Updates from the Human Research Protection Program
This notice provides end-of-year updates on new guidance and materials, reminders about submissions, and announcements on what’s coming in 2023.
New:
New: Communication with Participants re: COVID-19 Testing Policy Change
UCSF has recently announced that pre-visit COVID-19 testing is no longer required for any asymptomatic research participants, including those undergoing aerosol-generating procedures (AGPs). If your study consent forms include information about pre-visit COVID-19 testing performed solely for the purpose of adhering to previous UC policy, you should let these participants know that this testing is no longer required. Please provide the following communication to participants to notify them about this change.
New: Certificate of Translation Required for Greater-than-Minimal-Risk Study Consent Forms
The IRB now requires that Certificates of Translation be submitted alongside translated consent forms for Greater than Minimal Risk Studies. Certificates of Translation are encouraged but not required for Minimal Risk studies.
New: Documentation from Non-Engaged Sites
Guidance has been published to the IRB website regarding acceptable documentation from non-engaged sites that are collaborating with UCSF researchers. Please see the Letters of support vs. IRB approval guidance to ensure that you are submitting proper documentation to the IRB.
New: GDPR Guidance
The UCSF IRB has issued guidance on how to comply with General Data Protection Regulation (GDPR) requirements for qualifying Human Subjects Research. GDPR is a European data privacy law that protects the personal data of people located in the European Economic Area (EEA).
Updates:
Updated: Initial Submission Checklist
The IRB’s Initial Submission Checklist has been updated to include additional items for researchers to consider when submitting a new study to the IRB, along with links to relevant guidance.
Reminder(s):
Use the Current IRB Consent Form Templates
When submitting a new study, be sure to use the currently posted consent and assent form templates. New studies that do not use the current templates will be returned to the PI without review.
Coming in 2023:
Consent Form Statement NIH DMS Policy
Effective January 25, 2023, prospective NIH grant and contract applications will be subject to a new data management and sharing policy (for more information, visit the UCSF library’s NIH DMS Policy webpage or contact Data Services Librarian Ariel Deardorff at [email protected]). In early 2023, the IRB will share a new template statement that must be included in consent forms for studies subject to the new NIH policy.
Inviting PIs to IRB Meetings
For greater-than-minimal-risk studies, the IRB may invite the PI to attend an IRB meeting via Zoom in order to briefly present the study and answer IRB member questions. A goal of this process is to improve efficiency of IRB review. If the IRB determines that a study may benefit from this process, an IRB coordinator will reach out to the PI in advance of the meeting to check availability and provide more information.