Health Sciences and Minimal Risk IRBs, IRB News/Volume 11, Number 3, March 2019
Upcoming Workshops on Changes of Protocol
The How to Complete Changes of Protocol workshop will provide an overview of the process for submitting changes of protocol to the Health Sciences IRBs. The workshop will focus on when changes of protocol are required, the change submission process, and how to effectively submit changes. The workshop is directed at researchers submitted to the HS IRBs who are new to the change process as well as for those looking for help on how to effectively submit changes.
Two workshop opportunities will be offered in April:
- Wednesday, April 17th from 2-3 PM in room 1309 of the Health Sciences Learning Center (HSLC). Registration for this workshop is available here.
- Thursday, April 18th from 12:30-1:30 PM in room 1309 of the HSLC. Registration for this workshop is available here.
Reminder: When NOT to Submit Changes for Exemptions
Our office has been receiving quite a few changes for projects determined to be exempt and, in some cases, did not need to be submitted per IRB guidance. When assessing whether a change is needed for your exemption, please keep the following in mind:
- A detailed table describing when changes for exemptions are needed can be found here.
- Changes in personnel for exemptions do NOT need to be submitted unless:
- The PI is being changed;
- A new conflict of interest needs reporting; or
- New personnel external to the UW/UW Health, or Madison VA are being added.
- NOTE: While not required, study teams can submit changes to add points of contact that need edit access or study team members that will be accessing medical records data.
- Changes to recruitment methods or materials do NOT need to be submitted for exemptions unless they are substantially different from those already reviewed by the IRB. If unsure about whether the change is considered substantial, please contact the staff reviewer that reviewed the application.
Improved ARROW Training Snapshot
With the update on March 31st, the training snapshot in ARROW will be updated with a new look and features. Highlights of the improvements include:
- Better interface to more clearly indicate whether all study team members have current training certifications
- When training is not complete, embedded links to the relevant training websites so study teams can more easily access the required training modules
- New notifications from ARROW when training certification is about to expire
If you have any questions about these improvements, please email email@example.com.