[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Rules and Regulations]
[Pages 53960-53963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27565]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AH72


Informed Consent for Patient Care

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

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SUMMARY: This document amends VA medical regulations concerning 
informed consent for patient care. It describes the requirements for 
obtaining and documenting informed consent. It also describes the types 
of treatments or procedures for which the patient's or surrogate's 
signature on a VA-authorized form is required and establishes a list 
and priority of surrogates authorized to act on behalf of patients who 
lack decision-making capacity. Further, it establishes an internal 
decision-making process for patients who lack decision-making capacity 
and who have no authorized surrogate. This is intended to protect 
patient rights and ensure that the patient (or the patient's surrogate 
or representative) receives sufficient information to make an informed 
health-care decision.

DATES: Effective Date: November 17, 1997.

FOR FURTHER INFORMATION CONTACT: Ruth-Ann Phelps, Ph.D., Veterans 
Health Administration, Patient Care Services (11B), 810 Vermont Avenue, 
NW, Washington, DC 20420, (202) 273-8473.

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on August 7, 1996 (61 FR 41108), we proposed to amend our 
regulations concerning informed consent for patient care. Interested 
parties were invited to submit written comments on or before October 7, 
1996. We received comments from one commenter, the American Psychiatric 
Association.

Comments

    The commenter suggested that whenever the word ``patient'' appears 
in the document, the phrase ``or patient surrogate'' should be added. 
In response, we have added the words ``or surrogate'' wherever 
appropriate. This is intended to clarify, consistent with the intent of 
the proposal, that a surrogate may give informed consent on behalf of a 
patient who lacks decision-making capacity.
    With respect to requirements regarding the administration of 
psychotropic medication to an involuntarily committed patient, the 
commenter asserted that the prescribing of such medications should be 
limited to psychiatrists, and further asserted that the multi-
disciplinary review committee constituted for purposes of review of the 
decision to administer or continue the administration of such 
medications should be required to include a psychiatrist. We do not 
believe that psychotropic medication should be prescribed only by 
psychiatrists. We believe that patients are adequately served as long 
as the prescribing physician is privileged to prescribe such 
medication. Also, we have added the requirement that the committee must 
include a psychiatrist or a physician who has

[[Page 53961]]

psychopharmacology privileges. We believe this is adequate for the 
types of determinations that need to be made.
    With respect to the revocation of consent (including the revocation 
of HIV testing consent), the commenter suggested that the regulations 
should require that documentation immediately be added at the place in 
the medical records that contained the earlier record of consent. No 
changes are made based on this comment. We note that the regulations 
provide that the informed consent process must be appropriately 
documented in the medical record. This requires documentation for 
revocations of consent, and we do not believe further instructions in 
the regulations are necessary (see Sec. 17.32(d)).
    The commenter suggested that consents regarding HIV testing 
(required to be on VA form 10-012) be filed in the patient record. No 
changes are made based on this comment. This already is required by 
these regulations (see Sec. 17.32(g)(4)).
    The proposal provided that HIV antibody testing must be 
accomplished by pre-test and post-test counseling. The commenter 
suggested that the counseling be at least equivalent to guidelines for 
testing from the Centers for Disease Control and Prevention and other 
Federal or State agencies which set HIV serologic testing policies. The 
commenter further suggested that the form and language of such 
counseling should be appropriate to the patient's or surrogate's 
educational level as well as cognitive and emotional state. No changes 
are made based on these comments. VA health-care professionals are 
provided with guidance commensurate with the guidelines suggested by 
the commenter. Further, there does not appear to be a need to 
specifically address the educational level and cognitive and emotional 
state of the patient or surrogate. This already is covered since the 
final rule requires that health-care professionals explain consent 
matters in language understandable to the patient or surrogate (see 
Sec. 17.32(c)).

Paperwork Reduction Act

    The collection of information contained in the notice of the 
proposed rulemaking was submitted to the Office of Management and 
Budget (OMB) for review in accordance with the Paperwork Reduction Act 
(44 U.S.C. 3504(h)). The information collection subject to this 
rulemaking concerns the disclosure requirements that non-VA physicians 
contracting to perform services for VA must follow in conducting 
informed consent procedures. The information provided is designed to 
ensure that the patients (or in some cases, others) have sufficient 
information to provide informed consent. Interested parties were 
invited to submit comments on the collection of information. However, 
no comments were received. OMB has approved this information collection 
under control number 2900-0583.
    VA is not authorized to impose a penalty on persons for failure to 
comply with information collection requirements which do not display a 
current OMB control number, if required.

Executive Order 12866

    This final rule has been reviewed by OMB under Executive Order 
12866.

Regulatory Flexibility Act

    The Secretary hereby certifies that the adoption of this final rule 
would not have a significant economic impact on a substantial number of 
small entities as they are defined in the Regulatory Flexibility Act, 5 
U.S.C. 601-612. The adoption of the final rule would affect VA 
beneficiaries but would not affect small businesses. Therefore, 
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial 
and final regulatory flexibility analyses requirements of Secs. 603 and 
604.


    The Catalog of Federal Domestic Assistance Program numbers are 
64.009, 64.010, 64.011.

Lists of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
Government contracts, Grant programs-health, Grant programs-veterans, 
Health care, Health facilities, Health professions, Health records, 
Homeless, Medical and Dental schools, Medical devices, Medical 
research, Mental health programs, Nursing home, Philippines, Reporting 
and recordkeeping requirements, scholarships and fellowships, Travel 
and transportation expenses, and Veterans.


    Approved: September 5, 1997.
Hershel W. Gober,
Acting Secretary of Veterans Affairs.

    In consideration of the foregoing, 38 CFR part 17 is amended as set 
forth below:

PART 17--MEDICAL

    1. The authority citation for part 17 continues to read as follows:


    Authority: 38 U.S.C. 501, 1721, unless otherwise noted.

    2. Section 17.32 is revised to read as follows:

Protection of Patient Rights


Sec. 17.32  Informed consent.

    (a) Definitions:
    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 involved. For the purpose of obtaining informed 
consent for medical treatment, the term practitioner includes medical 
and dental residents regardless of whether they have been granted 
clinical privileges.
    Signature consent. The patient's or surrogate's signature on a VA-
authorized consent form, e.g., a published numbered VA form (OF 522) or 
comparable form approved by the local VA facility.
    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

[[Page 53962]]

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 medical 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) The patient's or surrogate's signature on a VA-authorized 
consent form must be witnessed. The witness' signature only attests to 
the fact that he or she saw the patient or surrogate and the 
practitioner sign the form. When the patient's or surrogate's signature 
is indicated by an ``X'', two adults must witness the act of signing. 
The signed form must be filed in the patient's medical record. A 
properly executed OF 522 or other VA-authorized consent form is valid 
for a period of 30 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 30-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 
medical 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-

[[Page 53963]]

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 medical 
record. Testing must be accompanied by pre-test and post-test 
counseling.

(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, 7332, 7333)

[FR Doc. 97-27565 Filed 10-16-97; 8:45 am]
BILLING CODE 8320-01-P