Human Subjects - What Form Should I Use and What Should I Submit With the Form?
The Temple IRB is now accepting electronic 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.
While the system is currently open for use to all Temple University researchers, electronic submissions will become mandatory on the following dates:
April 1, 2013 - College of Medicine
May 1, 2013 - all other Colleges on the Health Science Campus
June 1, 2013 - Main Campus and all other campuses
Is My Activity Human Subjects Research?
The DHHS definition of research is "a systematic investigation. . . designed to develop or contribute to generalizable knowledge." To help in your analysis, you are welcome to use the WORKSHEET: human research determination.
You are also welcome to submit a synopsis of the proposed activity to:
The IRB will provide a written determination.
What Form Should I Use and What Should I Submit With the Form?
|Applications||When Do I Use It?|
|Application for Human Research||Medical or social and behavioral research. See the Application's signature page for the required supplemental documents.|
|Classroom Project/Activity||If your medical or social and behavioral classroom project/activity is human subjects research. See the Classroom Project/Activity Application's signature page for the required supplemental documents.|
|Investigator Protocol Template for Investigator-Initiated (non-sponsored) Medical Studies||If the Investigator's Department is on the Health Sciences Campus and the study is investigator-initiated (non-sponsored)|
|Investigator Protocol Template for Sponsored Medical studies||If the Investigator's Department is on the Health Sciences Campus and the study is sponsored|
|Investigator Protocol Template for Social and Behavioral Studies||If the Investigator's Department is on the main campus.|
|Consent Form Templates|
|Main Consent Form||If the study is medical or if the social and behavioral study is more than minimal risk.|
|Minimal Risk Social and Behavioral Consent Form||If the social and behavioral study is minimal risk.|