Final Reminder: New Exempt Protocol Training Requirement - Effective 10/1/22
Revised Guidance for Conducting In-Person Research During the COVID-19 Pandemic
New and Upcoming Resources
New staff, Valerie and Lydia
1. Final Reminder: New Exempt Protocol Training Requirement - Effective 10/1/22
As of October 1, 2022, all research team members on all active IRB protocols–new and previously approved–are required to complete online human participant research training. Previously, this training was only required for researchers on Expedited and Full Board protocols, but the Cornell IRB has expanded this requirement to include personnel listed on Exempt protocols, as well.
- This training can be completed through the CITI Program. We have recently published a guidance document to walk new CITI users through accessing the IRB Training (as well as any other CITI training you may be assigned by Cornell compliance groups).
- Researchers need to take training every five (5) years.
- The IRB office will not issue an approval/exemption letter for any pending protocols/amendments/continuing reviews if personnel are missing training. This has always been the case for Expedited and Full Board protocols, but starting October 1, this practice will be implemented for Exempt protocols, as well.
- Protocol PIs will be responsible for ensuring their research team members stay in compliance with this training requirement.
Please see our original IRB News announcement from July 29, 2022 for other details about this training requirement, including how to see if you are up-to-date with your IRB training.
2. Revised Guidance for Conducting In-Person Research During the COVID-19 Pandemic
- In line with other campus health & safety requirements, face masks are required for in-person, on-campus human participant research activities similar to clinical exams or procedures, or that take place in campus healthcare settings. For all other indoor human participant research activities, the IRB strongly encourages use of face masks for participants and research staff.
- We no longer require researchers keep a daily log of study participants, as Cornell University and the local public health department are no longer conducting contact tracing.
- The Sample Study Participant COVID-19 Information Sheet has been revised to reflect current safety measures. (This document is an appendix to the COVID-19 IRB guidance.)
If you are conducting in-person research on the Cornell Ithaca, Geneva, or Tech campuses, please review the revised guidance document in full. As always, please contact the IRB office with any questions.
3. New and Upcoming Resources
With the new Exempt protocol training requirement, there will be plenty of you who have never needed to take CITI training before having to access this resource for the first time. Never fear: we have published a guidance document on the IRB website to take you through the process of accessing any CITI training for the first time: Guide to Accessing CITI Training for Cornell Researchers. It will be located on the IRB Training page as of October 1st.
We have another resource currently in development: a library of real examples of informed consent documents that we hope can assist you with this essential element of your protocols by illustrating how different types of research enact informed consent principles. We will share more news as the project moves along.
4. RASS-IRB Tips
This is our first newsletter since our RASS-IRB system launched in February 2022– the new system has already made our jobs as staff members much easier, and we hope it has positively impacted you, as well. We wanted to take this opportunity to give a few tips about submitting protocols in the new system.
- The RASS Guide site is available with directions for various actions you might need to take in the RASS-IRB system. Specifically, we have over a dozen “how-to” guides, as well as multiple webinars available to introduce you to the new system and provide guidance for getting started with a new protocol. IRB and IT staff will continue to revise and add to these resources. If you need more individual assistance, you can easily make an appointment to meet on Zoom with RASS-IRB support or IRB staff using Microsoft Bookings.
- If you had your protocol approved before February 1, 2022, it is considered ‘migrated’ (from the old IRB system). Unfortunately, we were unable to bring all protocol data from the previous system to RASS-IRB, and as such, many migrated protocols do not currently contain much of the original protocol information. To process amendments to Expedited and Full Board protocols within RASS-IRB, we require that this information be entered into the system – we apologize for the inconvenience that this places upon researchers but hope you can understand the importance of having complete protocols in the new system. We can still process amendments to migrated Exempt protocols via e-mail. More information about this can be found on our website here.
- Your CITI Training records should be automatically imported into the RASS-IRB system, matching records based on your Cornell NetID. If you or one of your fellow investigators are in compliance with training but this does not show on your RASS-IRB protocol, log in to CITI and ensure that your primary e-mail is your Cornell NetID e-mail address. Directions for how to access that part of your CITI account are here, on page 4. The integration between CITI and RASS can take 24-48 hours, but if your training still isn’t registering after that, contact email@example.com.
5. New Staff, Valerie and Lydia
Please welcome our two new members of the IRB staff!
Valerie Ziarniak has been with ORIA for a little over a year and worked with the COI and IACUC teams in different temporary roles before being hired in June 2022 as the newest IRB Administrator. She conducts protocol pre-reviews, facilitates the IRB review process, and assists researchers in maintaining compliance with appropriate federal and state laws, ethical principles, and Cornell IRB guidelines. She lives in Rochester and works remotely most days but does travel to Ithaca from time to time.
Lydia Galarneau joined the IRB team in July 2022 as the new IRB Compliance Assistant. She manages the IRB inbox, processes new protocol submissions, and has been developing new guidance documents and tools for researchers like you. She moved from Buffalo to Ithaca in August, and lives on South Hill with her partner and their cats, Praxis and Milo.