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Getting your Consent Form (ICF) Approved Quickly

To create clear, simple consent documents:

  • Follow the instructions in the NIH IRB's template;
  • Adhere to the template design specified int the MS Word Style Sheet - margins, type size, font choices, use of bold, etc. - which can be used to control formatting;
  • Use  Plain Language instead of technical terms;
    • Refer to the PRISM Readability Toolkit which contains information about the principles of Plain Language, and examples for improving readability.
  • The IRB has compiled a document entitled Consent Library which includes Plain Language descriptions of procedures and corresponding risk information. The document can be downloaded as an MS Word file. The IRB does not intend that investigators must use the exact wording for most procedures. Both the descriptions of the procedures, and the associated risks, may be modified and adapted to match each study's specific requirements, with a few exceptions which are noted in the document;
  • Target the reading level as close as possible to Grades 6 - 8;
  • Have someone without a medical background, who is unfamiliar with the study, review the consent form;
  • Edit, revise, and edit again - until the document is clear and concise.
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Additional Resources for Consent Forms

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The ICF template contains all of the required elements of informed consent per the Revised Common Rule. If you follow this template, your consent will be compliant with all of the regulations.  

Please check out the Consent FAQs for more information.


Info

If you need a 508 compliant version of a template that can be read by a screen reader, please contact the IRB Office by email at IRB@od.nih.gov.

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For a study where you receive a model consent and the NIH is the reviewing IRB, use the following local consent template when research will occur in the Clinical Center (CC):

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