Revised on: 8/20/2021
This chapter describes the purpose and composition of the USC Human Research Protection Program (HRPP). It also addresses how the Program protects human subjects and how USC involves the community in research. Lastly, this chapter introduces the USC Flexibility Policy.
The University of Southern California (USC) Human Research Protection Program (HRPP) oversees all research involving human subjects at USC. At USC, the HRPP program has the full support of the upper levels of the administration including the Board of Trustees, the President, the Provost and the Provost’s staff. The members of the program include the Vice President of Research and Innovation, Director and staff of the HRPP, and staff, Chairs, members of the USC Institutional Review Boards (IRBs).
The HRPP team is supplemented by faculty from both campuses and the Office of Compliance for guidance and issue resolution. The primary responsibility of the HRPP is to assure the protection of subjects participating in USC research and continuing to meet and exceed accreditation standards. For studies involving USC neighboring communities, USC involves the community in planning, designing and participating in the conduct of research.
The University of Southern California is committed to conduct biomedical and behavioral research involving human subjects following the ethical principles embodied in The Belmont Report: Ethical Principles and Guidelines for the Human Subjects of Research found in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The USC IRBs have been established in compliance with existing regulations of the federal government under U.S. Department of Health and Human Services (DHHS) regulations in 45 CFR 46, the Food and Drug Administration (FDA) regulations in 21 CFR 50, 56 as well as other applicable federal regulations and state and local laws. USC complies with requirements stipulated by other federal agencies when they serve as sponsors or have oversight of research conducted at USC. For a list of applicable federal regulations, refer to: Federal Agencies.
The IRBs are in compliance with International Conference on Harmonization Good Clinical Practice Consolidated Guidelines insofar as those guidelines are consistent with the FDA and DHHS regulations pertaining to the protection of human subjects in research. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.
The USC IRBs operate with a Federalwide Assurance issued by the DHHS, Office for Human Research Protections (OHRP). The USC IRB’s are registered in the OHRP/FDA IRB database.
ALL human subject research projects at USC must be reviewed and approved by an IRB before research can begin. While the principal investigator has primary responsibility for the conduct of the study, the USC IRBs are responsible for protecting the rights and welfare of study subjects under Federal Wide Assurances (FWAs) granted by DHHS (http://www.hhs.gov/ohrp/assurances/assurances/index.html) to the University Park Campus and the Health Science Campus. This fundamental commitment to the protection of human subjects applies to all USC research involving human subjects regardless of whether the research is funded through government, non-profit or industry sponsors, through University funds, or not funded at all, and regardless of the location of the research.
The University and its researchers adhere to federal, California, and local regulations and laws as appropriate. USC will comply with requirements stipulated by other federal agencies when they serve as sponsors of research conducted at USC. Ethical and procedural guidelines by recognized organizations are also used for achieving best practices.
The HRPP oversees university wide human subjects’ protections through program oversight, education, policy setting, and outreach.
The IRBs at USC are delegated the authority to review all human subjects research proposals – funded or not – that are conducted by USC faculty, staff, graduate, and undergraduate students.
USC IRBs review, approve, and monitor all research involving human subjects under the jurisdiction of their FWAs. Each IRB office provides administrative support to the IRB committees, provides assistance to investigators who are preparing IRB applications, and maintains records of IRB reviews and approvals for investigators.
The USC IRBs are responsible for review of all biomedical and social and behavioral research conducted on the USC University Park Campus and Health Science Campus.
The Office of Compliance and/or the Office of General Counsel are available for assistance and legal counsel in applying laws to research involving human subjects.
Note: the terms “subject” and “participant” are used interchangeably throughout the Policies & Procedures.
HRPP and IRB organization chart: https://hrpp.usc.edu/oprs/
Institutional Official/Human Subjects Research
Vice President of Research and Innovation
University of Southern California
3720 South Flower Street, 3rd Floor
Los Angeles, CA 90089-4019
TEL: (213) 740-6709 FAX: (213) 740-8919
Director
Program Manager
Program Administrator
University of Southern California
3720 South Flower Street, 3rd Floor
Los Angeles, CA 90089-1146
TEL: (323) 442-0114
E-mail: hrpp@usc.edu
Web: https://hrpp.usc.edu/
Institutional Review Board
Associate Directors
Chairs
IRB Analysts
USC IRB
3720 South Flower Street, 3rd Floor
Los Angeles, CA 90089-1146
TEL: (323) 442-0114 FAX: (213) 821-5276
E-mail: hrpp@usc.edu
Office of Research Integrity
Research Integrity Officer
University of Southern California
3720 South Flower Street, 3rd Floor
Los Angeles, CA 90089-1146
TEL: (213) 821-7291
Research Technology Group / iStar
Director
University of Southern California
3720 South Flower Street, 3rd Floor
Los Angeles, CA 90089-1146
E-mail: istar@usc.edu
Web: https://istar.usc.edu
Clinical Trials Office (CTO)
Director
2011 N. Soto Street
Los Angeles, CA 90032
TEL: (323) 442-7218 FAX: (213) 342-0947
Web: https://clinicaltrials.usc.edu/contact-us/
The Human Research Protection Program oversees the ethical and regulatory affairs related to the protection of research subjects. The Program consists of the Vice President of Research and Innovation, the HRPP, four Institutional Review Boards, the Office of Research Integrity and the Department of Contracts and Grants. USC faculty, staff, and students are also participants in the HRPP. All these groups carry out their individual functions and endeavor to work together where their responsibilities intersect in human subjects protection.
The University’s commitment to ethical and compliant human subjects research is embodied in the USC Code of Ethics, Faculty Handbook, and the HRPP Policies and Procedures.
Human Research Protection Program
Responsible for: promoting excellence in human subjects research programs across the University, overseeing the IRB, providing human subjects education, seeking out and adopting best practices, advising the Vice President of Research and Innovation, maintaining accreditation, and providing a national voice and presence in human subjects protections.
Accountability within the HRPP is expected of all levels of responsibility. Communication is routinely shared among all components of the HRPP. IRB members are encouraged to directly contact the IRB staff, Directors, Chairs or HRPP with questions, concerns, or suggestions. Regulatory and IRB policy changes are provided to the members and staff via email, through the HRPP listserv, and at IRB meetings. Education sessions are held for members and staff at the meetings, and special education sessions for researchers are given on an as-needed basis.
Human Subjects Working Group
Human Subjects Working Group consisting of HRPP, IRB Chairs and Directors meet regularly on monthly phone calls to discuss best practices, address and solve issues, and share news or concerns that affect the HRPP. Any IRB related issues taking place on either campus can be discussed at that time.
Other meetings and phone calls take place, as necessary, to deal with any problems, issues, concerns. These calls or meetings can be initiated by any member of the HRPP team.
HRPP Website
The HRPP website receives thousands of visits per month and provides a wealth of information to all stakeholders in human subjects research. Not only is there guidance for investigators and IRB staff, there is also information for research participants/subjects. The website is continually updated with the most recent human subjects research policies, regulations, guidance, and news.
Human Subjects Research Listserv
Human Subjects Research Listserv is used by HRPP to communicate with IRB staff and members, as well as USC faculty, staff and students conducting human subjects research. This listserv includes the most recent information on federal and state regulations, IRB education opportunities at USC, human subjects news, legislation, and other pertinent human subjects research information that the USC community should be aware of.
Research Coordinator Bulletin and Education Meetings
Information specific for coordinators and research support staff is communicated through the research coordinator’s bulletin. Featured topics include educational sessions, coordinator events and networking opportunities, coordinator FAQs, national coordinator resources and articles of interest.
HRPP and the IRB offer education luncheons that provide policy updates, presentations that highlight current topics of interest in research, and guidance on how to use the IRB application system (on an ad hoc basis).
Program Communication
IRB staff meets regularly to ensure that issues within that IRB can be addressed and that all staff are made aware of any new regulations or guidance that may be available. Staff problems or concerns are also addressed at this time or can be done on an individual basis. Issues that can benefit or educate others in the HRPP are forwarded for discussion and distribution to the entire HRPP team.
The Director of the HRPP and Vice President of Research and Innovation meet as needed. In these meetings, issues pertaining to the HRPP are addressed as are new suggestions or decisions, needing input at the provost level.
Research Involving the Community
USC promotes the involvement of community members, when appropriate, in the design and implementation of research and the dissemination of results. Community involvement builds public awareness and trust in research. Additionally, the more involved the community is, the more likely it is to benefit from research discoveries.
Researchers have flexibility to develop their own approach to engagement, in keeping with the needs of a particular community. However, the approach must be rooted in ethical considerations – respect for persons, equitable selection of subjects, and beneficence – and should emphasize community outreach, consultation, involvement and collaboration.
Several initiatives have been established by the Southern California Clinical Translation Science Institute (SC-CTSI) that provide guidance for conducting community-engaged research. An overview of SC-CTSI services and available toolkits may be found on their website at Community Engaged Research.
In addition to CTSI resources, the HRPP website provides information for prospective research participants about types of research being offered at USC, questions to consider before participation, and contact information for reporting research complaints and concerns. Brochures are available in English and Spanish to inform individuals in the community about what to know before participating in a research study. For additional information, see references below.
Basis of Flexibility Policy
The University of Southern California has chosen to limit the application of the federal regulations to federally funded or federally regulated research. For research projects outside the scope of the federal regulations subjects will nonetheless be afforded equivalent protections. This Flexibility Policy is limited to studies involving no greater than minimal risk as well as no federal funding and not FDA regulated. The full policy can be found at the following link: USC Flexibility Policy (12/17/2018).
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests and any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.
This policy establishes flexibility in review, administration, and oversight of human subjects research. USC will also be encouraging and supporting additional opportunities for flexibility when encountered. Flex projects determined to be minimal-risk research do not require continuing review (unless specifically required by the IRB); and may still require a HIPAA waiver. Informed consent will not be required of minimal risk
studies eligible for the flex policy. However, should the reviewer determine informed consent is necessary; the study should not be flexed.
Implementation of Flexibility Policy
All human subjects research projects conducted or supported at USC remain subject to USC IRB policies and review, whether they qualify for this policy or not. When questions of applicability arise, studies will be reviewed on a case by case basis.
Inclusion/exclusion of any research project will be at the discretion of the USC Institutional Review Boards (IRBs).
The IRB may make exceptions to this policy for funded research that is not federally funded. Studies reviewed under this policy remain subject to USC IRB policies and review.
Should a study approved under the Flexibility Policy obtain federal funding or should the risk level change, it is the responsibility of the Principal Investigator to notify the IRB and submit an amendment for the change. Under no circumstances will FDA regulated research be reviewed under this policy. Minimal risk studies approved under the Flex Policy will require an amendment if there is a change in risk, funding, or scope.
Research projects that meet the federal definition for human subject research and exceed minimal risk are subject to the criteria for approval articulated in the regulations at 45 CFR 46 and/or FDA regulations as applicable and do not qualify for review under the flexibility policy.
A Flexibility Coalition was established by the University of Southern California to disseminate flexibility policies and encourage similar programs at academic Institutions across the United States.
