Office of Responsible Research Practices
The Ohio State University

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

Contact Information

Contact us with questions, to request consultation or assistance with preparing for an audit, or to set up a review.

Sandra Meadows, MPH, CIP
Quality Improvement Specialist
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-688-8641
Fax: 614-688-0366
meadows.8@osu.edu

Ellen Patricia, MS, CIP
Quality Improvement Program Director
Office of Responsible Research Practices
300 Research Administration Building
1960 Kenny Road
Columbus, OH 43210
Phone: 614-688-5556
Fax: 614-688-0366
patricia.1@osu.edu

FAQs

  1. What is the purpose of the OSU Human Research Protection Quality Improvement Program?
  2. What is the relationship between the Institutional Review Boards (IRBs) and the QI Program?
  3. What activities comprise the QI Program?
  4. What is the scope of the QI Program?
  5. What is the difference between a “for-cause” audit and a routine QI review?
  6. How are studies selected for routine QI review?
  7. How are individuals notified when their studies are selected for routine QI review?
  8. Does the Principal Investigator and/or research staff member need to be present for the entire QI review?
  9. How are findings communicated upon completion of a routine QI review?
  10. Who will receive the results of a routine QI review?
  11. What will be reviewed during a routine QI review?
  12. What can an investigator or research staff member do to prepare for a routine QI review?
  13. What if problems are identified when preparing for routine QI review?

Quality Improvement (QI) Program FAQs

1. What is the purpose of the OSU Human Research Protection Quality Improvement Program?

The Ohio State University supports a quality improvement program to promote and maintain ethical research conduct and compliance with state and federal regulations, federal guidance, institutional policies, and best practices for human research protections. The Human Research Protection Program (HRPP) QI Program evaluates and improves human research protections and HRPP activities through education, training, and monitoring.

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2. What is the relationship between the Institutional Review Boards (IRBs) and the QI Program?

The IRBs and QI Program are both components of the HRPP. The QI Program is charged with evaluating and enhancing human research protections through education, training, and monitoring. The IRBs are charged with reviewing and overseeing human research to ensure protection of research participants. The feedback received from QI reviews is a way for the IRBs to inform and improve these activities.

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3. What activities comprise the QI Program?

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-study site or investigator assistance
  • Assistance with IRB submissions, reporting, and recordkeeping
  • Consultation to investigators and study personnel.

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4. What is the scope of the QI Program?

All Ohio State University human research and activities of the Human Research Protection Program (HRPP) are included in the QI program. Information is obtained through interviews, observations, and records reviews. The QI program focuses primarily on the review of activities, policies, procedures, and records for the following groups:

  • Investigators and research staff participating in human subjects research (including expedited and exempt research)
  • IRBs
  • Office of Responsible Research Practices staff supporting IRB activities
  • Individuals involved in HRPP education and outreach.

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5. What is the difference between a “for-cause” audit and a routine QI review?

A for-cause (directed) audit is an audit of research or investigators that is initiated at the request of the IRB or the Institutional Official to obtain (or verify) information necessary to ensure compliance with regulations and institutional requirements. A for-cause audit is generally based on a concern, complaint, or an allegation that was brought to the attention of Office of Responsible Research Practices staff or the IRB and is used to inform decisions about the conduct of human subjects research and/or human subjects protection.

A routine (not-for-cause) QI review is an assessment or examination of a research-related practice or procedure with the possibility (or intention) of instituting change if necessary. Routine QI reviews of study activities and study documentation are performed on site as a service to investigators, with feedback provided regarding practices associated with the conduct of the study.

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6. How are studies selected for routine QI review?

Studies are randomly identified for routine on-site QI reviews from the list of all open protocols in the IRB database. Any study involving human subjects, including medical and non-medical studies and those that have received exempt determinations, may be selected for routine QI review. Exceptions to random selection include studies that have received QI reviews or for-cause audits within the same calendar year, studies closing prior to scheduled review, and “program protocols” under which human research is not conducted.

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7. How are individuals notified when their studies are selected for routine QI review?

The Principal Investigators are notified electronically or in writing that a particular study has been selected for QI review. (Note: Co-investigators and/or individuals listed as additional contacts will also be copied on the notification.) The QI staff will arrange a mutually agreeable appointment for on-site review, typically within 2-4 weeks of notification.

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8. Does the Principal Investigator and/or research staff member need to be present for the entire QI review?

No, the Principal Investigator (PI) and/or research staff member does not need to be present for the entire QI review. However, the QI staff will ask to meet with the PI and/or research staff member before and at the end of the review. The PI or research staff member may also be asked to be available (or to check in periodically) to answer any questions that may arise during the QI review.

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9. How are findings communicated upon completion of a routine QI review?

QI staff will provide verbal feedback to the Principal Investigator (PI) and/or research staff members participating in the review following its completion. Written reports are not generated, and only aggregate data will be kept by the QI staff. Results are not linked to investigators or their studies.

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10. Who will receive the results of a routine QI review?

The results of routine QI reviews are shared only with those participating in the review. Minor concerns are addressed directly with the Principal Investigator (PI) and/or research staff member. QI staff will also work with PIs to help them report serious concerns to the appropriate IRB. Aggregate results of QI reviews (without identifiers) are reported to the IRB Policy Committee, which has oversight responsibility for the Human Research Protection QI Program.

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11. What will be reviewed during a routine QI review?

QI staff will ask that specific study-related records are available for review. Documents to be reviewed will not be removed from the site.. Examples include (as applicable, based on the study):

  • IRB-approved documents, including initial, continuing, and amendment reviews
  • IRB-related correspondence, including IRB approval letters
  • Informed consent documents
  • Screening/enrollment lists used to identify potential participants
  • Sponsor correspondence
  • Reports of unanticipated problems and adverse events
  • Drug and device accountability records.

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12. What can an investigator or research staff member do to prepare for a routine QI review?

Organizing study-related records (even without a QI review) can be beneficial in helping to track study progress and meet required deadlines. Some helpful tips:

  • Review your system for maintaining current and complete records. As necessary, train all who generate, access, and store records on how to use the system.
  • Back up electronic records that you can’t afford to lose if failures occurred.
  • Assess the security of stored records to prevent unintended loss or access.
  • Perform inventories of items that require accountability (e.g., drugs, devices, survey documents).
  • Ensure that documents are organized and can be made available for review.
  • Use the self-assessment tools on the QI website to review your files for the appropriate contents.

For more information or assistance, please contact a Quality Improvement Specialist.

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13. What if problems are identified when preparing for routine QI review?

For events requiring prompt reporting, please see Event Reporting-Unanticipated Problems Involving Risks to Subjects or Others, Adverse Events, and Other Problems and Event reporting guidance or contact ORRP for assistance. For other problems or questions, please contact a Quality Improvement Specialist for guidance.

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