Informed Consent Template

The Informed Consent Template was developed by the Office of Human Research in collaboration with representatives of the research faculty, coordinators, center compliance offices, and the Office of Regulatory Affairs and are based on the ICH guidelines (ICH-E-6), FDA regulations (21CFR50). The intention of the Informed Consent Template is to provide Investigators, Sponsor-Investigators, and Clinical Research Coordinators with a format and guidelines for developing Informed Consent Documents that are compliant with Good Clinical Practice standards.
The template was last modified 8/9/2004.

Penn Version

For more information about developing the Informed Consent document, Penn faculty and staff should reference the Informed Consent Form Development section of the Penn Manual (PennKey required).

Informed Consent Template - with guidelines
This is a Informed Consent Template with guidelines under each heading describing the requirements of each section.
To use this annotated template:

• Open the Informed Consent Template with Guidelines
• Use File.. Save As.. to save the file on your computer.
• Use this template as a checklist to ensure that all required GCP elements of the consent form have been captured in your study consent form.

Informed Consent Template - without guidelines
This is a Informed Consent Template without guideline annotations, to save steps in deleting guideline language.
To use this Template:

• Open the Informed Consent Template
• Use File.. Save As.. to save the file on your computer.
• Review the standard language text provided for certain sections, modify as necessary
• Complete all sections according to the guidelines outlined in the Penn Manual (Informed Consent Form Development section of the Penn Manual)

Also available to view is a sample Informed Consent Form using the template.

External Version

Informed Consent Template - with guidelines
This is a Informed Consent Template with guidelines under each heading describing the requirements of each section. To use this annotated template:

• Open the Informed Consent Template
• Use File.. Save As.. to save the file on your computer.
• Use this template as a checklist to ensure that all required GCP elements of the consent form have been captured in your study consent form.

The Informed Consent Template is copyright-protected © 2005 by the Trustees of the University of Pennsylvania. If your institution wishes to use the Informed Consent Template, please reference the University of Pennsylvania as the original source for the template.

If you have any questions or need additional assistance, feel free to contact the Office of Human Research at 215-746-7400 or ohr@mail.med.upenn.edu.