SOP 041: WVU OHRP QI Program Activities

1. Purpose

This SOP describes the policies and procedures regarding WVU OHRP’s Quality Improvement Program and the activities within the scope of that program.

2. Overview

WVU OHRP supports a quality improvement (QI) program which promotes and maintains ethical research conduct and compliance with state and federal regulations, federal guidance, institutional policies, and best practices for human subject protections within the scope of research. WVU OHRP QI Program strives to evaluate and improve human research protections and activities through education, training, and monitoring.

3. Education and Training Goals

3.1. The purpose of the WVU OHRP QI Program is to promote the following via education, training, and outreach mechanisms:

• Protection of the rights, welfare, and safety of human subjects participating in WVU research
• Compliance with federal, state, and institutional requirements governing human subject research
• The integrity of university research and WVU OHRP activities
• Education and training of research stakeholders, including university faculty and administrators, researchers, research staff, IRB members, WVU OHRP staff, and students involved in human subjects research
• Evaluation and follow-up of QI initiatives, corrective actions, and implementation of new quality improvement activities.

4. Monitoring

4.1. The objective of a routine IRB review (i.e., audit) is to ensure proper documentation, recordkeeping, data analysis, and adherence to applicable Federal regulations and IRB policy to monitor, measure, and improve the effectiveness of WVU’s Human Research Protections Program. The review assesses the study conduct procedures, identifies errors and omissions, and is a means to provide the researcher with recommendations for corrections and improvements to protect the rights and welfare of research participants.

4.2. As part of WVU OHRP’s QI Program initiatives, the following types of monitoring will take place as necessary:

• Internal Compliance Reviews will be performed based on WVU OHRP needs and staff availability.
• Routine reviews and monitoring activities will be performed based on WVU OHRP needs and staff availability. Routine reviews and monitoring may include PI self-assessments.
• Directed reviews of specific research and/or researchers at the request of the IRBs, WVU OHRP Leadership, or Institutional Official will also be performed as necessary to support IRB review, ensure human subject protections, and meet WVU OHRP QI program goals.

5. Internal Compliance Review

5.1. Internal directed audits and random internal compliance reviews will be conducted. The results may impact current practices and may require additional educational activities, and will be reported to the Director. The internal compliance auditor (WVU OHRP Assistant Director or designee) will:

• Review the IRB minutes to determine that adequate documentation of the meeting discussion has occurred. This review will include assessing the documentation surrounding the discussion for the protection of vulnerable populations, as well as other risk/benefit ratio and consent issues that are included in the criteria for approval.
• Assess IRB minutes to assure quorum was met and maintained.
• Assess current adverse event reporting process.
• Ensure that privacy provisions, according to HIPAA, have been adequately reviewed, discussed, and documented in the IRB minutes.
• Evaluate the continuing review discussions to assure they are substantive and meaningful, and that no lapse has occurred since the previous IRB review.
• Observe IRB meetings or other related activities.
• Review IRB files to ensure retention of appropriate documentation and consistent organization of the IRB file(s) according to current policies and procedures.
• Review IRB database/electronic submission system to ensure accurate completion.
• Verify IRB approvals and reliance documentation for collaborating institutions or external performance sites.
• Review the appropriate metrics (e.g., time from submission to first review) to evaluate the quality, efficacy, and effectiveness of the IRB review process.
• Review the workload of IRB staff to evaluate appropriate staffing levels.

• Conduct other monitoring or auditing activities deemed appropriate by the IRB.

5.2. The Director or designated staff will review the results of internal compliance reviews with the IRB Chairs and Institutional Official (as needed). If any deficiencies are noted in the review, a corrective action plan will be developed by the Director and approved by the Institutional Official. The Director will have responsibility for implementing the corrective action plan, the results of which will be evaluated by the Institutional Official.

6. Procedure for Initiating a Routine Review

6.1. The WVU OHRP staff or designee selects a researcher or a research protocol for a routine review based on criteria that may include, but is not limited to one or more of the following:

• Research protocols involving procedures that are greater than minimal risk to participants
• Research protocols involving vulnerable populations
• Investigator-initiated drug and/or device studies
• Investigators conducting a large number of research projects
• Research protocols approved using expedited procedures that are not subject to continuing review

6.2. The WVU OHRP staff or designee contacts the researcher and establishes a time and place for the review. The WVU OHRP staff informs the researcher which documents are necessary for the review. The researcher must make such documents available at the time of the audit. Any other materials the WVU OHRP staff or designee deem necessary to accurately understand the research process under investigation shall be made available by the researcher upon request.

7. Procedure for Initiating a Directed Review

7.1. The convened IRB, IRB Chair, Subcommittee, or WVU OHRP Director may direct the WVU OHRP staff or designee to conduct a directed review (i.e., audit) in response to a particular concern. Concerns that may prompt a directed review include, but are not limited to, the following:

• Complaints or concerns made by a research participant, family member of the research participant, research staff member, or an employee of WVU or the covered entity
• Reports of audits or monitoring conducted by other committees affiliated with WVU OHRP/IRB, federal agencies, data and safety monitoring committees, or other agencies involved in the conduct of the research
• Issues of non-compliance

7.2. The WVU OHRP staff or designee contacts the researcher and establishes a time and place for the directed review. The WVU OHRP staff or designee informs the investigator which documents are necessary for the directed review. The researcher must make such documents available at the time of the review. Any other materials the WVU OHRP staff or designee deem necessary to accurately understand the research process under investigation shall be made available by the researcher upon request.

8. Procedure for Conducting a Review

8.1. Using the WVU IRB auditing documents and the researcher self-assessment checklist (if completed/available), WVU OHRP staff or designee reviews some or all aspects of the research records. These checklists become part of the final written report.

9. Procedures for Completing a Review

9.1. After a review, the researcher is informed of the result of the review in a written report from the WVU OHRP office. The written report is also sent to the IRB Chair, WVU OHRP Director, and other Institutional Officials and other units within WVU or the covered entity, as deemed appropriate. A closeout visit may also be scheduled, either virtually or in-person.

9.2. If the review does not identify any problems, no action is taken.

9.3. If the review identifies problems or deficiencies, the WVU OHRP staff or designee includes appropriate corrective actions in a time frame determined by the WVU OHRP staff member or designee. WVU OHRP staff is responsible for reviewing these corrective actions and follows up with the researcher to ensure the corrective actions are completed. WVU OHRP staff may accept confirmation of completion for the corrective actions through a statement from the researcher, other documentation from the researcher, or a follow-up review.

9.4. If the corrective actions are not completed, WVU OHRP staff or designee may recommend to the convened IRB that a suspension be considered for the research project that was reviewed or for the research projects that a researcher is conducting, according to the procedures in SOP 029: Suspension, PI Administrative Hold, and Early Termination.

9.5. If the review identifies non-compliance, such as lack of oversight, deliberate falsification or omission, failure to comply with the requirements and determinations of the IRB, significant protocol violations, or deviations or frequent occurrences of such, the IRB follows SOP 049: Non-Compliance and Research Misconduct. The IRB may request additional corrective actions as per this policy.

9.6. If the review identifies a problem that might be an unanticipated problem involving risks to participants or others, the IRB follows SOP 031: Research-Related Event Reporting. The IRB may request additional corrective actions as per this policy.

10. References

WVU Policies:
SOP 029: Suspension, PI Administrative Hold, and Early Termination.
SOP 031: Research-Related Event Reporting
SOP 049: Non-Compliance and Research Misconduct

AAHRPP:
Standard I-5