Forms and Templates
- Main Protocol Template 10-26-2014
- Minimal Risk Protocol Template 10-26-2014
- Chart Review Protocol Template 05-20-2015
Consent Form Templates
- Main Informed Consent Template 03-24-2015
- Minimal Risk Informed Consent Template 09-23-2014
Short Informed Consent Template (this template is to be used only if you will translate it into the subject's native language) 10-22-2014
Tufts University has given permission to share their foreign language short form consent templates. If you would like to use them, please change all references from Tufts University to Temple University. The foreign language short form consent templates can be found here.
- Informed Consent Form for Emergency Use 08-26-2014
This form is to be used only to collect authorization for Research Personnel who are not affiliated with Temple University, Temple University Health System, or Shriner's Hospital for Children. Affiliated individuals should be added to the eRA system and provide electronic authorization. The PI must always be listed and authorize via eRA, not on this signature form. To add affiliated individuals to eRA, please contact the IRB office at firstname.lastname@example.org or 215-707-3390.
Research Personnel not affiliated with Temple University, Temple University Health System, or Shriner's Hospital for Children should provide their authorization of participation by completing the information below. Include a scanned copy of this document with your IRB submission in eRA.
Humanitarian Use Device (HUD) Forms
- Application for an HUD
- Continuing Review Progress Report or Final Report for an HUD
- Modification of an HUD
- Modifications Required to Secure Approval of an HUD
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.