[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Proposed Rules]
[Pages 5204-5205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1218]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AM21


Medical: Informed Consent--Designate Health Care Professionals To 
Obtain Informed Consent

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: This document would amend U.S. Department of Veterans Affairs 
(VA) medical regulations on informed consent. The proposed rule 
authorizes VA to designate additional categories of health care 
professionals to obtain informed consent and sign the consent form.

DATES: Comments must be received on or before: April 3, 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 hhtp://
www.Regulations.gov. Comments should indicate that they are submitted 
in response to ``RIN 2900-AM21''. 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 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 and bring VA practice in line with broader community standards 
of care. Specifically, it would allow VA to designate appropriately 
trained health care professionals, (e.g. advance practice nurses and 
physician assistants) to conduct the informed consent discussion and 
sign the consent form. These changes will be documented in a revision 
to VHA Handbook 1004.1, Informed Consent for Clinical Treatments and 
Procedures. Any future expansion of the categories of designated health 
care professionals will be communicated to the field by the Under 
Secretary for Health's Office.
    In the years since the informed consent regulation was first 
published, the way in which VA delivers health care to veterans has 
changed dramatically. In the past most VA health care was provided 
primarily in an inpatient setting and the informed consent discussion 
was conducted by the physician treating the patient. Today there is 
more of a team approach to clinical care. Other highly trained health 
care professionals work with the treating practitioner to educate 
patients and respond to their questions about the potential risks and 
benefits of and

[[Page 5205]]

alternatives to the recommended treatment or procedure.
    Under the current definition of practitioner, residents may obtain 
the informed consent and sign the consent form even if they are not 
clinically privileged. This rule would extend that exception to other 
appropriately trained health care professionals, e.g., advanced 
practice nurses and physician assistants, if designated by the VA 
health care facility to perform this role. Allowing these health care 
professionals, in addition to residents, to complete the informed 
consent process by signing the form does not preclude discussion about 
the recommended treatment or procedure with the treating practitioner. 
Nor does it eliminate the responsibility of that practitioner to ensure 
that patients receive necessary information to make informed decisions 
and that these decisions are then appropriately documented in the 
health record.
    We are also making nonsubstantive changes to make the terminology 
used in the regulation consistent with current Department practice. 
These include changing ``health-care'' to ``health care'' and ``medical 
record'' to ``health record'' throughout the section.

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 document contains no provisions constituting a collection of 
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). 
The existing information collections associated with the informed 
consent process have been approved by OMB under control number 2900-
0583.

Executive Order 12866--Regulatory Planning and Review

    The Department of Veterans Affairs (VA) has examined the economic 
implications of this proposed rule as required by 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). Executive 
Order 12866 classifies a rule as significant if it meets any one of a 
number of specified conditions, including: having an annual effect on 
the economy of $100 million, adversely affecting a sector of the 
economy in a material way, adversely affecting competition, or 
adversely affecting jobs. A regulation is also considered a significant 
regulatory action if it raises novel legal or policy issues.
    The VA concludes that this proposed rule is a significant 
regulatory action under the Executive Order since it raises novel legal 
and policy issues under Section 3(f)(4). The VA concludes, however, 
that this proposed rule does not meet the significance threshold of 
$100 million effect on the economy in any one year under Section 
3(f)(1). The VA requests comments regarding this determination, and 
invites commenters to submit any relevant data that will assist the 
agency in estimating the impact of this rulemaking.

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 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: October 20, 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. Removing ``health-care'' each time it appears and adding in its 
place ``health care''.
    b. Removing ``medical record'' each time it appears and adding in 
its place ``health record''.
    c. In the list of definitions in paragraph (a), revising the 
definition of ``Practitioner''.
    The revision reads as follows:


Sec.  17.32  Informed consent and advance care planning.

    (a) * * *
    Practitioner. Any physician, dentist, or health care professional 
who has been granted specific clinical privileges to perform the 
treatment or procedure. For the purpose of obtaining informed consent 
for medical treatment, the term practitioner includes medical and 
dental residents and other appropriately trained health care 
professionals designated by VA regardless of whether they have been 
granted clinical privileges.
* * * * *
 [FR Doc. E6-1218 Filed 1-31-06; 8:45 am]
BILLING CODE 8320-01-P