You are here

Home

Forms & Templates

  1. Protocol
  2. Informed Consent
  3. Other Consent/Assent Documents
  4. International Research
  5. Non-CU Entity Research

Protocol

The following template provides essential topics of interest that the IRB looks for during review. Use the template to build your initial protocol document.

On December 1, 2011 the IRB office introduced a new informed consent template to be used for your eRA submissions. The following instructions are for this new informed consent template.

  1. Download a copy of the Informed Consent Template.
  2. Use the Guidance and Language Resource Text to assist you in filling in the specifics of your study.
  3. Save your final consent form to your computer.
  4. Upload your completed consent form to your eRA submission.
  • Informed Consent Template
    This template provides the essential skeleton for building a consent form for your study. Download the template and use the Consent Form Guidance and Language Resource Text, below, to assist you in filling in the specifics of your study. 
  • Informed Consent Guidance
    The Consent Form Guidance document describes the information that each section of the Template should contain. If some of the elements of informed consent do not apply to your research, simply omit the element and provide a rationale for the omission in the protocol document to the IRB. It is also recommended that the research team use the Language Resource Text, below, for assistance with wording for commonly used concepts and terms.
  • Language Resource Text (LRT)
    The LRT provides examples of language below the 8th grade reading level for commonly used concepts and terms. Research teams can incorporate the language into study documents, adapting it as needed based on the specifics of the study.

The following templates provide guidance for developing other essential consent/assent forms. Use the appropriate template(s) that is/are applicable to your study.

International Research

The following template provides guidance for investigators who will conduct research outside of the United States. Use the template to build a Local Review Letter.

Non-CU Entity Research

The following documents provide guidance for Non-CU entity research. Use the appropriate template(s) that is/are applicable to your study.