Informed Consent Form

An Informed Consent Form in the United States authorises a defined activity and evidences that the necessary permission was given.

The doctrine of informed consent in the United States traces its modern development to Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), in which the United States Court of Appeals for the District of Columbia Circuit established the patient-centered standard of disclosure — that providers must disclose information material to a reasonable patient's decision, not merely what a reasonable practitioner would disclose. Canterbury replaced the older professional standard in many US jurisdictions, and states including California, Washington, Pennsylvania, and Alaska have adopted variations of the patient-centered standard by statute or case law.

For clinical research conducted with federal funding or regulated by the Food and Drug Administration, the federal Common Rule (45 C.F.R. Part 46, revised 2018) and FDA regulations at 21 C.F.R. Parts 50 and 56 establish mandatory requirements for informed consent documents reviewed and approved by an Institutional Review Board (IRB). The 2018 revision of the Common Rule introduced requirements for a concise summary of the key information that a reasonable person would want to know before deciding to participate, to be placed at the beginning of consent documents. Under 45 C.F.R. § 46.116, the eight basic elements of informed consent include: a statement of the purpose of the research; a description of foreseeable risks or discomforts; a description of expected benefits; disclosure of appropriate alternative procedures or treatments; a statement of confidentiality protections; contact information for questions about the research and about participant rights; a statement that participation is voluntary; and a statement about any compensation available to research-related injury.

Beyond medical and research contexts, Informed Consent Forms are required for tattoo and body piercing services (mandated in states such as California, New York, and Texas for minors and recommended for adults), cosmetic procedures, fitness training, photography releases, and any activity where the provider wishes to document the participant's voluntary, informed agreement.

An Informed Consent Form in the United States is required whenever a healthcare provider, researcher, tattoo artist, cosmetic practitioner, personal trainer, or any other service provider needs to document that a participant voluntarily agreed to an activity after receiving complete disclosure of its risks, benefits, and alternatives.

Hospitals, outpatient surgery centers, and physician offices across all 50 states require written informed consent before performing elective surgical procedures — including orthopedic surgery, cardiac catheterization, endoscopy, cosmetic surgery, and any procedure requiring anesthesia. The Joint Commission (formerly JCAHO), which accredits more than 22,000 US healthcare organizations, mandates informed consent as a condition of accreditation. State medical licensing boards in California (Medical Board of California), New York (New York State Education Department), and Texas (Texas Medical Board) impose discipline on providers who perform procedures without adequate informed consent.

Clinical research studies conducted or funded by a US federal department subject to the Common Rule (45 C.F.R. Part 46) must obtain written informed consent from each research participant (or their legally authorized representative) before enrollment. Studies regulated by the FDA under 21 C.F.R. Part 50 — including drug trials, device trials, and biologic trials — require IRB-approved consent forms with the eight mandatory elements plus applicable additional elements. Research institutions affiliated with NIH (National Institutes of Health), NCI (National Cancer Institute), and VA (Department of Veterans Affairs) are subject to these requirements without exception.

Tattoo and body piercing studios in California (Health and Safety Code § 119302), New York, Florida, and Texas must obtain written consent from adult clients and parental consent for minors. Cosmetic procedure clinics performing Botox injections, dermal fillers, chemical peels, and laser treatments use informed consent forms to document disclosure of potential side effects and the voluntary nature of the elective procedure.

Personal training studios, martial arts schools, CrossFit gyms, and adventure sports operators (rock climbing, white-water rafting, skydiving) use Informed Consent Forms — often combined with liability waivers — to document that participants understood and accepted the inherent physical risks of the activity before participating.

A legally effective Informed Consent Form in the United States must contain the following essential components to satisfy the requirements of common law informed consent doctrine, the Common Rule (45 C.F.R. Part 46), FDA regulations (21 C.F.R. Part 50), and applicable state statutes.

The description of the procedure or activity must explain in plain language — avoiding technical jargon that the participant would not understand — the specific nature of the medical procedure, research study, or service to be performed. For surgical procedures, the description should name the specific operation, the body part involved, the anesthesia method, and the expected duration. For research, the description should explain the study purpose, the participant's specific activities (number of visits, blood draws, questionnaires), and the experimental nature of the intervention.

The disclosure of material risks must identify the reasonably foreseeable risks or discomforts associated with the procedure or activity — both common minor risks and rare but serious risks — in terms a reasonable person could understand. Under Canterbury v. Spence and its progeny, the materiality standard requires disclosure of risks that a reasonable patient would want to know before deciding, regardless of how remote the probability. The risk disclosure for a consent form used in surgery, for example, must cover infection, bleeding, anesthesia complications, nerve damage, and procedure-specific risks.

The expected benefits section must describe what the participant may gain from the procedure or activity — symptom relief, diagnostic information, potential cure, research advancement — without overstating expected outcomes. Providers must not promise outcomes or create unrealistic expectations.

The alternatives section must identify other reasonably available procedures or treatments, including the option of no treatment or no participation, and must briefly explain why the proposed procedure is being recommended over the alternatives. Under the patient-centered standard, a reasonable patient would want to know whether a less invasive or lower-risk alternative exists.

The voluntary participation and right to withdraw clause must state in clear language that participation is entirely voluntary, that the participant may refuse or withdraw consent at any time without penalty, without affecting the quality of their medical care (in the healthcare context), and without loss of any benefits to which they are otherwise entitled.

For research under the Common Rule or FDA regulations, the confidentiality protections section must explain how participant data will be stored, who will have access, how identifiable information will be protected or de-identified, and whether data may be shared with government agencies such as the FDA or NIH.

The contact information section must provide the name and phone number of a specific person the participant can contact with questions about the procedure or study, and a separate contact (such as an IRB or patient advocate) for questions about the participant's rights.

The signature and date block must capture the signature of the participant (or legally authorized representative for minors or incapacitated adults) with the date of signing, and in research contexts, the signature of the person obtaining consent. For research, the consent form must be provided to the participant in writing.