97-27565. Informed Consent for Patient Care  

  • [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
    
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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-
    
    [[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
    
    
    

Document Information

Published:
10/17/1997
Department:
Veterans Affairs Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-27565
Pages:
53960-53963 (4 pages)
RINs:
2900-AH72: Informed Consent for Patient Care
RIN Links:
https://www.federalregister.gov/regulations/2900-AH72/informed-consent-for-patient-care
PDF File:
97-27565.pdf
CFR: (2)
38 CFR 17.32(c))
38 CFR 17.32