News & Announcements
This page offers news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research. Note: Due to the nature of web page evolution, some links may be broken.
July 11, 2018
General Announcement: IRB Review Newsletter [PDF]
In this issue:
- Updated Office of Research Integrity (ORI) Website
- CITI “Revised Common Rule” Course meets 3-year Human Subject Refresher Training requirement
- New Guidance for Researchers and IRB Members on Research Banks, Registries, & Digital Data
- Consent Contact for Greater than Minimal Risk Research
- Registration now open for the Annual Regional Conference, Human Subject Protection: Roll With It
October 4, 2018 Northern Kentucky Convention Center Early-Registration Discount
June 20, 2018
General Announcement: Nonmedical IRB Meeting Schedule Change [PDF]
Starting September 2018, the Nonmedical Institutional Review Board (IRB) will be convening on a monthly basis rather than a triweekly schedule. The new schedule will provide researchers with more time between submission deadlines to prepare their applications for Full Review. This change will also allow researchers to be more proactive and to contact Office of Research Integrity (ORI) staff for questions or feedback on applications prior to IRB review. ORI monitors the volume of reviews conducted by each IRB and adjusts the schedule accordingly. To view meeting dates and submission deadlines, please see below.
June 6, 2018
General Announcement: Adding Tracking Text to Your Approved Consent Forms
Upon approval, the E-IRB system stamps Informed Consent documents with an Approved Stamp indicating the Approval Date. The system does not add an Expiration Date to the stamp. Generally, researchers are not permitted to make changes in consent/assent form(s) without prior IRB review and approval. However, the IRB does allow researchers to add text that serves as an internal tracking mechanism as long as it does not affect the information in the consent document, or confuse potential research participants. For example, researchers may add version numbers or consent form expiration dates in the footer of the document for tracking purposes or to facilitate compliance.