An informed consent form is a signed record that someone understood what a service or treatment involves (what you’ll do, what could go wrong, what else they could choose) and agreed to go ahead. This free template is written for wellness services and simpler treatments: dry needling at a PT clinic, a chemical peel at a skin studio, cupping, an intensive stretching program. Download it in Word or PDF and fill in the details of your specific service.
One thing to be clear about up front. This is a generic template. It is not a substitute for the procedure-specific consent a physician, dentist or hospital uses, and it isn’t designed for research studies.
When do you need an informed consent form?
You need one before you start a service or treatment that carries real risk, discomfort or a result the person might not expect. The legal idea behind it is old and simple. As Cornell’s Legal Information Institute puts it, “patients must generally give their informed consent prior to medical care.” A written form doesn’t create consent on its own; the conversation does. The form is your record that the conversation happened.
Take a massage therapist who adds cupping to the menu, and a new client who books it. Cupping can leave marks that last days, which surprises people. A two-minute explanation plus a signed consent means nobody feels misled when they look in the mirror the next morning.
Some situations call for a different document. For collecting a new client’s details and health history, use a patient intake form. For a gym, class or physical activity where you want participants to accept inherent risks, a release of liability waiver fits better. Consent says “I understand and agree to this treatment”; a waiver says “I accept the risks of this activity.” They overlap, but they aren’t the same thing.
What should an informed consent form include?
The heart of the form is the description of the service. Everything else hangs on it. Here’s what our template covers.
The service or procedure. Name it and describe what actually happens, in words the client will understand. “Your therapist will place silicone cups on your back for 5 to 10 minutes” beats “myofascial decompression therapy.”
Expected benefits. What the client can reasonably hope for, without promising results. “May reduce muscle tightness” is honest; “will cure your back pain” isn’t.
Risks and discomforts. The ones that are reasonably foreseeable, common or serious. Bruising, soreness, skin irritation, dizziness, whatever applies. Leaving out a known risk because it might scare people away defeats the purpose of the form.
Alternatives. Other options, including doing nothing. This is the section people skip most often, and it’s the one that shows the client had a real choice rather than a single option presented as the only one.
Aftercare and what to report. What the client should do afterward and which symptoms mean they should call you or see a doctor.
Questions and the right to stop. A statement that the client had the chance to ask questions, got answers, and can withdraw consent at any time, including partway through.
Health disclosure. The client confirms they’ve told you about conditions, medications and pregnancy that might make the service unsafe.
Signatures. The client signs, and the provider signs to confirm they explained it. Having both signatures shows the conversation went both ways. If the client is a minor, a parent or guardian signs in their own block as well.
What about research consent and medical procedures?
Research is a separate world. If you’re running a study with human participants that falls under federal rules, consent follows 45 CFR 46. Section 46.116 requires “legally effective informed consent,” information presented in a way a person can understand, and a list of basic elements including the study’s purpose and procedures, foreseeable risks, expected benefits, alternatives, confidentiality, contact information and a statement that participation is voluntary. It also bars exculpatory language that makes subjects waive their legal rights. Your IRB will normally approve the wording, so start from its template, not this one.
For medical procedures, rules on what must be disclosed vary by state, and your licensing board and malpractice insurer may require specific forms. If you’re a licensed clinician, use theirs.
If you’re a HIPAA covered entity (HHS defines that as health plans, clearinghouses, and providers who transmit health information electronically in connection with standard transactions), a signed consent form that includes health details is part of the patient’s protected information. Store it accordingly.
How do you fill it in and get it signed?
Fill in the service description, benefits, risks and alternatives for the one specific service. Resist the urge to make one form cover everything you offer; a vague form that lists twelve treatments tells the client very little. Then:
- Walk the client through it in person or on a video call before the appointment.
- Let them take it home or read it on their phone. Rushing a signature at the treatment table is exactly what you don’t want.
- Both of you sign. Give the client a copy.
- Keep the signed form with the client’s record for as long as your state or board requires.
E-signing is generally fine for consent forms. The signature itself is valid for most documents under federal and state law, which we cover in are electronic signatures legally binding. If you’re a HIPAA covered entity, the tool that stores signed forms needs to sign a business associate agreement with you. SignWren is not yet set up for HIPAA-covered data or BAAs, so it isn’t the right fit for covered practices. If you’re not covered, download it, fill in the blanks, and send it for e-signature with any tool you like. (SignWren isn’t live yet, but it’s being built for paperwork like this; the waitlist is here.)
This template is general information, not legal advice. For your specific service or practice, talk to a lawyer licensed where you are.