Consent Development

When developing a new consent form for initial review by the NIH IRB, use the templates that are found here on this webpage. Aim for a reading level between Grades 6 and 8. Use the current consent template and language from the NIH IRB Consent Library when writing a new consent document. This library on the OHSRP website has plain language descriptions of procedures and related risk information.

You need to provide information to the subject or their legally authorized representative (LAR) in a language they can understand. Organize and present this information clearly, so it helps them understand why they might want to participate or not.

• Always start with the current version of the consent/assent template.
• Use the Consent Library from the OHSRP website, which includes plain language descriptions of procedures and corresponding risk information. You can modify and adapt these descriptions to match your study's specific requirements, with a few exceptions noted in the document.
• Target the reading level as close as possible to Grades 6–8.
• Edit, revise, and edit again until the document is clear and concise.
• Ensure the margins follow the standard approved CF templates (pay particular attention to translated documents and documents with graphics).
• Make sure there is plenty of room in the footer for the IRB stamp.
• Be aware that using pictures or graphics in consent forms can sometimes create problems when PROTECT finalizes the document and converts it into a PDF. OHSRP suggests doing a test run by converting the consent document from MS Word to PDF and double-checking it before uploading it in PROTECT.

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. 

The IRB has assembled a compendium of procedure descriptions and their associated risks from consent forms.  This document, called the “consent library” is found below. To expedite approval of the study consent forms, study teams should use these examples.  The examples serve as a starting point and should be modified as necessary to match the requirements of the specific study.  There is some language inserted which cannot be altered (e.g. radiation risk language and GINA language); those sections are noted in the document. 

What if I only need to provide new study information to a limited number of previously enrolled subjects or inform subjects of a minor change?

The consent addendum should only be used for subjects who are currently taking part in an NIH IRB-reviewed study and have already signed the original consent.

Examples of when a consent addendum may be used are as follows:

• When just a limited number of existing subjects need to be informed of significant new findings developed during their participation that may impact their willingness to continue in the study. However, this information does not pertain to all subjects who are, or will be newly, enrolled. 
• When just a limited number of existing subjects need to be informed of specific minor changes (rather than having them sign a modified consent document), e.g., a change in planned procedure, or when follow up will be extended.

The consent addendum can be used to facilitate discussion with subjects since the changes/new findings are the only focus of the document.  Do not use a consent addendum if there are extensive changes or new risks – instead subjects should be re-consented with a modified consent document.

If you have questions whether a consent addendum is the appropriate mechanism for notifying existing subjects of a change, please contact the IRBO for guidance.

What if I am enrolling NIH subjects who will never be physically seen at an NIH site?

Use the template below if you are enrolling NIH subjects off-site; meaning these people will never come to an NIH site to be seen as a participant. For example, a field cohort or participants who are entirely remote where there is no physical contact with that person, or participants that are seen at non-traditional locations such as a church or community hall. If you are using Clinical Center resources in any way for the protocol (this includes using iMed for consent or sending in samples to an NIH CC lab for analysis) then you cannot use this template, and you would need to use the Clinical Center consent template instead for your protocol. It should be used in cases where the NIH Institutional Review Board (IRB) is the Reviewing IRB for this protocol.

What if the sponsor or study group has provided a model consent, and I need to prepare an NIH site consent that will be submitted to the NIH IRB?

Rewriting model consent forms from Sponsors to attempt to fit the NIH consent form templates often results in consents that do not satisfy regulatory or NIH requirements. The NIH IRB will accept and approve an ICF that differs from the NIH templates, provided that the document contains all required, and any applicable optional elements, per the HHS Common Rule (45 CFR 46) and FDA regulations (21 CFR 50), as applicable, and it is well written.

The consent form must include all required and optional elements under federal regulations. Additionally, it must meet specific NIH requirements: the document header must identify the NIH site; the NIH PI's name and contact information must be provided; use NIH injury language; incorporate NIH Privacy Act and Certificate of Confidentiality language; and have the NIH footer at the bottom of the ICF, so that PROTECT can stamp the form.

Note there are items that often appear in a model consent that are NOT allowed at the NIH: Sponsor research injury language and HIPAA language should all be removed, European Union General Data Protection Regulation (GDPR) language must also be removed.

The NCI CIRB has approved specific local context forms into which the model consent form should be inserted:

Use the following template when NIH is submitting to the NIH IRB and you receive a model consent from a sponsor:

What if the sponsor or study group has provided a model consent and I need to prepare an NIH site consent that will be submitted to an External Reviewing IRB?

NIH study teams should adhere to the Model Consent template approved by the External IRB and customize it by inserting NIH-specific language and formatting. They should avoid pasting text from the Model Consent into an existing NIH template.

Customizing the Model Consent ensures it meets NIH institutional requirements and communicates how the protocol will be implemented at the NIH site, especially if it includes additional procedures not covered in the Model Consent.

The consent form must include all required and optional elements under federal regulations. Additionally, it must meet specific NIH requirements: the document header must identify the NIH site, include the NIH PI's name and contact information (not an external PI), use NIH injury language, incorporate NIH Privacy Act and Certificate of Confidentiality language, and have the NIH footer at the bottom so PROTECT can stamp the form.

Contact the NIH Reliance and sIRB team at nih-reliance-sirb@nih.gov if additional guidance is needed.

Does the NIH team need to develop a model consent if it is the Lead Site and/or Sponsor and/or Coordinating Center and subjects will be enrolled at participating sites?

If the protocol will enroll subjects at multiple sites, develop a model consent for participating sites to customize into their own site-specific consents. The model consent should outline the protocol procedures conducted at all sites and provide space for sites to insert their locally required language such as the site’s research-related injury language or the contact details of its site PI. Use the template below to create the model consent, ensuring it is specific to the protocol, but not specific to any one site. Submit this model consent to the NIH IRB for review/approval prior to distribution to the sites.

What is commonly known as verbal consent, is in regulatory terms, referred to as informed consent with waiver of documentation. The same regulatory elements of written informed consent are required for verbal consent. The "verbal script" that must be developed is essentially a consent form to that will be read to the prospective subject.

Note that if you are conducting a study off-site (i.e., subjects will not be registered as patients at the Clinical Center), then you should include the Privacy Act language as part of the script. (This can be found in the Consent Library.)

When you use a verbal script, you must document the consent process in the medical or research record (as applicable).

Payment received as compensation for participation in research may be considered taxable income. The IRS reporting threshold for compensation payments has increased from $600 to $2,000 per calendar year effective January 1, 2026. Compensation payments to NIH research volunteers totaling $2,000 or more in a calendar year will be reported (most likely via Form 1099 - Miscellaneous Income).

Participants with questions about taxes or their filing status should be directed consult their tax professional or the IRS. NIH Study staff cannot answer tax questions. Participants with questions about NIH reporting to the IRS should be directed to the Clinical Research Volunteer Program at CC-PRPLRVSSupport@cc.nih.gov

New or modified consent forms must include the templated language explaining the new threshold. For ongoing studies with previously approved consent forms, study teams must either provide participants with the approved information sheet found below or provide participants verbal notification and document that conversation in the medical or research record .

FDA guidance: Informed Consent Guidance for IRBs, Clinical investigators, and Sponsors

OHRP: Simplifying Informed Consent

Plainlanguage.gov: How to Use Simpler Words and Phrases

Plainlanguage.gov: How to Write Using Active Voice (preferred) vs. Passive Voice

NCI CTEP: Tables of Possible Side Effects for Commonly-Used Oncology Drugs & Regimens

CDC: Center for Disease Control & Prevention Health Literacy Website

NIH: Plain Language: Getting Started or Brushing Up