Informed Consent Forms: What to Include and How to Write Them

A good informed consent form is a negotiation document, not a waiver. It tells a prospective participant exactly what you will ask of them, what it might cost them, and what they gain by saying yes. Under 45 CFR 46.116, consent must be given voluntarily, with sufficient information, in language the participant understands. The legal floor is a floor, not a ceiling, and most rejected consent forms fail on readability rather than on missing elements.

The required elements

The Common Rule lists the required elements of informed consent. In drafting terms, your form must include:

1. A statement that the study involves research, with the purpose stated plainly.
2. Expected duration of participation and a description of procedures.
3. Foreseeable risks or discomforts.
4. Reasonably expected benefits to the participant or to others.
5. Alternative procedures or courses of treatment, if applicable.
6. Confidentiality protections and any limits to them.
7. For research involving more than minimal risk: compensation and medical treatment in case of injury.
8. Contact information for study questions and for participants' rights.
9. A statement that participation is voluntary and may be withdrawn at any time without penalty.

The 2018 revisions to the Common Rule added a "key information" section at the top of the form — a concise summary that gives a prospective participant enough to decide whether to read further. This is not optional for most reviewed studies, and reviewers will flag forms that open with institutional boilerplate instead.

Write for a person, not for a lawyer

The single most common consent form mistake is tone. Drafts inherited from templates read like liability releases: dense paragraphs, passive voice, and legal hedges. A participant with an eighth-grade reading level should understand your form, which is the readability target most IRBs enforce.

Use short sentences. Use "you" and "we." Replace "participant" with "you" throughout. Replace "researcher" with your role or team. Break long sections with subheads. Use bulleted lists for activity steps and for risks.

An excellent model for consent language in interview and focus group research is available from The Qualitative Researcher — the guidance on explaining recording, transcription, and data destruction in plain terms is directly reusable.

Describing risks honestly

Acknowledge what is plausible, not what is catastrophic. For a survey about stress, the risk is emotional discomfort; for an interview about family trauma, the risk is re-traumatization. For any online study, the risk is a confidentiality breach through the platform. Name the risk, describe the mitigation, and give the participant a way to stop.

Avoid the phrase "there are no risks." Every study has at least one, even if it is just time commitment. Reviewers read "no risks" as either dishonesty or inattention.

Voluntariness and withdrawal

State that participation is voluntary and that the participant may withdraw at any time. Describe what happens to their data if they withdraw. If you will retain already-collected data after withdrawal, say so. If you will destroy it, say so. Do not leave this ambiguous — it is one of the most frequent reviewer comments.

Confidentiality and its limits

Confidentiality has limits, and the form must name them. If you are a mandatory reporter, say so. If data may be subpoenaed, say so. If you will publish quotes, say so and describe how you will de-identify them (pseudonyms, removed institutional names, aggregated demographics).

Our consent form guide includes sample paragraphs for each of these scenarios, and our consent form template includes the required structure.

Waivers of consent and documentation

Two different waivers exist. A waiver of documentation (no signature required) is appropriate for anonymous surveys and low-risk online research, authorized under 45 CFR 46.117(c). A waiver of consent (no consent process at all) is reserved for secondary data analysis of existing de-identified records and narrow other cases under 45 CFR 46.116(f). The two are often confused. Cite the correct regulatory basis in your protocol and label the waiver you are actually requesting.

Electronic consent

For online studies, the consent form becomes the first screen of the survey, and the participant indicates agreement by clicking through. Build the key information summary into the top of the screen, require a click-through before survey items are revealed, and offer a printable PDF version for records. Reviewers increasingly expect this pattern.

A test before you submit

Ask someone outside your field to read the form and tell you, in their own words, what the study is about, how long it takes, and what could go wrong. If they cannot answer those three questions in one reading, rewrite. The rewrite is easier than the reviewer cycle that will force you to do it later.