Quality Improvement Unit (QIU)

Policy

In an effort to promote OHRPP program accountability and optimize processes, the UCLA Office of the Human Research Protection Program monitors and measures the effectiveness and quality of its human research protection program. Based on the results of these measurements, necessary plans and improvements to the program are considered for implementation.

Overall Description and Goals

The primary purpose of the Quality Improvement Unit (QIU) is to provide post-approval monitoring and internal oversight, education and training to research professionals to assure that all OHRPP operations effectively support UCLA’s mandate to protect the rights and welfare of research participants. This includes compliance with institutional policies and procedures, and applicable federal, state and local laws pertaining to the protection of human subjects in research. The program consists of the following components:

• For-cause Audits and Routine Monitoring of Human Research Studies
• Handling of Complaints and Concerns About Human Subjects Research or the OHRPP
• Review and Assessment of OHRPP Operations and Procedures
• Review of Research Participants’ Survey of Study Experience
• Review of Feedback Survey for Education and Training Activities

Specific Components of the OHRPP QI Unit

For-cause Audits and Routine Monitoring of Human Research Studies

The QIU conducts routine post-approval monitoring on human research studies, selected based on risk assessment factors. For-cause reviews of research records may be requested by the reviewing IRB or other institutional stakeholders. Depending on the scope of the requested audit, these reviews may measure investigator understanding and compliance with laws, regulations and policies governing the conduct of human subject research. These reviews may also provide a measure of the effectiveness of investigator resources, quality and timeliness of Investigator/IRB communication, and access to and awareness of OHRPP policies, education and available training opportunities.

For example, the QIU might evaluate the following as indications that research teams understand and execute their responsibilities:

• Adequacy of resources to conduct the study (number of studies per PI; complexity of protocols)
• Qualifications and training of key personnel
• Regular communication between the PI and research team about the protocol and updates
• Enrolled subjects met the eligibility criteria
• Consent is being obtained appropriately
• Access to on-site and electronic research data is controlled
• Study drug is controlled and dispensed according to UCLA Research Drug Information Pharmacy policy
• Assessment of adverse events and deviations in order to understand relevance and determine appropriate reporting

Findings are provided to the Principal Investigator and the requesting IRB/institutional stakeholder for review and follow up as needed. Follow up may include a corrective action plan and/or a recommendation for additional education and training. For additional information see OHRPP Guidance and Procedure: Post Approval Monitoring.

Complaints and Concerns Regarding Human Subjects Research or the OHRPP

The QIU is responsible for the processing, review and inquiry into all complaints and concerns that are brought to the attention of the OHRPP/IRB regarding human subjects research conducted at UCLA and/or by UCLA OHRPP personnel. Complainants may include, but are not limited to subjects (past, present or potential), subject family members, investigators, other research staff, or any person with concerns.

Review and Assessment of OHRPP Operations & Procedures

Review and Assessment is based upon:

• Feedback from investigators regarding satisfaction with the IRB review process and services.
• Audits of the IRB files to measure compliance with OHRPP and other institutional policies and procedures, as well as applicable federal, state and local laws.
• Statistics showing IRB activities and timelines.

Internal Audits:
The QIU routinely conducts internal audits of OHRPP/IRB records. These audits involve sampling records based on particular themes, for example whether certain standard sections of the informed consent form (such as injury or costs) are included when expected and without unauthorized alteration, or that management plans from the Conflict of Interest Review Committee have been accounted for in the IRB review, and that relevant changes are made to the IRB application and to the consent form.

The sampling of records is representative of the five IRBs and allows the QIU to assess the rate of compliance or proper documentation of exceptions.

The QIU may also conduct for cause audits of OHRPP/IRB records.

Results and feedback of audits are provided to the Director, Associate/Assistant Directors and OHRPP staff for further education or other action, which is in turn monitored and revisited.

Research Participants’ Survey of Study Experience

Direct feedback from research participants provides an opportunity for the OHRPP to review and assess subjects’ considered opinions and assessment of their experience at UCLA and whether they believe that their rights and welfare were protected in accordance with federal regulations and institutional policies governing the conduct of human subject research.

Review of Feedback Survey for Education and Training Activities

Direct feedback from stakeholders receiving training from OHRPP provides an opportunity for OHRPP/QIU to improve existing trainings and create new training opportunities, based on stakeholder needs.

Annual Reporting

The OHRPP QIU prepares an annual report of its activities. The report includes an evaluation of the previous year’s activities and describes planned improvement initiatives.