NIH Policy for Data Management and Sharing, January 2023
On or after January 25, 2023, NIH grant applicants are required to submit a Data Management and Sharing Plan that outlines how their scientific data will be managed and shared, including made publicly available when appropriate. NIH defines scientific data as: "the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications." Please see University Research Administration guidance regarding this NIH policy at https://ura.uchicago.edu/page/nih-2023-data-management-and-sharing-policy-dms-policy or visit the NIH website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html.
Principal Investigators sharing de-identified human subjects data are encouraged to contact the Crown Family School - Chapin Hall IRB office to evaluate the de-identification process and to ensure that the plan is in compliance with any relevant privacy laws or explicit terms and conditions in data agreements with third parties. As a reminder, principal investigators must address their data sharing plan in relevant research protocols submitted to the IRB that describe key issues such as effective privacy and confidentiality protections for human subjects, considerations for de-identification and identification of data and whether data sharing should be restricted through controlled access, and determinations for informed consent.
Current University COVID-19 related guidance, October 2021
Researchers should consult the University of Chicago GoForward website at, https://goforward.uchicago.edu/, for the latest Phase 5 University COVID-19 related guidance. Researchers conducting human subjects research are expected to follow local site and University requirements, and guidelines from the Center for Disease Control, and World Health Organization with respect to preventing the spread of COVID-19.
Exception to the Single IRB Review Requirements, October 9, 2020
A single IRB review is not required for certain HHS-conducted or-supported cooperative or multi-institutional research activities during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. To learn more about how this exception may apply to your research, please visit: https://www.hhs.gov/ohrp/determination-exception-single-irb-review-requirement.html
COVID-19 and in-person human subjects research, March 18, 2020
Per the University of Chicago Provost's directive, all human subjects research involving direct contact with participants that does not directly benefit participants must be suspended immediately. Direct benefit, for the time being, means clinical therapies that are improving the mental/physical health of a research participant.
Research that can be conducted remotely, online, or by phone is strongly encouraged. Changes in IRB-approved research must be submitted to the IRB. Proposed changes may not be implemented prior to IRB review and approval unless the changes are necessary to eliminate apparent immediate hazards to the research subject.
No new human subject research will be approved at this time that involves direct in-person contact with research participants.
AURA IRB site will be unavailable from 8 pm March 8 to 6 am March 11
Over the next 3 weekends, AURA-IRB system will be undergoing maintenance to address performance issues. IT services is anticipating some improvements the first weekend and increased improvements as it progresses through each weekend. This maintenance process will be complete by March 25th. IT services will start this process March 8th, at 8PM and will continue until 6AM Monday March 11th. While the system is performing maintenance, the AURA IRB site will unavailable.