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Proposed Rule

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

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Department of Veterans Affairs.


Proposed rule.


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.


Comments must be received on or before: April 3, 2006.


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:// 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.

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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).

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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 Start Printed Page 5205alternatives 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.

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List of Subjects in 38 CFR Part 17

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Approved: October 20, 2005.

Gordon H. Mansfield,

Deputy Secretary of Veterans Affairs.

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

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

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

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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:

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.

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[FR Doc. E6-1218 Filed 1-31-06; 8:45 am]