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.
Program Activities
The QI Program is responsible for reviewing activities, policies, procedures, and records associated with human research protections and for providing related education and monitoring. Examples include:
- provide pre-approval investigator consultations
- conduct routine post-approval monitoring QI reviews of IRB-approved research projects
- conduct for-cause audits authorized by the IRBs or institutional official
- assist with preparation for external audits by sponsors or federal agencies
- assist with site or study-specific research self-assessments
- provide education and regulatory guidance to investigators, research staff, students, IRB members, ORRP staff, and research participants
- develop policies, procedures, and guidance tools
- point of contact for research-related complaints, noncompliance, and unanticipated problems
- provide guidance to investigators and study personnel with IRB submissions, reporting, and recordkeeping
Resources
Tools, Checklists, and Templates
- Informed Consent Self-Assessment Tool
- Recruitment Self-Assessment Tool
- Investigator Tools for Drug Research
- Investigator Tools for Medical Device Research
- Documentation and Recordkeeping Tips for Written Informed Consent
- FDA Inspections
- Event Reports Determination Guidance
- UPIRSO Decision Tree
- Noncompliance Decision Tree
