Dec 01, 2017 3:00 PMThe IRB office will be closed during the Winter Holiday (12/23/2017 through 1/1/2018)

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

1.3.2017

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

 

May 11, 2016 11:00 AMRevised Process for Submitting New Human Gene Transfer (HGT) Protocols

 

Apr 14, 2016 1:00 PMContinuing Review Form Update

April 14, 2016 - As promised, the piloted submission forms released on 3.1.16 have been updated to incorporate feedback and requests we recieved from the research community members who started using the new forms early.

Jan 25, 2016 6:00 PMNew HIPAA Template Language

The IRB has provided a new template for HIPAA language. A clean version is provided in the "Forms" page. A version showing the changes made in January 2016 compared to the old version is available under the "Recruitment and Consent" section of the "Guidance" tab.