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.

Additional Resources for Consent Forms

• Resources and Tools to Improve Consent Form Readability
• PRISM Readability Toolkit
• Side Effect Tables for Common Oncology Drugs
• Side Effect Tables of Common Oncology Drug Regimens

• NCI Risk Terms Library MICROMEDEX Scientific Terms (Informed Consent Terms for Risks Spreadsheet)

• Common Terminology Criteria for Adverse Events (Systems Based Lay Terms for Adverse Events Spreadsheet)

• How to Write Using Active Voice (preferred) vs. Passive Voice (a plainlanguage.gov resource)

• How to Use Simpler Words and Phrases (a plainlanguage.gov resource)

• NCI Checklist to Develop Easy-to-Read Informed Consent Documents

• Plain Language: Getting Started or Brushing Up (information and checklists via NIH webpage or pdf)

• Communicating Risks and Benefits: An Evidence-Based User’s Guide (FDA)

• NCI Using Online and Manual Readability Tools to Assess the Reading Level of Informed Consent Documents

• Center for Disease Control & Prevention Health Literacy Website