Routine
- Comprehensive on-site review of research
- Includes a sample of human subject research conducted across the University
- Selection is primarily risk-based (e.g., enrollment of vulnerable populations)
Quality Improvement (QI) Reviews
The OHSP Division of Research Quality Improvement (OHSP-QI) conducts QI reviews to:
- Evaluate compliance with the Institutional Review Board (IRB) approved protocol and applicable federal and state regulations and guidance, and institutional policy
- Assist sites to be ‘audit-ready’
- Provide on-site education
Study teams can also request a free review by contacting the OHSP Quality Improvement Team at ohsp_qi@urmc.rochester.edu.
Types of reviews
Directed (For Cause)
- On-site review requested by the Research Subjects Review Board (RSRB)
- Review may be comprehensive or targeted (e.g., review of consent process only)
Requested
- On-site review requested by study personnel (e.g., in support of a new Principal Investigator, transition in study oversight/staff or in preparation for site inspection)
- Review may be comprehensive or targeted (e.g., review of data and safety monitoring plan only)
QI process
The Reviewing IRB (either the RSRB or an External IRB) reviews and approves the research study and the Principal Investigator (PI) receives an IRB approval letter.
OHSP-QI identifies a study for review. Reviews are selected, in accordance with OHSP Policy, by risk identification and/or improvement opportunities identified from previous reviews. Selected reviews are confirmed by the OHSP Director.
The PI receives a memo via email from the OHSP Director indicating the:
- Intention for the review;
- Applicable regulations and/or guidelines that the review will be conducted under; and
- PI’s rights and responsibilities.
Review memos also state the review type (as described above) and requests follow-up to schedule the review.
The on-site review is conducted. During the review, the OHSP-QI Reviewer(s) meets with the PI and/or their designee to explain the review process and answer any questions. The review is then conducted, with on-site verbal feedback provided, as appropriate. Unless the review is targeting a specific component of the research, review parameters typically include (but are not limited to) a comprehensive evaluation of the following:
- Required study site files (e.g., IRB approval documentation)
- Subject eligibility
- Signed consent forms
- Protocol adherence
- Data integrity
- Adverse event reporting
- As applicable: delegation of responsibilities, investigational product accountability, and adherence to conflict of interest management plans, data and safety -monitoring plans, and site-specific standard operating procedures
Once the review is complete, the OHSP-QI Reviewer(s) meet with the PI and any study team members (at the PI’s discretion) to discuss and review preliminary findings and provide opportunity for immediate feedback, clarification, process analysis and recommendation, as necessary. Additional education and resources, based on findings and/or salient research issues, are also provided.
The PI will receive a QI Review file via email, documenting the findings from the QI review. The PI is then responsible for addressing each finding with an:
- Investigator Response: Explain why a finding occurred; be specific (what was the root cause of the error/oversight?).
- Investigator Corrective and Preventative Action Plan: Provide a concise, measurable solution to address the root cause and correct current practices, as needed. If multiple findings are identified, that resulted from a common root cause, preventative actions plans for one or more findings may be combined, when appropriate.
PI responses must be returned to the QI Reviewer(s) within 10 business days (actions taken in response to a finding are not expected to be completed within in this time period); extensions may be permitted, if requested. Failure to respond to review findings will result in an Unacceptable rating.
A Final QI Report is issued by the QI Reviewer(s), incorporating all aspects of the review conducted. The report consists of an overall rating, executive summary, protocol summary, review scope, and all findings, including the PI’s responses and corrective and preventative action plans.
Applicable final reports are initially reviewed by the OHSP Director, following which the report is issued to the PI via email. The report is cc’d to the RSRB Director, RSRB Coordinator, RSRB Board Chair and the PI’s Department Chair/Division Chief. Additional individuals/entities may also be cc’d, when appropriate, based on review rating and/or regulatory/institutional oversight.
The RSRB reviews the Final QI Report and makes a final determination on the findings/action plans included in the report. The PI is informed of the board’s determination via email/memo. Additional action may be required by the RSRB.
For studies utilizing a Reviewing IRB external to the RSRB (e.g., WCG or Advarra), final reports are reviewed internally by an Ad Hoc RSRB Committee. Based upon findings, reports may be forwarded to Reviewing IRBs.
Review ratings
Commendable
No deficiencies identified in a study with consent requirements with enrolled subjects.
Acceptable
- Lesser deficiencies are identified that do not appear to involve risk to subjects (includes Reviewer’s comments).
- No deficiencies and no local accrual however, accrual is possible.
- No deficiencies identified in a study without consent requirements.
- Deficiencies identified with site-corrected resolutions present prior to QI review.
- A review not encompassing all aspects of a standard review (i.e. consents only).
Acceptable with Follow-Up
- Multiple lesser deficiencies are identified.
- Any deficiency in which potential risk to subjects needs further consideration (i.e. Data and Safety monitoring; adverse event assessment/reporting; wet-ink consent form missing/photocopy present).
- Self-reported deficiencies identified to the RSRB and being addressed prior to the conclusion of the review.
- No regulatory/study site file in a Greater than Minimal Risk study.
- CAPA re-review with repeated subject findings.
Unacceptable
- No response from the Investigator during the review process after a reasonable effort has been made by the reviewer.
- Major deficiencies are identified.
- A single major deficiency which impacts human subject safety/welfare is identified (i.e. data collected before consent).
- Study activity/treatment with subjects during a lapse in approval (without prior submission to the IRB).
- One or more missing consent form(s).
Frequently asked questions (FAQs)
The complete process takes about 30 hours. However, the on-site portion of the review is, on average, three hours. The duration is dependent on the complexity of the study and quantity of subjects.
The most common findings identified during reviews include:
- Missing documentation in the study site file (e.g., missing IRB approval letters, IRB-approved versions of protocols and watermarked consent documents)
- Protocol non-adherence (e.g., enrollment of ineligible subjects, visits/assessments out of window, incomplete/incorrect study procedures)
- Consenting errors (e.g., incomplete/incorrect signatures/dates on the consent form, using an un-watermarked consent to document consent, using an outdated version of the consent to document consent)
Reach out
Contact us
If you have questions, want to discuss the guidance on this page further, or would like to request a review, please email us at ohspqi@urmc.rochester.edu.