Forms and Templates

Protocol Templates

• Investigator Protocol Template for Social and Behavioral Studies
• Investigator Protocol Template for Medical Studies

Consent Form Templates

• Main Consent Form Template
• Minimal Risk Social and Behavioral Consent Form Template
• Short Consent Form (this template is to be used only if you will translate it into the subject's native language)

  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.

Research Personnel Signature Forms

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 irb@temple.edu 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.

Genetic Information Nondiscrimination Act (GINA) forms

• English Genetic Information Nondiscrimination Act (GINA) Notification
• Spanish Genetic Information Nondiscrimination Act (GINA) Notification

HIPAA Forms

• English HIPAA Authorization Form
• Spanish HIPAA Authorization Form

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

Miscellaneous

• Contact Information
• IRB Member Information
• Modification of Approved Human Research
  • This form should only be used if you are the PI submitting a Modification request to add Research Personnel (i.e. Student Investigator or Study Coordiantor) to eRA, and you are unable submit the Modification via eRA.

What Form Should I Use and What Should I Submit With the Form?

Protocol Templates
Investigator Protocol Template for Medical Studies	If the Investigator's Department is on the Health Sciences Campus
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.

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:

irb@temple.edu

The IRB will provide a written determination.

 

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