UTMB HANDBOOK OF OPERATING PROCEDURES

Section 9 Clinical Policies Subject 9.3 Patient Rights Policy 9.3.17 Patient Consent - Overview and Basic Requirements

04/01/94-Originated 02/05/07- Reviewed w/ changes - Reviewed w/o changes Risk Management - Author

Patient Consent - Overview and Basic Requirements

Definitions

Adult: A person 18 years of age or older or a person under 18 years of age who has had the disabilities of minority removed. Minor is defined as an individual under the age of 18 and has not been legally emancipated by a court and is • not legally or previously married; • not serving in the armed forces; • not presently an offender in the Texas Department of Criminal Justice or other adult correctional facility; or, • not at least 16 years old and living away from home and managing their own financial affairs. Emancipated Minor: A person under the age of 18 who is legally emancipated by the courts and able to provide their own consent for treatment. Attending Physician: The physician with primary responsibility for a patient's treatment and care. Decision-making Capacity: The ability to understand and appreciate the nature and consequences of a decision regarding medical treatment and having the ability to reach an informed decision in the matter. Incapacitated: Lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of a treatment decision, including the significant benefits, risks, complications and reasonable alternatives to any proposed treatment Surrogate Healthcare Decision Maker: A person with decision-making capacity that is identified as the person who has the authority to consent to medical treatment on behalf of a patient in need of medical treatment. This includes an individual who has the authority by law or by agreement from the individual receiving treatment, to act in the place of the individual. This includes, but is not limited to, parents, spouses, siblings legal guardians or properly appointed agents, such as identified in a Medical Power of Attorney.

Types of Consent

Informed Consent: Adult patients and/or, when appropriate, patients' families or designated surrogates, receive from their physician information necessary to give informed consent prior to the start of any care, treatment or service. Informed consent allows the patient to fully participate in care, treatment or service decisions. Except in emergencies, the information needed to obtain informed consent includes, but is not limited to the following: • the patient's diagnosis • the general nature of the contemplated procedure and/or treatment- its purpose, whether it is experimental, and the name(s) of the person(s) performing the procedure or administering the treatment • the benefits, risks, discomforts, side effects, complications and potential problems related to recuperation associated with the procedure or treatment • the likelihood of success • the patient's prognosis if the procedure is not performed • reasonable alternative medical treatments Informed consent should be obtained for all procedures found in The Texas Medical Disclosure Panel, Procedures Requiring Full Disclosure of Specific Risks and Hazards - List A. Procedures not requiring procedures not requiring disclosure of specific risks and hazards - List B Expressed Consent: Either oral or written consent given by a competent person or authorized representative for incapacitated patient: • Oral Consent - Consent conveyed through speech. • Written Consent - Consent conveyed through written documentation. There are two forms used to document written consent: 1. Consent for Diagnosis and Treatment (General Consent) 2. Written Consent for Specific Medical and Surgical Procedures Implied Consent: Consent that may be inferred by the patient's actions or behavior such as extending the arm for a blood draw). Implied consent is rarely documented and may be relied upon only for care, treatment or service that is routine and does not involve significant risk(s). Implied consent may not be used for HIV testing except as expressly stated in Policy 9.3.10, Consent for HIV Antibody Testing.

Policy

In accordance with state and federal law, prior to providing care, treatment or services, consent will be obtained from either the patient or the patient's surrogate decision maker.

Exclusions

This policy does not address consent for participation in either clinical research or clinical trials that are governed by the Institutional Review Board (IRB). These policies are found at the following location: Consent for psychiatric treatment, either voluntary or involuntary, will be obtained in accordance with the Texas Mental Health Code. The UTMB Department of Legal Affairs and the Risk Management Office are available to clarify information and answer questions concerning this policy.

Who May Consent

1. An adult patient with decision-making capacity 2. Parents or legal guardian of an unemancipated minor Consent for the treatment of an incapacitated adult patient, the patient's legal guardian or properly appointed agent in a medical power of attorney, if one, may give consent for treatment on behalf of the patient. Note: Family relationships (including spouse) do not, by themselves, make one person the legal agent of another. When there is no agent appointed in a medical power of attorney or legal guardian to consent on behalf of an adult patient who is comatose, incapacitated, lacks decision-making capacity or otherwise mentally or physically incapable of communication, an adult from the following list, who has decision-making capacity, is available after a reasonably diligent inquiry, and is willing to consent to medical treatment on behalf of the patient, in order of priority, may act as the “surrogate decision maker”: (1) patient's spouse (2) an adult child of the patient who has the waiver and consent of all other qualified adult children of the patient to act as the sole decision-maker (3) a majority of the patient's reasonably available adult children (4) patient's parents(s) (5) the individual clearly identified to act for the patient (before the patient's incapacity), the patient's nearest living relative, or a member of the clergy.

Limitations on Surrogate Decision-Maker	In order to consent on behalf of the incapacitated adult patient, the surrogate may not, under any circumstance, consent to voluntary inpatient mental health services, electroconvulsive therapy ("ECT"); or the appointment of another surrogate. NOTE: Any dispute as to the right of a party to act as the patient's surrogate must be resolved by the applicable county's court having probate jurisdiction. Any decision by a surrogate must be based on knowledge of what the patient would desire, if known.
Physician Documentation of Consent by a Surrogate Decision-Maker	The attending physician shall document • the patient's comatose state, incapacity, or other mental or physical inability to communicate in the patient's medical record; • the proposed medical treatment; • the diligent efforts to contact or cause to be contacted persons eligible to serve as the patient's surrogate decision-makers and • the date and time of consent if a surrogate decision maker consents to medical treatment on behalf of the patient, including the attending physician's signature. • If the consent is not made in person, the surrogate decision maker's consent shall be reduced to writing in the patient's medical record, signed by the hospital or nursing home staff member receiving the consent, and countersigned in the patient's medical record or on an informed consent form by the surrogate decision-maker as soon as possible. Refer to Policy 9.3.3, Telephone Consent for Treatment/Procedure
General Rules Regarding Written Consent	General written consent for diagnosis and routine hospital services must be obtained upon each patient's admission to a UTMB hospital whether for a fixed or indefinite stay. Admission is defined as either an admission to the Emergency Department for 3 hours or longer, to Day Surgery for 1 day or an inpatient admission for an indefinite stay. Required Signatures on Written Consent Forms - Both the patient, or person legally authorized to consent on the patient's behalf, and the practitioner with clinical privileges who obtains the consent, must sign the appropriate form documenting the informed consent. This form becomes part of the patient's permanent medical record.
General Rules Regarding Written Consent, continued	The signature of the patient, or of the person legally authorized to consent on behalf of the patient, must be witnessed by a third party's signature. The third party granting informed consent about the proposed procedure or treatment may not be the patient's physician or surrogate After witnessing the signature of the consenting individual, the witness will sign the consent form in the designated space. Changes in Patient's Medical Condition After Consent Form for Specific Medical or Surgical Procedure Has Been Signed - Except when emergency dictates otherwise, a new informed consent discussion and new consent form for a specific medical or surgical procedure is required if the medical status of the patient has changed, resulting in increased risk or additional risk associated with the planned procedure or treatment between the time the patient's written consent was initially obtained and the time the procedure/treatment is to be administered. Unless revoked orally or in writing, written general consent is effective for the duration of the hospitalization, and written informed consent is effective until the listed procedures(s) are performed.
Specific Medical and Surgical Procedures	A Disclosure and Consent for Medical and Surgical Procedures form must be used to document consent of the patient, or consent of the party authorized to consent on the patient's behalf, for performance of any procedure falling within the following categories: * procedures or treatments included on the Texas Medical Disclosure Panel's list of Procedures Requiring Full Disclosure List of Risks, including administration of epidural, general, or spinal anesthesia, and administration of blood and blood products * all procedures requiring administration of general, spinal, epidural, or regional anesthesia other than local infiltration * both invasive and non-invasive procedures involving more than a slight risk of harm to the patient's body structure (a risk is more than slight when its disclosure would be material to a reasonable patient's decision of whether to accept or reject treatment) * experimental procedures

Withdrawal or Refusal of Consent

An adult with decision-making capacity, or person legally authorized to consent on the patient's behalf, who consents to a procedure or treatment may subsequently withdraw consent and refuse treatment in accordance with Policy 9.3.16, Refusal of Consent/Treatment. Other necessary medical treatment to which the patient or authorized person has consented will be continued.

References

Chapter 313, Health & Safety Code Institutional Handbook of Operating Procedures Policies: 9.3.10, Consent for HIV Antibody Testing & for Disclosure of Results 9.3.16, Refusal of Consent/Treatment 9.3.18, Consent for Treatment of a Minor 9.3.20, Informed Consent for Immunization of Minors 9.3.21, Consent for Sterilization 9.1.21, Examination and Treatment of Emergency Medical Conditions and Women in Labor