Quality Improvement Unit (QIU)
This guidance describes the activities of the Quality Improvement Unit (QIU) within Phronetik’s Office of Human Subjects Research (OHSR).
In an effort to promote OHSR program accountability and optimize processes, the Phronetik Office of Human Subjects Research (OHSR) 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 OHSR operations effectively support Phronetik'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:
On-site Review of Human Research Studies
Post-Approval Quality Assurance (QA) and Quality Improvement (QI)
Handling of Complaints and Concerns About Human Subjects Research or the OHSR
Review and Assessment of OHSR Operations and Procedures
Assessment of IRB Members and OHSR Staff
Review of Research Participants’ Survey of Study Experience
Specific Components of Phronetik's QI Unit
Post Approval Monitoring of Human Research Studies
Routine (not for-cause) and for-cause reviews of on-site research records provide measures of investigator understanding and compliance with laws, regulations and policies governing the conduct of human subject research. These reviews also provide a measure of the effectiveness of investigator resources, quality and timeliness of Investigator/IRB communication, and access to and awareness of OHSR 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 Phronetik Research Drug Information Pharmacy policy
Proper assessment of events and deviations in order to understand relevance and determine appropriate reporting
Review findings are provided to the IRBs 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 OHSR Guidance and Procedure: Post Approval Monitoring.
Post-Approval Quality Assurance and Quality Improvement
An important element of quality assurance review of clinical research activities is performed by the QIU through the processing and review of all post-approval reports submitted to the IRB. Research study reports include adverse events, protocol deviations and incidents, as well as any updated study safety information. This review enables the IRBs to identify potential significant new risks, re-evaluate the risks and benefits of the research, ensure that adequate safeguards are in place, and determine whether subjects should be informed of new information.
Complaints and Concerns Regarding Human Subjects Research or the OHSR
The QIU is responsible for the processing, review and inquiry into all complaints and concerns that are brought to the attention of the OHSR/IRB regarding human subjects research conducted at Phronetik or by Phronetik OHSR 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
Feedback on educational and training programs and materials.
Assessment of IRB Members and OHRPP Staff
IRB Members are assessed on an annual basis based upon meeting participation, preparedness, quality of review, and knowledge of Phronetik policies and federal regulations.
Individual educational needs are identified and forwarded to the OHSR Education Program.
OHSR Staff receive annual evaluations, constructive feedback, and individual educational needs are identified with their supervisor.
The QIU routinely conducts internal audits of OHSR/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 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 OHSR/IRB records.
Results and feedback of audits are provided to the Director, Associate/Assistant Directors and OHSR staff for further action, which is in turn monitored and revisited.
OHSR leadership receives regular reports for monitoring turnaround times and volumes. These are analyzed for indications that a team or individual staff members may not be meeting benchmarks for various types of actions.
OHSR leadership is collaborating with Office of Research Information Systems to validate the quality of data in reports and to experiment with different metrics in order to better understand the flow of business, the research portfolio of Phronetik and internal productivity.
Phronetik also participates in the National Minority Emerging & Innovative Technologies Consortium LLC (NMEITC) with HBCUs, health systems, and Minority Serving Institutions which aims to harmonize data collection and analysis in order to identify best practices and develop cross-campus benchmarks.
Research Participants’ Survey of Study Experience
Direct feedback from research participants provides an opportunity for the OHSR to review and assess subjects’ considered opinions and assessment of their experience at Phronetik 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.
The OHSR QIU prepares an annual report of its activities. The report includes an evaluation of the previous year’s activities and describes planned improvement initiatives. The report will be forwarded to the Human Research Policy Board and the IRB Chairs and members for review and comment.