NCI DCP Informed Consent Template for CP-CTNet Cancer Prevention Trials - Consent Template

Sep 1, 2026

Consent summary and guidance template for drafting informed consent documents for NCI, DCP CP-CTNet cancer prevention trials. Includes fields for protocol and informed consent version dates, required instructions for listing prior CIRB-approved changes by page and section with point-by-point descriptions and justifications. Provides author notes on compliance with federal regulations, readability and plain-language best practices, formatting standards, color-coded instruction handling, and optional use based on approval status after November 10, 2025.

LanguageEnglish

CategoryForms

FormatDOCX

Pages45

Reading Time16 min

AccessFree to download

Summary of Changes - Consent

Protocol and Informed Consent Metadata

Change Listing Requirements (Previous CIRB-Approved Version)

Template Applicability (Approval on Hold After Nov 10, 2025)

Notes for Informed Consent Document Authors

Purpose and Language/Formatting Guidance

Instructions on Including/Excluding Author Notes

SUMMARY OF CHANGES – Consent NCI Protocol #: Local Protocol #: Protocol Version Date: Protocol Title: Informed Consent Version Date: Please provide a list of changes from the previous CIRB-approved version of the Informed Consent Document (ICD). The list shall identify by page and section each change made to the ICD with hyperlinks to the section in the ICD. All changes shall be described in a point-by-point format (i.e., Page 3, section 1.2, replace “xyz,” and insert “abc”). When appropriate, a brief justification for the change should be included. **Required Template for Protocols granted Approval on Hold After November 10, 2025** Optional for all other studies NCI, DCP Informed Consent Template for CP-CTNet Cancer Prevention Trials ~Notes for Informed Consent Document Authors: ~ Purpose: This document provides a template to follow when writing informed consent documents (ICDs) for many types of cancer prevention trials. It recognizes the significant differences between various types of trials and provides phase-specific examples of recommended ICD language. This ICD template is not meant to be fully comprehensive. However, the lay language used, and the format of the information should be followed as closely as possible when applying it to a specific study. In all cases, ICD authors should use clear, concise language. Reminder: The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. These requirements are changed in the Final Revisions to the Common Rule (also known as the Federal Policy for the Protection of Human Subjects), which are in effect as of January 19, 2018. These regulations are available at: HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html" https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html. FDA-regulated clinical investigations must also comply with the requirements for consent at 21 CFR 50 and IRB review at 21 CFR 56. Note on Certificate of Confidentiality Issues: Beginning with the December 12, 2017 version of this template, the new Certificate of Confidentiality protections covering all NIH-funded research are addressed in the “Who will see my medical information?” section. The language in this template has been edited from NIH’s suggested consent language to align with the health literacy and plain language goals of this template. These notes and instructions for authors should not be included in the consent form. ~Instructions to Informed Consent Document Authors: ~ Document Length and Language: The NCI strongly recommends that the ICD not exceed 16 pages, excluding the “Optional Studies” section. Suggestions for making the informed consent more concise include: Focus on what makes the study different from the care a patient would typically receive. Instead of trying to cover everything that might happen during the trial, limit the information to the research issues. Eliminate repetition of information. Use lay language and explain concepts simply. Consider using shorter words and sentences. Longer words and sentences make the consent form difficult to read. Replace complex medical terminology with common, easily understood words. Use online and/or manual readability tools to assess the reading level of your ICD. The 2015 IOM report on “Informed Consent and Health Literacy” recommends an eighth grade reading level or lower. Information about readability assessments can be downloaded from the CTEP ICD website. If possible, ask patient advocates to review the document before submitting it to the CIRB. The advocates can help identify potential comprehension challenges for patients. Use of Example Text: Edit the text examples as necessary to make the language specific to your study question since many statements throughout the template are generic. Examples are not given for every study situation. Consent authors should review all examples i

FAQs

What information must be provided in the “Summary of Changes - Consent” section?

It must include a list of changes from the previous CIRB-approved informed consent document, identifying each change by page and section, with a point-by-point description and hyperlinks to the relevant ICD sections.

When is this template required versus optional?

It is required for protocols granted approval on hold after November 10, 2025, while it is optional for all other studies.

What guidance does the template give for readability and wording?

Authors should use clear, concise lay language, avoid unnecessary repetition, replace complex medical terminology with common words, and consider an eighth-grade reading level or lower.

Sep 1, 2026

Upload by Chloe Bennett