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Quality Assurance (QA)/Quality Improvement (QI) Research Pilot Project

Distinguishing between quality improvement (QI)/quality assurance initiatives (QA) and human subjects’ research requiring IRB review is often challenging, especially when there is an overlap between these goals.  Beginning February 17, 2014, the IRB is launching a new pilot initiative to facilitate the process of determining which projects are QI/QA and which projects are considered research. According to the Office of Human Research Protections (OHRP), quality improvement (QI) and quality assurance (QA) initiatives may or may not be considered research.

The IRB, in collaboration with faculty of the Perelman School of Medicine, is working to develop parameters to clearly outline which projects may be considered strictly QI/QA and do not require IRB review, and which projects qualify as human subjects research and require IRB review. 

To assist with this initiative we encourage individuals working on QA/QI projects to submit to the IRB for an assessment. Your participation will result in the following:

·         The IRB and faculty will provide prompt feedback about whether the project should be submitted for formal IRB review or you will be provided with a letter from the IRB that can be used for publication.

·         You will assist the IRB in creating an efficient process for determining IRB review of projects that have QI/QA goals. 

A new abbreviated submission form for QI/QA is available on the IRB’s Forms page here: http://www.upenn.edu/regulatoryaffairs/index.php?option=com_content&task=view&id=20&Itemid=8 

If you have a QI/QA project, please email your completed submission form to the following dedicated QI/QA email address: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it  

Submitters will receive a formal determination that their project qualifies as QI/QA not requiring IRB review or will receive additional instructions on submitting to the IRB.   

Please feel free to contact the QI review team with any questions at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SUBMITTING TO THE IRB:

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

August 14, 2013

PLEASE NOTE:  On Friday, August 16th the Office of Animal Welfare will be closed due to the paid Special Administrative Day Off for Penn faculty and staff awarded by Amy Gutmann, Vincent Price and Craig Carnaroli to thank us for our efforts in supporting the Making History campaign.  There will be no one in the office to receive and process submission on Friday, August 16h.  ARIES will be available for submissions and they will be processed on Monday, August 19th.

September 10, 2012

ARIES Updates

The ARIES system was recently updated to streamline the review process with regards to seconary reviews (Compliance, Diagnostics, and EHRS)...

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April 4, 2012

ARIES and PennERA Updates

Several modifications and improvements have recently been made to the ARIES system.  Some important changes are detailed below...

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January 9, 2012

ARIES Updates

Several modifications and improvements have recently been made to the ARIES system.  Some important changes are detailed below...

                                                                          more »

New ARIES Training Dates

ARIES training sessions are available to researchers and research staff who create, review, or submit animal protocols.  These sessions will provide...

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IACUC Guidelines & Policies

The following Guidelines and Policies are either new or have been recently revised...

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OLAW Notices

Adoption and implementation of the Guide for the Care and Use of Laboratory Animals: Eighth Edition (NOT-OD-12-020)...

                                                                          more »

July 29, 2010

ARIES User Training Now Available

User training for the ARIES system is now available for researchers and research staff. Users can sign up for one of the 5 sessions through Knowledge Link.

more »

May 3, 2010

Animal Research Information & Electronic Submissions (ARIES)

Released on February 22, 2010, ARIES has seen two months of high activity. Over 340 people have used ARIES and 55% of all protocol submissions have been via ARIES.

more »

April 15, 2010

Guidance on Confirming Appropriate Charges to NIH Awards during Periods of Noncompliance for Activities Involving Animals (NOT-OD-10-081)

The Office of Laboratory Animal Welfare (the compliance office within the NIH/PHS/DHHS) put forth a new notice clarifying a previous notice...

more »

April 19, 2010

Instructions for Completion & Technical Evaluation of the VAS in NIH Contract Proposals (NOT-OD-10-049)

The NIH put forth a new notice clarifying their requirement for completion of the Vertebrate Animal Sections in NIh proposals.

more »

October 2009

Form E now INACTIVE

Form E has been replaced with Knowledge Link training modules... 

more »

August 31, 2009

Challenge Grant Just-In-Time and IACUC Protocols

The Challenge Grant program and other federal awards related to the "Stimulus Package" will make their Just-In-Time notifications in the next few weeks...

more »

August 31, 2009

IACUC Guideline on Mouse Breeding and Cage Density and ULAR SOP Correction of Overcrowded Mouse Cages 

IACUC guideline on Mouse Breeding and Cage Density was approved by the IACUC in October 2008 and sent to the faculty in a previous "IACUC Announcement" in November 2008...

more »

August 31, 2009

Changes in the Training Program

The IACUC recently approved changes to the training program, including Occupational Health and Safety Program-Risk Assessment, "Conditionally Acceptable" Euthanasia, and "Aseptic Technique" Training...

more » 

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...

more »



 
  

 
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