VCOM Institutional Policy and Procedure Manual

e. Collection of data since the time of approval lapse will not be permitted to be used for publication. f. Instruction for the PI to contact the IRB as soon as possible to rectify the matter. 7. Any suspension or termination of approval will be reported to the Dean and the President of the College by letter, as stipulated in the VCOM Institutional Review Board (IRB) Policy 8. The notice of approval expiration will be sent electronically to the PI immediately and the original letter will be sent via mail, and the PI will be required to submit a new protocol application for review and approval before the research may resume 9. Upon receipt of a continuing review application, the IRB coordinator will verify completeness of the documents. 10. If a continuing review application is incomplete, the IRB coordinator will communicate with the PI by email to obtain completion. 11. When the continuing review application is deemed to be complete, the IRB coordinator in conjunction with the IRB Chair Person will review the application to determine whether expedited or convened committee review is applicable. 12. If the continuing review is to be performed under full board review, the complete continuing review documents will be sent electronically to the primary reviewer(s) two weeks prior to the meeting date, and one week prior to the meeting date for all other IRB members. a. IRB actions to be taken are delineated under Section 7 of VCOM IRB Policy, Criteria for Approval b. The PI will be notified in writing of the IRB’s decision as stipulated in the VCOM IRB Policy 13. IRB meeting minutes will document deliberations, actions, and votes for each protocol undergoing continuing full board review 14. If the continuing review is to be performed through expedited procedure, as delineated in the VCOM IRB Policy, Section 10 Types of Review, the IRB Coordinator in conjunction with the IRB Chair Person, will designate one or two primary reviewers based upon the proposed changes to the protocol and/or recruitment process: a. Protocols previously reviewed under expedited procedure may be solely reviewed by the Chairperson as per the VCOM IRB Policy b. Reviewer(s) will be chosen based upon member expertise and the protocol under study c. The IRB Coordinator will attempt to assign continuation applications to the protocol’s original expedited reviewer or primary reviewers d. Primary reviewer(s) designated will be notified by email and requested to perform the review within a two week timeframe e. If the primary reviewer(s) are unable to perform the review due to time constraints, another member of the IRB will be designated by the Chair Person f. If there are no IRB members available with the appropriate area of expertise, then the IRB Chair Person may elect to request the services of an external reviewer that possesses the required qualifications 15. Expedited reviewers that have accepted a designated review will be sent all pertinent continuing review records electronically and will be required to respond with their recommendations within 2 weeks: a. If additional information is needed within the 2 week time period, the reviewer(s) is(are) to contact the IRB Coordinator who will in turn contact the PI by email to obtain the additional information b. If the reviewer(s) after two weeks offer recommendations for revision, these recommendations will be sent to the PI in writing in the form of a letter, as approved by the IRB Chair Person