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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

PROGRAM DESCRIPTION (February 2005, revised March 2008)

 • Overview and Purpose
 • Mission
 • Organization
 • Scope
 • Types of Research Reviewed
 • Ensuring That Human Research Participants Are Protected
 • Concerns or Suggestions
 • Improving Human Research Protections at UCSF
 • Acknowledgments

 • Campus Administrative Policies # 100-16


This is a summary of the plan for UCSF’s Human Research Protection Program (HRPP). To understand all elements of the program, it is necessary to consult the HRPP website, the CHR Handbook for Members, and the HRPP Procedures Manual.

Overview and Purpose

The Human Research Protection Program (HRPP) of the University of California, San Francisco in partnership with the research community, is responsible for ensuring the ethical and equitable treatment of all human research subjects in studies being conducted at UCSF and its affiliates and partners and/or being conducted by UCSF faculty regardless of site of activity. The HRPP is also responsible for ensuring compliance with federal regulations, state laws and University polices as well as national standards for research involving human participants.

The HRPP creates a full circle of protection for research subjects and researchers by providing education and training, the Committee review process and post-approval monitoring and reviews.

Full circle


Mission

The Mission of the HRPP is

  • to promote the welfare and rights of human research participants

  • to facilitate excellence in human research and

  • to 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: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research.


Organization

The UCSF HRPP is located administratively within the Office of Research. The Institutional Official for the HRPP is the Executive Vice Chancellor who delegates the oversight of the program to the Associate Vice Chancellor, Research. See organizational chart and Responsibilities in Research Involving Human Subjects.

Both the HRPP Policy Group and the IRB Panels operate under the leadership of the Executive Vice Chancellor.

  • The HRPP Policy Group serves as an advisory group to the Executive Vice Chancellor. It is a standing committee composed of the Chairs and Vice-Chairs of each of the IRB panels, the Institutional Official, the Associate Vice Chancellor for Research, the HRPP Director and Associate Directors, UCSF Legal Counsel, the Deputy Associate Chief of Staff for Clinical Research at the VA, a member of the Research Advisory Board, a representative of the Clinical and Translational Research Institute and other members as appointed by the Executive Vice Chancellor.  If one of the members previously mentioned is not a member of the Cancer Center, then a representative from the Cancer Center will also be appointed.  Others may be invited to or request to attend the meeting to provide additional expertise or perspectives.

    The group meets two to four times a year to review, revise, and develop UCSF policies for the protection of human subjects and human research at UCSF. Before policies are finalized and promulgated, they are reviewed and approved by UCSF Legal Counsel with input from UC General Counsel as needed.

  • The Committee on Human Research (the CHR) is UCSF's Institutional Review Board (IRB). Operating under Federal regulations, State laws, and institutional policies, the CHR reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects. At present the CHR is composed of four panels that share equal authority and responsibility. Each panel of the CHR is composed of faculty members, at least one non-affiliated member, and one non-scientist. The Executive Vice Chancellor appoints CHR chairs and members. No University official can overrule a disapproval by a CHR panel, although others in the institution may decide that a study that is approved by the CHR should not go forward. See About the Committee on Human Research for details.

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 three units of the Office of the HRPP are described below:

  • The Committee on Human Research Review Unit supports the activities of the CHR 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 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 Education and Assessment Unit conducts and manages educational outreach for the HRPP and screens applications for completeness before forwarding to the CHR Review Unit. See Human Subjects Protections Training web page for more details about the educational opportunities.

All of the HRPP Analysts are college educated, several with advanced degrees, a third of them are Certified IRB Professionals and all are very knowledgeable and available to provide consultation and assistance to the researchers.

In addition to the three units described above, there is the Front Desk Group, a team of dedicated staff who handle the intake, data entry and other administrative and clerical tasks for the office. 
 

The UCSF HRPP adheres to Campus Administrative Policies 100-16: Research Involving Humans as well as UCSF Medical Center Policies 6.07.11 regarding patient participation in research protocols. The UCSF HRPP also operates according to the University of California Office of Research policies and guidelines pertaining to research. In addition, because the CHR reviews studies being conducted at the San Francisco Veterans Affairs Medical Center, it also makes sure that its policies and procedures are in alignment with those at the SF VAMC. As appropriate for particular studies depending on funding source and agency jurisdiction, the HRPP applies the following basic legal principles:

  • Federal Policy for Protection of Human Subjects: Common Rule (45 CFR 46).

  • Food and Drug Administration Regulations (Title 21): Protection of Human Subjects (21 CFR Part 50); Institutional Review Boards (21 CFR Part 56); Investigational Device Exemptions (21 CFR Part 812); Investigational Device Exemptions for Intraocular Lenses (21 CFR Part 813); Investigational New Drug Application (21 CFR Part 312).

  • Office of Civil Rights Health Insurance Portability and Accountability Act (45 CFR Parts 160 and 164)

  • Department of Veterans Affairs regulations 38 CFR 17 and VHA Handbook 1200.5

  • Applicable California Law

  • University of California Policy on the Protection of Human Subjects in Research, policies 18-200, and 18-210 through 18-240.

  • Any other applicable federal, state or local regulations.

Scope

The CHR reviews

  • Research projects involving human subjects (including the use of human biological specimens) conducted by faculty from the University of California, San Francisco, the Veterans Affairs Medical Center (VAMC), the Northern California Institute for Research and Education (NCIRE), San Francisco General Hospital (SFGH), J. David Gladstone Institutes, Ernest Gallo Clinical and Research Center (EGCRC) and the San Francisco Department of Public Health, regardless of site of activity or funding source, or even if there is no funding, to ensure the ethical and equitable treatment of those subjects;

  • Human research projects for the Blood Centers of the Pacific and the Blood Systems Research Institutue, and the Goldman Instiutute on Aging when UCSF faculty are involved in the research;

  • Human research projects being conducted at UCSF facilities or involving UCSF patients or employees (including students, faculty or staff).

    Click on links provided above for definitions of “research,”  “human subjects” and “faculty.” Click on the following link Federal Wide Assurances for more information about each of the sites listed above.

  • Human research conducted by UCSF students and staff, as well as faculty, generally must be reviewed by the CHR. For more information, see the HRPP website, Who Must Have CHR Approval before Enrolling Human Subjects in Research.

  • Human research being conducted by faculty or investigators from institutions with whom UCSF has established Memorandums of Understanding for the UCSF IRB to review their studies.  See the information on the HRPP website for Working with Other Institutions and Units.

The Quality Improvement Unit  performs post approval monitoring and assessments of CHR-approved projects.  The unit is also involved with the quality assurance and improvement of the HRPP itself.

The Education and Assessment Unit provides educational and training opportunities for all researchers who have or plan to have CHR-approved studies and screens all applications submitted to the CHR for review.

Criteria for defining when an activity is research involving human participants are discussed in detail on the HRPP webpage Frequently Asked Questions about Applying to the Committee on Human Research.


Types of Research Reviewed

The vast majority of the human research projects are related to the health sciences but within that area the UCSF IRB reviews a broad range of research. Nearly half the studies are clinical trials or other biomedical studies. About 25% of the studies are social and behavioral in nature. The remaining studies involve no subject contact and include, for example, medical records review, the study of human biological specimens, or policy review.

Because the mission of UCSF is advancing health worldwide™ the human research participants in the studies include a wide range of individuals from all walks of life and from all over the world. Many of the participants are healthy individuals. Others are patients in clinics and hospitals throughout the Bay Area and with a wide. range of health concerns.  Please click here for a listing of research areas by topic Adults of all ages, including the very elderly, children, pregnant women, veterans, people from a wide variety of ethnic backgrounds, international populations, people whose decision-making capacity is impaired, and prisoners are among the many types of research participants in research being conducted by UCSF researchers. The HRPP attempts to ensure that special protections are provided for participants who are vulnerable for any reason or economically disadvantaged.


Ensuring That Human Research Participants are Protected

Human research protection is a collaborative, ongoing enterprise involving multiple groups at UCSF: high level administrators, the pharmacy staff, researchers and their staff, HRPP, the chairs and members of the CHR, sponsors and funding agencies, staff from the Office of Sponsored Projects, hospital and campus risk management, legal counsel, and the research participants themselves as they provide valuable feedback to the researchers. Included in this group must also be the Research Institutes themselves, and the various administrative and support services provided to researchers.

To ensure that all interested parties are aware of ethical principles, regulations, policies, and procedures, HRPP outreach and education--including required on-line training for research key personnel, CHR members and HRPP staff—works hand-in-hand with educational courses and websites of UCSF schools, departments, and other administrative groups charged with responsibility for the ethical, safe and legal conduct of the research enterprise. Researchers are asked to fill out complex applications which are then carefully screened by HRPP staff and reviewed by the CHR, in order to ensure awareness of and compliance with regulations.

HRPP, primarily through its Quality Improvement Unit, performs post-approval monitoring, including screening of adverse events and incidents and on-site and in-office 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 Clinical Research Office of the Veterans Affairs Medical Center. 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 CHR.

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.


Concerns or Suggestions

Everyone involved in the human research enterprise—including researchers, staff, residents, students, and study participants—is encouraged to communicate concerns, suggestions, and allegations of coercion or undue influence to the HRPP office or higher officials, including the Executive Vice Chancellor. Web pages facilitating communication include For Researchers and Staff: Concerns, Complaints, Suggestions, and Compliments and For Research Volunteers: Reporting Research-Related Concerns and Complaints. People may report their concerns anonymously if they so desire.


Improving Human Research Protections at UCSF

In addition to the feedback mechanisms described in the links above (including Survey Monkey questionnaires for both participants and researchers), the HRPP CHR and QIU have gone through formal Quality Improvement processes that have resulted in reorganizations to increase efficiency and effectiveness in both units. The HRPP also frequently discusses and coordinates program improvements with its primary constituents and collaborators at UCSF, including the Comprehensive Cancer Center, the Clinical and Translational Sciences Institute, the Clinical Research Centers, the VA Clinical Research Office, the Research Advisory Board, the Medical Center Clinical Billing Office, the HIPAA Privacy Office, and the Office of Sponsored Projects, to name a few.


Acknowledgements

Many pages of the HRPP web site are a direct result of generous support from the National Institutes of Health in form of a grant to the HRPP: “Enhancement of UCSF Human Subjects Protection Program,” S07-RR018260.