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The Office of Nursing Research would like to ensure that all research staff, fellows, graduate students, and faculty are aware of required human subjects research training.  All individuals engaged in research (undergraduate and graduate students, faculty and staff) are required to complete training in human subjects research.  The Office of the Vice Provost for Research has developed a second online training option for faculty who do social and/or behavioral research.  

All research staff are required to renew human subjects training every three years. The ONR will notify individuals when their certification is expiring.   

Additional information is available at http://www.med.upenn.edu/ohr/ or http://www.upenn.edu/regulatoryaffairs/ or contact the Office of Research at research@nursing.upenn.edu. 

•  Patient Oriented Research Certification Program

This web-based training program is mandatory for School of Medicine Faculty and Staff, Clinical Care Associate Physicians, Physicians at affiliated hospitals, and research staff working with those physicians who conduct human subjects research. For more information and instructions to access the program, visit http://www.med.upenn.edu/ohr/por/index.html

The POR Certification Program consists of 2 levels, depending on the level of review required for your research - Exempt/Expedited Review or Full Board Review.

You must have a PENN Key and Password in order to complete this training available at http://www.med.upenn.edu/ohr/por/index.html

• CITI Training-Biomedical and Social and Behavioral Sciences

            All personnel - faculty, research fellows, students, and staff - engaging in human
            research must have documented discipline-appropriate training in human research
            protections. The Collaborative Institutional Training Initiative web-based modules
            satisfy this requirement for all personnel except those working in the School of
            Medicine. The SOM requires completion of Patient Oriented Training (see details
            above).

            For researchers conducting biomedical research outside the SOM, The IRB may
            recognize completion of the POR training program as fulfilling this requirement. Please
            contact the IRB for permission to use POR to satisfy the training requirement.

            To access the program, visit http://knowledgelink.upenn.edu. 

            You must have a PENN Key and Password in order to complete this training.  

• HIPAA Authorization

The HIPAA Authorization template has been updated and streamlined. This template can be accessed on Office of Human Research (OHR) and Office of Regulatory Affairs (ORA) websites: http://www.med.upenn.edu/ohr/ or http://www.upenn.edu/regulatoryaffairs/.          

Although the institutional preference is to keep the HIPAA Authorization separate from the research subject’s informed consent form, researchers can incorporate the elements of the HIPAA Authorization in the confidentiality section of the informed consent, so long as all relevant elements of the HIPAA Authorization template are included. Researchers are encouraged to consult with OHR and ORA when combining the authorization and informed consent. OHR may be contacted at 215-746-7400 and ohr@mail.med.upenn.edu. ORA may be contacted at ora@pobox.upenn.edu.

HIPAA training can be accessed at http://knowledgelink.upenn.edu

You must have a PENN Key and Password in order to complete this training available at http://www.med.upenn.edu/ohr/por/index.html

INTERNATIONAL COMPILATION OF HUMAN SUBJECTS RESEARCH PROTECTIONS

2007 Edition

Compiled by: Office of Human Research Protection, US Department of Health and Human Services