The IRB has released guidance on associated IRB requirements related to the 2023 NIH Policy for Data Management and Sharing of scientific data generated from NIH funded research. The National Institutes of Health (NIH) issued the final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This Policy is effective January 25, 2023 and applies to research funded or conducted by NIH that results in the generation of scientific data. The DMS policy establishes the requirements to submit Data Management and Sharing Plans to the NIH for all grant applications or renewals generating scientific data. For details, please review https://irb.upenn.edu/guidance/nih-data-management-and-sharing.
The IRB office will be closed during the Winter Holiday break (12/26/22 - 1/2/23). Please carefully read this announcement and plan accordingly.
Are you new to the IRB submissions process and in need of guidance? Attend one of our IRB 101 Training Sessions! IRB staff will cover basic types of submissions including initial applications, continuing reviews, modifications, and reportable events. We’ll also provide an overview of how to use the Human Subjects Research Application (HS-ERA) system to submit applications to the IRB for review. Information will be provided for both biomedical and social-behavioral researchers. Sessions will be held via Zoom and last 90 minutes to allow time for Q&A. Any questions can be directed to Diana Floegel, Senior Regulatory Analyst. Sign up for sessions here: https://upenn.co1.qualtrics.com/jfe/form/SV_9Ti3s7EHg13yje6.
A number of new and updated guidance documents have been posted including: New guidance on NJ State law, Updated 2018 Common Rule guidance, Updated remote consent guidance, New guidance on Suicide Ideation and Behavior Risk Mitigation, and Updated Data and Safety Monitoring guidance. Please click for more details.
The Biomedical and Social Behavioral Consent form templates have been updated. Additional guidance has been added in multiple sections throughout the documents to better set expectations and assist study teams with developing consent forms. Likewise, some template language has been adjusted for clarity and to better align with regulatory requirements. The templates can be found on the IRB forms page: https://irb.upenn.edu/forms.
The Penn IRB is seeking physician scientist members to serve as IRB members. IRB members ensure the protection of the rights and welfare of participants as well as contribute to the evaluation of research on its scientific merits and standards of clinical practice. Physicians with oncology experience are greatly needed. Membership is not limited to Penn staff and faculty. Please share with anyone you may know who may be interested. Members receive onboarding training and observe meetings prior to receiving assignments. Attendance can be flexible with your schedule. Interested parties should contact the IRB Director at email@example.com.
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 firstname.lastname@example.org.
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.