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.
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 16ththe 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
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...