**Protection of Patient Rights**

**§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 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 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.

\(f\) *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
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)

\[49 FR 9173, Mar. 12, 1984. Redesignated and amended at 61 FR 21965,
21966, May 13, 1996; 62 FR 53961, Oct. 17, 1997; 70 FR 71774, Nov. 30,
2005; 71 FR 68740, Nov. 28, 2006; 72 FR 10366, Mar. 8, 2007\]

**Supplement *Highlights* references**: 30(1), 34(2), 36(1).

Reserved