Informed Consent for Patient Care

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

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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

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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-

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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]

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