An informed consent form is the written document a participant reads and signs (or that documents an oral consent process) before enrolling in research. Regulations tell institutions what the consent process and its documentation must accomplish; they do not supply a ready-to-use form. This page walks through one, section by section, so a research administrator, new IRB coordinator, or investigator can see how the required elements of 45 CFR 46.116 and, for FDA-regulated or ICH-region trials, ICH E6 map onto actual document language.
For the underlying requirements and regulatory reasoning, see the companion guide Informed Consent in Research: What It Requires and How It Works. This page focuses specifically on the document itself.
What a consent form has to do, structurally
Two separate regulatory questions sit behind every consent form:
- Is the consent process adequate? Governed in the US by 45 CFR 46.116 — voluntariness, comprehension in language understandable to the participant, and disclosure of what a reasonable person in the participant’s position would want to know before deciding.
- Is the consent documented adequately? Governed separately by 45 CFR 46.117. This is the basis for the standard distinction that the form is not the same thing as consent — a signed form documents that a process occurred; it is not itself the ethical safeguard. An IRB can, under defined conditions, waive the signed-documentation requirement (46.117(c)) even where the underlying consent process (46.116) is fully required.
For FDA-regulated drug, biologic, or device trials, and for any trial conducted under ICH-region regulatory reliance, Good Clinical Practice under ICH E6 imposes an overlapping but not identical set of expectations, generally covering the same substantive disclosures as 46.116 plus explicit expectations around monitor/auditor/IRB access to records and, depending on the trial, sponsor-specific compensation-for-injury language. Where a study is both Common-Rule-governed and FDA-regulated, the consent form has to satisfy both frameworks simultaneously — in practice this means the more protective of the two requirements controls for any given element.
The required elements, and where they appear below
The basic elements a US consent process/document must cover, per 46.116(b)-(c) and mirrored closely by ICH E6’s disclosure expectations, are annotated against the sample sections that follow:
- A statement that the study involves research, its purpose, expected duration, and procedures
- Reasonably foreseeable risks or discomforts
- Reasonably expected benefits (to the participant or others)
- Disclosure of appropriate alternative procedures or treatments, if any
- Extent of confidentiality of records
- For research involving more than minimal risk: an explanation of whether compensation or medical treatment is available if injury occurs
- Whom to contact with questions about the research, about participants’ rights, and in the event of a research-related injury
- A statement that participation is voluntary and refusal or withdrawal involves no penalty or loss of benefits otherwise entitled
- Since the 2018 Common Rule revisions, where applicable: a statement about whether identifiable private information or biospecimens collected may be used for future research, even after identifiers are removed
Worked example: a composite informed consent form
Study title, sponsor names, and institutional details below are placeholders — replace bracketed text; none refer to a real study.
[INSTITUTION LETTERHEAD]
INFORMED CONSENT TO PARTICIPATE IN RESEARCH
Study Title: [Descriptive, non-technical title]
Principal Investigator: [Name, department, contact]
Protocol/IRB Number: [Number]
1. Invitation and purpose. You are being asked to take part in a research study. This form explains the study so you can decide whether to participate. Taking part is entirely your choice. [Plain-language statement of the research question/purpose.] (Satisfies element 1 — statement that this is research, and its purpose.)
2. What participation involves. [Step-by-step description of procedures, in the order a participant will experience them, including approximate time commitment and number of visits.] (Element 1 — procedures and expected duration.)
3. Risks and discomforts. [Enumerated, specific risks — physical, psychological, social, or legal — ranked roughly by likelihood/severity, including risks of any procedure performed solely for research purposes.] (Element 2.)
4. Possible benefits. [Direct benefits to the participant, if any, stated honestly — many studies offer none directly to the participant — plus anticipated benefits to future patients or knowledge generally.] (Element 3.)
5. Alternatives. [Alternative procedures or treatments available outside the study, including the alternative of standard care or no treatment, where relevant.] (Element 4 — required specifically where the research involves treatment; omitted from purely observational/survey studies where it does not apply.)
6. Confidentiality. [How identifiable data will be stored, who will have access, de-identification approach, and any limits on confidentiality — e.g., mandatory reporting obligations, or IRB/sponsor/FDA/OHRP access to records for audit purposes.] (Element 5. Certificate of Confidentiality protections, where obtained, are typically disclosed here — see the Certificate of Confidentiality (CoC) entry.)
7. Compensation for research-related injury. [Applicable only where the study involves more than minimal risk: whether medical treatment is available if injury occurs, at what cost, and where to seek it. Many US institutions state plainly that no financial compensation beyond treatment is provided, absent negligence — language here is institution- and sponsor-specific.] (Element 6 — required only where applicable; state plainly if not applicable rather than omitting the section.)
8. Costs and payment to participants. [Any costs to the participant, and any payment/reimbursement for participation, including schedule and conditions — e.g., prorated payment for partial completion.]
9. Future use of data or biospecimens. [Statement of whether identifiable private information or biospecimens collected in this study may be used or distributed for future research, even after removing identifiers, and whether the participant will be asked for separate consent for that future use — see broad consent for the regulatory option that allows a single consent covering unspecified future secondary research use.] (Element 9 — required since the 2018 Common Rule revisions, where applicable.)
10. Voluntary participation and withdrawal. Taking part in this study is voluntary. You may decline to participate, or withdraw at any time, without penalty or loss of benefits to which you are otherwise entitled. [Any consequences of withdrawal specific to this study, e.g., handling of data already collected.] (Element 8.)
11. Who to contact. Questions about the study: [PI name/contact]. Questions about your rights as a research participant, or to report a concern: [IRB/ethics-committee contact, independent of the study team]. In case of research-related injury: [contact]. (Element 7.)
12. Statement of consent. I have read this form, or had it read to me, and I have had the opportunity to ask questions. I voluntarily agree to participate in this study.
Participant signature: _____________________ Date: _______
Person obtaining consent signature: _____________________ Date: _______
Notes on the elements a template alone won’t get right
Reading level and plain language
46.116(a)(3) requires disclosure “in language understandable to the subject” — many IRBs operationalize this as institutional guidance recommending a specific target reading level (commonly in the 6th-to-8th-grade range for general-population studies), shorter sentences, and avoidance of technical/legal jargon, though the regulation itself does not specify a numeric grade level. Where a study population includes participants with limited English proficiency, a validated translation — not an ad hoc one — is typically required by the IRB, and the translated and English versions must say the same thing.
Short-form and oral consent processes
Where consent is obtained orally (e.g., with a non-English-speaking participant and an interpreter, or in specific waiver circumstances), 46.117 permits a short written form stating that the required elements were presented orally, plus a summary the IRB approves and a witness to the oral presentation — this is a distinct documentation pathway from the full written form shown above, not a substitute IRB approval mechanism.
Assent for pediatric or other populations that cannot independently consent
Where participants are children or others who cannot legally consent for themselves, the form above is replaced or supplemented by parental/guardian permission plus, where the IRB determines the participant is capable, a separate age-appropriate assent document — assent is the participant’s own affirmative agreement, not merely the absence of an objection. See 45 CFR 46 Subpart D for the regulatory basis, and Vulnerable Populations in Research for the broader set of populations (pregnant women, prisoners, cognitively impaired adults) that trigger additional protections beyond Subpart A.
Waiver of the signed-form requirement
An IRB may waive the requirement for a signed form under 46.117(c) in two narrow circumstances: where the signed form would be the only record linking the participant to the study and the principal risk is a confidentiality breach (with the participant then asked whether they want documentation linking them to the research), or where the research is minimal-risk and involves no procedures that would normally require written consent outside a research context. This is a separate provision from waiving the consent process itself (46.116(f)), which has its own four-part test and is commonly conflated with the documentation waiver.
Frequently asked questions
Is this an IRB-approved template I can use directly?
No. This is an illustrative composite built to show the structural mapping between regulatory requirements and document language. Every institution’s IRB maintains its own required consent template, and using an unapproved template for a real submission will be rejected at review. Start from your own IRB’s current template.
What’s the difference between a consent form and the informed consent process?
The process (46.116) is the ongoing exchange of information and opportunity for questions that allows a participant to make a genuinely voluntary, informed decision. The form (46.117) documents that the process occurred. A perfectly worded form does not substitute for an inadequate process, and — under narrow IRB-approved conditions — a form can be waived even where the underlying process is fully required.
Does every consent form need every section shown here?
No. Some elements apply only when relevant — alternatives-to-treatment language applies to interventional studies, not surveys; compensation-for-injury language applies only where the research involves more than minimal risk; future-use-of-biospecimens language applies only where biospecimens or identifiable data are collected and retained. IRBs generally expect a section to be explicitly addressed (including stating plainly that it does not apply) rather than silently omitted.
How is an ICH E6 (clinical trial) consent form different from a Common Rule one?
The substantive disclosure elements are closely aligned, but ICH E6-governed trials typically add explicit language about direct access to source records for monitors, auditors, the IRB/ethics committee, and regulatory authorities (e.g., FDA), and sponsor-specific compensation and confidentiality provisions tied to the clinical trial agreement. Where a study is subject to both frameworks, the form must satisfy the more protective requirement for any given element.
