NIH INFORMED CONSENT TEMPLATE FOR EXPANDED ACCESS (including single patient) AT THE NIH CLINICAL CENTER - Version 9 - Use instructions

Sep 1, 2026

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NIH informed consent template for expanded access protocols, including single-patient use, for the NIH Clinical Center, aligned with NIH policies and the revised Common Rule (rCR). Provides required NIH language, section headers, document headers/footers, and optional sections, with specific rules on what cannot be changed without clearance from OHSRP and OGC and how to update investigator-highlighted areas before IRB submission. Includes guidance on consent readability, proofreading, signature page block selection, and required footer/version and IRB numbering updates.

LanguageEnglish

CategoryForms

FormatDOCX

Pages10

Reading Time4 min

AccessFree to download

GENERAL INSTRUCTIONS FOR USE OF THIS TEMPLATE

Required NIH Language

Section Headings and Document Formatting

Optional Section Headings

Other Text and Consistency Rules

Signature Page

Applicable Signature Blocks

Witness Block Guidance

Reading Level and Proof Reading

Proofreading Checklist

Nomenclature for Clean Consent Documents

PRINCIPAL INVESTIGATOR and Study Details

Consent Version and Contact Information

KEY INFORMATION ABOUT THIS TREATMENT

Understanding the Treatment Choice

Language Adjustments for Special Consent Contexts

NIH INFORMED CONSENT TEMPLATE FOR EXPANDED ACCESS (including single patient) AT THE NIH CLINICAL CENTER Version 9: 01-26-2026 GENERAL INSTRUCTIONS FOR USE OF THIS TEMPLATE This template must be used for expanded access protocols (including single patient) conducted at the NIH Clinical Center. The template comprises NIH required language, document headers, document footers, and section headings, as well as optional section headings and instructional language, and is consistent with NIH policies and the revised Common Rule (rCR). Required NIH Language: Changes to required language cannot be made without clearance from the Office of Human Subjects Research Protections (OHSRP) and the NIH Office of the General Counsel (OGC). Required NIH Language is included throughout the consent template and is colored in blue for the purposes of this template. Change all font to black when you submit to the NIH IRB. Note that in this version the language regarding the storage of data for future use and sharing is now in blue. The document header and footer may not be revised except for areas highlighted in yellow; these highlighted sections must be updated by the investigator prior to submission to the IRB. Section Headings: 12-point, Times New Roman is the preferred font. Use one font throughout the document. All section headings are required unless the section heading is highlighted (e.g., (As applicable)). Additional section headings and content may be added at the discretion of the investigator and the IRB. Remove (As applicable) from the optional section headings if using the optional section; remove the entire optional section heading if not using the optional section. Other text: 12-point, Times New Roman is the preferred font. Use one font throughout the document. Text should be justified or aligned left. Larger font size may be used for visually-impaired populations. Italicized or bolded font may be used to emphasize certain information. Bullets and other spacing are encouraged to facilitate readability. Ensure that incorrect, instructional, and non-applicable language is removed from the body of the consent form prior to review by the IRB. Italicized, and/or highlighted instructional language below should be removed and replaced with the consent language as applicable. Language that is in regular black font is not required NIH language but is standard consent language that the NIH IRB would like to be used in all consent documents as applicable. Use the “Consent Library” for suggested procedure descriptions and risks. Signature Page: Please keep only the signature blocks that are applicable to your study. Delete the blocks which are not applicable. If your study is enrolling people over the age of 18, or the consent will also be used to consent minors when they reach the age of 18, keep the “Adult Research Participant” block. If your study allows for enrollment of cognitively impaired adult subjects or would allow cognitively impaired subjects to remain on study should they lose capacity after enrollment, keep the “Legally Authorized Representative” block. If your study is enrolling minors, keep the “Parent/Guardian of a Minor Participant” block If your study is enrolling older minors, and you do not have a separate assent form for minors to sign and are using this form as the assent, then keep the “Assent” block. ALWAYS leave the “Investigator” block Include the “Witness” block if there are no eligibility restrictions in the protocol based on language that would prohibit enrollment of a non-English speaking participant or if you may enroll blind and/or illiterate subjects. Otherwise, remove this block. Reading Level and Proof Reading: The preferred reading level is 8th grade or lower if possible. Proofread, and spell check the final clean document. Please ensure: No section headings are separated from the section text across page breaks There are no blank pages Any tables you have inserted are within the document margins The protoc

FAQs

What is this template intended for?

It is intended for expanded access protocols (including single patient) conducted at the NIH Clinical Center, and is built to meet NIH-required consent language and structure.

Which parts of the required NIH language can be changed?

Changes to required NIH language cannot be made without clearance from the Office of Human Subjects Research Protections (OHSRP) and the NIH Office of the General Counsel (OGC).

How should investigators handle the signature page and optional blocks?

Keep only the signature blocks applicable to the study, always leaving the “Investigator” block and following study enrollment rules for adult participants, legally authorized representatives, parents/guardians, and assent as applicable. Include the “Witness” block only under the stated eligibility restrictions.

Sep 1, 2026

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