[Code of Federal Regulations]
[Title 38, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 38CFR17.32]

[Page 628-632]
 
            TITLE 38--PENSIONS, BONUSES, AND VETERANS' RELIEF
 
                CHAPTER I--DEPARTMENT OF VETERANS AFFAIRS
 
PART 17_MEDICAL--Table of Contents
 
Sec.  17.32  Informed consent and advance care planning.

    (a) Definitions:
    Advance Directive. Specific written statements made by a patient who 
has decision-making capacity regarding future health care decisions in 
any of the following:
    (i) VA Living Will. A written statement made by a patient on an 
authorized VA form which sets forth the patient's wishes regarding the 
patient's

[[Page 629]]

health care treatment preferences including the withholding and 
withdrawal of life-sustaining treatment.
    (ii) VA Durable Power of Attorney for Health Care. A written 
instruction on a VA form which designates the patient's choice of health 
care agent.
    (iii) State-Authorized Advance Directive. A non-VA living will, 
durable power of attorney for health care, or other advance health care 
planning document, the validity of which is determined pursuant to 
applicable State law. For the purposes of this paragraph and paragraph 
(h) of this section, ``applicable State law'' means the law of the State 
where the advance directive was signed, the State where the patient 
resided when the advance directive was signed, the State where the 
patient now resides, or the State where the patient is receiving 
treatment. VA will resolve any conflict between those State laws 
regarding the validity of the advance directive by following the law of 
the State that gives effect to the expressed wishes in the advance 
directive.
    Close friend. Any person eighteen years or older who has shown care 
and concern for the patient's welfare, who is familiar with the 
patient's activities, health, religious beliefs and values, and who has 
presented a signed written statement for the record that describes that 
person's relationship to and familiarity with the patient.
    Decision-making capacity. The ability to understand and appreciate 
the nature and consequences of health care treatment decisions.
    Health care agent. An individual named by the patient in a Durable 
Power of Attorney for Health Care.
    Legal guardian. A person appointed by a court of appropriate 
jurisdiction to make decisions for an individual who has been judicially 
determined to be incompetent.
    Practitioner. Any physician, dentist, or health care professional 
who has been granted specific clinical privileges to perform the 
treatment or procedure. For the purpose of obtaining informed consent 
for medical treatment, the term practitioner includes medical and dental 
residents and other appropriately trained health care professionals 
designated by VA regardless of whether they have been granted clinical 
privileges.
    Signature consent. The patient's or surrogate's signature on a VA-
authorized consent form.
    Special guardian. A person appointed by a court of appropriate 
jurisdiction for the specific purpose of making health care decisions.
    Surrogate. An individual, organization or other body authorized 
under this section to give informed consent on behalf of a patient who 
lacks decision-making capacity.
    (b) Policy. Except as otherwise provided in this section, all 
patient care furnished under title 38 U.S.C. shall be carried out only 
with the full and informed consent of the patient or, in appropriate 
cases, a representative thereof. In order to give informed consent, the 
patient must have decision-making capacity and be able to communicate 
decisions concerning health care. If the patient lacks decision-making 
capacity or has been declared incompetent, consent must be obtained from 
the patient's surrogate. Practitioners may provide necessary medical 
care in emergency situations without the patient's or surrogate's 
express consent when immediate medical care is necessary to preserve 
life or prevent serious impairment of the health of the patient or 
others and the patient is unable to consent and the practitioner 
determines that the patient has no surrogate or that waiting to obtain 
consent from the patient's surrogate would increase the hazard to the 
life or health of the patient or others. In such circumstances consent 
is implied.
    (c) General requirements for informed consent. Informed consent is 
the freely given consent that follows a careful explanation by the 
practitioner to the patient or the patient's surrogate of the proposed 
diagnostic or therapeutic procedure or course of treatment. The 
practitioner, who has primary responsibility for the patient or who will 
perform the particular procedure or provide the treatment, must explain 
in language understandable to the patient or surrogate the nature of a 
proposed procedure or treatment; the expected

[[Page 630]]

benefits; reasonably foreseeable associated risks, complications or side 
effects; reasonable and available alternatives; and anticipated results 
if nothing is done. The patient or surrogate must be given the 
opportunity to ask questions, to indicate comprehension of the 
information provided, and to grant permission freely without coercion. 
The practitioner must advise the patient or surrogate if the proposed 
treatment is novel or unorthodox. The patient or surrogate may withhold 
or revoke his or her consent at any time.
    (d) Documentation of informed consent. (1) The informed consent 
process must be appropriately documented in the health record. In 
addition, signature consent is required for all diagnostic and 
therapeutic treatments or procedures that:
    (i) Require the use of sedation;
    (ii) Require anesthesia or narcotic analgesia;
    (iii) Are considered to produce significant discomfort to the 
patient;
    (iv) Have a significant risk of complication or morbidity;
    (v) Require injections of any substance into a joint space or body 
cavity; or
    (vi) Involve testing for Human Immunodeficiency Virus (HIV).
    (2) A patient or surrogate will sign with an ``X'' when the patient 
or surrogate has a debilitating illness or disability, i.e., significant 
physical impairment and/or difficulty in executing a signature due to an 
underlying health condition(s), or is unable to read and write. When the 
patient's or surrogate's signature is indicated by an ``X,'' two adults 
must witness the act of signing. By signing, the witnesses are attesting 
only to the fact that they saw the patient or surrogate and the 
practitioner sign the form. The signed form must be filed in the 
patient's health record. A properly executed VA-authorized consent form 
is valid for a period of 60 calendar days. If, however, the treatment 
plan involves multiple treatments or procedures, it will not be 
necessary to repeat the informed consent discussion and documentation so 
long as the course of treatment proceeds as planned, even if treatment 
extends beyond the 60-day period. If there is a change in the patient's 
condition that might alter the diagnostic or therapeutic decision, the 
consent is automatically rescinded.
    (3) If it is impractical to consult with the surrogate in person, 
informed consent may be obtained by mail, facsimile, or telephone. A 
facsimile copy of a signed consent form is adequate to proceed with 
treatment. However, the surrogate must agree to submit a signed consent 
form to the practitioner. If consent is obtained by telephone, the 
conversation must be audiotaped or witnessed by a second VA employee. 
The name of the person giving consent and his or her authority to act as 
surrogate must be adequately identified for the record.
    (e) Surrogate consent. If the practitioner who has primary 
responsibility for the patient determines that the patient lacks 
decision-making capacity and is unlikely to regain it within a 
reasonable period of time, informed consent must be obtained from the 
patient's surrogate. Patients who are incapable of giving consent as a 
matter of law, i.e., persons judicially determined to be incompetent and 
minors not otherwise able to provide informed consent, will be deemed to 
lack decision-making capacity for the purposes of this section. If the 
patient is considered a minor in the state where the VA facility is 
located and cannot consent to medical treatment, consent must be 
obtained from the patient's parent or legal guardian. The surrogate 
generally assumes the same rights and responsibilities as the patient in 
the informed consent process. The surrogate's decision must be based on 
his or her knowledge of what the patient would have wanted, i.e., 
substituted judgment. If the patient's wishes are unknown, the decision 
must be based on the patient's best interest. The following persons are 
authorized to consent on behalf of patients who lack decision-making 
capacity in the following order of priority:
    (1) Health care agent;
    (2) Legal guardian or special guardian;
    (3) Next-of-kin: a close relative of the patient eighteen years of 
age or older, in the following priority: spouse, child, parent, sibling, 
grandparent, or grandchild; or
    (4) Close friend.

[[Page 631]]

    (f) Consent for patients without surrogates. (1) If none of the 
surrogates listed in paragraph (e) of this section are available, the 
practitioner may request Regional Counsel assistance to obtain a special 
guardian for health care or follow the procedures outlined in this 
paragraph (f).
    (2) Facilities may use the following process to make treatment 
decisions for patients who lack decision-making capacity and have no 
surrogate. For treatments or procedures that involve minimal risk, the 
practitioner must verify that no authorized surrogate can be located. 
The practitioner must attempt to explain the nature and purpose of the 
proposed treatment to the patient and enter this information in the 
health record. For procedures that require signature consent, the 
practitioner must certify that the patient has no surrogate. The 
attending physician and the Chief of Service (or his or her designee) 
must indicate their approval of the treatment decision in writing. Any 
decision to withhold or withdraw life-sustaining treatment for such 
patients must be reviewed by a multi-disciplinary committee appointed by 
the facility Director. The committee functions as the patient's advocate 
and may not include members of the treatment team. The committee must 
submit its findings and recommendations in a written report to the Chief 
of Staff who must note his or her approval of the report in writing. 
After reviewing the record, the facility Director may concur with the 
decision to withhold or withdraw life support or request further review 
by Regional Counsel.
    (g) Special consent situations. In addition to the other 
requirements of this section, additional protections are required in the 
following situations.
    (1) No patient will undergo any unusual or extremely hazardous 
treatment or procedure, e.g., that which might result in irreversible 
brain damage or sterilization, except as provided in this paragraph (g). 
Before treatment is initiated, the patient or surrogate must be given 
adequate opportunity to consult with independent specialists, legal 
counsel or other interested parties of his or her choosing. The 
patient's or surrogate's signature on a VA authorized consent form must 
be witnessed by someone who is not affiliated with the VA health care 
facility, e.g., spouse, legal guardian, or patient advocate. If a 
surrogate makes the treatment decision, a multi-disciplinary committee, 
appointed by the facility Director, must review that decision to ensure 
it is consistent with the patient's wishes or in his or her best 
interest. The committee functions as the patient's advocate and may not 
include members of the treatment team. The committee must submit its 
findings and recommendations in a written report to the facility 
Director. The Director may authorize treatment consistent with the 
surrogate's decision or request that a special guardian for health care 
be appointed to make the treatment decision.
    (2) Administration of psychotropic medication to an involuntarily 
committed patient against his or her will must meet the following 
requirements. The patient or surrogate must be allowed to consult with 
independent specialists, legal counsel or other interested parties 
concerning the treatment with psychotropic medication. Any 
recommendation to administer or continue medication against the 
patient's or surrogate's will must be reviewed by a multi-disciplinary 
committee appointed by the facility Director for this purpose. This 
committee must include a psychiatrist or a physician who has 
psychopharmacology privileges. The facility Director must concur with 
the committee's recommendation to administer psychotropic medications 
contrary to the patient's or surrogate's wishes. Continued therapy with 
psychotropic medication must be reviewed every 30 days. The patient (or 
a representative on the patient's behalf) may appeal the treatment 
decision to a court of appropriate jurisdiction.
    (3) If a proposed course of treatment or procedure involves approved 
medical research in whole or in part, the patient or representative 
shall be advised of this. Informed consent shall be obtained 
specifically for the administration or performance of that aspect of the 
treatment or procedure that involves research. Such consent shall be in 
addition to that obtained for the administration or performance of the

[[Page 632]]

nonresearch aspect of the treatment or procedure and must meet the 
requirements for informed consent set forth in 38 CFR Part 16, 
Protection of Human Subjects.
    (4) Testing for Human Immunodeficiency Virus (HIV) must be voluntary 
and must be conducted only with the prior informed and (written) 
signature consent of the patient or surrogate. Patients who consent to 
testing for HIV must sign VA form 10-012, ``Consent for HIV Antibody 
Testing.'' This form must be filed in the patient's health record. 
Testing must be accompanied by pre-test and post-test counseling.
    (h) Advance health care planning. Subject to the provisions of 
paragraphs (h)(1) through (h)(4) of this section, VA will follow the 
wishes of a patient expressed in an Advance Directive when the attending 
physician determines and documents in the patient's health record that 
the patient lacks decision-making capacity and is not expected to regain 
it. An advance directive that is valid in one or more States under 
applicable State law, as defined in paragraph (a) of this section, will 
be recognized throughout the VA health care system.
    (1) Witnesses. A VA Advance Directive: Living Will and Durable Power 
of Attorney for Health Care must be signed by the patient in the 
presence of two witnesses. Neither witness may to the witness' knowledge 
be named in the patient's will, appointed as health care agent in the 
advance directive, or financially responsible for the patient's care. VA 
employees of the Chaplain Service, Psychology Service, Social Work 
Service, or nonclinical employees (e.g., Medical Administration Service, 
Voluntary Service, or Environmental Management Service) may serve as 
witnesses. Other individuals employed by the VA facility in which the 
patient is being treated may not sign as witnesses to the advance 
directive. Witnesses are attesting only to the fact that they saw the 
patient sign the form.
    (2) Instructions in critical situations. VA will follow the 
unambiguous verbal or non-verbal instructions regarding future health 
care decisions of a patient who has decision-making capacity when the 
patient is admitted to care when critically ill and loss of capacity may 
be imminent and the patient is not physically able to sign an advance 
directive form, or the appropriate form is not readily available. The 
patient's instructions must have been expressed to at least two members 
of the health care team. The substance of the patient's instructions 
must be recorded in a progress note in the patient's health record and 
must be co-signed by at least two members of the health care team who 
were present and can attest to the wishes expressed by the patient. 
These instructions will be given effect only if the patient loses 
decision-making capacity during the presenting situation.
    (3) Revocation. A patient who has decision-making capacity may 
revoke an advance directive or instructions in a critical situation at 
any time by using any means expressing the intent to revoke.
    (4) VA policy and disputes. Neither the treatment team nor surrogate 
may override a patient's clear instructions in an Advance Directive or 
in instructions in critical situations, except that those portions of an 
Advance Directive or instructions given in a critical situation that are 
not consistent with VA policy will not be given effect.

(The information collection requirements in this section have been 
approved by the Office of Management and Budget under control number 
2900-0583)

(Authority: 38 U.S.C. 7331-7334)

[62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 
71 FR 68740, Nov. 28, 2006; 72 FR 10366, Mar. 8, 2007]