Black box medication list
A black box medication list is a clinical reference of drugs that carry an FDA b...
Last Updated: Oct 14, 2026
The Informed Consent Action Network (ICAN) is a US vaccine-policy advocacy group, not a regulator or a clinical consent standard. Practices that need to document consent still need a form that holds up to scrutiny.
This free template gives you that form. It records the proposed treatment, its benefits, risks, and alternatives, and the patient’s right to withdraw. It closes with signatures from the patient and clinician.
Download your free informed consent action network template
A clinical consent form covering patient details, the proposed procedure, benefits, risks and side effects, alternatives, photography consent, and relevant medical history. It ends with a consent declaration and signature lines for the patient, clinician, and parent or guardian.
Download template
Key takeaways
Informed consent is a patient’s voluntary, informed agreement to treatment, built on disclosure of risks and benefits, understanding, free choice, and capacity to decide.
FDA 21 CFR Part 50 sets federal consent requirements for research and clinical investigations, while HIPAA governs patient authorization for using and disclosing health information.
The four core principles are disclosure, comprehension, voluntariness, and competence, and each one should be visible in your consent form.
ICAN is a vaccine-policy advocacy group, so its name carries no clinical or regulatory weight on a consent form.
Pabau, the practice management platform we build, captures consent digitally, stores the e-signature, and files the signed form in the patient record for audits.
Found our content helpful?
What is an informed consent form?
An informed consent form records that a patient was told about a proposed treatment, understood its risks and benefits, and agreed voluntarily. It does three jobs:
- It protects the practitioner by showing that consent was obtained.
- It respects the patient’s right to decide what happens to their own body.
- It creates an audit trail for regulators such as the FDA, HHS, and CQC if compliance is questioned.
The clinical concept and the Informed Consent Action Network share a name and little else. ICAN’s positions on vaccine safety are disputed by mainstream medical organizations, and it sets no clinical standard. This template follows FDA, HIPAA, CQC, and professional medical guidance instead.
The four core principles of informed consent
Every compliant informed consent form should demonstrate four widely recognized elements, consistent with guidance from the HHS Office for Human Research Protections (OHRP). They apply in clinical practice and research alike:
- Disclosure: The practitioner explains what will be done, why, the expected outcome, and the potential risks. A form without specific risk disclosure fails this test.
- Comprehension: The patient shows they understand the information, not just that they received it. Use plain language, skip jargon, and note how you confirmed understanding (for example, “Patient verbally confirmed understanding of infection risk”).
- Voluntariness: Consent is given freely, without coercion, pressure, or undue influence. A patient who signs while in pain, sedated, or rushed can’t give valid voluntary consent. The signature alone doesn’t prove it.
- Competence (decision-making capacity): The patient must have the mental and legal capacity to make the decision. Minors, patients with cognitive impairment, and people under guardianship may need extra safeguards. For a child, use a consent to treat minor form signed by a parent or legal guardian.
What should your consent form include?
A complete form has mandatory and recommended sections. Use this checklist to audit your current template. If you run research, also check it against FDA 21 CFR Part 50.
How to adapt and use the template
Adapting the form to your practice takes five steps:
- Customize the treatment and risk sections: Replace the generic treatment description with your specific procedure (for example, “Botox injection to forehead lines”). List the risks and benefits that apply to your patients and practice. Describe any alternatives clearly so patients can make an informed choice.
- Add your practice branding and contact details: Insert your practice name, address, phone number, and after-hours emergency contact. Emergency contact details are good practice, so patients know who to call if complications arise. In England, the consent process must also respect CQC Regulation 11.
- Screen for contraindications: Add a yes/no checklist of absolute contraindications (for example, current medications, pregnancy, or allergies) and relative ones. Relative contraindications are conditions where the procedure may still go ahead with extra precautions. Make sure the patient answers every item and the practitioner reviews the answers before treatment.
- Choose how you capture consent: Pick wet signatures on paper or e-signatures through digital intake forms. A hybrid also works, where the patient signs a printed copy at the appointment. Digital consent is faster to search and files straight into the patient record, which cuts manual filing errors.
- Store and retain it securely: After signing, file the consent in the patient’s electronic record with secure patient record storage and audit timestamps. Keep the original paper or PDF for as long as your jurisdiction requires. Seven to 10 years is a common general range, not a rule. In England, the NHS Records Management Code of Practice sets eight years after the patient’s last treatment for adult records. In the US, check your state’s retention law and the statute of limitations for your treatment type.
FDA, HIPAA, and CQC consent rules
Informed consent is a legal requirement, but which rule applies depends on where you practice and what you’re doing. Here’s how the main US and English regulators frame it.
FDA 21 CFR Part 50. The FDA requires informed consent for the clinical investigations it regulates, such as studies of drugs and devices. A clinical procedure falls under it only when it is part of such an investigation. Under 21 CFR 50.25(a), the consent must cover eight basic elements:
- A statement that the study involves research, and its purpose
- Reasonably foreseeable risks or discomforts
- Benefits the subject or others can reasonably expect
- Appropriate alternative procedures or treatments
- How the confidentiality of records will be maintained
- Any compensation or medical treatment available if injury occurs
- Contacts for questions and for research-related injuries
- A statement that participation is voluntary and that refusing carries no penalty
Signed, dated documentation of that consent is a separate requirement under 21 CFR 50.27.
HIPAA Privacy Rule. HIPAA requires practices to get patient authorization before using or disclosing protected health information (PHI) for purposes beyond treatment, payment, and health care operations. Informed consent and HIPAA authorization are separate documents. Consent is clinical, while authorization covers how health information is used. Where you need both, use a dedicated HIPAA authorization form alongside this template.
CQC Regulation 11 (England). The Care Quality Commission regulates health and social care in England only. Regulation 11 requires care and treatment to be provided only with the consent of the relevant person. If the person lacks capacity, providers must act under the Mental Capacity Act 2005. Consent given under pressure, in pain, or without enough information is not valid.
Side by side, the three rules govern three different documents, which is why one form can’t satisfy all of them.
Research vs. clinical consent. If you run clinical trials or enroll patients in studies, consent requirements are stricter. An institutional review board (IRB) must review and approve the form. Researchers must also disclose more about study risks, compensation, and data use than clinical consent requires. A clinical consent template like this one won’t meet federal research standards on its own.
Pro Tip
Have a healthcare attorney review your consent form before you roll it out. A form that passes in one state (such as California) or country (such as the UK) may fail in another. A lawyer can check it against your treatments, patient population, and jurisdiction, and spot the clauses that need changing.
How Pabau handles consent capture and storage
Many practices still download a PDF like this one, print it, collect a wet signature, then scan the page into a patient file. Each handoff is a chance for a form to go missing before an audit.
In Pabau’s digital forms, you build a consent form once per treatment and send it to the patient before the visit. Patients sign on their own device, and the signed form files against their record with a timestamp. Your front desk stops chasing paperwork on the day.
Pabau GO, our iOS app for practitioners, shows outstanding consents in each patient’s pre-appointment checklist. Practitioners can see whether consent is signed before treatment starts, so no one treats on an unsigned form.
Collect signed consent before every treatment
Pabau sends treatment-specific consent forms before the appointment, captures the e-signature, and files it in the patient record. Your consent trail is ready when an auditor asks.
Conclusion
A consent form is only as strong as the conversation behind it. Use this template as the record, but make disclosure, comprehension, and the patient’s freedom to say no part of every consultation.
Before you roll it out, tailor the risks to each treatment and have a healthcare attorney check it against your jurisdiction. Decide where signed copies will live, too. Pairing the form with automated compliance tracking keeps renewals and audits from slipping.
Book a demo to see how Pabau sends, collects, and files signed consent forms, so each one stays attached to the right patient record.
Continue your research
Treating adults outside a research setting? Medical consent form for adults gives you a general consent template for routine treatment.
Need to use or share patient health information? HIPAA authorization form covers the separate authorization HIPAA requires.
Treating a patient under 18? Consent to treat minor form records a parent or guardian’s permission before treatment.
Running a dental practice? Dental treatment consent form adapts consent and its legal requirements to dental procedures.
Releasing records to a third party? Authorization for release of confidential information documents the patient’s permission before records leave your practice.
Frequently asked questions
What is the difference between informed consent and the Informed Consent Action Network (ICAN)?
Informed consent is a clinical and legal standard. It means a patient’s voluntary, informed agreement to a medical procedure. ICAN is a US advocacy organization focused on vaccine policy and litigation. It isn’t a clinical authority or regulator, and this template follows clinical consent standards rather than ICAN’s advocacy.
What are the four elements of informed consent?
The four core elements are disclosure (providing full information), comprehension (confirming understanding), voluntariness (no coercion), and competence (the capacity to decide). Document all four in the consent form and your practitioner notes.
Is a patient’s signature alone enough to prove informed consent?
No. A signature proves only that the patient signed the form, not that they understood it, agreed freely, or had capacity. Note how you confirmed comprehension, such as “Practitioner reviewed risks and alternatives with the patient.” Record any barriers to understanding, like language or cognitive impairment. Keep contemporaneous notes in the patient record alongside the signed form.
How long should you keep signed consent forms?
In the US, follow your state’s record retention law and the statute of limitations for malpractice claims. Limitation periods typically run two to 10 years from the injury, and longer for minors. In England, the NHS Records Management Code of Practice sets eight years after the patient’s last treatment for adult records. Some jurisdictions require longer retention for serious procedures, so check with your regulator.
Can I use a digital consent form, or must the patient sign in person?
Digital consent is legally valid in most US states and the UK, provided the e-signature tool keeps an audit trail, timestamps, and encryption. That applies whether you use DocuSign, Adobe Sign, or built-in practice software. Many practices send forms before the appointment through a patient portal, capture the e-signature, and file it automatically. That’s compliant and faster than paper.
What if my patient cannot read or understand English?
Use a qualified interpreter, and document their name and credentials in the record. Avoid relying on family members except in an emergency, because accuracy and voluntariness can’t be assured. Provide the form in the patient’s primary language where possible, signed by the patient and the interpreter or clinician. Never rely on the signature alone without checking understanding.
Found our content helpful?
