May 07, 2018 3:45 PMUPenn Human Research Protections Program Navigation Tool
Feb 06, 2018 6:45 PMUpdated IRB Determination Letter Templates
In alignment with last year’s release of the Reliance Agreement letter template with no IRB administrator signature, the IRB has new letter templates for the following determinations:
Jan 18, 2018 6:45 PMCommon Rule Change Implementation Delay
The government has announced a 6-month delay in the implementation of the revised Common Rule. The revised implementation date is July 19, 2018. The process of submission to the IRB and review/approval will continue unchanged until this date.
Submissions received after 12/18/2017 will likely not be processed until after we return from the Winter Holiday break. Please be mindful of expiration dates for your protocols and submit accordingly, as there is no guarantee that items submitted after 12/18/2017 will be checked/assigned/reviewed
Oct 30, 2017 9:00 AMExpanded Access: FDA Describes Efforts to Ease Application Process
Sep 11, 2017 11:30 AMNotice of Changes to NIH Policy for Issuing Certificates of Confidentiality (CoC)
To increase the protection of privacy of research participants, as of October 1, 2017, NIH funded researchers who are who are collecting identifiable, sensitive information as part of their NIH funded research will automatically be issued a CoC as part of the term and condition of their awa
Aug 11, 2017 5:15 PMIRB OFFICE RELOCATION
The IRB office will be moving on Friday August 11, 2017.
Jul 25, 2017 9:00 AMSYSTEM WIDE HSERA UPDATE
On the evening of July 24, 2017 HSERA is scheduled for a system wide update. All department heads, investigators, and research support staff will be affected by these changes. Please see below to review detailed information related to each component of the update:
Jul 20, 2017 2:45 PMHSERA System-wide Update
7.20.17 - On the evening of July 24, 2017 HSERA is scheduled for a system wide update. All department heads, investigators, and research support staff will be affected by these changes. Please see below to review detailed information related to each component of the update:
Jun 14, 2017 12:00 PMIRB Office Unscheduled Closing
DUE TO A SUDDEN STAFF EMERGENCY THE IRB OFFICE WILL BE CLOSED STARTING AT 1 PM TODAY. WE WILL RE-OPEN TOMORROW MORNING (6.15.17)
Apr 17, 2017 12:00 PMSUBMISSION PROCEDURE UPDATE
This news item details the new requirement for providing a complete list of documents with all submissions for greater than minimal risk research.
Mar 01, 2017 5:00 PMNew Continuing Review Form Feedback Survey
On March 1, 2016 the IRB released the pilot version of the new submission form for Continuing Review. The Continuing Review submission form became required as of June 1, 2016.
Jan 24, 2017 10:15 AMCTMS-New HIPAA Language & New EMR Consent Form Language
In alignment with the roll out of the Clinical Trial Management System (CTMS) by the Office of Clinical Research, the IRB has released updated language templates related to HIPAA and Electronic Medical Record.
Jan 03, 2017 1:15 PMHappy New Year
Nov 30, 2016 9:00 AMNew Penn Medicine Policy for Clinical Research
Dear Penn Medicine Colleague:
Aug 02, 2016 3:30 PMNew Form Available for HIPAA Waiver Requests
An updated version of the Request for Waiver of HIPAA Authorization form has been developed. The new version is now available on the IRB website and is required for all new studies seeking to obtain a waiver of HIPAA authorization submitted after August 1, 2016.
Jul 26, 2016 10:15 AMNew Document Available for Data Protection Requirements
The Penn IRB has released a new document outlining requirements for electronic data protection for research involving the use of directly-identifiable protected health information.
Jul 07, 2016 12:45 PMHSERA Continuing Review Application Revisions - update
HSERA Continuing Review Application Revisions - update
Jul 07, 2016 10:15 AMHSERA Continuing Review Format Change
The formatting revisions to the HSERA Continuing Review application have been fully implemented. The "How to Submit" page for continuing reviews has been updated with instructions for creating continuing reviews with the new application.
Jun 08, 2016 1:00 PMHSERA CONTINUING REVIEW FORMAT REVISION