Brief History of the Problem

Research Misconduct

 

The definition of research misconduct was recently revised by the Public Health Service (PHS).  The revised definition addresses concerns raised since the original definition published in 1989.  The major points remain the same:  FF&P (FABRICATION, FALSIFICATION, and PLAGIARISM.  As a general rule most institutional policies on scientific misconduct regard only these three actions to fall under the rubric of scientific misconduct.  The University of Memphis policy and procedures on scientific misconduct follow this tradition.

 

The University definitions and policies and procedures will be revised to coincide with the new PHS definitions by 2003.  What follows in this training material on Scientific Misconduct is based on the new Federal Guidelines and Definitions.

 

Learning Objectives

 

Define the three basic forms of research misconduct and give an example of each.

Describe the role of federal agencies in investigating and adjudicating charges of misconduct.

Describe the rights and responsibilities of whistleblowers.

Identify cases where issues of authorship do not involve misconduct.

Identify cases where authorship disputes definitely do involve misconduct.

 

Relevant University of Memphis Policies and Procedures

 

(http://policies.memphis.edu/Procedures/2b_Academic_Procedures/2b0112b.html)

(http://policies.memphis.edu/Procedures/2b_Academic_Procedures/2b0112a.html)

 

Relevant Federal Policies and Procedures

 

2000: Federal Research Misconduct Policy

The Office of Science Technology and Policy originally proposed a new, government-wide definition of scientific misconduct in Octorber of 1999.  That Policy, including a new definition of misconduct, has been approved, but must still be implemented by individual federal agencies.

http://ori.dhhs.gov/html/news/fedreg76260.asp

 

2000: National Science Foundation

Code of Federal Regulations: TITLE=45 PART=689 SECTION=1

http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr689_00.html

 

2000: Public Health Service

Code of Federal Regulations: TITLE=42 PART=50 SECTION=102

http://www.access.gpo.gov/nara/cfr/waisidx_00/42cfr50_00.html

 

 

New Definition of Scientific Misconduct

 

The following material is a reproduction of the notice in the Federal Register which contains the new definition of misconduct adopted by Federal Agencies.  This is divided into six sections labeled I through VI.

 

Federal Policy on Research Misconduct

 

No rights, privileges, benefits or obligations are created or abridged by issuance of this policy alone.  The creation or abridgment of rights, privileges, benefits or obligations, if any, shall occur only upon implementation of this policy by the Federal agencies.

 

I. Research Misconduct Defined

 

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.  Research, as used herein, includes all basic, applied, and demonstration research in all fields of science, engineering, and mathematics.  This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and research involving human subjects or animals.

 

Fabrication is making up data or results and recording or reporting them.

 

Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  The research record is the record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

 

Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.  Research misconduct does not include honest error or differences of opinion.

 

II. Findings of Research Misconduct

 

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, or knowingly, or recklessly; and

The allegation be proven by a preponderance of evidence.

 

III. Responsibilities of Federal Agencies and Research Institutions

 

Agencies and research institutions are partners who share responsibility for the research process.  Federal agencies have ultimate oversight authority for Federally funded research, but research institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institution.

 

The term ``research institutions'' is defined to include all organizations using Federal funds for research, including, for example, colleges and universities, intramural Federal research laboratories, Federally funded research and development centers, national user facilities, industrial laboratories, or other research institutes.  Independent researchers and small research institutions are covered by this policy.

 

Agency Policies and Procedures.  Agency policies and procedures with regard to intramural as well as extramural programs must conform to the policy described in this document. 

 

Agency Referral to Research Institution.  In most cases, agencies will rely on the researcher's home institution to make the initial response to allegations of research misconduct.  Agencies will usually refer allegations of research misconduct made directly to them to the appropriate research institution.  However, at any time, the Federal agency may proceed with its own inquiry or investigation.  Circumstances in which agencies may elect not to defer to the research institution include, but are not limited to, the following: the agency determines the institution is not prepared to handle the allegation in a manner consistent with this policy; agency involvement is needed to protect the public interest, including public health and safety; the allegation involves an entity of sufficiently small size (or an individual) that it cannot reasonably conduct the investigation itself.

 

Multiple Phases of the Response to an Allegation of Research Misconduct. A response to an allegation of research misconduct will usually consist of several phases, including: (1) an inquiry--the assessment of whether the allegation has substance and if an investigation is warranted; (2) an investigation--the formal development of a factual record, and the examination of that record leading to dismissal of the case or to a recommendation for a finding of research misconduct or other appropriate remedies; (3) adjudication--during which recommendations are reviewed and appropriate corrective actions determined.

 

Agency Follow-up to Institutional Action.  After reviewing the record of the investigation, the institution's recommendations to the institution's adjudicating official, and any corrective actions taken by the research institution, the agency will take additional oversight or investigative steps if necessary.  Upon completion of its review, the agency will take appropriate administrative action in accordance with applicable laws, regulations, or policies.  When the agency has made a final determination, it will notify the subject of the allegation of the outcome and inform the institution regarding its disposition of the case.  The agency finding of research misconduct and agency administrative actions can be appealed pursuant to the agency's applicable procedures.

 

Separation of Phases.  Adjudication is separated organizationally from inquiry and investigation.  Likewise, appeals are separated organizationally from inquiry and investigation.

 

Institutional Notification of the Agency.  Research institutions will notify the funding agency (or agencies in some cases) of an allegation of research misconduct if (1) the allegation involves Federally funded research (or an application for Federal funding) and meets the Federal definition of research misconduct given above, and (2) if the institution's inquiry into the allegation determines there is sufficient evidence to proceed to an investigation.  When an investigation is complete, the research institution will forward to the agency a copy of the evidentiary record, the investigative report,  recommendations made to the institution's adjudicating official, and the subject's written response to the recommendations (if any).  When a research institution completes the adjudication phase, it will forward the adjudicating official's decision and notify the agency of any corrective actions taken or planned.

 

Other Reasons to Notify the Agency.  At any time during an inquiry or investigation, the institution will immediately notify the Federal agency if public health or safety is at risk; if agency resources or interests are threatened; if research activities should be suspended; if there is reasonable indication of possible violations of civil or criminal law; if Federal action is required to protect the interests of those involved in the investigation; if the research institution believes the inquiry or investigation may be made public prematurely so that appropriate steps can be taken to safeguard evidence and protect the rights of those involved; or if the research community or public should be informed.

 

When More Than One Agency is Involved.  A lead agency should be designated to coordinate responses to allegations of research misconduct when more than one agency is involved in funding activities relevant to the allegation.  Each agency may implement administrative actions in accordance with applicable laws, regulations, policies, or contractual procedures.

 

IV. Guidelines for Fair and Timely Procedures

 

The following guidelines are provided to assist agencies and research institutions in developing fair and timely procedures for responding to allegations of research misconduct.  They are designed to provide safeguards for subjects of allegations as well as for informants.  Fair and timely procedures include the following:  Safeguards for Informants.  Safeguards for informants give individuals the confidence that they can bring allegations of research misconduct made in good faith to the attention of appropriate authorities or serve as informants to an inquiry or an investigation without suffering retribution.  Safeguards include protection against retaliation for informants who make good faith allegations, fair and objective procedures for the examination and resolution of allegations of research misconduct, and diligence in protecting the positions and reputations of those persons who make allegations of research misconduct in good faith.

 

Safeguards for Subjects of Allegations.  Safeguards for subjects give individuals the confidence that their rights are protected and that the mere filing of an allegation of research misconduct against them will not bring their research to a halt or be the basis for other disciplinary or adverse action absent other compelling reasons.  Other safeguards include timely written notification of subjects regarding substantive allegations made against  them; a description of all such allegations; reasonable access to the data and other evidence supporting the allegations; and the opportunity to respond to allegations, the supporting evidence and the proposed findings of research misconduct (if any).

 

Objectivity and Expertise.  The selection of individuals to review allegations and conduct investigations who have appropriate expertise and have no unresolved conflicts of interests help to ensure fairness throughout all phases of the process. 

 

Timeliness.  Reasonable time limits for the conduct of the inquiry, investigation, adjudication, and appeal phases (if any), with allowances for extensions where appropriate, provide confidence that the process will be well managed.

 

Confidentiality During the Inquiry, Investigation, and Decision-Making Processes.  To the extent possible consistent with a fair and thorough investigation and as allowed by law, knowledge about the identity of subjects and informants is limited to those who need to know.  Records maintained by the agency during the course of responding to an allegation of research misconduct are exempt from disclosure under the Freedom of Information Act to the extent permitted by law and regulation.

 

V. Agency Administrative Actions

 

Seriousness of the Misconduct.  In deciding what administrative actions are appropriate, the agency should consider the seriousness of the misconduct, including, but not limited to, the degree to which the misconduct was knowing, intentional, or reckless; was an isolated event or part of a pattern; or had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.

 

Possible Administrative Actions.  Administrative actions available include, but are not limited to, appropriate steps to correct the research record; letters of reprimand; the imposition of special certification or assurance requirements to ensure compliance with applicable regulations or terms of an award; suspension or termination of an active award; or suspension and debarment in accordance with applicable government-wide rules on suspension and debarment.  In the event of suspension or debarment, the information is made publicly available through the List of Parties Excluded from Federal Procurement and Nonprocurement Programs maintained by the U.S. General Services Administration.  With respect to administrative actions imposed upon government employees, the agencies must comply with all relevant federal personnel policies and laws.

 

In Case of Criminal or Civil Fraud Violations.  If the funding agency believes that criminal or civil fraud violations may have occurred, the agency shall promptly refer the matter to the Department of Justice, the Inspector General for the agency, or other appropriate investigative body.

 

VI. Roles of Other Organizations

 

This Federal policy does not limit the authority of research institutions, or other entities, to promulgate additional research misconduct policies or guidelines or more specific ethical guidance.

 

Barbara Ann Ferguson,

Assistant Director for Budget and Administration, Office of Science and

Technology Policy.

[FR Doc. 00-30852 Filed 12-5-00; 8:45 am]

BILLING CODE 3170-01-P

 

Plagiarism and Authorship Dispute

 

Sometimes authors have a falling out and may attempt to resolve their dispute about ownership and authorship by turning the matter into a charge of scientific misconduct.  For the most part, this is not appropriate.  Plagiarism has a rather specific boundary in the definition of scientific misconduct.  The following material clarifies the difference between authorship disputes and plagiarism and is taken from the Office of Research Integrity (ORI) website with permission from ORI (http://ori.dhhs.gov/html/policies/plagiarism.asp).

 

ORI Working Definition of Plagiarism

 

Although there is widespread agreement in the scientific community on including plagiarism as a major element of the PHS definition of scientific misconduct, there is some uncertainty about how the definition of plagiarism itself is applied in ORI cases.

 

The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged communication, such as a grant or manuscript review.

 

Substantial unattributed textual copying of another's work means the unattributed verbatim or nearly verbatim copying of sentences and paragraphs which materially mislead the ordinary reader regarding the contributions of the author.  ORI generally does not pursue the limited use of identical or nearly-identical phrases which describe a commonly-used methodology or previous research because ORI does not consider such use as substantially misleading to the reader or of great significance.

 

Many allegations of plagiarism involve disputes among former collaborators who participated jointly in the development or conduct of a research project, but who subsequently went their separate ways and made independent use of the jointly developed concepts, methods, descriptive language, or other product of the joint effort.  The ownership of the intellectual property in many such situations is seldom clear, and the collaborative history among the scientists often supports a presumption of implied consent to use the products of the collaboration by any of the former collaborators.  For this reason, ORI considers many such disputes to be authorship or credit disputes rather than plagiarism.  Such disputes are referred to PHS agencies and extramural institutions for resolution.  From ORI Newsletter, Vol 3, No. 1, December 1994.

 

Whistleblowing

 

The following materials are resources on the issue of whistleblowing.  Whistleblowing refers to making allegations of misconduct.  Allegations may be found to be true or false.  Regardless of final adjudication, the allegation of misconduct can have serious consequences both for the whistleblowing accuser and for the accuse party.  These materials are designed to familiarize the reader with issues from both sides of such allegations.

 

Whistleblower Protection Act of 1989

http://thomas.loc.gov/cgi-bin/query/z?c101:S.20.ENR

 

Whistleblower's Roles, Rights, and Protections

Office of Research Integrity, Dept. of Health and Human Services

http://ori.hhs.gov/html/misconduct/whistleblowers.asp

 

Glazer M (1983).  Ten whistleblowers and how they fared. Hastings Center Report 13(6):33-41.

 

Gunsalus CK (1998): How to blow the whistle and still have a career afterwards. Science and Engineering Ethics 4(1): 51-64.

This is an excellent summary for whistleblowers about what to expect and how to proceed. It is essential reading for anyone who is involved in an allegation of research misconduct.

 

Office of Research Integrity (1993): "The Whistleblower's Conditional Privilege to Report Allegations of Scientific Misconduct."

Prepared by ORI lawyers, describes protections for whistleblowers in defamation suits. Issued 12/93. (available from ORI at: http://ori.dhhs.gov/html/publications/studies.asp)

 

Office of Research Integrity (1995): ORI Guidelines for Institutions and Whistleblowers.

Intended to provide guidance in responding to possible retailiation agianst whistlelbowers in cases involving PHS extramural lresearch and provide information to whistleblowers regarding the appropriate method for submitting a retliation complaint. Issued 11/95. (available from ORI at: http://ori.hhs.gov/html/publications/guidelines_guidelin.ASP)

 

Office of Research Integrity (1995): Consequences of Whistleblowing.

Report on the study of "Consequences of Whistleblowing for the Whistleblower in Misconduct in Science Cases" conducted by the Research Triangle Institute. Issued 10/95. (available from ORI at: http://ori.dhhs.gov/html/publications/studies.asp)

 

Office of Research Integrity (1998): Consequences of Being Accused of Misconduct.

Report on the "Survey of Accused but Exonerated Individuals in Research Misconduct Cases" conducted by the Research Triangle Institute. Issued 12/98. (available from ORI at: http://ori.dhhs.gov/html/publications/studies.asp)

 

Office of Research Integrity (2000): Managing Allegations of Scientific Misconduct: A Guidance Document for Editors. ORI: January 2000.

(available from ORI at: http://ori.hhs.gov/html/publications/guidelines.asp)

 

Case Studies of Research Misconduct

 

The following case studies are located at the University of California San Diego website on Responsible Conduct of Research.  These cases are meant to provoke discussion and thought as a means for learning how to apply the F, F & P standards. 

 

Quarterly Newsletter from Office of Research Integrity

includes recent case summaries

http://ori.dhhs.gov/html/publications/newsletters.asp

 

Case Summaries and Results

http://ori.dhhs.gov/html/misconduct/casesummaries.asp

 

Broad W, Wade N (1982): Betrayers of the Truth. Simon and Schuster, New York. Review of historical examples of scientific misconduct prior to 1982.

 

IMANISHI-KARI CASE (CHRONOLOGICAL ORDER) SUMMARY: Margot O'Toole, a postdoc working in the laboratory of Thereza Imanishi-Kari, alleged that Imanishi-Kari had falsified and possibly fabricated data. Over a period of ten years, this case was reviewed by Tufts University, MIT, NIH, the Office of Scientific Integrity, the U.S. Congress, the Office of Research Integrity, and the Appeals Board of the Dept. of Health and Human Services. The final finding vindicated Imanishi-Kari of research misconduct, although the Appeals Board concluded that "A degree of sloppiness in recording and maintaining data certainly may warrant criticism of Dr. Imanishi-Kari's care in recordkeeping."

 

Weaver D, Reis MH, Albanese C, Costantini F, Baltimore D, Imanishi-Kari T (1986). Altered repertoire of endogenous immunoglobulin gene expression in transgenic mice containing a rearranged mu heavy chain gene [retracted by Weaver D, Albanese C, Costantini F, Baltimore D (1991). In: Cell 65(4):536] Cell 45(2):247-59.

 

Anderson C (1991). Scientific misconduct. NIH: Imanishi-Kari guilty. Nature 350(6316):262-3.

 

Stewart WW, Feder N (1991). Analysis of a whistle-blowing. Nature 351(6329):687-91.

 

O'Toole M (1991). O'Toole re-challenges: the Imanishi-Kari affair. Nature 351(6329):692-3.

 

Imanishi-Kari T (1991). OSI's conclusions wrong. Nature 351(6325):344-5.

 

Baltimore D (1991). The Imanishi-Kari affair. Baltimore declares O'Toole mistaken. Nature 351(6325):341-3.

 

Anderson C (1991). Imanishi-Kari affair. Baltimore resigns. Nature 354(6352):341.

 

Anderson C, Watson T (1992). US drops Imanishi-Kari investigation; Baltimore withdraws Cell retraction. Nature 358(6383):177.

 

Hamilton DP (1992). U.S. attorney decides not to prosecute Imanishi-Kari. Science 257(5068):318.

 

Travis J (1993). Imanishi-Kari says her new data shows she was right. Science 260(5111):1073-4.

 

Anderson C (1993). Imanishi-Kari case. Secret service analysis goes to pieces. Science 260(5115):1715.

 

Gavaghan H (1994). ORI finds Imanishi-Kari guilty of misconduct, proposes 10-year ban. Nature 372(6505):391.

 

Kevles DJ (1998): The Baltimore Case: A Trial of Politics, Science, and Character. Norton, New York.

 

Marwick C (1996): Appeals board exonerates Baltimore, Imanishi-Kari. JAMA 276: 266.

 

Research Integrity Adjudications Panel (DHHS Appeals Board)

Final findings: June 21, 1996

Search for "Kari"

http://www.hhs.gov/search

 

DARSEE CASE SUMMARY: John Darsee, a cardiologist at Harvard Medical School, was reported to have published over 100 papers and abstracts between 1979 and 1981. After being observed fabricating data, and following investigations in 1981, 15 of 20 research articles examined were retracted.

 

Relman AS (1983). Lessons from the Darsee affair. New England Journal of Medicine 308:1415-1417.

 

Stewart WW, Feder N (1987). The integrity of the scientific literature. Nature 325:207-214.

 

Braunwald E (1987). On analysing scientific fraud. Nature 325:215-216.

 

SUMMERLIN CASE SUMMARY: Summerlin had initially reported that tissue kept in organ culture for a period of time could then be transplanted without rejection into another animal.  When these findings weren't being replicated by others at the Sloan Kettering in New York, Summerlin went to meet with Good, who was considering publication of a retraction.  While on the elevator to Good's office, Summerlin used a felt pen to mark black patches on the backs of the white mice.  Although Good did not view the mice, the "patches" were later discovered in the animal facility.  Summerlin argued that he had painted the patches because of the pressure he was under to succeed and publish.

 

Summerlin WT, Broutbar C, Foanes RB, Payne R, Stutman O, Hayflick L, Good RA (1973): Acceptance of phenotypically differing cultured skin in man and mice. Transplantation Proceedings, 1973 Mar, 5(1):707-10.

 

Broad W, Wade N (1982): Betrayers of the Truth. Simon and Schuster, New York., pp. 153-157.

 

Hixson J (1976): The Patchwork Mouse. Doubleday, New York.

 

SLUTSKY CASE SUMMARY:  Over a period of two years, Slutsky was publishing a paper at the rate of one every ten days.  Although he was at first viewed as a rising star, a performance review of his published work uncovered an example of identical data in two different publications.  Subsequent investigation revealed an extensive process of misrepresentation including the reporting of experiments and analyses that had never been performed and the listing of co-authors who were not aware that they had been included on the papers.  Following a thorough review of 137 publications, 12 were found to be fraudulent and 48 questionable.

 

Engler RL, Covell JW, Friedman PJ, Kitcher PS, Peters RM (1987). Misrepresentation and responsibility in medical research. New England Journal of Medicine 317:1383-1389.

 

Clear and useful exposition of a case of misconduct discovered at UC San Diego.

San Diego's tough stand on research fraud (1986). Science 234:534-535.

 

BREUNING CASE SUMMARY: Stephen Breuning, an investigator at the University of Pittsburgh, was a researcher studying the use of drugs for treatment of individuals with mental retardation.  The work was widely cited and served as a basis for treatment and policy. In 1983, Breuning was alleged to have fabricated much of the data.  Over a period of several years, often difficult for the primary whistleblower, Robert Sprague, Breuning was ultimately found to have falsified research data.  After admission of guilt, Breuning was placed on probation for 5 years and held responsible for paying back a portion of his salary to the University of Pittsburgh.

 

Byrne G (1988): Breuning sentenced.Science 242(4881):1004

 

Holden C (1987). NIMH finds a case of "serious misconduct". Science 235:1566-1567.

 

Garfield E, Welljams-Dorof A (1990): The impact of fraudulent research on the scientific literature. The Stephen E. Breuning case. JAMA 263(10):1424-6.

 

GALLO CASE SUMMARY:  Between 1983 and 1984, French scientists of the Pasteur Institute and U.S. scientists independently reported discovery of a viral cause for AIDS.  Over the next five years, charges surfaced that the lead U.S. scientist, Robert Gallo, may have misappropriated the virus from the French laboratory.  Based on those charges, Congressman John Dingell initiated an invetigation of the allegations.  Gallo and a senior colleague (Popovic) were initially found guilty of "minor misconduct".  Subsequent reports suggested that recordkeeping in the Gallo laboratory was poor.  By 1991, a preliminary report from the Office of Scientific Integrity noted evidence of misconduct by Gallo, but a final report essentially held him responsible only for inadequate oversight of work done under his leadership.  By the end of 1992, the newly formed Office of Research Integrity (ORI) found Gallo to be guilty of research misconduct.  In late 1993, the ORI dropped the allegations against Gallo and Popovic because, based on "new standards," the evidence was insufficient to prove their case.  This highly publicized case brings into question a number of issues including recordkeeping in research and the process of handling allegations of research misconduct.

 

Popovic M, Sarngadharan MG, Read E, Gallo RC (1984). Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre-AIDS. Science 224(4648):497-500.

 

Palca J (1990). Article on Gallo prompts inquiry. Science 247(4938):19.

 

Gallo aide convicted on three counts. Science 257(5068):323.

 

Culliton BJ (1992). NIH report vindicates Gallo on conduct of AIDS research. Nature 357(6373):3-4.

 

Cohen J (1993). HHS: Gallo guilty of misconduct Science 259(5092):168-70.

 

Culliton BJ (1993). Misconduct charges against Gallo withdrawn after Popovic decision. Nature 366(6452):191.

 

Culliton BJ (1995). Dingell disavows 'Dingell' report on Gallo. Nature Medicine 1(3):188.