Over the past two years, the availability and capabilities of video conferencing tools have greatly expanded on campus, leading to redundant services with overlapping capabilities. As such, the BlueJeans Virtual Meetings service will be removed from the Common Good service portfolio next fiscal year (July 1, 2022) and will no longer be available to the majority of users after June 30, 2022. This announcement does not affect Penn Medicine’s use of BlueJeans for Telehealth nor the use of the BlueJeans Events service. Because of the change to the status of the University’s BlueJeans service, the use of BlueJeans Virtual Meetings will no longer be acceptable when hosting virtual subject visits or meetings where PHI and / or PII are discussed after June 30, 2022. The use of Penn Medicine’s Microsoft Teams or Zoom continue to be approved, provided the appropriate guidance is followed. IRB applications or research protocols that involve Penn Medicine patients and explicitly refer to Blue Jeans provided by the University should plan to submit a modification to revise the language in their applications/protocols. The IRB recommends pairing this with another planned modification. Subject consent forms may need to be revised, but existing subjects do not need to be re-consented due to this change. For questions or concerns about the change, please contact email@example.com.
The IRB is announcing plans to require select research studies submitted prior to 1/21/19 to consent participants on the revised Common Rule elements.
Starting July 1, 2022, requests to rely on the CHOP IRB must be submitted in HSERA and follow the IRB reliance procedures outlined on the IRB website: https://irb.upenn.edu/reliance-agreements. These requests will no longer be accepted and processed via email with the new fiscal year. Please email Patrick Stanko with any associated questions about submitting reliance agreements.
The IRB office will be closed during the Winter Holiday break (12/24/2021 - 1/4/2022). Please click to read more about impending IRB submission deadlines to ensure your submission is reviewed before the break if necessary.
Penn Medicine and Penn Audit, Compliance and Privacy have developed a new guidance on the sharing of data and biospecimens with third parties. This guidance was shared with faculty on Wednesday, November 3. It is important that the Penn Medicine research community be familiar with this guidance when submitting proposals to the IRB. The guidance is available online here: https://oacp.upenn.edu/penn-medicine-guidance-on-sharing-data-and-biolog....
A team of seasoned clinical research professionals along with OCR Compliance and ACC DOCM collaborated to create a PSOM Guidance for Adverse Event Assessment, one that aligns with clinical workflows. The intent of the guidance is to provide early, mid and senior career investigators a roadmap for how to investigate, perform, and confirm AE assessments. The guidance will be posted on the OCR website www.med.upenn.edu/ocr/faq.html under Adverse Events.
As of May 21, 2021, Research Resumption has moved into Phase III. More details are online here: https://research.upenn.edu/resources/resumption/phase3. As noted in the link above, "centralized approval of research or resumption plans is not required; however, a school may elect to maintain its own policies regarding research activity." Please check with your school representatives to ensure you are compliant with local policies.
IRB Fee information has been updated to reflect that, as of May 6, 2021, if the IRB billing office is unable to secure a budget code for the charges from the department within two months from the date of billing, they will automatically charge the department’s 01XX01 Fund. It will then be the responsibility of the department to reallocate the charges to the correct sponsor project fund. See https://irb.upenn.edu/mission-institutional-review-board-irb/irb-fees for more information and a signed memo from the Vice Provost for Research.