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Informed Consent Writing Tip Sheet

Informed consent is one of the central protections the regulations provide to research participants. 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.

To print this checklist, right-click and select ‘Print’. You can then use this checklist offline as a PDF if desired.

Informed consent’s function is to provide the potential participant with sufficient information regarding a research study’s:

Part C of the Belmont Report contains three requirements for the informed consent process:

Language and Reading Level

Ensure the ICF is written in a way that will make sense to the study’s specific participant 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. Many aim for a sixth-grade or eighth-grade reading level; before proceeding with a specific approach, make sure it is appropriate for your study. Flesh-Kincaid readability tools can help with grade level assessments.

If you are targeting a community that includes a sizable number of non-English speakers: Have translated ICFs available for when English is not a potential participant’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 participant.

If your study will enroll children younger than the legal age of majority in 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.

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 Food and Drug Administration (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), also consider the ICH basic elements.

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

ICH-GCP 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.

FDA/Common Rule Additional Elements of Informed Consent

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

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