[Federal Register Volume 61, Number 153 (Wednesday, August 7, 1996)]
[Proposed Rules]
[Pages 41108-41111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19907]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AH72


Informed Consent for Patient Care

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes to amend VA regulations concerning 
informed consent for patient care. It is proposed to describe the 
requirements for obtaining and documenting informed consent. It is also 
proposed to describe the types of treatments or procedures for which 
the patient's signature on a VA-authorized form would be required and 
to establish a list and priority of surrogates authorized to act on 
behalf of patients who lack decision-making capacity. Further, it is 
proposed to establish 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.

DATE: Comments must be received on or before October 7, 1996.

ADDRESSES: Mail or hand deliver written comments to: Director, Office 
of Regulations Management (02D), Department of Veterans Affairs, 810 
Vermont Avenue, NW, Room 1154, Washington, DC 20420. Comments should 
indicate that they are submitted in response to ``RIN 2900-AH72.'' All 
written comments will be available for public inspection at the above 
address in the Office of Regulations Management, Room 1158, between the 
hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except 
holidays).


[[Page 41109]]


FOR FURTHER INFORMATION CONTACT: Ruth-Ann Phelps, Ph.D., Veterans 
Health Administration, Office of Professional Affairs (10A2), 810 
Vermont Avenue, NW, Washington, DC 20420, (202) 273-5813.

SUPPLEMENTARY INFORMATION: This document proposes to amend VA 
regulations concerning informed consent for patient care. Section 7331 
of title 38 United States Code provides:

    The Secretary, upon the recommendation of the Under Secretary 
for Health * * * shall prescribe regulations establishing procedures 
to ensure that all medical and prosthetic research carried out and, 
to the maximum extent practicable, all patient care furnished under 
this title shall be carried out only with the full and informed 
consent of the patient or subject or, in appropriate cases, a 
representative thereof.

    Current VA regulations, found at 38 CFR 17.32, set forth VA policy 
and describe the process for obtaining informed consent for patient 
care.
    VA proposes to amend these regulations to clarify patient rights 
and responsibilities under this section and to include more detail 
about the process of obtaining informed consent. In addition, the 
proposal contains an internal decision-making process for making 
treatment decisions for patients who lack decision-making capacity and 
who have no authorized surrogate. In a medical emergency consent would 
be implied. This proposal describes the conditions under which the 
practitioner may provide necessary medical care without the patient's 
or surrogate's express consent.
    This proposal also includes additional protections for patients 
when the treatment at issue is considered extremely hazardous, involves 
the administration of psychotropic medication to a committed patient 
against his or her will, or involves testing for human immunodeficiency 
virus (HIV). These safeguards are designed to ensure that patients 
receive adequate counsel and information before they undergo such 
procedures and that decisions made by a surrogate in this circumstance 
are consistent with the patient's best interest.
    The proposal would also amend the definition of ``practitioner,'' 
which currently reads as follows:

    Practitioner includes any physician, dentist, or health care 
professional who has been granted specific clinical privileges to 
perform the diagnostic or therapeutic procedure involved.

    VA proposes to include medical and dental residents in this 
definition of practitioner because such residents who are authorized to 
perform treatments or procedures would need to be involved in the 
informed consent process under the proposed regulations. The revised 
definition specifies that the term practitioner includes medical and 
dental residents regardless of whether they have been granted clinical 
privileges.
    We also note that proposed Sec. 17.32 does not address informed 
consent for research except to note that, in addition to the informed 
consent for medical treatment, the practitioner must obtain specific 
consent for any aspect of the treatment or procedure that involves 
approved medical research. There are separate regulations that govern 
informed consent for research (see 38 CFR Part 16--PROTECTION OF HUMAN 
SUBJECTS).

Paperwork Reduction Act

    The collection of information contained in this notice of proposed 
rulemaking has been submitted to the Office of Management and Budget 
for review in accordance with the Paperwork Reduction Act (44 U.S.C. 
3504(h)). Comments on the collection of information should be sent to 
the Office of Management and Budget, Attention: Desk Officer for the 
Department of Veterans Affairs, Office of Information and Regulatory 
Affairs, Washington, DC 20503, with copies to the Director, Office of 
Regulations Management (02D), Department of Veterans Affairs, 810 
Vermont Avenue, NW, Washington, DC 20420.
    The collection of information included in the proposed revision to 
Sec. 17.32 in this rulemaking proceeding concerns the disclosure 
requirements that non-VA physicians contracting to perform services for 
VA must follow in conducting informed consent procedures. The 
provisions are consistent with standard medical practice in the 
community.
    The Department considers comments by the public on these proposed 
collections of information in--
     Evaluating whether the proposed collection(s) of 
information are necessary for the proper performance of the functions 
of the Department, including whether the information will have 
practical utility;
     Evaluating the accuracy of the Department's estimate of 
the burden of the proposed collections of information, including the 
validity of the methodology and assumptions used;
     Enhancing the quality, usefulness, and clarity of the 
information to be collected; and;
     Minimizing the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    OMB is required to make a decision concerning the proposed 
collections of information contained in this document between 30 and 60 
days after publication of this document in the Federal Register. 
Therefore, a comment to OMB is best assured of having its full effect 
if OMB receives it within 30 days of publication. This does not affect 
the deadline for the public to comment to the Department on the 
proposed regulations.
    Title: Informed Consent.
    Summary of collection of information: 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.
    Description of the need for information and proposed use of 
information: The collection of information subject to this rulemaking 
is designed to obtain informed consent.
    Description of likely respondents: non-VA health care providers 
contracting to perform services for VA.
    Estimated total annual reporting burden: 60,000 hours.
    The estimated annual burden per respondent: \1/4\ hour.
    Estimated number of respondents: 240,000.
    Estimated annual frequency of responses: 1 per episode.

Regulatory Flexibility Act

    The Secretary hereby certifies that the adoption of this proposed 
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 proposed 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 
sections 603 and 604.

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

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug

[[Page 41110]]

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, 
Veterans.

    Approved: October 11, 1995
Jesse Brown,
Secretary of Veterans Affairs.

    Editorial note: This document was received at the Office of the 
Federal Register on July 31, 1996.

    For the reasons set out in the preamble, 38 CFR part 17 is proposed 
to be amended as set forth below:

PART 17-MEDICAL

    1. The authority citation for part 17 is revised 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; is familiar with the patient's 
activities, health, religious beliefs and values; and 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 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 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 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 if the proposed treatment is novel or unorthodox. 
The patient 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 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 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 patient has consented to a treatment plan that 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

[[Page 41111]]

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-disciplinary committee, 
appointed by the facility Director, must review that decision to ensure 
it is consistent with the patient's wishes or 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 will must be reviewed by a multi-disciplinary committee 
appointed by the facility Director for this purpose. The facility 
Director must concur with the committee's recommendation to administer 
psychotropic medications contrary to the patient's wishes. Continued 
therapy with psychotropic medication must be reviewed every 90 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 
signature (written) 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.

(Authority: 38 U.S.C. 7331, 7332, 7333)

[FR Doc. 96-19907 Filed 8-6-96; 8:45 am]
BILLING CODE 8320-01-P