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Florida State University IRB Quality Improvement/Quality Assurance Program

The FSU Human Subjects Office conducts quality improvement/quality assurance activities on an ongoing basis to strengthen human research protections and to support FSU’s commitment to continuous improvement in research compliance.

The main goals of the program are:

  1. To insure research is being conducted in accordance with federal regulations governing the protection of research participants, FSU policies and procedures, and good clinical practice (GCP) guidelines.
  2. To provide researchers a review of their research procedures, determining from a source other than the investigator’s continuing review, that no material changes have occurred in the project since the IRB previous review.
  3. To provide researchers with one-on-one and group educational opportunities regarding human subjects research.
  4. To facilitate communication between the IRB/Human Subjects Office and researchers at FSU.

Every fall semester, projects will be selected for random review based on the following criteria:

  • Investigator initiated studies
  • Protocols in which subjects have been enrolled or identifiable data have been obtained
  • May include exempt or expedited protocols, as well as full committee protocols
  • Investigator held IND or IDE studies
  • More than minimal risk studies
  • Studies with SAEs or protocol deviations reported
  • High enrollment studies
  • Outside monitoring reports from sponsors indicating deficiencies

Selection criteria for Directed or For Cause reviews of projects are described below. The main goal of directed monitoring is to investigate possible noncompliance with the requirements for the research study. Actions plans and additional education may be employed to remedy noncompliance or potential noncompliance.

  • The reviews can be requested by the FSU IRB, the Vice President for Research, or the Research Compliance Officer.
  • Significant risks to subjects, failure of an investigator to comply with the federal and/or institutional requirements, concerns or allegations about the conduct of the study brought to the IRB’s attention, or any study requiring further scrutiny as deemed appropriate.

Research activities/actions and responsibilities that may be reviewed during the review and site visit:

  1. Recruitment and compensation
  2. Informed consent process, signed consent documents
  3. Subject population
  4. Study enrollment and logs
  5. Research subject files
  6. Continuing Review
  7. Modifications/amendments
  8. Unanticipated problems involving risks and adverse events
  9. Record keeping
  10. Sample storage
  11. Study data records and transmission procedures
  12. Data destruction and Security
  13. Data and Safety Monitoring Board and Plan (if required)
  14. Protocol adherence (violations/deviations)
  15. Other areas as determined by the review

Results of the Q/I Q/A reviews:

Following completion of the QI/QA review, the HSC staff will prepare a written report to be provided to the Principal Investigator and the IRB. The report will include areas of review, any deficiencies or identified noncompliance, and may include recommendations or action items needed to be addressed or corrected.