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SOP 028: Post-Approval Submissions

1. Purpose

This SOP describes the process for the review and approval of post-approval protocol submissions (amendments, deviations, and closures) to a previously approved protocol for research conducted under the auspices of the WVU IRBs.

2. Overview

Changes to approved Full Board and Expedited protocols cannot be made or conducted on human subjects without approval from WVU IRB in the form of an amendment, , except where necessary to eliminate apparent immediate hazards to human subjects.

3. Procedures for Amendment Submissions

3.1. Researchers must submit requests for proposed changes to the IRB in the form of an amendment request (not applicable for NHSR, Flex, and Exempt) or “notify the IRB” request (not applicable for NHSR) in the WVU electronic protocol submission system. Amendment submissions should be submitted no later than 30 days after receiving changes from sponsors, collaborators, etc.

3.2. During amendment review, the IRB determines whether the research with the proposed changes meets the regulatory criteria for approval and any other applicable requirements are met.

3.3. Amendments cannot be submitted for NHSR, Exempt, or Flex protocol types. Changes to these protocol types which increase the level of risk to participants OR in which federal funding is added would require the protocol to be resubmitted as a new project.

4. Procedures for Deviation Submissions

4.1. Researchers are required to report deviations that meet one or more of the following criteria:

    • Intended to eliminate an apparent immediate hazard to a research participant; or
    • Caused possible harm to participants or others, or placed them at increased risk of harm - including physical, psychological, economic, or social harm; or
    • Possible serious or continuing non-compliance

4.2. Any report of a deviation to the IRB should be made in a timely fashion but no later than 10 working days of its occurrence or identification. If a deviation report is not submitted within 10 working days of its occurrence or identification, the IRB should make a serious/continuing noncompliance determination (see SOP 049: Non-Compliance and Research Misconduct).

4.3. The PI or research staff report(s) deviations by completing a “Notify IRB” submission request in WVU’s electronic protocol submission system.

4.4. WVU OHRP staff perform a thorough review and evaluation of the deviation. Requests for clarifications, corrections, or revisions to the report from the PI are made if further information is needed to evaluate the deviation.

4.5. The deviation is evaluated to determine if it had a significant effect on the participants’ rights, safety, or welfare or corrupted the integrity of the resultant scientific data. The IRB Chair may be consulted at any time during this process for assistance.

4.6. Any corrective actions taken should be described in the  PI’s proposed preventive, corrective action plan and should include the active process for addressing the causal elements to ensure that  the reviewer can conclude that the PI has a viable plan in place for assuring the safety of the research participants and the oversight of data integrity.

4.7. After the review and evaluation of the incident, the following actions may be taken:

    • The IRB acknowledges the deviation with no further actions indicated.
    • The deviation is returned to the PI to be submitted as an adverse event and/or unanticipated problem involving risks to participants or others. Please see SOP 031: Research Related Event Reporting.
    • If the OHRP staff determines that the deviation possibly meets the definition of serious or continuing non-compliance according to SOP 049: Non-Compliance and Research Misconduct, the deviation is handled according to the procedures outlined in that SOP.

5. Procedures for Protocol Closure Submissions

5.1. The completion or termination of the research project is considered a change in activity to the protocol and must be reported to the IRB. The PI submits a final project (or closure) report to notify the IRB of the completion or termination of a project, including protocols determined to be exempt. A final project/closure report provides information to the IRB regarding the final status of the project and allows the IRB to close the protocol within the WVU electronic protocol submission system.

5.2. If the PI fails to apply for continuing review or fails to submit a final project report, the IRB may administratively close the protocol. When the IRB acknowledges closure reports, the protocol file is closed, and no further activity related to the protocol may be conducted. Protocol files are retained as described in SOP 039: IRB Records and Data and Information Management.

5.3. Submission of Final Project/Closure Reports

5.3.1. Final project reports should be submitted within 30 days after the completion or termination of the protocol.

5.3.2. The following documentation is required for IRB review: Final project/closure report application submitted via the WVU electronic protocol submission system. Preliminary or final results, if applicable. Sponsor documentation of research project completion or termination, if it exists. Closure information and/or documentation from IRB of Record for Central and Single IRB protocols.

5.4. IRB Review of Final Project/Closure Reports

5.4.1. A designated member of the IRB reviews all final project/closure reports and, if needed, requests further information from the PI to clarify any questions that may arise.

5.4.2. Once the IRB has determined that sufficient information is provided, the PI will receive acknowledgement of the final project report and closure of the protocol from the electronic protocol submission system.

5.5. IRB Administrative Closure

5.5.1. If a protocol expired and a protocol application review or a final project/closure report has not been submitted, the protocol will be administratively closed by the IRB. Refer to SOP 021: Approval Period and Determination of Expiration of procedures regarding expired protocols.

6. References

WVU Policies:
SOP 021: Approval Period and Determination of Expiration
SOP 031: Research Related Event Reporting
SOP 039: IRB Records and Data and Information Management
SOP 049: Non-Compliance and Research Misconduct

Federal Regulations:
45 CFR 46.109
45 CFR 46.110

Element III.2.D