Research Misconduct

(and what should you do about it)

What is

This policy applies to federally-funded research and proposalssubmitted to Federal agencies forresearch funding. It thus applies toresearch conducted by the Federalagencies, conducted or managed for the Federal government by contractors, orsupported by the Federal governmentand performed at research institutions,including universities and industry.

Federal Policy on Research Misconduct

I. Research 2 Misconduct Defined

Research misconduct is defined asfabrication, falsification, or plagiarismin proposing, performing, or reviewingresearch, or in reporting researchresults.

· Fabrication is making up data orresults and recording or reporting them.

· Falsification is manipulatingresearch materials, equipment, orprocesses, or changing or omitting dataor results such that the research is notaccurately represented in the researchrecord.3

· Plagiarism is the appropriation ofanother person’s ideas, processes,results, or words without givingappropriate credit.

· Research misconduct does notinclude honest error or differences ofopinion.

Federal Policy on Research Misconduct

The policy addresses researchmisconduct. It does not supersedegovernment or institutional policies orprocedures for addressing other forms ofmisconduct, such as the unethicaltreatment of human research subjects ormistreatment of laboratory animals usedin research, nor does it supersedecriminal or other civil law. Agenciesand institutions may address these otherissues as authorized by law and asappropriate to their missions andobjectives.

Federal Policy on Research Misconduct

ResearchMisconduct

(F F P)

AnimalWelfare

Violations

HumanSubject

Violations

July 12, 1993 M-3, Part I

Chapter 15

CHAPTER 15. MISCONDUCT IN SCIENTIFIC RESEARCH 15.01 PURPOSE The purpose of this chapter is to define "misconduct in scientific research," and to establish policies and procedures for the reporting, investigating, and resolving of complaints alleging scientific misconduct by VA (Department of Veterans Affairs) investigators. The procedures are designed to protect public confidence in the integrity of research conducted in VA, and at the same time, protect the rights and reputations of individuals accused of misconduct. 15.02 POLICY It is the policy of VA's R&D (Research and Development) Program to require high ethical standards for all research activities and,if necessary, to inquire,investigate,and resolve promptly and fairly all alleged, or apparent misconduct in science. The R&D Program management will take appropriate action against individuals if it is determined that misconduct has occurred. 15.03 SCOPE a. The policies and procedures described in this chapter apply to all instances of alleged, or apparent, misconduct involving research, research training, and related activities conducted by VA investigators regardless of source of funding (or even if unfunded). NOTE: Issues that are not primarily scientific are outside the scope of this chapter, for example, conflicts of interest, sexual harassment, etc. b. Investigators receiving support from other Federal agencies such as the National Institutes of Health, or the National Science Foundation, may be subject to additional scientific misconduct policies such as those contained in 42 CFR (Code of Federal Regulations) Subpart A (Public Health Service), or 45 CFR 689.1 through 689.9 (National Science Foundation). 15.04 DEFINITION "Misconduct" is defined as: a. Serious deviation, such as fabrication, falsification, or plagiarism, from accepted practice, in carrying out research, or in reporting the results of research; or b. Material 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. 15.05 GENERAL RESPONSIBILITIES a. The scientific community in general, and VA investigators in particular, are expected to make every effort to prevent scientific misconduct.

15.04 DEFINITION "Misconduct" is defined as: a. Serious deviation, such as fabrication, falsification, or plagiarism, from accepted practice, in carrying out research, or in reporting the results of research; or b. Material 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.

M-3, Part I, Chapter 15

DRAFT (January 29, 2004) VHA HANDBOOK 1200.14

CONTENTS

RESEARCH MISCONDUCT HANDBOOK

PARAGRAPH PAGE 1. Purpose ...................................................................................................................................... x 2. Background ................................................................................................................................ x 3. Scope .......................................................................................................................................... x 4. Definitions ................................................................................................................................. x 5. Responsibilities and Safeguards.................................................................................................. x 6. General Procedures .................................................................................................................... x 7. Allegations ................................................................................................................................. x

8. Inquiry ........................................................................................................................................ x 9. Investigation ............................................................................................................................... x 10. Adjudication ............................................................................................................................. x

What should you do about

Research Misconduct

(nothing)

ResearchMisconduct

(F F P)

HumanSubject

Violations

AnimalWelfare

Violations

HSHS

HS

HSHS

AW

AW

FFP

FFP

FFPAW

HS

HS HSHS

HSHS

AWAW

FFPFFP

FFP

AWHS

ResearchMisconduct

(F F P)

Research Integrity Officer ( R I O )

Peter N. Poon, JD, MAPeter N. Poon, JD, MA

Office of Research Office of Research Oversight (ORO)Oversight (ORO)

(202) 565-8107(202) 565-8107

peter.poon@hq.med.va.gopeter.poon@hq.med.va.govv