INFORMED CONSENT — GENERAL MEDICAL

Purpose of This Form

This form documents the process of informed consent for a proposed medical procedure, treatment, or diagnostic test. The doctrine of informed consent is a fundamental principle of medical law requiring that a healthcare provider disclose material information about a proposed treatment or procedure, enabling the patient to make a knowledgeable, voluntary decision about whether to proceed.

LEGAL FOUNDATION: The modern informed consent doctrine was established in Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), which adopted the "reasonable patient" standard — requiring disclosure of all information that a reasonable person in the patient's position would find material to their decision. Cobbs v. Grant, 8 Cal. 3d 229 (Cal. 1972), adopted a similar patient-based standard requiring disclosure of "all significant perils" including the risk of death, bodily harm, and problems of recuperation.

TWO STANDARDS IN AMERICAN LAW:
- Reasonable Patient Standard (majority of jurisdictions): The provider must disclose what a reasonable patient would consider material to their decision. Used in: CA, DC, FL, LA, NJ, OH, OK, PA, TX, WA, and others.
- Reasonable Physician Standard (professional community standard): The provider must disclose what a reasonable physician in the same or similar community would disclose under similar circumstances. Used in: AR, CO, DE, ID, IN, KY, ME, MI, MN, MT, NE, NH, NC, SC, TN, VT, VA, WI, and others.
- Hybrid/Statutory Standards: Some states have adopted statutory standards that incorporate elements of both (e.g., NY, TX).

SECTION 1: PATIENT INFORMATION

Patient Full Legal Name: [________________________________]

Date of Birth: [__/__/____]

Medical Record Number: [________________________________]

Address: [________________________________]

City/State/ZIP: [________________________________]

Telephone: [________________________________]

Primary Language: [________________________________]

Interpreter Needed: ☐ Yes ☐ No

SECTION 2: PROVIDER INFORMATION

Treating/Performing Provider Name: [________________________________]

Title/Specialty: [________________________________]

License Number: [________________________________]

Facility Name: [________________________________]

Facility Address: [________________________________]

Date of Proposed Procedure/Treatment: [__/__/____]

Time (if scheduled): [____]

2.1 Additional Providers

Identify all providers who will participate in the procedure, including assistants, residents, fellows, or other practitioners who will perform a significant portion of the procedure.

☐ Teaching/training institution: Medical students, residents, or fellows may observe or participate in the procedure under the supervision of the attending physician. ☐ I consent to their participation. ☐ I do not consent to their participation.

SECTION 3: DESCRIPTION OF PROPOSED PROCEDURE/TREATMENT

3.1 Name of Proposed Procedure/Treatment

[________________________________]

3.2 Description in Plain Language

The provider must describe the proposed procedure or treatment in language the patient can understand, avoiding technical jargon unless the terms are explained.

[________________________________]

[________________________________]

[________________________________]

[________________________________]

3.3 Purpose of the Proposed Procedure/Treatment

Explain why the procedure or treatment is being recommended and what it is expected to accomplish.

[________________________________]

[________________________________]

[________________________________]

3.4 Expected Benefits

Describe the reasonably expected benefits of the proposed procedure or treatment.

[________________________________]

[________________________________]

[________________________________]

SECTION 4: MATERIAL RISKS AND POSSIBLE COMPLICATIONS

The provider must disclose all material risks — those risks that a reasonable person in the patient's position would consider significant in deciding whether to consent. This includes common risks (even if not serious), rare but serious risks (especially those involving death, disability, or disfigurement), and risks specific to this patient's condition.

4.1 Common Risks (risks occurring in more than 1% of cases)

☐ Pain and discomfort

☐ Bleeding

☐ Infection

☐ Swelling and bruising

☐ Scarring

☐ Allergic reaction to medications or materials

☐ Nausea and vomiting

☐ Other: [________________________________]

4.2 Less Common but Serious Risks (risks occurring in less than 1% of cases but of significant consequence)

☐ Nerve damage (temporary or permanent)

☐ Organ damage or perforation

☐ Blood clots (deep vein thrombosis, pulmonary embolism)

☐ Stroke

☐ Heart attack

☐ Adverse reaction to anesthesia

☐ Need for additional surgery or treatment

☐ Permanent disability

☐ Death

☐ Other: [________________________________]

4.3 Risks Specific to This Procedure/Treatment

[________________________________]

[________________________________]

[________________________________]

[________________________________]

4.4 Patient-Specific Risk Factors

Document any conditions or circumstances that increase this patient's individual risk level.

☐ Advanced age

☐ Obesity

☐ Diabetes

☐ Cardiovascular disease

☐ Pulmonary disease

☐ Bleeding disorder or anticoagulant use

☐ Immunocompromised status

☐ Smoking

☐ Prior surgeries or procedures in the same area

☐ Allergies: [________________________________]

☐ Current medications: [________________________________]

☐ Other risk factors: [________________________________]

SECTION 5: ALTERNATIVES TO THE PROPOSED PROCEDURE/TREATMENT

The provider must discuss reasonable alternatives, including the risks and benefits of each alternative and the option of no treatment.

5.1 Alternative Treatment Options

5.2 No Treatment / Watchful Waiting

Risks of declining or delaying the proposed procedure/treatment:

[________________________________]

[________________________________]

[________________________________]

Expected outcome without treatment:

[________________________________]

[________________________________]

SECTION 6: EXPECTED OUTCOMES AND RECOVERY

6.1 Expected Outcome

Describe the expected outcome of the procedure/treatment. Note that no guarantees can be made.

[________________________________]

[________________________________]

I understand that no guarantee has been made to me regarding the outcome of this procedure or treatment.

6.2 Recovery Information

Expected recovery time: [________________________________]

Post-procedure restrictions or limitations: [________________________________]

Follow-up appointments required: [________________________________]

Medications that may be prescribed: [________________________________]

SECTION 7: SPECIAL CONSENT CATEGORIES

If any of the following apply, the patient must provide specific consent for each applicable category.

7.1 Anesthesia Consent

☐ This procedure involves anesthesia. Type of anesthesia to be administered:

☐ General anesthesia

☐ Regional anesthesia (spinal, epidural, nerve block)

☐ Local anesthesia

☐ IV sedation / Monitored anesthesia care (MAC)

☐ Topical anesthesia

Anesthesia provider name: [________________________________]

Risks specific to anesthesia include: allergic reaction, breathing difficulties, aspiration, cardiovascular complications, nerve damage, nausea, vomiting, malignant hyperthermia (rare), brain damage, death.

☐ I consent to the administration of anesthesia as described above.

☐ I decline anesthesia and understand the consequences.

7.2 Blood Transfusion Consent/Refusal

☐ This procedure may require a blood transfusion.

Risks of blood transfusion include: allergic reaction, fever, infection (including but not limited to hepatitis, HIV, and other bloodborne pathogens), hemolytic transfusion reaction, transfusion-related acute lung injury (TRALI), volume overload, and death.

☐ I consent to receiving blood and blood products as deemed medically necessary.

☐ I refuse all blood and blood products. I understand that refusal of blood transfusion may result in serious complications, including death, and I accept full responsibility for the consequences of this decision. I release the healthcare providers and facility from liability arising from my refusal of blood products.

Jehovah's Witness / Religious Objection to Blood Products:
☐ I refuse blood and blood products based on religious beliefs. I understand and accept the risks, including death. I request that alternative methods of treatment be used to the extent available.
☐ I consent to the following blood fractions or alternatives (check all accepted):
☐ Albumin
☐ Immunoglobulins
☐ Clotting factors
☐ Erythropoietin (EPO)
☐ Cell salvage / Autotransfusion
☐ Hemodilution
☐ Other: [________________________________]

7.3 Diagnostic Procedure Consent

☐ This consent is for a diagnostic procedure.

Diagnostic procedure: [________________________________]

I understand that the diagnostic procedure may reveal unexpected findings that could require additional treatment or procedures, for which separate consent may be sought.

7.4 Surgical Procedure Consent

☐ This consent is for a surgical procedure.

I understand that during the surgery, unanticipated conditions may be discovered that require extension or modification of the planned procedure:

☐ I authorize the surgeon to perform any additional procedure(s) that, in the surgeon's professional judgment, are necessary or advisable during the course of surgery.

☐ I authorize additional procedures only in the case of a life-threatening emergency.

☐ I do not authorize any additional procedures. If an unanticipated condition is discovered, I request that the surgeon complete the planned procedure and consult with me before performing any additional procedure.

7.5 Experimental, Investigational, or Off-Label Treatment

☐ The proposed treatment involves an experimental, investigational, or off-label use.

Description: [________________________________]

☐ I understand that the proposed treatment or use of medication/device is experimental, investigational, or for an off-label indication not specifically approved by the FDA for my condition.

☐ I understand that additional risks may be unknown because this is an experimental/off-label use.

☐ I have been informed of available FDA-approved alternatives.

Note: If this involves a clinical trial or research study, a separate research informed consent under the Common Rule (45 C.F.R. Part 46) and/or FDA regulations (21 C.F.R. Part 50) is required.

7.6 Photography, Recording, and Educational Use

☐ I consent to clinical photography or recording for treatment documentation purposes.

☐ I consent to the use of de-identified photographs, recordings, or images for medical education, training, or quality improvement purposes.

☐ I consent to the use of photographs, recordings, or images for publication in medical journals or presentations, provided my identity is protected.

☐ I do not consent to any photography or recording beyond what is required for treatment purposes.

SECTION 8: EMERGENCY EXCEPTION TO INFORMED CONSENT

This section documents the legal exception to informed consent in emergency situations.

Under the emergency exception doctrine, informed consent is not required when:

1. The patient is incapacitated or unable to consent (due to unconsciousness, severe impairment, or other incapacity);
2. No legally authorized representative is available to provide consent;
3. The patient faces an imminent threat to life or serious harm; and
4. A reasonable person in the patient's position would consent to the treatment.

If this procedure is being performed under the emergency exception:

☐ This procedure is being performed without prior informed consent because an emergency condition exists.

Description of emergency: [________________________________]

Basis for determining patient incapacity: [________________________________]

Efforts made to locate authorized representative: [________________________________]

Provider Name: [________________________________]

Date/Time: [__/__/____] at [____]

SECTION 9: THERAPEUTIC PRIVILEGE

The therapeutic privilege is a limited exception to the duty of disclosure, applicable only when the provider reasonably believes that disclosure would so seriously upset the patient as to be medically contraindicated. This exception is narrowly construed.

☐ Therapeutic privilege has been invoked. The following information was withheld from the patient because, in the provider's professional judgment, disclosure would:

☐ So seriously upset the patient that the patient would not be able to rationally weigh the risks and benefits

☐ Cause severe psychological harm

Information withheld: [________________________________]

Medical justification: [________________________________]

Provider Signature: ______________________________

Date: [__/__/____]

WARNING: The therapeutic privilege is disfavored by courts and should be invoked only in exceptional circumstances. It may not be used to withhold information merely because the provider believes the patient will refuse treatment. Consult legal counsel before relying on this exception.

SECTION 10: PATIENT CAPACITY ASSESSMENT

10.1 Capacity to Consent

The provider has assessed the patient and determined:

☐ The patient has decision-making capacity — The patient demonstrates the ability to:
- Understand the relevant information being disclosed
- Appreciate how the information applies to their own medical situation
- Reason about the options (weigh risks and benefits)
- Communicate a choice

☐ The patient lacks decision-making capacity — If checked, consent must be obtained from a legally authorized representative (see Section 13).

Basis for capacity determination: [________________________________]

10.2 Factors Affecting Capacity

☐ Patient is alert, oriented, and demonstrates understanding

☐ Patient is under the influence of medications that may affect cognition (specify): [________________________________]

☐ Patient has a cognitive impairment or developmental disability

☐ Patient has a psychiatric condition that may affect decision-making

☐ Patient is a minor (see Section 13.3)

☐ Other: [________________________________]

SECTION 11: REFUSAL OF TREATMENT (INFORMED REFUSAL)

A patient who has decision-making capacity has the right to refuse any proposed treatment or procedure. The provider should document the refusal and the potential consequences discussed.

11.1 Informed Refusal Documentation

☐ The patient has been offered the proposed procedure/treatment described in Section 3 and has declined.

Reason for refusal (if provided): [________________________________]

Consequences of refusal discussed with patient:

☐ The condition may worsen

☐ Additional treatment may become necessary

☐ Permanent injury or disability may result

☐ Death may result

☐ Other: [________________________________]

The patient acknowledges understanding the risks of refusing treatment.

Patient Signature (refusal): ______________________________

Date: [__/__/____]

Provider Signature: ______________________________

Date: [__/__/____]

Witness Signature: ______________________________

Date: [__/__/____]

SECTION 12: AGAINST MEDICAL ADVICE (AMA) DISCHARGE

If a patient wishes to leave the facility or discontinue treatment against the recommendation of the treating provider.

☐ The patient has requested discharge/discontinuation of treatment against medical advice.

The following has been explained to the patient:

☐ The medical condition being treated and its current status

☐ The recommended course of treatment

☐ The risks of leaving/discontinuing treatment, including but not limited to:

☐ Worsening of the medical condition

☐ Serious complications that may be life-threatening

☐ Death

☐ Other: [________________________________]

☐ Instructions for follow-up care and when to seek emergency treatment

☐ Prescriptions and medications currently being administered

Patient Statement: I, the undersigned, hereby acknowledge that I am leaving this facility (or discontinuing treatment) against the advice of my treating physician(s). I have been informed of the risks of doing so, including those listed above. I release the healthcare providers and facility from responsibility for any adverse consequences that may result from my decision.

Patient Signature: ______________________________

Date: [__/__/____]

Time: [____]

Provider Signature: ______________________________

Date: [__/__/____]

Witness Signature: ______________________________

Date: [__/__/____]

If the patient refuses to sign the AMA form:
☐ Patient refused to sign AMA documentation. This refusal was witnessed by: [________________________________]

SECTION 13: ADVANCE DIRECTIVES AND DNR INTEGRATION

13.1 Advance Directive Status

☐ Patient has an advance directive on file (Living Will, Healthcare Power of Attorney, or POLST/MOLST)

☐ Copy obtained and placed in medical record

☐ Patient does not have an advance directive

☐ Patient has been offered information about advance directives (per 42 U.S.C. § 1395cc(f) — Patient Self-Determination Act)

13.2 Do Not Resuscitate (DNR) / Do Not Intubate (DNI) Status

☐ Patient has a valid DNR order

☐ Patient has a valid DNI order

☐ DNR/DNI status has been discussed in the context of this procedure

☐ Patient wishes to suspend DNR/DNI during the procedure and immediate post-operative period

☐ Patient wishes to maintain DNR/DNI during the procedure

Note: Many facilities have policies requiring a discussion about DNR status in the perioperative setting. Document the patient's wishes clearly.

SECTION 14: STATE-SPECIFIC INFORMED CONSENT REQUIREMENTS

14.1 California

(a) Standard: California follows the reasonable patient standard (Cobbs v. Grant, 8 Cal. 3d 229 (1972)). The provider must disclose all significant perils, defined as "the risk of death or bodily harm, and problems of recuperation."

(b) MICRA (Cal. Civ. Code § 3333.1): The Medical Injury Compensation Reform Act of 1975 caps noneconomic damages in medical malpractice actions (including informed consent claims). As of January 1, 2023, under AB 35, the caps are $350,000 for cases not involving death, increasing $40,000 annually for 10 years; and $500,000 for wrongful death cases, increasing $50,000 annually for 10 years.

(c) Arbitration Agreements: Under Cal. Code Civ. Proc. § 1295, a contract for medical services may include an agreement to arbitrate disputes, provided it meets specific requirements (bold 10-point red type notice, 30-day rescission period, not a prerequisite to treatment).

(d) Physician Extenders: When a physician assistant or nurse practitioner will perform a procedure, the supervision arrangements must be disclosed.

(e) Experimental Treatment: Cal. Health & Safety Code § 24170 et seq. (Protection of Human Subjects in Medical Experimentation Act) requires specific informed consent for experimental procedures, including written consent in the patient's language.

14.2 Texas

(a) Standard: Texas uses a statutory/panel-based approach. The Texas Medical Disclosure Panel (established under Tex. Civ. Prac. & Rem. Code § 74.103) publishes lists of procedures and their associated risks and hazards that must be disclosed.

(b) List A and List B Procedures:
- List A procedures require specific written disclosure of risks identified by the Panel (22 Tex. Admin. Code § 601.2–601.6). The use of a Panel-approved disclosure form creates a rebuttable presumption that adequate disclosure was made.
- List B procedures are those for which the Panel has determined no specific disclosure is required. A signed consent form for a List B procedure creates a rebuttable presumption that adequate disclosure was made.
- Procedures not on either list are governed by the general duty of disclosure under the reasonable patient standard.

(c) TMLA (Tex. Civ. Prac. & Rem. Code Ch. 74): The Texas Medical Liability Act governs medical malpractice claims, including informed consent claims. Section 74.104 provides that a physician or health care provider has a duty to disclose risks and hazards inherent in the proposed treatment or procedure when the treatment or procedure involves an invasive procedure in which there is a substantial risk of harm to the patient.

(d) Emergency Exception: Under Tex. Civ. Prac. & Rem. Code § 74.106, consent is implied when the patient is unconscious or otherwise unable to consent and an immediate threat to life exists.

14.3 Florida

(a) Standard: Florida follows the reasonable patient standard. Under Fla. Stat. § 766.103(3), informed consent requires that "a reasonable individual, from the information provided by the physician, would have a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures."

(b) Florida Medical Consent Law (Fla. Stat. § 766.103): No recovery is allowed against a physician in an action for treating without informed consent when:
- (a) The action of the physician was in accordance with an accepted standard of medical practice among members of the medical profession with similar training and experience in the same or similar community; and
- (b) A reasonable individual would have a general understanding of the procedure, alternatives, and substantial risks from the information provided.

(c) Written Consent Presumption: A consent form that provides a general description of the procedure, the alternatives, and the material risks, signed by the patient, creates a rebuttable presumption that informed consent was obtained.

(d) Emergency Exception: Under Fla. Stat. § 766.103(4), consent is implied when an emergency exists, the patient is unable to give consent, and there is no one legally authorized and available to give consent.

14.4 New York

(a) Standard: New York uses a hybrid approach under N.Y. Pub. Health Law § 2805-d. "Lack of informed consent" means the failure of the person providing professional treatment or diagnosis to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved as a reasonable medical, dental or podiatric practitioner under similar circumstances would have disclosed, in a manner permitting the patient to make a knowledgeable evaluation.

(b) Scope of Actions (N.Y. Pub. Health Law § 2805-d(2)): The right of action for malpractice based on lack of informed consent is limited to cases involving:
- Non-emergency treatment, procedure, or surgery; or
- A diagnostic procedure that involves invasion or disruption of the integrity of the body.

(c) Defenses (N.Y. Pub. Health Law § 2805-d(4)): Defenses to a lack of informed consent claim include:
- (a) The risk not disclosed is too commonly known to warrant disclosure;
- (b) The patient assured the practitioner they would undergo the treatment regardless of the risk, or did not want to be informed of the risks;
- (c) Consent was not reasonably possible (emergency);
- (d) The practitioner used reasonable discretion because disclosure could adversely and substantially affect the patient's condition (therapeutic privilege).

(d) Causation: The patient must prove that a reasonably prudent person in the patient's position would not have undergone the treatment if properly informed of the risks (a subjective/objective hybrid test).

SECTION 15: LANGUAGE ACCESSIBILITY

15.1 Language Assistance

Under Title VI of the Civil Rights Act of 1964 and CMS Conditions of Participation (42 C.F.R. § 482.13), healthcare facilities receiving federal funds must provide meaningful access to patients with limited English proficiency (LEP).

☐ Patient speaks, reads, and understands English. No interpreter services needed.

☐ Patient requires interpreter services. Language: [________________________________]

Method of interpretation:

☐ In-person qualified medical interpreter

☐ Qualified bilingual staff member

☐ Telephone interpretation service

☐ Video remote interpretation (VRI) service

☐ American Sign Language (ASL) interpreter

IMPORTANT: Family members, friends, and minor children should NOT be used as interpreters for informed consent discussions unless specifically requested by the patient after being offered qualified interpreter services.

15.2 Translated Consent Form

☐ This consent form has been provided in the patient's primary language: [________________________________]

☐ This consent form is in English. The contents have been fully interpreted to the patient by a qualified interpreter (identified in Section 18.4 below).

15.3 Patient Literacy

☐ Patient has been assessed as being able to read and understand this form.

☐ Patient cannot read. This form has been read aloud to the patient, and the patient verbally confirms understanding.

SECTION 16: PATIENT QUESTIONS AND CONFIRMATION OF UNDERSTANDING

16.1 Patient Acknowledgment

I, the undersigned patient (or authorized representative), confirm and acknowledge the following:

☐ The proposed procedure/treatment described in Section 3 has been explained to me in terms I understand.

☐ The material risks and possible complications described in Section 4 have been explained to me.

☐ The alternatives to the proposed procedure/treatment, including the option of no treatment, have been discussed with me as described in Section 5.

☐ The expected outcomes and recovery information in Section 6 have been explained to me.

☐ I have been given the opportunity to ask questions and all of my questions have been answered to my satisfaction.

☐ I understand that no guarantee has been made to me regarding the outcome of the procedure or treatment.

☐ I understand that I have the right to refuse or withdraw consent at any time before the procedure begins, or at any point during the procedure when withdrawal is medically feasible, without affecting my right to future care.

☐ I understand that unforeseen conditions may require additional or different procedures than those planned.

☐ I am signing this consent form voluntarily, without coercion or undue influence.

16.2 Patient Questions (Optional Documentation)

Questions asked by the patient and responses provided:

[________________________________]

[________________________________]

[________________________________]

SECTION 17: CONSENT STATEMENT

I hereby consent to the performance of the procedure/treatment described in Section 3 of this form, to be performed by the provider(s) identified in Section 2, at the facility identified in Section 2.

I have read and understand this entire form (or it has been read and interpreted to me). I have been given adequate time to consider my decision. I consent voluntarily.

SECTION 18: SIGNATURES

18.1 Patient

Printed Name of Patient: [________________________________]

Signature: ______________________________

Date: [__/__/____]

Time: [____]

18.2 Legal Representative (if patient lacks capacity or is a minor)

Printed Name: [________________________________]

Relationship to Patient: [________________________________]

Legal Authority (check one):

☐ Parent of minor patient

☐ Legal guardian (guardianship documentation on file)

☐ Healthcare power of attorney / Health care proxy (documentation on file)

☐ Court-appointed conservator (court order on file)

☐ Next of kin (when no other authorized representative is available and as permitted by state law)

☐ Other: [________________________________]

Signature: ______________________________

Date: [__/__/____]

Time: [____]

18.3 Witness

A witness attests that the patient (or representative) signed this form voluntarily and appeared to understand its contents. Some states and facilities require one or two witnesses.

Printed Name of Witness: [________________________________]

Title/Role: [________________________________]

Signature: ______________________________

Date: [__/__/____]

Time: [____]

Second Witness (if required):

Printed Name: [________________________________]

Signature: ______________________________

Date: [__/__/____]

18.4 Interpreter (if applicable)

I have accurately and completely interpreted the contents of this informed consent form and the provider's discussion with the patient, including all questions and responses.

Interpreter Name: [________________________________]

Interpreter ID/Credentials: [________________________________]

Language Interpreted: [________________________________]

Interpretation Method: ☐ In-person ☐ Telephone ☐ Video

Signature: ______________________________

Date: [__/__/____]

Time: [____]

18.5 Treating/Performing Provider

I confirm that I have explained the proposed procedure/treatment, its risks, benefits, and alternatives to the patient (or authorized representative) in terms the patient can understand. I have answered the patient's questions. In my professional judgment, the patient (or representative) demonstrated adequate understanding and voluntarily consented.

Printed Name of Provider: [________________________________]

Title/Specialty: [________________________________]

Signature: ______________________________

Date: [__/__/____]

Time: [____]

SECTION 19: PROVIDER DOCUMENTATION CHECKLIST

For provider and facility risk management documentation.

☐ Patient identity verified (name band, photo ID, or verbal confirmation)

☐ Informed consent discussion occurred before sedation or premedication was administered

☐ Procedure/treatment described in plain language the patient could understand

☐ Material risks, including rare but serious risks, were disclosed

☐ Alternatives, including no treatment, were discussed

☐ Expected outcomes and recovery were explained

☐ Patient had opportunity to ask questions — all questions were answered

☐ Patient demonstrated understanding (teach-back or confirmation)

☐ Patient voluntarily consented (no coercion, undue influence, or duress)

☐ Capacity assessment documented (patient has decision-making capacity or authorized representative consented)

☐ Interpreter services provided if needed (qualified medical interpreter used)

☐ Consent form signed by patient (or authorized representative), witness, and provider

☐ Signed consent form placed in patient's medical record

☐ Copy of consent form offered to patient

☐ Time-out / Verification procedure completed (surgical safety checklist) (if applicable)

☐ Applicable state-specific requirements met (TX Medical Disclosure Panel form, CA MICRA arbitration, etc.)

Sources and References

• Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972): https://law.justia.com/cases/federal/appellate-courts/cadc/22099/22099.html
• Cobbs v. Grant, 8 Cal. 3d 229 (Cal. 1972): https://law.justia.com/cases/california/supreme-court/3d/8/229.html
• Informed Consent Doctrine — Legal Information Institute: https://www.law.cornell.edu/wex/informed_consent_doctrine
• AMA Journal of Ethics — Informed Consent: What Must a Physician Disclose: https://journalofethics.ama-assn.org/article/informed-consent-what-must-physician-disclose-patient/2012-07
• Cal. Civ. Code § 3333.1 (MICRA): https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=3333.1&lawCode=CIV
• Cal. Code Civ. Proc. § 1295 (Arbitration): https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=1295&lawCode=CCP
• Cal. Health & Safety Code §§ 24170–24179.5: https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=24170&lawCode=HSC
• Tex. Civ. Prac. & Rem. Code Ch. 74 (TMLA): https://statutes.capitol.texas.gov/Docs/CP/htm/CP.74.htm
• Tex. Civ. Prac. & Rem. Code § 74.103 (Medical Disclosure Panel): https://statutes.capitol.texas.gov/Docs/CP/htm/CP.74.htm#74.103
• Tex. Civ. Prac. & Rem. Code § 74.104 (Duty of Disclosure): https://statutes.capitol.texas.gov/Docs/CP/htm/CP.74.htm#74.104
• 22 Tex. Admin. Code §§ 601.2–601.8 (Medical Disclosure Panel Lists): https://www.sos.state.tx.us/tac/index.shtml
• Fla. Stat. § 766.103 (Florida Medical Consent Law): https://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&URL=0700-0799/0766/Sections/0766.103.html
• N.Y. Pub. Health Law § 2805-d (Informed Consent): https://www.nysenate.gov/legislation/laws/PBH/2805-D
• 42 C.F.R. § 482.13 (CMS Conditions of Participation — Patient Rights): https://www.law.cornell.edu/cfr/text/42/482.13
• Joint Commission Informed Consent Standards: https://www.jointcommission.org
• Title VI of the Civil Rights Act of 1964 (Language Access): https://www.justice.gov/crt/fcs/TitleVI
• HHS Limited English Proficiency Guidance: https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html