HRPP

The HRPP is committed to strengthening USC’s policies governing Human Subjects Research (HSR) and ensuring the policies comply with the Federal Regulations for the protection of human subjects (HHS: OHRP/ FDA). Please view all of our Policies and Procedures. 

The HRPP is committed to furthering education at all levels of the Human Subject Protection Program. We have implemented an education policy that requires all USC human subjects researchers to complete training in Human Subjects Protection regardless of the researchers’ funding source, or study risk-level. We offer regular and ongoing human subjects educational training sessions covering federal regulations, human subjects ethics and history, the Institutional Review Board process, conflicts of interest, and more. We provide IRB members with monthly education and refreshers in research regulations as needed.

To maintain excellence in the protection of human subjects and to meet federal and Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements, a successful monitoring program is essential. At USC, the Quality Improvement program serves to keep investigators cognizant of rules, to correct procedural errors, and most importantly, to increase protections for subjects enrolled in research projects. Quality Improvement procedures also include assessing internal HRPP and IRB processes. 

Please refer to Chapter 17 of our policies for more information.

There are four Institutional Review Boards (IRB) at USC responsible for protecting the rights and welfare of study participants. There are three Biomedical IRBs and one Social Behavioral IRB. 

Each IRB is sufficiently qualified through the experience, expertise, and diversity of its members (46.107). Each IRB has a minimum of five members:

• At least one member with scientific background
• At least one member with non-scientific background
• At least one member not affiliated with USC
• Representatives of administration
• Alternate members – Formally appointed alternate IRB members may represent IRB members, provided the alternate’s qualifications are comparable to the primary member to be replaced.

Length of Service and Attendance Requirements

Appointments to the IRBs are for a period of one year. Continued tenure on the IRB is at the discretion of the HRPP Director and IRB Associate Directors in consultation with the IRB Chairs.

If a member is unable to attend a meeting, the IRB office must be informed sufficiently in advance so that an alternate can be invited to attend. Frequent absences will be cause for removal.

Duties

Members of each IRB or their designated alternates are required to:

• Participate in agreed upon number of convened IRB meetings
• Review the IRB application and informed consent form for research proposals
• Review and complete a written critique of research proposals including review of clinical trial protocol, questionnaire(s), advertisement(s), investigator’s drug brochure, and informed consent form when assigned as a reviewer by the Chair or IRB staff
• Review expedited actions of the Chair and IRB designee
• Review and promptly inform the Chair of corrections or additions to Full Board
  meeting minutes
• If substantive changes have been requested to a study, members, at a convened meeting, must review and verify that contingencies have been satisfied.
• Selected IRB members may be appointed as expedited reviewers and can review changes to previously approved research during the period covered by the original approval. Changes that may be reviewed by an expedited reviewer are those that do not alter the original approval criteria. Additional training is provided to IRB members who are appointed to be expedited reviewers

Please view Chapter 5 of our policies for more information.

If interested in joining as an IRB member, please email hrpp@usc.edu. 

The HPC brings together members of the USC research community to provide advice and support regarding the Human Protection efforts at USC. The charter for the group will be to:

1. Identify pain points with the IRB submission and review process and brainstorm solutions.
2. Operate as a sounding board for plans being made to improve efficiency in relation to the IRB review and approval process.
3. Operate as a sounding board regarding educational needs for faculty, staff, and students regarding the ethical conduct of human subjects research and the IRB review and approval process.
4. Advocate on behalf of the HRPP with USC leadership and members of the research community regarding the ethical conduct of human subjects research and the IRB review and approval process.