Quality Assurance and Improvement Program
Objectives of the Program
The Quality Assurance and Quality Improvement (QA/QI) Program is a function within the Office of Research Integrity under the Office of Research and Economic Development. The QA/QI Program was developed to strengthen human research protections at FIU and to demonstrate FIU’s commitment to continuous improvement in research compliance. Identifying the strengths and weaknesses of protection efforts is essential to maintaining a quality program and enables the ORI and the Institutional Review Board (IRB) to continue FIU’s tradition of excellence.
Implementation of the QA/QI Program at FIU serves to evaluate human research protections at varying levels, increase awareness of existing processes, operating procedures, educational programs, and acquire information necessary for enhancing protections. The QA/QI Program provides a means to assess FIU’s level of compliance with federal, state, and institutional regulations, and Good Clinical Practice (GCP) guidelines, which is a key element in meeting the highest standards for human subject protections.
Components of the program focus on educating the University’s researchers on the ethical and regulatory responsibilities by which human subjects are protected. It also allows researchers, ORI staff, and IRB members the opportunity to improve human research protections performance. The QA/QI Program can provide useful information to identify educational/training initiatives for researchers, their staff, ORI staff, and IRB members.
An announcement regarding this program was previously distributed to the FIU community by the Vice President for Research. A copy of that memorandum can be accessed online here: QAP Memo Announcement.
Mechanisms of Review
Selection Criteria for Identifying Projects to be Reviewed Randomly
- Include IRB approved protocols in which subjects have been enrolled or identifiable data have been obtained.
- Include at least one Full Board submission per year.
- May include Exempt or Expedited protocols.
- May include federal, state, or industry funded projects.
- May exclude protocols that are subject to ongoing agency audits.
Selection Criteria for Directed and For-Cause Reviews of Projects
- The reviews can be requested by the FIU IRBs, the Vice President for Research or, the University Compliance Officer.
- The reviews are typically implemented due to unusual circumstances, significant risks to subjects, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IRB’s attention, or any case requiring further scrutiny as deemed appropriate.
Areas Reviewed during the Site Visit
Areas covered during the review may include the following components:
- Recruitment & Compensation
- Subject Population
- Subject Enrollment
- Informed Consent (Content and Process)
- Data Collection, Storage, Transmittal, Destruction, and Security
- Data and Safety Monitoring Board (DSMB) and Plan (DSMP)
- Adverse Events
- Project Personnel (Qualifications and IRB Training)
- Continuing Review
- Protocol Adherence (Violations/Deviations)
- Other areas as determined by the review
Outcome of Reviews
Following completion of the QA/QI review, ORI will prepare a written report for the PI. The report may include recommendations for aligning the research protocol, if necessary, with institutional policies and regulatory requirements and/or specify corrective actions, if any.
- If the quality improvement review identifies a need for revision of the research protocol or informed consent processes, the PI is responsible for submitting an amendment/modification to the current approved protocol in accordance with IRB requirements.
- If the quality improvement review identifies serious or continuing noncompliance, ORI and the PI will adhere to established processes of the FIU Office of Research and Economic Development and IRB for the investigation, correction and reporting of any material noncompliance, as may be required or appropriate.
Resources for Investigators
The following resources will help you be prepared for a QA/QI Review:
- Best Practices for Conducting Research
- Preparing for a Scheduled QA/QI Review
- Informed Consent Process Checklist
The following FDA, OHRP, and ICH are helpful for quality assurance:
- ORI Misconduct Interactive Video
- FDA Good Clinical Practice (GCP)/Clinical Trial Guidance Documents
- FDA Inspections of Clinical Investigators: Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors
- FDA Warning Letters
- OHRP Determination Letters
- International Conference on Harmonisation (ICH) E6: Good Clinical Practice: Consolidated Guidance