Human Subjects

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 is deemed exempt from further IRB review. Note that the determination for exemption is made by HRPP, not the investigator.

  • 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. Click here to view a PowerPoint presentation regarding an investigator's responsibilities.

  • 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

    The IRB will provide a written determination.

  • As a reminder, you must not conduct human subjects research without prior IRB review and approval (or an IRB determination that the research is exempt).

  • Electronic submission via the eRA system is now required for all IRB submission - 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.

  • Please see an important update regarding IRB approval

▲  Back to Top