December 6, 2000

ORCA ALERT # 5:

New Federal Policy on Research Misconduct

Today, December 6, 2000, the Office of Science and Technology Policy (OSTP) published a Notification of Final Policy which sets forth a new federal policy on research misconduct.  This policy applies to all federally-funded research and proposals submitted to Federal agencies for research funding.  Research conducted by the VA, or otherwise supported by VA funds, falls within the scope of this new policy.

There is no immediate urgency for you to do anything right now.  Continue to follow the VA’s policy on research misconduct as contained in M-3, Part I, Chapter 15, notifying ORCA if an investigation of research misconduct commences at your institution.

Among the provisions of the federal policy is a new definition of research misconduct:  “Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”  The terms “fabrication, falsification, and plagiarism” (FFP) are further defined in the policy.  Research misconduct does not include honest error or differences of opinion.  A finding of research misconduct requires that (1) there be a significant departure from accepted practices of the relevant research community; (2) the misconduct be committed intentionally, or knowingly, or recklessly; and (3) the allegation be proven by a preponderance of the evidence.

The new federal policy places primary responsibility for prevention and detection of research misconduct on research institutions, although the relevant Federal agency maintains ultimate oversight authority.  The new federal policy also sets forth guidelines that research institutions should abide by in developing fair and timely procedures.  These include:  safeguards for informants; safeguards for subjects of allegations; objectivity and expertise in the review and investigation of allegations; timeliness; and confidentiality.

Federal agencies are required to implement the new federal policy within one year.  VA intends to promulgate specific regulations as a part of 38 CFR and replace its current misconduct policies in order to conform with the federal policy.  One change required by the new policy is a revision of the VA’s definition of research misconduct.  The VA’s policy currently includes within the definition of research misconduct: “[m]aterial failure to comply with Federal requirements affecting specific aspects of the conduct of research e.g., the protection of human subjects and the welfare of laboratory animals.”  These sorts of infractions fall outside of the new federal definition of research misconduct, and will be (or are already) covered by other VA policies.

ORCA has the lead on the implementation of this new policy and is working with several offices across Headquarters on the issuance of any interim and final policies and guidance.  Detailed instructions will be forthcoming over the course of the next several months.

Questions about the new federal policy on research misconduct can be addressed to Peter Poon at (202) 565-8107 or via e-mail at peter.poon@hq.med.va.gov.