken as a whole, the educational efforts and monitoring seek to increase awareness of ethical issues and promote a culture of regulatory compliance in human research at UCSF and associated institutions.

The HRPP has gone through formal quality improvement processes that have resulted in reorganizations to increase its efficiency and effectiveness. The HRPP also frequently discusses and coordinates program improvements with its primary constituents and collaborators at UCSF.

University Administration is responsible for the rights and welfare of human research participants. UCSF through the Office of the Executive Vice Chancellor assures the federal government that the campus is in compliance with federal regulations regarding the protection of human subjects in research and that no research involving human subjects is conducted without prior review and approval.

UCSF grants the IRB the authority to function independently of other organizational entities in its role in protecting research participants.

UCSF provides adequate resources to support the activities of the HRPP, which includes the IRB and the Quality Improvement Unit.

UCSF may provide treatment and compensation for injured research subjects.

The University provides legal protection for members of the IRB and to principal investigators granted approval to conduct such research who have met their obligations in good faith.

University Administration is responsible for assuring that investigations occur for individual incidents or allegations of misconduct pertaining to the use of humans in research. To report incidents of non-compliance or unauthorized research, call the IRB at (415) 476-1814. For a more detailed description of this process, please read Reporting Research-Related Concerns and Complaints.

The University provides whistle-blowing protection for anyone who reports an activity that violates any regulations and policies on the use of human subjects.

Under the provisions of the federal Freedom of Information Act and California's Public Records Act, the University is required, upon request, to release to the public documentation on any active or retired protocol.

The IRB Leadership Group is composed of the HRPP Director and the Chairs and Vice Chairs of all six IRB Committees. The group meets monthly to address major HRPP policy issues, increase harmonization of review processes across panels, and develop standard protocol review practices.

See the About the IRB page for more information on the roles and responsibilities of the IRB.

The Director of the HRPP reports to the Associate Vice Chancellor and is responsible for the daily functioning and overall planning and development of the HRPP. The units of the HRPP are described below:

• The IRB Review Unit supports the activities of the IRB panels in a variety of ways. They coordinate the committee reviews by setting the agendas, assigning reviewers to the studies, providing regulatory and policy support and guidance during the review process, and preparing follow up communication for the investigators after the meeting.
• The Quality Improvement Unit (QIU) provides post-approval support for researchers by assessing and helping to manage post approval events and by conducting on-site reviews of studies. In addition, the QIU is responsible for conducting directed investigations. The unit is also involved with the quality assurance and improvement of the HRPP itself. The QIU also handles education and training.