Quality Improvement Program
The Ohio State University Human Research Protection Quality Improvement (QI) Program was established to promote and maintain ethical research conduct. The primary mission of the QI Program is to evaluate and improve human research protections through education, training, and monitoring. Quality Improvement staff work with investigators, research staff, and the IRBs to ensure research is compliant with regulations, guidance, institutional policies, and best practices for human research protections.
Activities
The QI Program is responsible for reviewing activities associated with human research protections and for providing related education and monitoring. Examples include:
- Routine on-site QI reviews
- Assistance with site or study-specific researcher self-assessments
- Post-approval monitoring of research activities
- Pre-approval site or investigator assistance
- Assistance with IRB submissions, reporting, and recordkeeping
- Educational offerings (e.g., Forms Help, IRB Information sessions)
- Assistance with preparation for external audits by sponsors or federal agencies
- Point of contact for research-related complaints
- Consultation to investigators and study personnel.
Tools, Checklists, and Templates
- Informed Consent Self-Assessment Tool
- Recruitment Self-Assessment Tool
- Remote Monitoring Form
- Documentation and Recordkeeping Tips for Written Informed Consent
- General Informed Consent Requirements (OHRP Educational Video)
Contact Information
Contact us with questions, to request consultation or assistance with preparing for an audit, or to set up a review.
