The mission of Temple University's Human Research Protection Program (HRPP) is to protect the rights, dignity, and welfare of human subjects who participate in the research programs of the Temple System. Specifically, the HRPP has authority over all human subjects research conducted using any property or facility of Temple and under the direction of any employee, student, or agent of Temple. This authority extends to Temple University Hospital System employees, who must submit human subjects research to HRPP.
Human subjects research is reviewed via three methods: a convened IRB; expedited review; or exempt review. Note that the determination for exemption is made by HRPP, not the investigator, and therefore must always be submitted formally.
The HRPP supports Temple's dedication to excellence in research by promoting the ethical principles of respect for persons, beneficence, and justice as discussed in The Belmont Report. Investigators have ethical and Institutional responsibilities in conducting human subjects research.
For more information, please refer to the Human Research Protection Program Plan and the WORKSHEET: Human Research Determination. For example, the Human Research Protection Program Plan provides the FDA definition of research and the DHHS and FDA definitions of human subjects. The Human Research Determination worksheet can guide you through the analysis of whether an activity is human subjects research.
If you have questions about whether an activity is Human Research, submit a synopsis of the proposed activity to: firstname.lastname@example.org.
The IRB will provide a written determination.
As a reminder, you must not conduct human subjects research without prior IRB review and approval.
- Please visit the IRB ERA Training and review the training materials and tutorial videos for more information and instructions on how to submit items electronically to the IRB using the ERA system.
- Research personnel are required to complete human research protection training which includes the Biomedical Research or Social/Behavior Research courses and the Practice Runs Training. Please complete the required training by accessing CITI Program.
HRP-001 POLICY –Definitions is provided here
- Access the IRB Committee Meetings & Deadlines here
- Electronic submission via the ERA system is required for all IRB submissions - including new applications for human subjects protocols, continuing reviews, Reportable New Information submissions, requests for modifications to approved human subjects research, initial (only) WIRB reviews, and study closures. Please visit the ERA Documentation & Training page and review the training materials and tutorial videos for more information and instructions on how to submit items electronically to the IRB using the ERA system.