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
Continuous Quality Improvement (CQI) Program Diagram
In addition to developing and maintaining policies, the HRPP provides and supports resources to facilitate the ethical conduct of research and research regulatory compliance. Below is a list of initiatives that make up and support CQI activities:
HRPP Executive Committee
On a weekly basis individual and group meetings are held amongst the HRPP Director, IRB Associate Directors and HRPP staff to discuss updates to regulations, implementation of new procedures, and best research practices.
Education
Virtual office hours are offered to assist social behavioral and biomedical investigators in 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.
The 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 retreats for training and professional development.
HRPP 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.
Listserv Newsletter
The HRPP distributes a periodic newsletter to keep the USC research community informed of updates in regulations, policies, best practices, and relevant research news.
Research Coordinator Outreach
Periodic virtual meetings are offered to research coordinators – they include current topics related to best practices, regulatory updates, networking opportunities, national coordinator educational resources, and articles of interest. Updates in IRB submission processes and requirements are also provided.
Human Protection Council (HPC)
The Human Protection Council (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 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 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 Hospital Los Angeles IRB meet with iStar personnel monthly to address iStar upgrades, glitches and solutions. Needs for improvement and refinement of the iStar system are identified and logged for discussion 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
The 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.
Collaboration and Networking with Other Institutions
The HRPP collaborates and networks with other institutions (i.e., CHLA, UCLA) regularly to discuss best practices in policy and guidance development.
Audits
Not-for-cause and for-cause audits of research studies are conducted by the HRPP. Studies reviewed are selected from all categories of studies conducted and approved by the USC IRBs. Records reviews are conducted for studies of all levels of risk, including transnational research and studies with National Cancer Institute oversight.
HRPP and IRB personnel also conduct assessments of IRB operations and the iStar system to identify trends and issues related to study approval times, IRB and investigator response time, IRB workload, and changes or deficiencies in policy implementation and process. Refer to the rest of this chapter for additional information.
Audits For-Cause
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 OPRS personnel.
Audit Procedures
The IRB Chair initiates 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
If the investigator is a student researcher, the IRB may request to have the files inspected in the faculty advisor’s office
- Research Case Report Forms (CRF)
- Informed Consent (IC) 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 OPRS. 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
Procedures for Investigator Visit Assessment
OPRS notifies the Principal Investigator in writing of being selected for the CQI assessment. The CQI team schedules the assessment with the Principal Investigator (PI) and/or research team. The CQI team may request updated subject enrollment numbers for each IRB approved study to guide the assessment.
During the site visit, the CQI team conducts some of the following activities:
- Interviews the PI/research team to assess their knowledge of the study procedures
- Solicits feedback from researchers on the IRB process
- Inspects documentation that subjects met inclusion criteria
- Inspects study records and storage facilities
- Review signed consent and HIPAA forms
- Inspects documents and coding mechanisms used to protect confidentiality
- Reviews documentation of adverse events and unanticipated problems
After the assessment, the CQI team prepares a report summarizing findings or recommendations. Once reviewed and approved by the OPRS Program Director, the final report is forwarded to the PI. If findings are identified, the Principal Investigator must submit a response addressing each deficiency and include an action plan to prevent similar deficiencies in the future. In some cases, a follow-up assessment and/or training session(s) may be required.
If serious and/or continuing non-compliance is found, the CQI assessment report will be submitted to the IRB Chair and/or the IRB. The IRB will make recommendations to correct any issues of serious and/or continuing noncompliance. Refer to Section 18.8 – Procedure for Handling Reports of Noncompliance for more information.
The CQI team maintains a record of audit findings which is also used to identify trends and areas that are difficult or confusing for investigators. OPRS reviews audit findings to determine if improvements to the IRB process, electronic submission system or educational materials can be made to promote investigator compliance. When improvements to the system are identified, OPRS works with the IRB and/or iStar team to implement such changes.
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
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.
Not-for-cause
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.
OPRS assesses internal IRB processes on an ongoing basis. These are primarily done through iStar-generated reports.
Assessment of the IRB process includes:
- Review of IRB minutes and Full Board meeting agendas, with particular attention to subject complaints, adverse events, and ad hoc agenda items (miscellaneous problems/issues/suspensions/audits)
- Examination of IRB staff pre-reviews for accuracy
- Review of official IRB letters for accuracy, correct regulatory citations, and clarity
- Review of researcher feedback/complaints
- Review of the various forms and guidance documents found on the IRB websites, functionality of the website and hyperlinked documents
- Analysis of IRB processes (Not Human Subjects Research / Coded Data short application, other) to identify process issues
- Monitoring of new IRB staff members for accuracy, and the proper application of regulations and USC policies
- Review of ad hoc items as necessary
