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.

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 checklists, worksheets, templates, procedures, and guidance tools
• point of contact for research-related concerns, noncompliance, and unanticipated problems
• provide guidance to investigators and study personnel regarding IRB submissions, reporting, and recordkeeping

Post-approval monitoring (PAM) is an education-focused QI program that monitors research projects to confirm that the research is being conducted as approved, thus ensuring compliance with the federal regulations and guidelines that govern human subjects research. Active studies are selected for review and monitoring based on the PAM annual plan which is approved by the senior associate vice president for research operations. Studies from all three Ohio State IRBs and externally ceded studies may be selected. PAM visits often focus on, but are not limited to, review of recruitment practices, potential participant screening, adherence to eligibility criteria, informed consent procedures, consent congruency with the sponsor contract, document storage, conflict management plan (CMP) implementation (if applicable), participant privacy, and confidentiality of data. 

The post-approval monitoring team contacts investigators at the time of study selection and provides a questionnaire to complete and a study document request (if applicable). This is an opportunity for researchers to take time to review study processes and procedures and to ensure they are consistent with institutional approvals, federal regulations, and university policies. Upon completion of the review, the PAM team provides the PI and designated team members with an email summary. 

Researchers are expected to submit any requested information in a timely manner, as outlined by the PAM team, and self-report any requested compliance items via a reportable new information submission and/or amend the research through a modification submission. Educational recommendations (e.g., best practices) provided during the monitoring process should also be taken into consideration. Failure to self-report any issues identified in a reasonable timeframe will result in reporting to the institutional official (IO), ORRP director, and/or IRB chair. The post approval monitoring SOP can be found in the Huron library. 

The ORRP education program supports the QI team mission by providing educational and operational support to internal staff, investigators, and IRB members. Its goal is to enhance understanding of, and support compliance with, federal regulations, state and local laws, institutional IRB operating procedures, and ethical research principles. Education is also provided to address monitoring and compliance concerns, and to enhance QI program initiatives. Program Activities 

• weekly investigator office hours
• presentations to departments, classes, or other groups
• IRB member onboarding, continuing education, and support
• ORRP staff training and support
• developing guidance documents and operating procedures
• campus-wide webinars
• recorded training sessions for researchers and IRB members
• one-on-one assistance to study teams
• departmental outreach

To ensure the protection of research participants, federal regulations and IRB policy require study teams to submit reportable events to the IRB for review. Unanticipated problems can occur in any type of research (medical or non-medical) and may include occurrences such as adverse events, subject complaints, protocol deviations, and other unexpected events involving risk. Events requiring prompt reporting by investigators and research staff may involve physical, psychological, social, legal, or economic harms.