E6-20111. Medical: Informed Consent-Extension of Time Period and Modification of Witness Requirement for Signature Consent

AGENCY:

Department of Veterans Affairs.

ACTION:

Final rule.

SUMMARY:

This document adopts as a final rule the proposed rule amending the Department of Veterans Affairs (VA) medical regulations on informed consent. This final rule extends the period of time during which a signed consent form remains valid from 30 to 60 days and eliminates 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 and write.

DATES:

Effective Date: December 28, 2006.

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:

In a document published in the Federal Register on March 9, 2006 (71 FR 5204), VA proposed to amend its medical regulations at 38 CFR 17.32 on informed consent. Specifically, it proposed to extend the time during which a signed consent form is valid from 30 to 60 days. Also, it proposed to eliminate the requirement that a consent form be witnessed, except in those situations where the patient or surrogate signs with an “X” due to a debilitating illness or disability. VA provided a 60-day comment period that ended on May 6, 2006. No comments were received. Based on the rationale set forth in the proposed rule and those contained in this document, we are adopting the provisions of the proposed rule as a final rule without change.

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, and 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 has no such effect on State, local, and tribal governments, or on 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 § 17.32 have been approved by the Office of Management and Budget (OMB) under 2900-0583.

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 final 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 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: October 23, 2006.

Gordon H. Mansfield,

Deputy Secretary of Veterans Affairs.

For the reasons set out in the preamble, VA amends 38 CFR part 17 to read as follows:

PART 17—MEDICAL

1. The authority citation for part 17 continues 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:

§ 17.32

Informed consent and advance care planning.

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(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 and 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)