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.

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.

Sign up for the IRB Updates Listserv
Subscribe to the Temple University IRB listserv to receive regular updates on human subjects research policies, procedures, news, and information - including changes and upgrades to the Human Subjects Module in eRA.

To join this listserv send an email to listserv@listserv.temple.edu. In the body of the email enter "subscribe IRB-UPDATES yourfirstname yourlastname" (no quotes).

What is Human Subjects Research?

The IRB reviews human subjects research. The activity has to be considered "research" and has to involve "human subjects" for the IRB to review it.

The DHHS definition of research is "a systematic investigation. . . designed to develop or contribute to generalizable knowledge."

Please note that research results do not have to be published or presented at a professional meeting to qualify the experiment or data gathering as research. From DHHS' perspective, the contribution to generalizable (widely applicable) knowledge makes an experiment or data collection research, regardless of publication and regardless of being done as part of a classroom project or activity.

In addition, a person cannot circumvent the DHHS regulatory definition of research by claiming that there was no intent to develop or contribute to generalizable knowledge. The IRB evaluates the investigator's proposed actions and behavior, rather than the investigator's intent, to discern the design of the activity.

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:

irb@temple.edu

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).



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