Please note that the IRB was closed on 10/29/2012 and 10/30/2012 due to the University closure for the storm. Incoming items received through the electronic submission system or received via paper will be processed in the order they were received starting on 10/31/2012. The review timeline for items submitted will be delayed by the two day period of the office closure. If you have an item that requires rush review, please contact the Administrator for the Board assigned to the review to request this and the Administrator will provide an updated review timeline for that submission. Please limit rush requests to only those items that warrant a rush review.
Please visit the Forms page of the IRB website for the most recent version of the informed consent form template. The informed consent form templates have been revised to include standard language to describe the reporting requirements for certain infectious diseases and have been updated to include new language describing the inclusion of research results in the electronic medical record (EMR). The language related to research results and the EMR will be required for most studies as of February 1, 2012. For more information please visit the Guides page for a new guidance document on the required language. Please visit the training page for information on upcoming training sessions that discuss the new required language.
The Office of the Vice Provost for Research (OVPR) in partnership with the Division of Information Systems and Computing has developed a web-based application (FIDES) as the sole means for disclosure of financial interests and relationships related to participation in specific research projects. Individuals will be able to log in to FIDES with their PennKey and Password to submit eDisclosures at any time via FIDES using a Penn-supported web browser. As of Wednesday February 1, 2012, paper disclosures will no longer be accepted by the OVPR and should no longer be uploaded in the HS-ERA application. If a member of your study team has a conflict of interest to disclose, please visit: https://fides.isc-seo.upenn.edu/
August 23 2011
IMPORTANT: Please note that electronic submission of new initial human subjects research protocols via HS-ERA will become required no later than 9/19/2011. This includes research that is believed to qualify for exemption from IRB review (HS-ERA will replace both paper submissions and RFE), research that qualifies for expedited review or research that requires convened review. This system will also be used to seek verification from the IRB that a submission either does not meet the definition of research or does not meet the definition of using human subjects.The IRB will offer sessions that provide hands-on training for those who are unfamiliar with the HS-ERA system. Please review our training schedule for the Fall for these offerings.If you have any questions or require assistance in order to be electronically compatible to use HS-ERA by the proposed date, please contact either Tracy Ziolek (
or 215-746-6272) or Pearette Allen (
For a schedule of HS-ERA trainings, please visit the Training page of the IRB website. To register for a training, please visit KnowledgeLink at http://knowledgelink.upenn.edu. The Fall Workshops are available under the “Catalog” tab, listed under the courses offered by the Office of Regulatory Affairs.
The IRB has released a new guidance document for researchers who conduct NIH supported or conducted Genome Wide Association Studies. The document summarizes the IRB’s policies and submission/review procedures for IRB Certification Letters for submission of data to NIH GWAS registries. For more details, please visit the guidance page of the IRB website.
Human Subjects Electronic Research Application is a secure, web based protocol application that allows the creation, submission, routing, and approval of IRB applications. The application is available to researchers at Penn with a valid PennKey and password at https://medley.isc-seo.upenn.edu/hsProtocol/jsp/fast.do
September 10, 2012
The ARIES system was recently updated to streamline the review process with regards to seconary reviews (Compliance, Diagnostics, and EHRS)...
The IACUC recently approved changes to the training program, including Occupational Health and Safety Program-Risk Assessment, "Conditionally Acceptable" Euthanasia, and "Aseptic Technique" Training...
March 17, 2009 The Stimulus Package and IACUC Submissions ...In order to remain compliant with the federal-mandated protocol review requirements AND do so in a timely manner despite an increased volume of protocol submissions, the IACUC asks for the faculty’s assistance in assuring that this process runs smoothly...