Informed Consent

Source: Common law doctrine of informed consent, established in Schloendorff v. Society of New York Hospital, 211 N.Y. 125 (1914) ("Every human being of adult years and sound mind has a right to determine what shall be done with his own body"). Federal regulations for research: 45 C.F.R. Part 46 (Common Rule). Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972) established the patient-centered "reasonable patient" standard.

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Written in plain language for general understanding. This is educational content, not legal advice. Based on federal statutes and official sources.

Federal Law

What is this right?

Informed consent means your doctor must explain a treatment, procedure, or test to you in plain language before you agree to it. You have the right to understand what will be done, why it is recommended, what the risks and benefits are, and what alternatives exist — including the option of doing nothing.

Informed consent is not just signing a form. It is an ongoing conversation between you and your healthcare provider. You must be given enough information to make a meaningful decision, and you must agree voluntarily — without pressure, threats, or being rushed. You also have the right to refuse any treatment, even if your doctor recommends it.

When does it apply?

This right applies when:

  • A doctor recommends surgery, a medical procedure, or a treatment plan
  • You are asked to participate in a clinical trial or medical research study
  • A healthcare provider wants to prescribe medication with significant risks or side effects
  • You are deciding whether to continue or stop treatment

Exceptions where informed consent is not required:

  • Medical emergencies: If you are unconscious or unable to communicate, and delaying treatment would risk death or serious harm, providers can treat you without consent under the emergency exception.
  • Therapeutic privilege: In rare cases, a doctor may withhold information if disclosing it would seriously harm the patient (this exception is very narrow and controversial).
  • Patient waiver: You can voluntarily tell your doctor that you do not want to know the details and want them to make the decision. This must be a genuine, informed choice.

Common misconceptions:

  • “Signing the form means I gave informed consent” — The form is evidence of consent, but true informed consent requires a conversation where your questions are answered.
  • “I can't say no to my doctor” — You always have the right to refuse treatment. A competent adult can refuse any medical procedure, even lifesaving ones.
  • “Informed consent only applies to surgery” — It applies to any treatment, test, or procedure that carries risks, including medications, imaging tests, and vaccinations.

What should you do?

Step 1: Ask your doctor these questions before any procedure: What exactly will be done? Why do you recommend it? What are the risks and possible complications? What are the benefits? Are there alternatives? What happens if I choose not to do it?

Step 2: Take your time. You are not required to decide immediately unless it is a true emergency. Ask for written information about the procedure and take it home to review.

Step 3: If you do not speak English well, request an interpreter. Healthcare providers that receive federal funding must provide language access services under Title VI of the Civil Rights Act of 1964 (42 U.S.C. § 2000d).

Step 4: If you decide to refuse treatment, tell your doctor clearly. Ask them to document your refusal and their explanation of the risks of refusing. This protects both you and the provider.

Step 5: If you believe you were treated without proper informed consent, contact a medical malpractice attorney. You can also file a complaint with your state medical board or the hospital's patient advocate.

What should you NOT do?

Don't sign consent forms without reading them. The form should describe the procedure, risks, benefits, and alternatives. If anything is unclear, ask questions before signing.

Don't feel pressured to decide on the spot. Unless it is a genuine emergency, you have the right to think about your options, get a second opinion, and consult with family members.

Don't assume consent for one procedure covers other procedures. Consent is specific. If your surgeon finds a different problem during surgery, they generally cannot perform an additional procedure without your prior consent (unless it is a medical emergency).

Don't confuse informed consent with a guarantee. Consenting to a procedure means you understand the risks — it does not mean the doctor is promising a specific outcome.

New Jersey Law
NJ

How New Jersey differs from federal law

New Jersey has detailed informed consent protections through case law and statute:

  • NJ Advance Directives Act (N.J.S.A. 26:2H-53 et seq.): One of the most comprehensive advance directive laws in the country. Allows patients to create instruction directives (living wills) and proxy directives (healthcare power of attorney), and provides detailed rules for surrogate decision-making.
  • Informed consent standard: New Jersey follows the "prudent patient" standard established in case law — providers must disclose what a reasonable patient would want to know. This is a patient-centered standard rather than a physician-centered one.
  • NJ Patient's Bill of Rights (N.J.A.C. 8:43G-4.1): Requires hospitals to inform patients of their right to make informed decisions about care, including the right to refuse treatment and the right to be told about their diagnosis, treatment, and prognosis in terms they can understand.
  • Mental health treatment: N.J.S.A. 30:4-24.2 provides specific informed consent requirements for mental health treatment, including the right to refuse medication except in emergencies or when a court orders treatment.

Additional Steps in New Jersey

File a complaint with the NJ Department of Health at nj.gov/health or call (800) 792-9770. For medical malpractice involving informed consent, contact the NJ State Bar Association Lawyer Referral Service at (800) 792-8315. Contact Legal Services of New Jersey at lsnj.org for free legal help.

Relevant Law: N.J.S.A. 26:2H-53 et seq. (Advance Directives Act), N.J.A.C. 8:43G-4.1 (Patient's Bill of Rights), N.J.S.A. 30:4-24.2 (mental health treatment consent)

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