Quality Improvement Program

Quality Improvement Program:

The Quality Improvement Program (QIP) is a unit within the HSPPO. The Director of the HSPPO has oversight of the QIP. The QIP is independent of the Biomedical and Social, Behavior and Education IRB but works in collaboration with the chairs and members of both committees.

QIP’s mission:

  • Assist investigators and the research staff
  • To ensure of institutional regulatory compliance
  • Provide education to the research community in all areas of human subjects research.

Human Subject Research QA/QIP Objectives:

1. To assist investigators and the research staff by being a resource and providing guidance throughout the course of their study.

  • Provide study start up assistance for new investigators
  • Provide on-site study quality improvement consults in a specific area to ensure that the research is being conducted in accordance with the best practices. This would be confidential and not become part of the IRB record or file.
  • Provide on-site education and training to the research community.  (this should be handled by an on-line request form that could be created)
  • Provide assistance in preparing for external audits (i.e. FDA audit, sponsor audits, etc.)

2. To ensure institutional regulatory compliance with federal (FDA and OHRP), state, institutional and local regulations and guidance.

  • Conduct quality improvement reviews to assess the quality, efficiency, and effectiveness of the HSPP. These would be for regulatory compliance and subject safety.
  • Conduct directed (for cause) on site visits as a requested by the IRB, IRB Chair, Director of the HSPPO, or external regulating agencies.
  • Conduct internal measurements and assist Principal Investigator's in completing corrective actions, when necessary, based on IRB determinations for compliance with federal regulations, institutional policies, procedures and local guidelines (Emergency Use, UPIRTSO, HUD, NHSR, and appropriate follow ups, etc)

3. Conduct audits and surveys to assess the quality, efficiency and effectiveness of the Human Subject Protection Program

    • Conduct random on-site reviews for regulatory compliance and subject safety
    • Conduct directed (for cause) on site visits as a request by the IRB, IRB Chair, or Director of the HSPPO
    • Recommendation of actions based on on-site observation during random or directed on-site visits.
    • Investigate allegations of non-compliance through IRB reviews, HSPPO staff concerns or complaints received through the Compliance Hotline. Reporting potential non-compliance to the IRB and proposals of corrective actions.
    • Reporting potential serious or continuing non-compliance to the IRB and Institutional Officials with a proposal of a corrective action plan.

    4. Identify areas of improvement and recommendations on how to achieve the improvement

      • Root Cause Analysis
      • Corrective Action Plan Development
      • Education and Training

      5. All human subject research is conducted under an approved protocol- always cite the current approved working protocol in all related                             correspondence.

          6. Develop a Tool Kit of Study Management tools for Investigators and Coordinators