[Federal Register Volume 71, Number 46 (Thursday, March 9, 2006)]
[Proposed Rules]
[Pages 12154-12155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3290]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AM19


Medical: Informed Consent--Extension of Time Period and 
Modification of Witness Requirement for Signature Consent

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: This document proposes to amend the U.S. Department of 
Veterans Affairs (VA) medical regulations on informed consent by making 
two substantive changes. We propose to extend the period of time during 
which a signed consent form remains valid from 30 to 60 days and 
eliminate the requirement that a third party witness the patient or 
surrogate and practitioner signing the consent form, except in those 
circumstances where the patient or surrogate signs with an ``X'' due to 
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 or write.

DATES: Comments must be received on or before: May 8, 2006.

ADDRESSES: Written comments may be submitted by mail or hand delivery 
to: Director, Regulations Management (00REG1), Department of Veterans 
Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; fax 
comments to (202) 273-9026; or e-mail comments through http://www.Regulations.gov. Comments should indicate that they are submitted 
in response to ``RIN 2900-AM19.'' All comments received will be 
available for public inspection in the Office of Regulation Policy and 
Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., 
Monday through Friday (except holidays). Please call (202) 273-9515 for 
an appointment.

FOR FURTHER INFORMATION CONTACT: Ruth Cecire, PhD., Policy Analyst, 
Ethics Policy Service, National Center for Ethics in Health Care (10E), 
Veterans Health Administration, Department of Veterans Affairs, 810 
Vermont Avenue, NW., Washington, DC 20420; 202-501-2012 (this is not a 
toll-free number).

SUPPLEMENTARY INFORMATION: Section 7331 of title 38, United States Code 
(U.S.C.), directs the Secretary of Veterans Affairs to promulgate 
regulations to ensure that, to the maximum extent practicable, all 
patient care carried out under the authority of title 38 U.S.C. is 
accomplished with the informed consent of the patient or the patient's 
surrogate. These VA medical regulations, set forth at 38 CFR 17.32 and 
titled ``Informed Consent'', were published in the Federal Register as 
a final rule on October 2, 1997 (62 FR 53961).
    The proposed rule would amend VA medical regulations on informed 
consent. Specifically, it would extend the time during which a signed 
consent form is valid from 30 to 60 days. Also, it would eliminate the 
requirement that a consent form be witnessed, except in those 
situations where the patient or surrogate signs with an ``X''. We are 
specifically interested in obtaining comments from non-VA providers, 
patients and other concerned community members with respect to both of 
these changes.
    Often, the informed consent discussion takes place and the 
requisite forms are signed before a procedure is scheduled. Under the 
current rule, a signed consent form is valid for 30 days. If the 
procedure is later scheduled for a date beyond that 30 day window, the 
patient and practitioner must sign and date a new consent form. In our 
experience a number of treatments or procedures that require signature 
consent are scheduled more than 30 days in advance. Extending the 
period during which signed consent forms remain valid would enable 
patients to avoid having to return to the facility just to sign a new 
form or to re-sign when they come for the procedure.
    Under current regulations, witnesses who sign the consent form only 
attest to the fact that they saw the patient and the practitioner sign 
the form. They do not attest to the content of the informed consent 
discussion, or that the process was voluntary, or that the patient was 
capable of giving informed consent. Nor do they attest to the identity 
of the individuals signing the form. Experience has shown that finding 
an appropriate witness is sometimes difficult and creates an impediment 
to the timely completion of the informed consent process. Given the 
above, it is not clear that the witness requirement benefits the 
veteran, especially since there are other means to verify the 
signatures if there is a dispute, e.g., by comparing the signature on 
the form against other documents signed by the patient. Therefore, we 
do not think it necessary to continue this practice for general 
signature consent. However, two witnesses would still be required to 
sign the consent form when the patient or surrogate signs with an 
``X''.
    In addition, we propose to make the following non-substantive 
changes to Sec.  17.32: in paragraph (a), removing ``,

[[Page 12155]]

e.g., a published numbered VA form (OF 522) or comparable form approved 
by the local VA facility''; and in paragraph (d)(2), removing 
``OF522''. These references to OF522, Request for Administration of 
Anesthesia and Performance of Operations and Other Procedures, are 
obsolete. Use of the OF522, which is a general form, in VA health care 
facilities is being phased out. Facilities now have access to 
procedure-specific VA-authorized consent forms.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in an expenditure by 
State, local, or tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any given year. This rule would have no such effect on 
State, local, or tribal governments, or the private sector.

Paperwork Reduction Act of 1995

    This rule contains no new collections of information under the 
Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information 
collections associated with the informed consent procedures under Sec.  
17.32 have been approved by OMB under 2900-0853.

Executive Order 12866

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The Order 
classifies a rule as a significant regulatory action requiring review 
by the Office of Management and Budget if it meets any one of a number 
of specified conditions, including: Having an annual affect on the 
economy of $100 million or more; creating a serious inconsistency or 
interfering with an action of another agency, materially altering the 
budgetary impact of entitlements or the rights of entitlement 
recipients, or raising novel legal or policy issues. VA has examined 
the economic, legal, and policy implications of this proposed rule and 
concluded that it is a significant regulatory action because it raises 
novel policy issues.

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule will 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 rule will affect only individuals and will not 
directly affect any small entities. Therefore, pursuant to 5 U.S.C. 
605(b), this rule is exempt from the initial and final regulatory 
flexibility analysis requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans 
Dental Care.

List 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 homes, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

    Approved: November 29, 2005.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.

    For the reasons set out above, VA proposes to amend 38 CFR part 17 
to read as follows:

PART 17--MEDICAL

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

    Authority: 38 U.S.C. 501, 1721, and as stated in specific 
sections.

    2. Section 17.32 is amended by:
    a. Revising the section heading.
    b. In paragraph (a), in the definition of signature consent, 
removing ``, e.g., a published numbered VA form (OF 522) or comparable 
form approved by the local VA facility''.
    c. Revising paragraph (d)(2).
    d. Revising the authority citation at the end of the section.
    The revisions read as follows:


Sec.  17.32  Informed consent and advance care planning.

* * * * *
    (d) * * *
    (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 or 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 medical 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.
* * * * *
(Authority: 38 U.S.C. 7331-7334)

 [FR Doc. E6-3290 Filed 3-8-06; 8:45 am]
BILLING CODE 8320-01-P