The Office of Regulatory Affairs

1/9/08The Office of Regulatory Affairs is moving to 3624 Market Street, Suite 301 S. The ORA will be closed on January 17 - 21 and will reopen in our new location at 9 AM, January 22.

6/28/07
University of Pennsylvania Earns Accreditation for Human Research Protection Program from AAHRPP:
The University of Pennsylvania has received full accreditation for its human research protection program from the Association for the Accreditation of Human Research Protection Programs, Inc., a nonprofit that works with organizations that conduct research to raise the level of protection for participants. Continued...

2/23/07
Electronic Request for Exemption (RFE) now Universally Available:
The Human Subjects Research Protocol Request for Exemption (RFE) module is a secure web-based application that allows Human Subjects investigators to electronically submit information for research they feel is eligible for IRB exemption status. It streamlines the submission, review, tracking, and approval process for Human Subjects Requests for Exemptions and will eventually replace the paper Claim of Exemption Form currently in use.
The Human Subjects Protocol Request for Exemption (RFE) module is accessible to anyone at Penn with a valid PennKey and PennKey password, provided that the person's school/center has been set up for access. Follow the instructions below, and if you cannot access the application, check with your school/center's business administrator to see if access for your organization was set up. Continued...

1/18/07
School District of Philadelphia approval required to conduct research within the school district:
The School District of Philadelphia frequently receives requests from outside individuals and agencies to conduct research studies. While it is District policy to cooperate with researchers whose projects might benefit education, it is incumbent on the District to ensure that such activities do not interfere with the instruction, or require excessive pupil or staff time. For this reason, all requests to conduct studies research studies in schools, utilizing questionnaires, surveys, interviews, focus groups, and/or requests for student data, are screened by the Office of Research and Evaluation's Research Review Committee. Ultimate responsibility for authorization rests with the Director of the Office of Research and Evaluation and the Chief Accountability Officer. Continued...

12/4/06
REVISED Cooperative Agreement with CHOP:
The Upenn/CHOP Cooperative agreement has been in effect for a year and has recently been revised to include additional scenarios.  Please review the revised agreement to determine if a protocol meets the criteria for a single IRB review by either an IRB at Penn or CHOP. Continued...

10/3/06
New Information about the CISCRP on the Participants Page:
The University of Pennsylvania has joined the Circle of Supporters for Center
for Information and Study on Clinical Research Participation (CISCRP).  The mission of the CISCRP is to:   Educate, inform and empower patients, the public, medical and research professionals, the media and policymakers about clinical research participation and what it means to be an active participant in the process. MORE...

New IACUC Protocol Form Released
 The IACUC has published the 2005 version of the IACUC Protocol Submission form. The 2004 version will be accepted until July 2005, after that date only the 2005 Protocol Form will be accepted.

2/27/03
IACUC Policies updated
 The IACUC has published their official policies concerning Cage Cards. The Protocol Amendment Forms have also been updated.