Feb 03, 2023 10:00 AMIRB 3

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 06, 2023 11:30 AMIRB 1

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 07, 2023 4:00 PMIRB 6

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 13, 2023 12:00 PMIRB 8

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 14, 2023 10:45 AMIRB 4

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 16, 2023 11:45 AMIRB 2

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Feb 22, 2023 12:00 PMIRB 5

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

Mar 01, 2023 11:00 AMIRB 7

Video Conferencing/Human Research Protections Program Office of the Institutional Review Board 3600 Civic Center Blvd, 9th Floor

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Jan 06, 2023 12:00 PMNew IRB Requirements: 2023 NIH Policy for Data Management and Sharing

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.

Oct 12, 2022 11:30 AMWinter Holiday Break and IRB Operations

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.

Sep 26, 2022 11:30 AMIRB-101 Virtual Training Sessions

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.

Sep 26, 2022 11:15 AMNew & Updated Guidance

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.

Sep 26, 2022 11:00 AMNew Informed Consent Templates

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.

Jun 16, 2022 5:15 PMPhysician IRB Members Needed

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 jessyoos@upenn.edu.

May 19, 2022 11:30 AMContinued Use of Blue Jeans with Penn Medicine Patients in Research

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 bluejeans-psomchanges@pennmedicine.upenn.edu.

Apr 14, 2022 4:00 PMRevised Common Rule Consent Changes

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.

See past news »

IRB Educational Series Archive - Click here to download slides presented at various IRB training sessions

  • Minimal Risk Studies for First Time Submitters (Social/Behavioral/Educational Science) : Provides a full background for new submitters on what the IRB is & how they relate to your study, as well as tips to navigate your first SBS submission
  • Minimal Risk Studies for First Time Submitters (Biomedical Science) : Presents an introduction to IRB submissions for biomedical students & researchers, including a thorough outline of whether your project requires IRB review & tips for submitting
  • Comparative Effectiveness Trials : Outlines the landscape of considerations from the IRB when evaluating comparative effectiveness trials, including what study teams should outline in both their protocols & informed consent forms to facilitate review
  • The Common Rule : A comprehensive outline of what the Common Rule entails, including an outline of what’s changing (including broad consent, elements for consent, & ongoing requirements for continuing review) as well as how this will impact the submission of your studies
  • How to Conduct an IRB Reliance Agreement : Great for biomedical teams considering NIH funding. A complete overview of what reliance agreements are & how they work, as well as what you need to know as a submitter in order to request & obtain an agreement; also reviews expectations moving forward if relying on the Penn IRB
  • Got Data? What you need to Protect Your Research at Penn : Discussions of common concerns raised with data protection plans as well as best practices & considerations to better protect the data of your study; also includes a thorough refresher of the components & requirements outlined by HIPAA protections