Consent Templates and Guidance

The templates on this page are intended to help investigators construct documents that are as short as possible and written in plain language.  The informed consent form (ICF) templates provided by the IRB comply with federal regulations. 

Considerations before writing the consent document

Standard Language

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.   For any questions about the use of this language in your consent, please contact irb@od.nih.gov

Tips for developing a new consent form

Writing a consent form that uses plain language, and that is brief and clear, requires substantial effort. This effort can be lessened by using the consent template and adding the required information from the consent library (see more information below). However, making the effort to develop consents with these attributes, at the time of the initial submission, will greatly speed up the approval of the study. To get your consent form (s) approved quickly, it is incumbent upon the study team to create clear, simple consent documents.

Getting your consent form (ICF) approved quickly

To create clear, simple consent documents:

• Read and follow the IRB's advice on writing 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 [link]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

• PRISM Readability Toolkit
• Side Effect Tables for Common Oncology Drugs
• Side Effect Tables of Common Oncology Drug Regimens

Consent Templates for use at NIH sites

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.

What if the sponsor or study group has provided a model consent, or you are submitting a consent to an external 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 of the required, and any applicable optional elements, as required by the HHS Common Rule (45 CFR 46) and if applicable, FDA regulations (21 CFR 50), and it is well written.

The consent form must include the required elements and optional elements under the federal regulations. In addition, it must include NIH required language: the document header must identify the NIH site; the NIH PI (and not an external PI) must be listed and their contact information provided; NIH's injury language must be used; the NIH Privacy Act and Certificate of Confidentiality language must be used; and the NIH footer must be used at the bottom of the ICF, so that the eIRB system 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.

You can insert a model consent form into the following consent templates, whether the NIH is the reviewing IRB, or we are relying on an external IRB.

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

For all other external IRBs or for a study where you receive a model consent and the NIH is the reviewing IRB, use the following local consent template when research will occur in the Clinical Center (CC):

What if the NIH is the Coordinating Center and/or Sponsor and needs to write a model consent form to distribute to participating sites?

If the protocol will be conducted at multiple sites, then a model consent should be developed that all participating sites will insert into their local template. In addition, space must be provided to include the local context language for the site.  Use the template below to create the model consent, which is specific to the protocol, but not specific to any one of the sites. This model consent must be submitted to the IRB for review/approval prior to distribution to the sites.

Model Consent template when NIH is the Coordinating Center

CREATING AN INFORMED CONSENT FOR VERBAL CONSENT

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).

Insert Julie’s template for a verbal script

SINGLE PATIENT IND/EXPANDED ACCESS

The need for an investigational drug or biologic may arise in an emergency situation that does not allow time for submission of an IND. The FDA can authorize shipment of the test article (drug, biologic or device) in advance of the IND/IDE submission.  Information about the process for physicians can be found on this FDA website and this additional website. 

The FDA requirements and regulations for an emergency IND for the use of an investigational drug or biologic, are slightly different than for an emergency use of a device. In both situations, FDA must conclude that the use of the test article is for a "serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition."

Emergency Use is a special category of the Expanded Access to Investigational Drugs for Treatment Use. Most of the time, the IRB will have sufficient time to review investigators’ requests for expanded access to an investigational drug. Even though only a single individual (or a small group) will receive the investigational drug, this is considered research (a clinical investigation) under the FDA regulations, since the product is yet not approved by the FDA.

2017 FDA Guidance: IRB Concurrence

On October 3, 2017, the FDA issued new guidance regarding individual patient expanded access INDs. The new pathway still involves a submission to the IRB, but the IRB can now provide concurrence by the Chair, or another IRB member, rather than review and approval by the convened board. To use this pathway, the sponsor-investigator needs to request 'Authorization to Use Alternative IRB Review Procedures' from the FDA. This can be done either on FDA form 3926 (section 10.b.), or, if submitting using a FDA form 1571, by a separate attachment to the FDA. Note: This pathway is only available when a physician sponsor-investigator will hold the IND; it is not available when the pharmaceutical sponsor will hold the IND.

To obtain concurrence, the sponsor-investigator should select "Single Patient Expanded Access Application" in iRIS, complete the submission, and attach the documentation that was submitted to the FDA (e.g. FDA form 3926).

Consent Template for Single Patient Treatment IND or IDE (expanded access)
This consent form is an example, designed specifically for Expanded Access use, including Single Patient emergency, or non-emergency, use. It is assumed that this template will be used as a starting point and might need modifications to adapt to the single patient to be treated. The example assumes the use of a drug or device. The actual content will vary depending on the nature of the investigational agent or device, and whether procedures are done as part of the clinical investigation or for clinical care. Note that our consent template for this refers to the use of the product as treatment, and not as research.