Announcements

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.

As a result of the 21st Century Cures Act, Penn Medicine is required to allow patients increased access to their electronic medical record. With the Cures Act, by default, research-related information* that is placed in the participant’s EMR will now be available within 10 days via MyPennMedicine (MPM), Penn Medicine’s patient portal. This goes into effect on April 2, 2021. Please review the IRB Guidance on the impact of 21st Century Cures Act on research protocols to determine whether you may need to submit an amendment to the IRB.

The IRB has released and updated version of the Protocol Supplement for Requests to rely on an External IRB. This form is available online here: https://irb.upenn.edu/forms

The IRB Office has moved! Please note that as of 8/5/2020, the IRB office is located at 3600 Civic Center Boulevard, 9th Fl. Philadelphia, PA 19104