Dear Investigators,
I am writing to follow up on the message on Monday, March 16, from Provost Lee regarding the University’s direction to immediately stop research activities that require in-person interactions with subjects unless they directly benefit the subject, to rapidly reduce the number of people in research laboratories and spaces, and to develop a plan preparing for the possibility of a total lab closure. It is not expected that any projects with in-person activities currently overseen by the SBS-IRB Office will meet the threshold of providing direct benefit (as this exception is generally meant to cover treatment-based, medical research). Please contact sbs-irb@uchicago.edu with questions.
The Social and Behavioral Sciences Institutional Review Board office is here to help. Below please find information that may answer some of your immediate questions:
Amendments:
If a study team chooses to modify their procedures to replace in-person study visits with virtual or phone options for recruitment, consent, administering questionnaires, surveys, or other means, please remember that these changes must be reviewed and approved in advance by amendment, unless necessary to eliminate immediate, apparent hazards to a participant and there is not sufficient time to obtain IRB approval.
- In general, most transitions to remote interactions will require prospective review and approval.
- If an investigator needs to make an immediate, unexpected change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made prior to formal amendment request and approval and then reported to the IRB promptly and an amendment submitted, generally within 5 days. If the research team is unsure whether their changes meet this threshold, please contact the SBS IRB Office.
- If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the SBS IRB Office at sbs-irb@uchicago.edu.
- The SBS IRB office will prioritize these modifications. Please be sure to consider all changes necessary, update all sections of the main study application as appropriate, and upload corresponding materials (e.g., requesting a waiver of documentation of consent to use verbal/online process rather than a written process, revised consent materials/scripts, updated participant materials and instructions/communications, revised location and data security, etc.). See https://aura.uchicago.edu/page/aura-irb-training-resources for guidance on submitting amendments in AURA. For online and verbal consent templates, please see https://sbsirb.uchicago.edu/templates/.
Data Access and Security:
Research Teams should consider whether or not appropriate data security and confidentiality measures can be put in place for research teams to conduct work at an alternate location. Please remember that any changes that deviate from a currently approved protocol must be approved by amendment prior to relocating the data, and changes may also require notification/amendments to agreements.
- Appropriate IT security and confidentiality measures consistent with your SBS-IRB approved study, sponsor/contract requirements, and UChicago ITS policies (e.g. encryption, use of VPN, use of UChicago Box, etc.) are required. PI\research teams should consider grant or contractual obligations related to data security, storage, and confidentiality measures prior to allowing research team members to work from a location outside of the University. Please check with the IRB, IT, grants, URA as appropriate.
- For those supported by the Social Sciences Research Computing Services (SSCS), the SSCS can rapidly assist transiting research materials to an appropriate location and can work within their research support team and Research Computing Center (RCC) to find a suitable location for research materials. SSCS (https://sscs.uchicago.edu) emphatically asks that users seek their support before attempting upgrades.
- For those not supported by SSCS, we offer the this list for IT contacts: https://sbsirb.uchicago.edu/files/2017/01/IT-contacts.xlsx (this will download as an excel file and is also available at https://sbsirb.uchicago.edu/investigatorguidance/ under Data Security and Storage).
Remote Tools:
- Researchers whose materials are stored on either SSCS’s departmental servers, Athens, Acropolis, Cronus [aka Rhodes,] or RCC’s Midway systems will be able to access their data using the VPN and standard sharing protocols. Guidance on how to do so is available as follows:
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- Accessing SSD Departmental Files: https://sscs.uchicago.edu/2019/07/17/how-do-i-access-files-on-the-server/
- Accessing RCC’s Midway files User Guides: https://rcc.uchicago.edu/docs/
- SSCS and RCC can also provide advanced computational resources to SSD researchers, allowing teams to access statistical research tools such as R, Matlab and Stata, among others
- For those not supported by SSCS, we offer the this list for IT contacts: https://sbsirb.uchicago.edu/files/2017/01/IT-contacts.xlsx (this will download as an excel file and is also available at https://sbsirb.uchicago.edu/investigatorguidance/ under Data Security and Storage).
- Qualtrics: https://its.uchicago.edu/2019/05/07/training-tip-qualtrics/
- Zoom: https://its.uchicago.edu/web-conferencing/
Suspending Research and Research Unable to be Modified:
- In the event projects cannot be modified to remove in-person interactions, research will need to be temporarily halted during this time. Most temporary, voluntary pauses in research activities do not constitute a suspension of research. However, some sponsored projects may define such a pause as a suspension and require reporting such suspensions. Please contact your grants administrator with questions.
- We are sensitive to the fact that some researcher, especially students, with project deadlines may need to consider new projects entirely. Please contact our office and we will prioritize review of the new submission.
- Please do not submit a new study as an amendment if an entirely new project is proposed. Submitting as an amendment, rather than a new study, will not improve timeline for review and may actually result in missed sections and additional delays/confusion. Please contact sbs-irb@uchicago.edu with questions.
Notifying Collaborators, Community Partners, and Study Sponsors:
Principal investigators or their designees should consider contacting their collaborators, community partners, grants administrators, and/or study sponsors to notify them of any changes or delays, as appropriate. As noted above, some suspensions of funded research may need to be reported.
Again, we are here to help. Please email sbs-irb@uchicago.edu for any general questions, or reach out to me directly with a specific issue. We appreciate your patience as we all work to accurately and quickly respond to these changing circumstances.
Best,
Cheri
Cheri Pettey
Director, Social and Behavioral Sciences IRB
1155 E. 60th Street, Room 418
Chicago, IL 60637
(773) 702-2915