The Human Research Protection Program (HRPP) conducts Continuous Quality Improvement (CQI) activities to measure and improve HRPP effectiveness, quality, and compliance with IRB policies and procedures, and applicable federal, state, local laws, and national accreditation standards. Outcomes of CQI activities are fed back into the process, resulting in improved protections for human subjects and increased efficiency. The CQI Program:
- develops and maintains USC Human Research Protection Program (HRPP) according to national best practices, regulations and guidelines
- keeps investigators cognizant of rules, corrects procedural errors, and
- increase protections for human research participants
- auditing and assessing investigator compliance with the HRPP policies and procedures and IRB requirements
In addition to developing and maintaining policies, the HRPP creates resources to facilitate compliance in the USC research community. Below is a list of initiatives that make up and support CQI activities:
The CQI team provides periodic reports of the HRPP/IRB internally and to external stakeholders to make improvements when necessary, educate the community on performance, and develop/revise guidance.
HRPP Executive Committee
Weekly meetings are held amongst the HRPP Director and IRB Associate directors and HRPP staff to discuss updates to regulations, implementation of new procedures, and best research practices.
Virtual office hours are offered to assist social behavioral and biomedical investigators preparing a protocol for first time IRB review. Virtual Center for Excellence in Research (CER) workshops are offered to the entire research community each semester on a monthly basis.
HRPP offers classroom education as guest lecturers to discuss human subjects protections with students (incoming PhD students, medical students, undergrad scholars). HRPP and IRB staff attend quarterly retreat for training and professional development.
HRPP and IRB Website
The website provides the latest information to the USC research community including guidance, consent templates, policies, educational resources, and contact information. Website analytics are reviewed periodically to determine web traffic, reader interest and improve site content.
HRPP distributes a periodic newsletter to keep the USC research community informed of updates in regulations, policies, best practices, and relevant research news.
Human Protection Council (HPC)
The HRPP 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 is to:
- Identify pain points with the IRB submission and review process and brainstorm solutions.
- Operate as a sounding board for plans being made to improve efficiency in relation to the IRB review and approval process.
- 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.
- Advocate on behalf of the HRPP/IRB with USC leadership and members of the research community regarding the ethical conduct of human subjects research and the IRB review and approval process.
iStar Development Meetings
Representatives from HRPP, USC IRBs and Children’s Los Angeles IRB meet with iStar personnel monthly to address iStar upgrades, glitches and solutions. Also, iStar issues and suggestions identified at various stages of the CQI process are addressed and discussed at these meetings.
Policies and Procedures Review and Updates
HRPP Policies and Procedures are regularly updated in response to changing regulations and revised processes. Changes to Policies and Procedures are communicated to the IRB members, IRB staff, investigators, and research staff via the HRPP website and listserv announcements. The Policies are available on the HRPP website.
IRB Member and Administration Education
HRPP arranges educational sessions for IRB members to discuss best practices, upcoming policy changes and other topics. Current topics and articles of interest are also provided on a regular basis.IRB Members may access this information via the Members Only webpage.
Collaboration and Networking with Other Institutions
The HRPP collaborates and networks with other Institutions (CHLA, UCLA) regularly to discuss best practices in policy and guidance development.
Post Approval Oversight
The USC HRPP will employ multiple methods of Post-approval oversight including audits, progress updates to ensure compliance with the approved procedures and IRB regulations and policies.
Types of oversight:
Progress updates will be expected for all investigators that had an approved exempt or expedited study that were not assigned an expiration date upon approval. Progress updates will be sent to investigators every two years. Investigators will have two options at the time of receipt of the progress update: 1) to close the study (see section 8.3) or 2) fill out the progress update form and keep the study open for an additional two years when the process will be repeated.
Annual Post-approval monitoring self-assessment will be expected of all investigators that had a study approved by the full board(GTMR) unless they are monitored by a sponsor .Annual Post-approval monitoring self-assessment will also be expected of all investigators that had a expedited study approved by the IRB that has a continuing review. Self-assessments may be asked for by the IRB at Continuing review.
For-cause audits are reactive, direct, and aimed to investigate or substantiate an allegation or complaint received by the Human Research Protection Program (HRPP). Allegations or complaints may be submitted to the HRPP through written correspondence, anonymous phone call, or other avenues. Information received from a sponsor, the FDA, a whistleblower, the IRB, IRB Chair, OPRS, an investigator, or a subject may all lead to a for-cause audit. Audits may also be initiated in response to protocol amendments, continuing reviews, and other submissions or communications with the IRB. Additionally, funding agencies may request a for-cause audit due to allegations of noncompliance, adverse events, or other causes of concern.
Low-risk/ non-clinical studies rarely warrant a for-cause audit. A main goal of for-cause audits is to collect sufficient information for the IRB to determine a course of action on serious or continuing non-compliance or reported allegations and complaints. For-cause audits are conducted by IRB and HRPP personnel.
The IRB Chair, member, staff, or HRPP Director may initiate for-cause audits based on an allegation, complaint, deficiencies found by IRB review activities, and/or information from media or scholarly reports.
The IRB discussion of the allegation and subsequent determination are documented in the IRB meeting minutes.
The following items/processes may be inspected:
- IRB (iStar) submissions and communications
- Researcher Files
- Research Case Report Forms (CRF)
- Informed Consent Form (ICF) Documents
- Review of Consent Process
Quality Assessments (Not-For-Cause)
Quality assessments are not-for-cause assessments conducted by designees of the HRPP. The assessment team performs routine assessments/re-assessments. In some cases, a follow-up assessment may be conducted to ensure compliance has been met. Results of these assessments are educational and not routinely submitted to the IRB unless deemed necessary by HRPP. Research studies are chosen for quality assessment by the HRPP staff using the following criteria:
- Schools and/or departments that submit high volumes of studies to the IRBs
- Investigators who have a high volume of active protocols
- Investigator-initiated protocols
- Studies including vulnerable subjects
- Recommendations by IRB staff
Audits by External Entities
External audits may be conducted by regulatory agencies (FDA, OHRP), a sponsor, or other entities external to USC (AAHRPP). External audits may be conducted for-cause or not for-cause.
For-cause audits by entities external to USC may arise from an anonymous complaint, an unanticipated problem reported by the investigator to a sponsor or federal agency (FDA), noncompliance reports, or other. For-cause audits may arise from a self-report or be complaint-driven.
Routine, not for-cause audits maybe conducted by entities external to USC. Investigators or sponsors may hire consultants to review a protocol, clinical practices, or other aspects of research. Clinical trial sponsors frequently send trial monitors to verify data integrity and adherence to regulatory requirements.