By Jenny Kucera, IRB Administrator/Education Coordinator
Several questions have come into the IRB Office during the last quarter. The information below addresses some of these questions, providing additional information on protocol changes using referenced protocols, how to change a Principal Investigator, and IRB approved registries/tissue banks.
It’s important that the IRB application reflects the most current version of a protocol. To insure that the IRB reviewers only need to reference the current version of the protocol, update all the sections of the IRB application when referencing protocols not just the section that has been changed. For those sections which were not changed simply add the comment “No changes. Updated reference only”. When referencing page numbers in a protocol please use a “clean”, non-track changes, version to avoid any version confusion.
If you have occasion to switch a person who is already listed on the study and is “authorized to consent” in Section II status to Principal Investigator (PI) you can first make the necessary changes in Section I of the IRB application, then put the Informed Consent Form (ICF) into edit mode which then will automatically update the ICF with the new PI. If you are removing their authorization to document consent then you must update both Section II of the IRB application and the ICF manually. This applies to all research applications. However, “Authorization for Consent” in Section II of the tissue banking and data registry applications must always be revised manually.
An IRB application may be necessary to access tissue samples or registry data even when the Biorepository or Registry is already IRB approved. This is frequently the case when data or samples contain any of the 18 HIPAA identifiers. Please contact the IRB office before initiating any study utilizing a Biorepository or Registry to determine whether you need an IRB application to proceed.
Upcoming IRB Educational sessions include:
- February 9, 2016 “NIH-funded Human Subjects Research: When and How to Work with Sponsored Programs Administration” presented by Deb Vetter and Beth DeCarolis.
All lectures will be in Sorrell 1005 from 11 AM—12 PM. Lunch is provided.