HRPP AND IRB OPERATIONAL PROCEDURES AS OF CLOSE OF BUSINESS 12/9/22
OVPRI is preparing an office-wide message, which will include the following information from the VCU and VCU Health HRPP:
To avoid the last-minute rush of submissions please note that after December 9, 2022 (COB), non-emergency submissions may not be reviewed until we return from the winter holiday due to the high volume of submissions we receive which are currently in our pipeline and limited staff.
What about the submissions in progress before December 9, 2022?
The VCU and VCU Health HRPP faculty and staff are reviewing and responding to initial, continuing reviews and amendment submissions already in progress in accordance with our policies through December 21, 2022. We return to normal operations following the winter break, January 3, 2023.
Can my research team prepare new human research protocols over the winter holiday?
Yes. Research teams may continue to perform their normal operations. Submissions that have not yet been reviewed will be moved to a “paused” state on December 21, 2022 and will be unpaused when we return to normal operations following the winter break, January 3, 2023.
Will the HRPP systems be available over the winter holidays?
Absolutely! The HRPP on-line systems remain open 24/7/365. In fact it is an ideal time to check your human research training status and review your study status, personnel, and review schedules.
Absolutely! The HRPP on-line systems remain open 24/7/365. In fact it is an ideal time to check your human research training status and review your study status, personnel, and review schedules.
- CITI – to complete requisite and optional online research ethics and integrity training
- RAMS IRB – to upload your final research protocol and complete your IRB submission form
Will the faculty and staff of the HRPP and VCU IRB be available for emergency issues, reports, or concerns?
Yes.If you are submitting any of the following prompt reports/submissions to the HRPP/IRB during the winter holiday, please ensure that the following procedure is followed:
- Research team completes a submission in RAMS-IRB for one of the following:
- Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO), this may include VCU site SAEs.
- Emergency use protocols (Note: Emergency use protocols must be submitted to the IRB within 5 days after said event).
- Research team alerts the HRPP staffperson on-call via email to [email protected] and/or via voice-mail to (804) 828-0868.
- Research team member should actively monitor the situation and always exercise beneficience (acting in the best interest of the patient in a case of emergency).
- Research team member should recontact the HRPP staffperson on-call if the situation escalates or no reply is received (within 24 hours) to ensure that the message was effectively communicated ([email protected] and/or via voice-mail (804) 828-0868).
Thank you, and have a happy winter holiday.
Categories Announcements and Updates