VCOM Institutional Policy and Procedure Manual

45 CFR 46.108(a) 45 CFR 46.108(b) 45 CFR 46.115(a)(6) 45 CFR 46.115(a)(2)

Following written procedures

Approval by quorum at convened meetings Maintaining adequate documentation

Detail of IRB meeting minutes

5.

PROCEDURE 1. All IRB approval letters, to include initial or continuing reviews, will specifically state the following information to inform Principal Investigators (PIs) of their responsibilities related to continuing review: a. Next continuing review date is typed in bold b. IRB approved research must be reviewed no less than once per year. If the IRB deems that review should be performed more frequently than once per year, this will also be stipulated. The criteria for protocols requiring more frequent review is delineated in the VCOM Institutional Review Board (IRB) policy. c. PIs will be notified that approximately 30 days prior to approval expiration they will receive by email a Progress Report Form, Form D, from the IRB Coordinator. d. PIs will be instructed to complete this report and submit it, along with any other pertinent documentation, to the IRB Coordinator a minimum of two weeks prior to the review date. e. PIs will be advised that if re-approval is not obtained prior to expiration, all activities involving human subjects must cease immediately, except where necessary to eliminate immediate hazards to the subjects. f. PIs will be instructed to submit Form D, as a final report, should the study terminate prior to approval expiration. 2. The IRB coordinator will send a copy of all approval letters electronically to the PIs and will also send all original letters by mail within one week following approval, thus notifying PIs of their responsibilities for continuing review over the next year 3. The IRB coordinator will contact the PI by email approximately 30 days prior to expiration of IRB approval requesting the submission of all applicable continuing review documents be submitted two weeks prior to protocol expiration: a. Form D b. Updated Informed Consent c. Proposed modifications d. Any other applicable documents as requested by the IRB 4. If the IRB coordinator does not receive a response from the PI within ten business days or approximately two weeks, a second email notice will be sent requesting the submission of all applicable documents as soon as possible. 5. If the IRB coordinator does not receive the continuing review application within one week prior to expiration of approval, a final notice will be sent electronically to the PI, requesting the required documentation. 6. If there has been no response from the PI, and the approval period has expired, the IRB Chair Person will notify the PI by letter as a notice of approval expiration, of the following information: a. Federal regulations require continuing review of research be conducted by the IRB not less than once per year. b. Federal regulations make no provision for any grace period extending the conduct of the research beyond the expiration date of IRB approval.

c. Investigators must plan ahead to meet required continuing review dates. d. Research must cease and enrollment of new subjects cannot occur