Dec 06, 2021 11:45 AMIRB #1

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

Dec 07, 2021 4:00 PMIRB #6

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

Dec 09, 2021 11:45 AMIRB #2

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

Dec 10, 2021 10:00 AMIRB #3

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

Dec 13, 2021 12:00 PMIRB #8

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

Dec 14, 2021 10:45 AMIRB #4

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

Dec 15, 2021 12:00 PMIRB #5

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

Jan 05, 2022 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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Nov 11, 2021 9:15 AM2021 Winter Holiday Break and IRB Operations

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.

Nov 04, 2021 12:00 PMPenn Medicine Guidance on Sharing Data and Biological Samples with Third Parties

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....

Sep 20, 2021 8:45 AMNew PSOM and ACC Adverse Event Assessment Guidance

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.

Jul 01, 2021 11:00 AMSummer 2021 Phase III Research Resumption

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.

May 07, 2021 4:45 PMUpdate on IRB Billing

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.

Apr 02, 2021 11:00 AMThe Impact of the 21st Century Cures Act & Electronic Medical Records Access on Clinical 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.

Sep 30, 2020 11:15 AMUpdated Protocol Supplement for Requests to Rely on External IRBs

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

Aug 01, 2020 2:30 PMThe IRB Office has moved!

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

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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