COMPREHENSIVE INFORMED CONSENT AND TREATMENT AUTHORIZATION

(North Carolina – Court-Ready Template)

[// GUIDANCE: Insert this template into firm letterhead or EMR system as appropriate. Numbering auto-updates in most word processors when using built-in heading styles.]

TABLE OF CONTENTS

1. Document Header
2. Definitions
3. Operative Provisions
4. Representations & Warranties
5. Covenants & Restrictions
6. Default & Remedies
7. Risk Allocation
8. Dispute Resolution
9. General Provisions
10. Execution Block

1. DOCUMENT HEADER

1.1 Parties.
This Comprehensive Informed Consent and Treatment Authorization (the “Agreement”) is entered into as of [EFFECTIVE DATE] (the “Effective Date”) by and between:

(a) [FULL LEGAL NAME OF HEALTHCARE PROVIDER], a [ENTITY TYPE] duly organized and validly existing under the laws of the State of North Carolina, with its principal office at [ADDRESS] (“Provider”); and

(b) [FULL LEGAL NAME OF PATIENT], date of birth [DOB], residing at [ADDRESS] (“Patient”), or the Patient’s duly authorized legal representative identified below (“Representative,” and together with Patient, the “Patient Party”).

1.2 Recitals.
A. Provider will furnish certain healthcare services, treatments, procedures, or interventions to Patient (collectively, the “Treatment”) as more fully described herein.
B. North Carolina law, including N.C. Gen. Stat. § 90-21.13, requires Provider to secure informed consent prior to non-emergency Treatment.
C. The parties desire to set forth their mutual understandings, rights, and obligations concerning the Treatment, risk allocation, and related matters.

NOW, THEREFORE, in consideration of the mutual promises herein and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the parties agree as follows:

2. DEFINITIONS

Unless the context clearly requires otherwise, capitalized terms have the meanings set forth below and apply equally to singular and plural forms.

“Applicable Law” – All federal, state (including but not limited to N.C. Gen. Stat. § 90-21.13), and local statutes, regulations, rules, and professional standards governing the Treatment and Provider’s practice.

“Capacity” – The ability of Patient to understand the nature and consequences of Treatment and to make a knowing and voluntary healthcare decision.

“Complications” – Any unintended or adverse medical event or outcome arising from or related to the Treatment, including without limitation infection, bleeding, drug reaction, or anesthesia-related incident.

“Disclosure Statement” – The written disclosure of risks, benefits, alternatives, and other information delivered to Patient pursuant to Section 3.2.

“Malpractice Limits” – Statutory caps and immunities applicable under North Carolina medical malpractice law, including any limits on non-economic damages then in effect.

“Protected Health Information” or “PHI” – Defined as in 45 C.F.R. § 160.103.

“Representative” – A person authorized under Applicable Law to make healthcare decisions on behalf of Patient who lacks Capacity (e.g., parent of a minor, guardian, health-care agent under a durable power of attorney).

3. OPERATIVE PROVISIONS

3.1 Grant of Consent

(a) Subject to the terms herein, Patient hereby voluntarily and knowingly consents to Provider’s performance of the Treatment described in Section 3.2.
(b) If Patient lacks Capacity, Representative grants such consent on Patient’s behalf and certifies authority to do so.

3.2 Description of Treatment and Disclosure Requirements

(a) Treatment Description. Provider will perform: [DETAILED DESCRIPTION OF PROCEDURE / COURSE OF TREATMENT] (the “Procedure”).
(b) Required Disclosures. Prior to execution of this Agreement, Provider has provided Patient with:
(i) the Disclosure Statement describing:
1. the nature and purpose of the Procedure;
2. the material risks and Complications, including remote but serious risks;
3. expected benefits and likelihood of success;
4. practicable alternatives (including foregoing Treatment); and
5. the probable result of declining Treatment;
(ii) an opportunity to ask questions and receive satisfactory answers; and
(iii) information about Provider’s credentials and role of other licensed personnel or trainees.

3.3 Right to Withdraw

Patient may revoke consent at any time prior to commencement of the Procedure without penalty, except for medically necessary actions to preserve Patient’s life or health.

3.4 Financial Responsibility

(a) Patient remains responsible for all fees, copayments, co-insurance, deductibles, and non-covered charges in accordance with Provider’s then-current financial policies.
(b) If insurance benefits are assigned to Provider, Patient remains liable for any unpaid balance.

3.5 Conditions Precedent

Provider’s obligation to render Treatment is conditioned upon:
(a) receipt of executed Agreement;
(b) verification of Capacity or Representative authority; and
(c) completion of any pre-operative requirements (e.g., labs, imaging, consent for anesthesia).

4. REPRESENTATIONS & WARRANTIES

4.1 Patient Party Representations

Patient or Representative represents, warrants, and covenants that:
(a) Patient possesses Capacity, or Representative possesses full legal authority to consent;
(b) All personal, medical, and insurance information provided is accurate and complete;
(c) Patient has fully read, understands, and voluntarily signs this Agreement; and
(d) No promise or inducement has been made except as expressly set forth herein.

4.2 Provider Representations

Provider represents that:
(a) Provider and all assisting personnel are duly licensed and in good standing;
(b) Provider will furnish Treatment in accordance with Applicable Law and the standard of care prevailing in North Carolina; and
(c) Provider carries professional liability insurance meeting or exceeding statutory requirements.

4.3 Survival

Representations and warranties survive completion of the Treatment to the extent necessary to enforce the parties’ respective rights hereunder.

5. COVENANTS & RESTRICTIONS

5.1 Patient will comply with all pre- and post-operative instructions and follow-up appointments.

5.2 Patient will immediately notify Provider of any unexpected Complications or changes in condition.

5.3 Provider will maintain Patient’s PHI in compliance with HIPAA and state privacy laws; Patient acknowledges receipt of Provider’s Notice of Privacy Practices.

5.4 Neither party will assign or delegate rights or obligations hereunder without the other party’s prior written consent, except Provider may assign to an affiliated entity or billing service.

6. DEFAULT & REMEDIES

6.1 Events of Default.
(a) Non-Payment by Patient of undisputed amounts within [___] days of statement date;
(b) Breach of Section 5 by Patient;
(c) Breach of Section 4.2 by Provider.

6.2 Notice and Cure. The non-breaching party shall provide written notice; the breaching party has [15] days to cure (or such shorter period as medical urgency requires).

6.3 Remedies. Subject to Section 7:
(a) Provider may suspend non-emergency services until cure;
(b) Either party may pursue monetary damages up to the limits set forth in Section 7;
(c) Attorneys’ Fees: The prevailing party in any action to enforce this Agreement is entitled to reasonable attorneys’ fees and costs.

7. RISK ALLOCATION

7.1 Indemnification – Informed Consent Protection

Patient shall indemnify, defend, and hold harmless Provider and its employees from and against any and all third-party claims arising out of (i) Patient’s material breach of this Agreement or (ii) Patient’s failure to follow medical advice, except to the extent caused by Provider’s negligence, willful misconduct, or violation of Applicable Law.

7.2 Limitation of Liability

(a) Statutory Caps. Recovery for non-economic damages is limited to the Malpractice Limits then codified under Applicable Law.
(b) Exclusion of Certain Damages. Neither party will be liable for incidental, consequential, or punitive damages, except to the extent such limitation is prohibited by Applicable Law.
(c) Maximum Liability. In no event will Provider’s aggregate liability exceed applicable professional liability insurance policy limits.

7.3 Insurance

Provider shall maintain continuous professional liability coverage in commercially reasonable amounts.

7.4 Force Majeure

Neither party shall be liable for delay or failure in performance caused by events beyond reasonable control, including but not limited to natural disaster, war, terrorism, epidemic, or governmental order, provided that the affected party uses commercially reasonable efforts to resume performance.

8. DISPUTE RESOLUTION

8.1 Governing Law

This Agreement and all disputes arising hereunder shall be governed by and construed in accordance with the substantive laws of the State of North Carolina, without regard to conflict-of-laws principles.

8.2 Forum Selection

Subject to Section 8.3, the parties agree to exclusive jurisdiction and venue in the state courts located in [COUNTY], North Carolina for any action arising out of or relating to this Agreement.

8.3 Optional Arbitration

[// GUIDANCE: Delete if arbitration not desired.]
(a) Election. If both parties initial below, any dispute shall be resolved by binding arbitration administered by [ARBITRATION SERVICE] in accordance with its healthcare rules.
(b) Procedure. Single arbitrator; discovery limited to medical records and expert reports; award reasoned and final.
(c) Preservation of Injunctive Relief. Nothing herein limits a party’s right to seek temporary injunctive relief in state court to protect health or safety.

Provider Initials _ Patient/Rep Initials _

8.4 Jury Trial

Nothing herein constitutes a mandatory waiver of the constitutional right to a jury trial. Any waiver must be knowing, voluntary, and executed in a separate, conspicuous writing.

9. GENERAL PROVISIONS

9.1 Amendment & Waiver. No amendment or waiver is effective unless in writing and signed by both parties.

9.2 Severability. If any provision is held invalid or unenforceable, it shall be limited or severed to the minimum extent necessary, and the remainder shall remain in full force.

9.3 Integration. This Agreement (including any exhibits and the Disclosure Statement) constitutes the entire understanding and supersedes all prior oral or written communications relating to the subject matter.

9.4 Counterparts; Electronic Signatures. This Agreement may be executed in counterparts (including via electronic signature in compliance with N.C. Gen. Stat. Chapter 66, Article 40) each of which is deemed an original and all of which together constitute one instrument.

9.5 Successors & Assigns. This Agreement binds and benefits the parties and their respective heirs, representatives, successors, and permitted assigns.

10. EXECUTION BLOCK

IN WITNESS WHEREOF, the parties have executed this Agreement as of the Effective Date.

PROVIDER

[NAME & CREDENTIALS]
Title: [TITLE]
Date: _______

PATIENT

I, the undersigned Patient, certify that I have read and understood this Agreement and voluntarily consent to the Treatment described herein.

[PATIENT NAME]
Date: _______

REPRESENTATIVE (If Applicable)

By signing below, I affirm that I am legally authorized to consent to healthcare on behalf of Patient and I hereby do so.

[REPRESENTATIVE NAME & RELATIONSHIP]
Legal Authority: [E.G., PARENT, GUARDIAN, POA]
Date: _______

WITNESS

[// GUIDANCE: Witness not mandatory under NC law but advisable for high-risk procedures.]

Name: ____
Date: ____

NOTARY (Optional)

State of North Carolina, County of __
Subscribed and sworn before me this day of __________, 20.

Notary Public
My commission expires: _____

[// GUIDANCE: Attach the detailed Disclosure Statement and Provider’s Notice of Privacy Practices as Exhibits A and B, respectively. Retain original in medical record per 21 C.F.R. § 50.27(b) recordkeeping requirements (if federally funded) and N.C. Medical Board guidelines.]