Page 172 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Appendix A – IRB Approval Lapsed Study Template
RESEARCH ADMINISTRATION
TO:
Research Administration SOP No: Q002 SOP Title: Lapsed IRB Study Process
FROM: Deborah (Deb) Town, RN, MSN, CCRC, CHRC Senior Director, Research Administration
DATE:
RE: IRB Approval Lapse
Dear Investigator and Study Team:
Children’s Research Administration received notification that your IRB approval has lapsed for study IRB #_______, Velos #_____, titled ___________________________.
Federal regulations require that all IRB-approved protocols be reviewed by the IRB at least every 365 days during the life of the study and they make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. As such, your site approval at Children’s has also lapsed and will remain in lapsed status until IRB approval is re-instated.
Please be advised of the IRB stipulations requiring that all research activities stop. This includes:
• No new subject recruitment or enrollment;
• No further collection of data/information from or about living individuals;
• No further research-related interventions or interactions with currently enrolled subjects (unless
the IRB acknowledges it is in the best interests of the individual subjects to continue
participation in the research interventions or interactions.);
• No expenditure of funds granted for the project; and
• No further data analysis.
If the study is administratively closed by the IRB and you are required to resubmit your protocol, you will also be required to resubmit your performance site review application.
Please notify Children’s Research Administration immediately if you have requested an extension from the IRB deeming that it is in the best interest of currently enrolled subjects to continue research-related interventions during the period of lapsed approval.
Should you have any questions about this communication, please contact Children’s Research Administration at 214-456-6220.
SOP No. 2, Date: 4/13/16; revised 5/3/16; 7/5/16; 8/2/16; 10/13/16; 11/29/18; 03/18/19, 05/31/22