IRB Newsletter Fall 2021

1. Updated IRB guidance on research during the COVID-19 pandemic

We recently updated our guidance for researchers conducting on-campus human participant research during the COVID-19 pandemic. This guidance is a living document and will continue to be updated periodically as New York State and Cornell University public health restrictions change. We encourage all researchers to review the document, as well as the IRB COVID-19 FAQs webpage. Below are some changes we want to highlight:

• Researchers and study participants generally must adhere to the same campus-wide public health requirements as other Cornell community members and visitors to campus. Learn about Cornell’s current face masking and physical distancing requirements on the main Cornell COVID-19 Response website.
• If your human participant research project involves procedures that don't meet the campus public health requirements, then the protocol will need additional review from EHS (Environment, Health and Safety). Please reach out to the IRB team, and we will help facilitate this review.
• As part of revising IRB guidance for research during the pandemic, the Sample Study Participant COVID-19 Information Sheet and the Study Participant Self-Screening Attestation have been updated. They can also be found at the bottom of the IRB COVID-19 guidance webpage.

2. New online IRB system in development

We are very excited to announce that a new online IRB protocol management system is being developed! It is being built on the same platform as the Sponsored Research system (called the Research Administration Support System, aka RASS). We anticipate transitioning to the new system in 2022. The new system will help streamline many of the IRB submission and review processes, making it easier to keep track of your protocols and communications with the IRB administrative team, and hopefully shorten review times, as well.

There is still a lot of work to be done prior to launching the new system, and we will be in touch with the research community more often in the coming months. Please keep an eye out for updates. If you are interested in helping us test the new system, please email us at irbhp@cornell.edu. We have also been working hard to clean up the protocol records in our current system in order to prepare to migrate the data to the new system; some of you may have already heard about this project over the summer, when we were emailing investigators about closing older protocols. If you have any other protocol that can be closed*, please email irbhp@cornell.edu to let us know. The fewer protocols we migrate to the new system, the easier the migration and data validation process will be. Thank you for your support and assistance!

   *IRB Protocols can be closed if they meet the following criteria:
       1. Any enrollment of participants is permanently closed;
       2. All participant interventions and interactions are complete, including collection of long-term follow-up data/samples;
       3. No additional identifiable private information will be obtained; and
       4. Any analysis of identifiable private information is complete.

Note: Once an IRB protocol has been closed, investigators may continue to perform data analysis, manuscript preparation, and publication activities, as long as identifiable information is NOT being accessed. Data and samples—including identifiable private information—may be kept after a protocol has been closed, in accordance with the IRB-approved research plan and informed consent documents. If you plan to use those identifiable data/samples for future research, you must obtain IRB approval prior to beginning the new research project.

3. Tips on submitting a new protocol application

Whether you are new to human subjects research or have past experience with the IRB, we hope these tips will help to guide you through the IRB application process:

• The Forms – We are currently using a paper-based process, so all application forms are available for download on our website. The forms can be digitally filled out, and then attached in an email sent to irbhp@cornell.edu. You can find the new protocol application form here (which should be used for all protocol review types, including those that may be exempt), and the amendment request form here.
• Decision Tree – When preparing a new project, consult the Human Subjects Decision Tree to determine whether your project requires any sort of IRB review. This tree is designed to give you better understanding of how Human Research Protection Program staff determine whether projects meet the regulatory definition of human subjects research. As always, check with the IRB team (irbhp@cornell.edu) if you have questions or if you need an official determination.
• Review/Approval Times – Please expect, at minimum, 2-3 weeks for exempt reviews, 3-4 weeks for expedited reviews, 2-3 weeks for exempt or expedited amendments, and 4-6 weeks for all full board reviews. We are a small team that handles 125 submissions, on average, each month. We appreciate your continued patience.
• Training – Have all members of your research team complete the online human subjects research ethics training, ideally prior to submission of your application. Note: while the training is currently not required for exempt research, we always strongly recommend it, regardless of review level.
• For students, consult your faculty advisor in designing your study, as well as for review and sign-off on the final IRB protocol application and research materials. You must include your advisor’s signature on the application form, or their attestation via email, when submitting a new protocol, amendment, or request for continuing review.
• Consult the IRB FAQs to inform your study design and materials. Consult the IRB COVID-19 FAQs to inform your research activities during the COVID-19 pandemic.
• What to submit with your IRB application:
  1. A completed application form with a clear description of your research and procedures
  2. Informed consent form/script (translations as needed)
  3. Research instruments (surveys, questionnaires, interview scripts, SOPs)
  4. Recruitment materials (flyers, posters, emails, online messages, verbal scripts)
  5. Documentation of approval/support for research being conducted at other locations (e.g., in high schools, at a library, etc.)

As always, reach out to the IRB Team (irbhp@cornell.edu) if you have any questions or concerns related to the application process or your project.