CATS IRB Upgrade:

Coming Summer 2023
The system will be down for about five days, including a weekend. More details to come via email before next webinar
Minimal changes for most users; mainly user-friendly upgrades to increase usability
- Administrative Reviews will no longer be required starting with the upgrade
Substantial changes to External IRB, training and resources will be made available prior to upgrade

Sunsetting:

HRP-904: Non-Penn State Health Researcher Form
Penn State Health Zoom starting June 1. The University Zoom will not be affected.
- PHS is moving to Teams for all teleconferencing that requires HIPAA compliance. For those with Zoom in cited in protocol, no changes need to be made to protocol until regular modification or continuing review.
- Submit that your team moved from PSH Zoom to Teams for HIPAA compliant communications.
- If you do not need HIPAA compliant communications, then the University instance of Zoom will suffice.
- Those working at covered entities speak with their analyst before making a decision about using Zoom or Teams given the sensitivity of HIPAA rules and regulations.

Changes to the HRP-903 and submission process; all protocols that indicate radation -- whether for usual care or for research procedures -- require HRP-903
HRP-903 must be submitted directly to CTO by the PI or designee
- Study teams complete HRP-903 since the PIs are experts in the field, and it’s their decision what is standard of care for their patients.
All studies that use radiation, even if standard of care, will now have radiation language on the consent form.
- Template language added to HRP-109, consent language document.
This changes does not apply to legacy studies or studies already having approval. This is only for new study submissions moving forward. For changes to radiation dosage as part of protocol modifications, then the HRP 903 will need to be updated. However, for those without changes to their protocol, no requests will be made for teams to update their HRP-903.

Monday, May, 2, 2023, 2pm-3pm

Password: 759925

Thursday, May 4, 2023 8am-9am

Password: 104582

REDCAP and Social Security Numbers:
- REDCAP cannot capture SSNs on this platform. We are working on changing the policy. In the interim, we have created a work around and are piloting the usability and feasibility of this approach. More information to follow.
CTO Ancillary Review: STAR System:
- All studies conducted at the College of Medicine or Penn State Health faciltiies that meet the definition of clinical trials according to the NIH will need to submit the STAR submission ancially review. No one will be held-up by the process unless they are using billable services. The ancillary review is being added as a means of counting the number of active clinical trials within the institution. This practice is only applicable for new submissions.
RNI:
- HRP-103: added new language to help PIs determine if they should submit a RNI to IRB, specifically for Investigator Brochures.