- Refer to the PRISM Readability Toolkit which contains information about the principles of Plain Language, and examples for improving readability.
Additional Resources for Consent Forms
- Resources and Tools to Improve Consent Form Readability
- PRISM Readability Toolkit
- Side Effect Tables for Common Oncology Drugs
- Side Effect Tables of Common Oncology Drug Regimens
- NCI Risk Terms Library MICROMEDEX Scientific Terms (Informed Consent Terms for Risks Spreadsheet)
- Common Terminology Criteria for Adverse Events (Systems Based Lay Terms for Adverse Events Spreadsheet)
- How to Write Using Active Voice (preferred) vs. Passive Voice (a plainlanguage.gov resource)
- How to Use Simpler Words and Phrases (a plainlanguage.gov resource)
- NCI Checklist to Develop Easy-to-Read Informed Consent Documents
- Plain Language: Getting Started or Brushing Up (information and checklists via NIH webpage or pdf)
- Communicating Risks and Benefits: An Evidence-Based User’s Guide (FDA)
- NCI Using Online and Manual Readability Tools to Assess the Reading Level of Informed Consent Documents
- Center for Disease Control & Prevention Health Literacy Website
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.
Library of Consent Language:
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.
Please check out the Consent FAQs for more information.
If you need a 508 compliant version of a template that can be read by a screen reader, please contact the IRB Office by email at IRB@od.nih.gov.
What if I only need to provide new study information to a limited number of previously enrolled subjects or inform enrolled 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.
If you need a 508 compliant version of a template that can be read by a screen reader, please contact the IRB Office by email at IRB@od.nih.gov.
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, when the NIH is the reviewing IRB, or we are relying on the NCI CIRB.
The NCI CIRB has approved specific local context forms into which the model consent should be inserted:
For a study where you receive a model consent use the following local consent template when research will occur in the Clinical Center (CC):
For a study where you receive a model consent and an external IRB is reviewing, add NIH required language to the model consent template provided. Do NOT insert the external IRB’s model consent into an existing NIH template.
Contact the NIH Reliance and sIRB team at nih-reliance-sirb@nih.gov if additional guidance is needed.
What if the NIH is the Lead Site 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 Lead Site:
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).
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.
Expanded Access (including single patient) Consent Template:
