NCI Informed Consent Template for Adult Cancer Trials - Consent Form Template Version Date November 27 2018

Aug 30, 2026

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NCI informed consent document template for adult cancer trials provides author-focused guidance for drafting oncology informed consent documents across many trial types. It emphasizes compliance with 45 CFR 46.116 and 45 CFR 46.117 and additional FDA/IRB requirements, and explains how to structure phase-appropriate, lay-language content. Instructions cover avoiding unnecessary author notes, limiting length to 16 pages excluding optional studies, improving readability, editing generic example text, and applying consistent typography and formatting.

LanguageEnglish

CategoryForms

FormatDOCX

Pages51

Reading Time18 min

AccessFree to download

Purpose and scope

Regulatory compliance reminders

Writing guidance for ICD authors

Document length and readability

Use of example text and study-specific edits

Formatting requirements

Color-coded instruction text rules

Consent form structure options

Study schema inclusion

Using more than one consent in a study

Patient educational attachments

Table of contents elements for authors

NCI Informed Consent Template for Adult Cancer Trials NCI Consent Form Template Version Date: November 27, 2018 ~Notes for Informed Consent Document Authors: ~ Purpose: This document provides a template to follow when writing informed consent documents (ICDs) for many types of oncology trials. It recognizes the significant differences between various types of trials and provides phase-specific examples of suggested 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 and 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, 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 informed consent document. 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 IRB. 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 in a section, even if the example is for a different study type, to identify language that may apply to their study. Formatting: Use 1-inch margins for top, bottom, and sides of the page. Use Times New Roman size 14 font and bold the main section headings. Use Times New Roman size 12 font for the body of the document. Do not use all capital letters or italics to call attention to information. Use other formatting sparingly. Color-Coded Information: ~Instructions to consent authors for are highlighted in this color and set apart by the tilde symbol, “~”. This text should not be included in the consent form for patients. Depending on the instructions, the text that follows

FAQs

What is the purpose of the NCI informed consent template for adult cancer trials?

It provides guidance for authors drafting informed consent documents for many oncology trial types, including suggested phase-specific language and formatting. It is designed to be adapted to the specific study while keeping content clear and concise.

Which regulatory requirements must the consent process and documentation follow?

The consent process must comply with 45 CFR 46.116 and the documentation must comply with 45 CFR 46.117. For FDA-regulated investigations, consent must also meet 21 CFR 50 and IRB review must meet 21 CFR 56.

What formatting and readability practices does the template recommend?

It recommends limiting the ICD to 16 pages (excluding the optional studies section), using clear lay language, and targeting an eighth-grade reading level or lower. It also specifies 1-inch margins, Times New Roman 14pt for main headings, and Times New Roman 12pt for body text, with limited use of special capitalization or italics.

Aug 30, 2026

Upload by Cipher