02-10596. VA Research Misconduct Policy

AGENCY:

Department of Veterans Affairs.

ACTION:

Notice of Intent to Adopt Federal Research Misconduct Policy.

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 within one year of the policy's issuance (12/6/00).

The VA hereby publicizes its intent to adopt the Federal Policy on Research Misconduct with respect to all research subject to VA approval. Operational implementation of the Federal Policy will be effected by revising relevant, internal VA procedures to conform to the requirements of the Federal Policy. The VA's internal, research misconduct policies and procedures will be fully consistent with and circumscribed by the Federal Policy. Therefore, 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 will be created by the VA's internal, research misconduct policies and procedures.

These policies and procedures will 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 Compliance and Assurance, 811 Vermont Ave., NW., (10R), Suite 574, Washington, DC 20420, [phone].

SUPPLEMENTARY INFORMATION:

The VA's internal, research misconduct policies and procedures will be fully consistent with and circumscribed by the Federal Policy.

I. Research Misconduct Defined. Under VA policies and procedures, the definition of “research misconduct” will strictly adhere to that of the Federal Policy. Moreover, the component terms “fabrication”, “falsification”, “plagiarism”, and “research” shall be defined as by the Federal Policy.

II. Findings of Research Misconduct. The Federal Policy standard for making a finding of research misconduct will be adopted by the VA. Specifically, a finding of research misconduct will require that:

• There be a significant departure from accepted practices of the relevant research community; and
• The misconduct be committed intentionally, or knowingly, or recklessly; and
• The allegation be proven by a preponderance of evidence.

III. Responsibilities of the VA and Local Research Facilities Conducting VA Research. Local VA Medical Centers (VAMCs) and their affiliates that conduct VA research will bear primary responsibility for the prevention and detection of research misconduct within their own facilities and conducting inquiries and investigations when required. However, the VA's Office of Research Compliance and Assurance (ORCA), through one of its Regional Offices (RO), may conduct its own inquiry or investigation for reasons specified in the Federal Policy. Further clarification on the roles and responsibilities of the VAMCs and VA Central Office will be set forth in appropriate VA directives and guidelines.

IV. Fair and Timely Procedures.

• Safeguards for Informants. VA policies and procedures will include provisions for protecting informants who make good faith allegations of research misconduct to appropriate authorities or who cooperate in good faith with inquiries or investigations of research misconduct.
• Safeguards for Respondents. VA policies and procedures will include 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).
• Objectivity, Fairness, and Expertise. VA policies and procedures will include provisions for ensuring objectivity, fairness, and expertise in the review of allegations.
• Timeliness. VA policies and procedures will include provisions establishing reasonable time limits for the conduct of the inquiry, investigation, adjudication, and appeal phases (if any), with allowances for appropriate extensions.
• Confidentiality during the Inquiry, Investigation, and Decision-Making Process. VA policies and procedures will place limits on public disclosure of the identity of respondents and informants consistent with a fair and thorough investigation and as allowed by law.

V. VA Administrative Actions. The VA will consider the seriousness of the misconduct in deciding what administrative actions are appropriate. If it believes that criminal or civil fraud violations may have occurred, the VA will promptly refer the matter to the Inspector General for the VA.

Dated: April 23, 2002.

(Authority: 65 FR 76260)

Anthony J. Principi,

The Secretary of Veterans Affairs.