The IRB accepts only online submissions. The protected Google forms required for submission are only available to those with a functioning University of Lynchburg account. Only Lynchburg faculty and staff (not students) are permitted to submit proposals to the IRB. Please see specific instructions below regarding proposal submission.
Please note that only faculty/staff may serve as a PI (graduate students may serve as Co-PI).
Prior to submitting a proposal, all members of the research team must complete the CITI Program ethics training on the protection of human research participants. An image of each research team member’s valid CITI certificate of completion must be included in the research protocol proposal (item #11). An ethics certificate is valid for three years after completion of the training. A valid NIH certificate will be accepted through August 2021.
On the main page of the IRB website, complete the request form for the appropriate proposal template (e.g. minimal risk, full board, class project waiver, etc.). Within 24 hours of completing the request form, you will receive an email with a Google document link to the proposal template. Please be sure to provide a detailed response to all questions in the Google document proposal template.
The PI should share the completed proposal with the IRB Director, Dr. Alisha Walker Marciano. Only faculty/staff should submit completed proposals (no student submissions).
Suggestions for revisions and/or approval notification will be emailed to the PI approximately 7-10 days after submission (with the exception of college breaks when the IRB response time may be delayed).
After revisions have been made, the revised proposal should be shared again with the IRB Director, Dr. Alisha Walker Marciano.
Please see the Resources for a Successful Application page for a proposal checklist and for models of completed proposals, consent forms, etc.
Adverse Events and Unanticipated Problems
Per IRB policy, any adverse events and unanticipated problems must be reported to the IRB in writing immediately following any such occurrence and should not be held for notification until the yearly study status check-in or closure. There is not a form for reporting these items – contact the IRB Director, Dr. Alisha Walker Marciano, immediately via email at IRB-HS@lynchburg.edu, and provide as much detail as possible (including the study approval number, PI name, the title of the study, and the details of the adverse event and/or unanticipated problem)
Full Board Review Submission Deadlines for Spring 2019
These deadlines apply only to proposals submitted for full board review, which are reviewed once per month when the full board convenes.
|Full Board Meeting Date||Deadline for Submissions|
|2 p.m. Friday, Feb. 7||5 p.m. Friday, Jan. 31|
|2 p.m. Friday, Mar. 6||5 p.m. Friday, Feb. 28|
|2 p.m. Friday, Apr. 3||5 p.m. Friday, Mar. 27|
|2 p.m. Friday, May 1||5 p.m. Friday, Apr. 24|
Withdrawal from Review
If for any reason the Principal Investigator (PI) wishes to withdraw the research study proposal from review, they may do so by sending an email to the IRB Director at IRB-HS@lynchburg.edu. Documentation and communication will be retained by the IRB; however, a determination will not be made upon the request for withdrawal. If a PI wishes to have the IRB reconsidered (placed under review), then a new submission must be made. In other words, once a study is withdrawn it will not be reopened and reviewed.
Please note: If a Principal Investigator (PI) does not respond to a request for clarification, revisions, or additional information within 15 business days of the date of the request, then the research study proposal will be classified as “withdrawn by PI due to non-response.” If a PI requires more time to complete the request, please email the IRB at IRB-HS@lynchburg.edu.
Please contact the IRB Director, Dr. Alisha Walker Marciano, at IRB-HS@lynchburg.edu.