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Informed Consent Writing Tip Sheet

Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs).  The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

Note: Individual institutional review boards (IRBs) may have their own specific policies regarding how ICFs should be formatted, how to address certain regulatory criteria, and other considerations. Always check with your IRB of record to confirm you understand its requirements.

Part C of the Belmont Report notes that respect for persons requires subjects be given the opportunity to choose what will or will not happen to them. The informed consent plays a key role in this respect and should adhere to three main elements:

Language and Reading Level

Ensure the ICF is written in a way that will make sense to the study’s specific subject population. U.S. regulatory agencies recommend written ICFs contain easy-to-read and understandable information so a lay person can make an informed decision about participating in a study.

Generally, the aim is for a sixth to eighth grade reading level; however, it is recognized that some consent forms require technical language which will make this level unreachable. Before proceeding with a specific approach, make sure it is appropriate for your study. Flesh-Kincaid readability tools can help with grade level assessments.

The consent form cannot include any exculpatory language. Exculpatory language is that which has the general effect of waiving or appearing to waive a subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability from negligence. The Food and Drug Administration (FDA) website has guidance titled Exculpatory Language in Informed Consent, which includes examples.

If you are targeting a community that includes a sizable number of non-English speakers: Have translated ICFs available when English is not a potential subject’s first language. Whenever possible, have translated ICFs available ahead of time so you don’t have to wait to have the consent conversation with a potential subject.

Should an unexpected non-English speaking subject arrive before a translated study ICF is available, the regulations permit providing an oral presentation of the informed consent information along with a short form consent document and a written summary of the oral presentation. To access Advarra’s translated short forms in over 20 languages, login to the Advarra CIRBI Platform and select “Reference Materials.”

If your study will enroll children younger than the legal age of majority in your area: Consider whether assent documents are appropriate (in addition to the standard ICF) and/or whether it may be suitable to add an assent signature line to the standard ICF. Most IRBs identify age ranges when assent may be necessary, so check with your IRB regarding their standards.

Advarra’s IRB requires an assent statement (separate signature block in the standard ICF) for subjects who are minors and old enough to understand the ICF as written (approximately 14-17 years old). An assent form is needed when younger subjects (approximately 7-13 years old) need the information presented in age-appropriate language. The IRB doesn’t typically require subjects 6 years old or younger to sign an assent statement or assent form.

Basic Elements of Informed Consent

The regulations are very specific regarding what to include in the ICF and what to exclude. The basic elements of informed consent are mandated by the Common Rule (i.e., Department of Health and Human Services [DHHS] Office of Human Research Protections [OHRP] regulations) and FDA regulations at 45 CFR 46.116 and 21 CFR 50.25 respectively.

To remain compliant with the International Council of Harmonization’s good clinical practice guidelines (ICH-GCP) for studies conducted outside the U.S., also consider the ICH basic elements. Note that many (though not all) ICH elements are well-aligned with U.S. requirements.

Remember that it is only necessary to include the regulatory elements applicable for a given study. For example, an FDA regulated study would not need to comply with the Common Rule unless there is also DHHS funding involved.

FDA and Common Rule Elements of Informed Consent

Additional Elements of Informed Consent

Note: These elements are instance-specific, and their applicability is at the IRB’s discretion. To help streamline the review process, sponsors and sites should communicate with the IRB regarding the circumstances informing the addition or omission of these elements.

For more information on informed consent, review: 21 CFR 50.20, 21 CFR 50.25, 45 CFR 46.116, 45 CFR 46.117, ICH Good Clinical Practice (GCP), FDA Information Sheet: Informed Consent, OHRP Informed Consent FAQs, Belmont Report, PlainLanguage.gov, NCCN Informed Consent Language Database

Note: This article was originally published April 14, 2022, and has been updated to include new and clarifying information. 

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