IRB Newsletter: Summer 2023

1. New NIH Data Sharing and Management Policy

In January 2023, a new NIH policy for Data Management and Sharing went into effect for NIH-funded research, and we at the Cornell University IRB are here to guide you through the implications for human participant research and your IRB protocols. We are putting together a guidance document regarding the impact of the policy on our process and procedures, and will post that on our website as soon as it is ready.

For now, when you are submitting protocols to the IRB for review that involve (or potentially involve) NIH funding, you should plan to include your Data Sharing and Management Plan in the protocol. In your RASS-IRB application, you can upload this in the Additional Documents section, under Other Documents.

We have also produced this news item, which includes resources for you to read to learn more about this policy change and how it might impact you and your research.

2. RASS-COI –System for Conflicts of Interest Reporting

Our colleagues at the Conflicts of Interest Office launched a new reporting system in December 2022, RASS-COI, which is integrated with RASS-IRB and RASS-OSP. This primarily impacts Cornell faculty and staff who are named on IRB proposals through the institution of ‘project-specific disclosures,’ which you can read more about on the RASS-COI Launch Plan. If you have any questions or concerns regarding COI reporting, including the project-specific disclosure, you should reach out to coi@cornell.edu.

3. One Year In: RASS-IRB Quirks and Reminders

It has been over a year since RASS-IRB launched in February 2022, and the system has improved our workflow and efficiency. We have learned a few quirks to the system that we would like to share with you so that you can avoid delays in the IRB review process:

• Chat Functionality: The chat/conversation feature for Review Comments is helpful for communicating about details of your protocol, but IRB staff do not get an alert if you put something in the chat – if you need to communicate something to the IRB administrator quickly, email or call them. Otherwise, they will only know to look at the Review Comment chat once you resubmit the protocol.
• Attestations Pending: Once a protocol has been submitted, it goes to an ‘attestations pending’ status until the Principal Investigator (and the Faculty Advisor, if relevant) have completed their attestations. Until the attestations have been completed, the IRB Administrator who has been assigned to the protocol will not see it in their queue, and cannot begin the review process.
• Protocol Resubmission: When you are returning your protocol with edits, make sure to complete the final step of the process of hitting the ‘Resubmit’ button at the very bottom of the page, to return the protocol to your IRB Administrator’s queue.
• Requirements Table: If you are unsure of where your protocol is in the review process, check the ‘Requirements’ table at the bottom of the page – this will tell you what requirements are still left unfinished.
• Human Subjects Training: If someone on your research team has completed training and the ‘Requirements’ table still shows that task as incomplete, do not worry. Cornell training on CITI is integrated with RASS-IRB, and updated within 48 hours. That said, the two systems connect based on NetID, so make sure that the team member’s CITI account has their Cornell NetID-based email address listed in their user profile.
  If you have already uploaded training documentation from non-Cornell training sources for that individual, the IRB Administrator will check over the documentation and mark the training requirement as complete during their review.
• Protocol Editing: If you are in the protocol and are unable to edit it, it is likely due to one of these reasons: either it has been re-submitted to the IRB, or someone else has it open. If it has been re-submitted, you can see that at the bottom of the ‘Requirements’ table. If someone else has it open, you can see their name at the top of the protocol, in a yellow banner. Only one person can view and edit a protocol at a time.
• Revision Comparison Tool: If you need to look at the ways that your protocol has changed between amendments, or between different iterations of the same review, you can use the Revision Comparison tool at the top of the ‘Requirements’ table.
• Document Uploading: The RASS-IRB system is intended to help keep protocols organized to avoid delays caused by confusion. To assist with this, upload individual study materials (e.g., interview scripts, consent forms) in the correct sections of the protocol record, rather than a single document containing multiple study materials.
• Seeking Assistance: When in doubt: a) check to see if the RASS Guide Site has a how-to guide for a particular task you have to complete in RASS-IRB, b) set up a Bookings appointment for a 1:1 Zoom consultation with the relevant IRB or RASS staff member, or c) write to rass@research.cornell.edu with system problems or irbhp@cornell.edu with human participant research or protocol questions.

4. Cornell University Buying Manual Update – Paying Human Participants

The new Section 630 of the Cornell Buying Manual provides guidelines to be followed when paying financial incentives to human research participants. If your protocol involves payments to human participants – whether through cash or gift card, if the research takes place in a lab or through online survey tools – you should familiarize yourself with these requirements and procedures. We have also added new text to our informed consent form templates to communicate key information about payment logistics (e.g., taxable income, business center staff access to personal identifiers, etc.).

5. Freedom of Information Request Procedures

Occasionally, researchers may receive requests for information that appear to be under the federal Freedom of Information Act (FOIA) or the New York State Freedom of Information Law (FOIL). The University Relations office is responsible for responding to such requests and has set up an e-mail address for public records requests originating from outside of Cornell University: publicrecords@cornell.edu. You can read more about Cornell’s FOIA/FOIL-related procedures on the University Relations website. If anyone contacts you with an apparent FOIA or FOIL request, please direct them to that website.

Relatedly, if a federal agency has received a FOIA request that impacts Cornell records, you may be contacted by that agency for your feedback. While University Relations is not responsible for responding to such requests, you may reach out to Office of Sponsored Programs (if applicable), University Relations (via publicrecords@cornell.edu), or Office of General Counsel for consultation.

6. Welcome, VPRI Dr. Krystyn Van Vliet

Dr. Emmanuel Giannelis, the Walter R. Read Professor of Engineering in the College of Engineering, has stepped down as Cornell’s Vice President for Research and Innovation (VPRI). He served in the position for five-and-a-half years beginning in 2017, and we thank him for his leadership.

Dr. Krystyn Van Vliet began her term as the new VPRI on February 1, 2023. The position includes the role of Cornell University’s Institutional Signatory Official for the purposes of our Federalwide Assurance (FWA) with the Department of Health and Human Services, wherein we commit to comply with federal human subjects research regulation 45 CFR 46. Dr. Van Vliet previously served as the Associate Provost and Associate Vice President for Research at MIT. She joined the faculty of MIT in 2004, serving as a professor of Materials Science and Engineering and Biological Engineering, specializing in material chemomechanics. We look forward to working with her in the years to come. You can read more about Dr. Van Vliet in this news item from the Cornell Chronicle.