[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Notices]
[Pages 52156-52157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-4787]


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DEPARTMENT OF VETERANS AFFAIRS


VA Research Misconduct Policy

AGENCY: Department of Veterans Affairs.

ACTION: Notice of VA Research Misconduct Policy.

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SUMMARY: On December 6, 2000, the Office of Science and Technology 
Policy (OSTP), Executive Office of the President, published a 
notification of a final Federal Policy on Research Misconduct (Federal 
Policy) (65 FR 76260). That policy set forth a definition of ``research 
misconduct'' and provided basic guidelines for responding to 
allegations of misconduct for all Federally-funded research and 
proposals for such research. Federal agencies that conduct or support 
research, including the Department of Veterans Affairs (VA), are 
required to implement the Federal Policy.
    VA publicized its intent to adopt the Federal Policy on April 30, 
2002 (67 FR 21325). On May 4, 2005, VA finalized and released its 
research misconduct policy, Veterans Health Administration (VHA) 
Handbook 1058.2. These internal policies and procedures are fully 
consistent with and circumscribed by the Federal Policy. To the extent 
that the Federal Policy was published in the Federal Register subject 
to notice and comment requirements, no additional substantive policies 
affecting the public are created by VA's internal research misconduct 
policies and procedures.
    These policies and procedures apply only to allegations of research 
misconduct as defined herein. Other ``research improprieties'' are 
handled according to separate, extant VA policies and procedures.

FOR FURTHER INFORMATION CONTACT: Peter Poon, Health Science Specialist, 
Office of Research Oversight (10R), 811 Vermont Ave., NW., Suite 574, 
Washington, DC 20420, (202) 565-8107.

SUPPLEMENTARY INFORMATION: VA's internal research misconduct policies 
and procedures are fully consistent with and circumscribed by the 
Federal Policy.

I. Research Misconduct Defined

    Consistent with the Federal Policy, VHA Handbook 1058.2 defines 
research misconduct as ``fabrication, falsification, or plagiarism in 
proposing, performing, or reviewing research, or in reporting research 
results.'' The component terms ``fabrication, falsification, and 
plagiarism,'' as well as ``research'' are further defined, consistent 
with the Federal Policy.

II. Findings of Research Misconduct

    VHA Handbook 1058.2 adopts the Federal Policy standard for making a 
finding of research misconduct. Specifically, a finding of research 
misconduct requires that:
     There be a significant departure from accepted practices 
of the relevant research community; and
     The misconduct be committed intentionally, knowingly, or 
with reckless disregard for the integrity of the research; and
     The allegation is proven by a preponderance of evidence.

III. Responsibilities of VA and Local VA Research Facilities

    Under VHA Handbook 1058.2, local VA Medical Centers (VAMCs) 
conducting research bear primary responsibility for the prevention and 
detection of research misconduct within their own facilities and 
conducting inquiries and investigations when required. Each VAMC 
designates a Research Integrity Officer (RIO) to oversee research 
misconduct cases at its facility. In exceptional circumstances, the 
VA's Office of Research Oversight (ORO) may conduct its own 
investigation.
    The purpose of an Investigation is to determine whether and to what 
extent research misconduct has occurred, who is responsible, and what 
corrective actions are appropriate. The VAMC Director transmits the 
Investigation Committee's Report, along with his or her own 
recommendations, to the designated Veterans Integrated Service Network 
(VISN) Director.
    The VISN Director adjudicates all cases of research misconduct 
within his or her geographical Network. The VISN Director's final 
decision and the Investigation Report are then reviewed by ORO Central 
Office for procedural conformance with VHA Handbook 1058.2. If the 
procedures substantially adhered to the Handbook, ORO notifies the 
Respondent of the outcome.
    Respondents have the opportunity to submit written appeals of 
research misconduct findings and proposed corrective actions to the 
Under Secretary for Health. The Under Secretary for Health reviews and 
makes a final decision on such appeals.

IV. Fair and Timely Procedures

     Safeguards for Informants. VHA Handbook 1058.2 includes 
provisions for protecting from retaliation informants who make good 
faith and reasonable allegations of research misconduct to appropriate 
authorities or who cooperate in good faith with inquiries or 
investigations of research misconduct.
     Safeguards for Respondents. VHA Handbook 1058.2 also 
includes provisions for protecting the rights of those who are the 
subject of research misconduct allegations, including timely 
notification, reasonable access to the data and other evidence 
supporting the allegations, and the opportunity to respond to 
allegations, evidence, and proposed findings of research misconduct (if 
any). Respondents may obtain the advice of legal counsel or a personal 
advisor, and have an opportunity to appeal research misconduct findings 
and proposed corrective actions to the Under Secretary for Health.
     Objectivity, Fairness, and Expertise. VA's research 
misconduct policies and procedures include provisions for ensuring 
objectivity, fairness, and expertise in the review of allegations. The 
Handbook requires that those acting in the role of RIO, member of an 
Inquiry

[[Page 52157]]

or Investigation Committee, and Adjudicator be replaced if they have an 
actual or apparent conflict of interest that cannot be resolved with 
respect to a particular case.
     Timeliness. VHA Handbook 1058.2 establishes specific time 
limits for the Inquiry (30 days), Investigation (90 days), Adjudication 
(30 days), and Appeal (45 days), with allowances for appropriate 
extensions.
     Confidentiality During the Inquiry, Investigation, and 
Decision-Making Process. VA's research misconduct policies and 
procedures emphasize the privacy of all participants and the 
confidentiality of information gathered in research misconduct 
proceedings to the extent possible consistent with a fair and thorough 
investigation and as allowed by law. Only those individuals who are 
specifically authorized to review a misconduct allegation will be 
provided with nonpublic information in connection with the misconduct 
proceeding.

V. VA Administrative Actions

    VHA Handbook 1058.2 lists a number of criteria to be considered in 
proposing corrective actions when research misconduct is found: the 
extent of the misconduct; the degree to which the misconduct was 
knowing, intentional, or reckless; the presence or absence of a pattern 
of misconduct; the consequences of the misconduct; the Respondent's 
position and responsibilities; the cooperation of the Respondent during 
the Investigation; the likelihood of rehabilitation; the type of 
corrective actions imposed in past cases with similar features, if any; 
and any other extenuating or aggravating circumstances.
    VA may take interim action(s) as necessary. If there is reasonable 
indication of a possible criminal violation, the matter will be 
promptly referred to the VA Inspector General or other appropriate 
investigative body.

(Authority: 65 FR 76260)

    Dated: August 26, 2005.
Gordon H. Mansfield,
Deputy Secretary of Veterans Affairs.
[FR Doc. E5-4787 Filed 8-31-05; 8:45 am]
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