G E y - UPV/EHU · Volume 770 Number 7 Misconduct and fraud in research 3 who were found guilty of...

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G E y Volume 110 Number 1 jULY 1991 Panelists: Richard L. Simmons,MD, Hiram C. Polk, Jr., MD, and Barbara Williams, PhD, Moderator: Constantine Mavroudis, MD, Pittsburgh,Pa., Louisuille, Ky., Bethesda, Md., and Chicago, lll. Misconduct and fraud in scientificresearch has recently attracted wide attention from researchers, government officials, and institutional administrators and has resultedin nationalguidelin es 10r definition, investigation, and sanctions. This repare summarizes the results 01 a questionnaire sent to the activemembers 01 the Society 01 University Surgeons in 1989concemingmisconduct and fraud in research. The repare alsogives the opinions01 the participants,who included Richard L. Simmons, MD, prolessor and chairman,Department 01 Surgery, University 01 Pittsburgh, "Quality assurance in laboratoryresearch",. Hiram C. Polk, fr., MD, chiel editor,American Journal of Surgery, prolessor and chairman, Department olSurgery, University 01 Louisville, "Peer review-Success or lailure",. and Barbara Williams, PhD, seniorscientist, Office 01 Scientific lntegrity, National lnstitutes01 Health, "Office 01 scientific integrity-National approachto qualityassurance."(SURGERY 1991;110:1-7.) From the Social and Legislativelssues Symposium, Society o/ University Surgeons Meeting, Los Angeles, Calif February 8-10, 1990 MISCONDUCT AND FRAUD in scientific researchis not a new phenomenon. The theories and practices of such notable scientists as Ptolemy, Galileo, Newton, Dalton, and Mendel have been called into question for irregu- larities concerning studies that were allegedly never performed, data that were toa good to be true (fudging), and experiments that could never be confirmed or repeated by other scientists.l. 2 During the last two decades, many scientistsl-3 were found to have faked data, falsified records, and plagia- rized scientific papers. These notable scientists included John Darsee, a Harvard cardiologist, who faked exper- iments and submitted abstracts and scientific papers for publication4; William T. Summerlin, a Sloan-Kettering physician-researcher, who painted white mice black to Cake intraspecies immunocompatibility when skin grafts were ~placed in a nutrient solution before trans- Committee members: Constantine Mavroudis, MD, Chair- man,Paul Addonizio, MD, R. Morton Bolman, MD, David L. Dunn, MD, John B. Hanks, MD, RonaldC. Merrell, MD, and BruceG. Sommer, MD. Accepted for publication Seplember 19, 1990. Reprint requests: Constantine Mavroudis, MD. Division of Cardiovascular- Thoracic Surgery,Box 22, Children's Me- morial Hospital, 2300Children 's Plaza, Chicago, lL 60614. 11/56/26170 SURGERY -."-,.. ~., I ".,,~::-:" ~:':"'::~ -:!~~¿-~~~?- .~ "'é! f"'"".;. .~. ;~.., -"':::,,-" ~ .,~;~~c '- ,t:;~"':' ':~:.- '" -

Transcript of G E y - UPV/EHU · Volume 770 Number 7 Misconduct and fraud in research 3 who were found guilty of...

Page 1: G E y - UPV/EHU · Volume 770 Number 7 Misconduct and fraud in research 3 who were found guilty of fraud. However, no general consensus was reached about the value of institutional

G E yVolume 110 Number 1

jULY 1991

Panelists: Richard L. Simmons, MD, Hiram C. Polk, Jr., MD, and Barbara Williams, PhD,Moderator: Constantine Mavroudis, MD, Pittsburgh, Pa., Louisuille, Ky., Bethesda, Md., andChicago, lll.

Misconduct and fraud in scientific research has recently attracted wide attention fromresearchers, government officials, and institutional administrators and has resulted innational gu idelin es 10r definition, investigation, and sanctions. This repare summarizesthe results 01 a questionnaire sent to the active members 01 the Society 01 UniversitySurgeons in 1989 conceming misconduct and fraud in research. The repare also givesthe opinions 01 the participants, who included Richard L. Simmons, MD, prolessor andchairman, Department 01 Surgery, University 01 Pittsburgh, "Quality assurance inlaboratory research",. Hiram C. Polk, fr., MD, chiel editor, American Journal ofSurgery, prolessor and chairman, Department olSurgery, University 01 Louisville,"Peer review-Success or lailure",. and Barbara Williams, PhD, senior scientist, Office

01 Scientific lntegrity, National lnstitutes 01 Health, "Office 01 scientificintegrity-National approach to quality assurance." (SURGERY 1991;110:1-7.)

From the Social and Legislative lssues Symposium, Society o/ University Surgeons Meeting,Los Angeles, Calif February 8-10, 1990

MISCONDUCT AND FRAUD in scientific research is not anew phenomenon. The theories and practices of suchnotable scientists as Ptolemy, Galileo, Newton, Dalton,and Mendel have been called into question for irregu-

larities concerning studies that were allegedly neverperformed, data that were toa good to be true (fudging),and experiments that could never be confirmed orrepeated by other scientists.l. 2

During the last two decades, many scientistsl-3 werefound to have faked data, falsified records, and plagia-rized scientific papers. These notable scientists includedJohn Darsee, a Harvard cardiologist, who faked exper-iments and submitted abstracts and scientific papers forpublication4; William T. Summerlin, a Sloan-Ketteringphysician-researcher, who painted white mice black toCake intraspecies immunocompatibility when skin graftswere ~placed in a nutrient solution before trans-

Committee members: Constantine Mavroudis, MD, Chair-man, Paul Addonizio, MD, R. Morton Bolman, MD, DavidL. Dunn, MD, John B. Hanks, MD, Ronald C. Merrell,MD, and Bruce G. Sommer, MD.Accepted for publication Seplember 19, 1990.

Reprint requests: Constantine Mavroudis, MD. Division ofCardiovascular- Thoracic Surgery, Box 22, Children's Me-morial Hospital, 2300 Children 's Plaza, Chicago, lL 60614.

11/56/26170

SURGERY

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SurgeryJuly 7997

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plantation2; and F~obert A. Slutsky, a University ofCalifornia-San Dic~go radiologist, who fabricated datato support papers that in turn were the focus of subse-quent double publilcation in separate journals.5

What makes talented and seemingly accomplishedresearchers resort to misconduct and fraud has been thefocus of much concern. Enger et al.5 proposed the "rot-ten-apple" versus lhe "rotten-system" theories, whichhave algO been discussed by Relman6 and Koshland:The first theory states that human frailty is ever presentand that some reseaLrchers with moral standards that aresuspect will resort 10 irnmoral practices. The other the-off faults the academic "publish or perish" environ-ment, which pressures scientists to out perform theirpeers to achieve national and international acclaim. Nodoubt, the reasons for these kinds of activities are mul-tifactorial, and consequently their solutions are simi-

larly complex.Landmark discoveries of great potential use to soci-

ety must ultimatel~f pass the test of reproducibility andtime, which eventllally will confirm quality assurance.What about the Test of scientific research? Must all ex-periments be duplicated? How can we detect plagia-rism? Who should we believe? Just what is fraud andmisconduct? Who will blow the whistle? These andother compelling questions have had a resounding effectin the scientific, pc}litical,8 and institutional cornmuni-ties ayer the last fc~w years and have resulted in edito-rial discourse and !~overnmental action. The Final Rulefor "Dealing With and Reporting Possible Misconductin Science,,9 was issued by the Public Health Service onAugust 8, 1989. 1m conjunction with this document,newly developed Offices of Scientific lntegrity and Sci-entific lntegrity Rc~view will oversee and investigate al-legations of misclonduct with full due process andenforce actions thaLt mar eventually include loss of Na-tional lnstitutes of Health (NIH) funding.

To address thes,e and other concerns, we conducted asurvey through a questionnaire of the active members ofthe Society of Un:iversity Surgeons in 1989. The datawere analyzed by the Cornmittee on Social and Legis-lative lssues of the Society in preparation for the "Mis-conduct and Fraud in Research" symposium. The sym-posium was organized in three parts that included pre-sentation of th,e questionnaire data; individualpresentations by ltichard L. Sirnmons, MD, professorand chairman, Department of Surgery, University ofPittsburgh, on "'Quality Assurance in LaboratoryResearch"; HiraIn C. Polk, Jr., MD, chief editor,American Joumal of Surgery, professor and chairman,Department of Surgery, University of Louisville, on"Peer Review-:Success or Failure"; and Barbara

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Williams, PhD, senior scientist, Office of Scientific In-tegrity, N ational Institutes of Health, on "Office of Sci-entific Integrity-National Approach to QualityAssurance"; and a question and answer periodo Thepurposes of this article are to document and analyze theresults of the questionnaire and to chronicle the high-

lights of the symposium.

MATERIAL, METHODS, AND RESULTS

The questionnaire was developed to assess attitudesof the membership conceming the definition, percep-tion, and correction of fraud. The questions wereselected to focus on afeas in which the respondents mightbe expected to disagree and on afeas in which subse-quent agreement was anticipated. Responses wereretumed by 204 (82%) of the members.

Seven questions dealt with definitions of fraud. Theresponses showed a strong condemnation of behaviors

such as discarding experiments, eliminating study pa-tients, and duplicative publication, although casual at-tention to accuracy of bibliography was treated moregenerously. However, even for those questions, agree-ment was far from uniformo Failure to completely reada coauthored manuscript, lack of meticulus review ofraw data, and submission of data not completelyconfirmed in abstracts were considered questionable inthe main, without any clear condemnation as fraud orendorsement as unethical behavior.

In answers to the eight questions conceming the per-ception or recognition of fraud, the membership ex.pressed a distrust of specific investigators and were notentirely secure in the accuracy of papers published, evenin "good" joumals. Confidente in the ability of peer re-viewers to detect fraud was far from complete, and mostmembers disagreed with the contention that fraud wasa new phenomenon in science.

Forty percent of the members were aware of at leastone incidente of fraud that had been openly investigatedin their institutions; 43O¡o of the members were aware ofat least one quiet inquiry. Twenty-seven percent of themembers had directly refuted data published by a col-league, and 15O¡o of the members had strongly suspectedfraud, which had not been investigated, in their univer-sities. These data contrast with the response that 75O¡oof the universities in our membership have ethics pol-icies that are related to science and that are widely com-municated to the faculty. Seventy percent of the mem-bers believe research fraud publicity penalized honest

researchers.Six questions related to correction or reduction of

fraud in our environment; the strongest endorsement(89O¡o) was for severe academic penalties for scientists

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who were found guilty of fraud. However, no generalconsensus was reached about the value of institutionalquality assurance progl"ams or open access to data.

Members of the Socil~ty seem to have a great interestand concern related to scientific fraud. The membersexpress some ambivalence in the definition of fraud.This is appropriate for any arta of ethics and calls foron-going dialogue among scientists to define acceptableand unacceptable behavior. The membership reports astrong perception that fraudulent behavior is an elementof our academic lives that is not new and is not precludedby ambient safeguards in our universities or joumals.Publicity surrounding academic fraud is hurtful tohonest scientists, and general agreement occurs only onacademic punitive measures. There is great interest re-garding ethical scientific behavior and better mecha-nisms to prevent, recognize, and respond to unaccept-able activities.

sharing credit with colleagues who are not involved inthe data generation. Such people are frequently de-scribed as brilliant loners whose future careers arethought to be assured by virtue of their close associationwith distinguished mentors who have given them whatturns out to be excessive independence. Conspiracy tocornmit scientific fraud is rare. To detect fraud in lab-oratory operations, one must (1) be suspicious of thebrilliant loner who seems to be uncooperative with bispeers; (2) be suspicious when one's own hypotheses areconstantly being proved right by the data; (3) be suspi-cious if experiments always seem to "work"-it is dif-ficult to so control the experimental conditions that re-producible results can be reliably obtained withoutmany trials; (4) insist on seeing fue raw data for everyrepeat experiments to be SUTe that there is not excessiveinternal consistency; (5) if results are suspicious, havethe experiment repeated by another investigator; andfinally, (6) listen to the substance of internal dissensionsand trivial fights between technicians and students. Irone is deaf to complaint, conflicts that could unduly in-fluence fue proper collection or analysis of data will bemissed.

Detecting fraud after the fact is difficult. How can oneprevent fraud from being cornmitted under one's nose?Recognition that fraud takes place in a social context,which permits sloppy science, is essential; then one canprovide a Tole model for scientific integrity. Equallyimportant, techniques can be taught for data gathering,analysis, and storage that permit fue advancement ofcareer goals while being faithful to scientific truth.

The laboratory director must never take credit that isnot due. This establishes the principIe that undeservedrewards are not desired. The laboratory director must"be there" to see and cornment on fue raw data dar af-ter day. There is no useful Tole for the director who ed-its abstracts on the dar of submission.

The laboratory director must minimize competitionfor precedence-both within the lab and with otherlaboratories. Working together and sharing credit forthe contribution acclerates progress and almost totallyeliminates the opportunity for duplicity because repli-cation and verification become pan of the process.

We must all recognize that "fudging" is a naturalconsequence of fue cornmon scientific idea that thebeautiful hypothesis is more important than fue data.Every dar, we are confronted with unexpected and un-interpretable results. Every day, investigators select ex-periments that "work" from those that do noto In fact,the good scientist can be defined as one who can tell the"forest'" from the "trees." Every published report con-tains distortions of the raw data that make fue data con-

DISCUSSION

The gathering interest from scientists, ethicists, leg-islators, and the media concerning misconduct and fraudin research has resultedl in intense global study. Polit-ical interest, public opillion, and scientific cornmunityconsultation has resulted in the Final Rule,9 put forthby the Office of Scientifi.: Integrity to provide definitionsand guidelines for misconduct prevention, preliminaryinvestigations, and due processo The participants of thissymposium have addressed these very important issuesfrom the viewpoint of él chairman of a department ofsurgery, a chief editor of a well-recognized surgicaljournal, and a senior scientist of fue Office of Scientific

Integrityo"Quality Assurance in Laboratory Research," Ri-

chard L Simmons, ~[D, proíessor and chairman,Department oí SurgeJY, University oí Pittsburgh.The point of my cornmunication is that all crime-in-cluding a "crime" that simply violates norms ratherthan laws-takes place in a social contexto That socialcontext of scientific fraud is the laboratory subculture inwhich norms mayor mar not strictly conform to fue ac-cepted tenet that "scieno~ is the search for the truth" and"honesty is the best policy o"

Evidence that fraud i:tl science has a social context inthe laboratory subculttlre comes from many sources,which include laboratoI'Y humor. 1 mention here com-mon phrases like "publish or perish," "fudge factor,"and "a rat is an animal which, given a drug, generatesa report," all of which suggest that careerism is moreimportant than scientific truth.

Blatant fraud is usually the product of a single indi-vidual who, although working alone, gains veracity by

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addressed in a more definitive manner. The tendency toinclude honorary authorship for everyone who haspassed through a laboratory or carried a chart in aproject is more prevalent in some institutions than oth-ers. The recent hue and cry by the popular press ayera distinguished scientist who finally had to admit that hehad relatively little knowledge of a particular experi-ment that likely is imperfect and of which he was a co-author is a case in point. Increasingly many journals aregoing to adopt the posture being established by theJournal oi the American Medical Association thatrequires coauthors to accept written personal responsi-bility for the conducting of the experiments, interpreta-tion of data, and general reliability of the work. Thesekinds of public disclaimers are moving forward in aconstructive way, and 1 suspect they will increasepaperwork but not become a majar handicap to mostactive laboratories.

The review process for a paper submitted to a jour-nal is typically understood by most of the people in thisaudience. Some concerns exist about bias toward youngversus established investigators and institution A as op-posed to institution B. As a matter of fact, a number oftrials have i;>een done to see if this is true, and much offue data are somewhat conflicting. No clear trend indi-cates a bias based on institutional affiliation or seniorityof the author. Given the amount of time devoted to theprocess of peer review, it mar be disconcerting to real-ize that something on the arder of 85% to 900;0 of paperssubmitted to a very high-quality journal ultimately getpublished somewhere.

Within recent years importance has been been fo-cused on the entire issue of peer review in monographform by Stephen Lock,11 the editor of fue British Med-ical Journal, and by the recent International Congresson Peer Review in Biomedical Publication held in May1989.12 The congress was a most worthy undertaking,and its proceedings will deserve attention and carefulscrutiny.13 1 might summarize some of fue conceptspresented, as 1 heard them, in the following comments:

First, peer review, like democracy, is an imperfectprocess. The real issue is to devise something better.Duplicate publications, in one fashion or another, havebeen studied in depth by Byron Bailey12 in fue surgicalfield of otolaryngology, and, again, it is a matter of greyversus black. The tendency to segment work, so-called"salami slicing," is fairly common. On the other hand,fewer than one third of those apparent duplications ap-peared deliberate efforts to conceal previous work,whereas two thirds of the duplications generally re-flected previously published related work, by the sameauthor(s), in a fair and honest fashion in their refer-ences. The segmentation issue is a tough one, and tiny

form to some reasonable hypothesis. No journal willpublish data in isolation from a hypothesis. Minimizingbias in the normal process of data analysis i~ the best wayto create an environment inconsistent with the possibil-ity of fraud.

Several guidelines mar help in this process. First,never accept the fir:.t experiment that works. Second,after many repetitions, which permit one to predict re-producibility, one must mentally discard that evi-dence-but preserve the raw data. Third, a set of "per-fectly controlled experiments" must then be performedto test the hypothesis that was deduced from the pilotdata. None of the daLta from these critical experiments,which challenge the paradigm, can be subject to dataselection bias.

The Harvard Medical School Guidelines,lo from In-vestigators in Scientific Research, provide a brief andclearly-stated set of useful laboratory practices. Brief,formal courses in pJ:oper scientific method need to beestablished in each institution to address proper scien-tific data managem(:nt. Both new and more seasonedinvestigators should be required to take these courses atintervals in their careers.

"Peer Review-Success or Failure," Hiram C.PoIk, Jr., MD, chi,~f editor, American Journal 01Surgery, professor and chairman, Department ofSurgery, Universit,r of LouisviIle. Misrepresentationin science is a long-standing issue that troubled Huxley,among others, nearl.y 150 years ago. How prevalentsuch misrepresentation is depends on its definition. Ifyou include certain areas that 1 personally think aresomewhat grey, as o]pposed to black, misrepresentationis very prevalent. If ~'{ou look at the issues that are out-and-out fraudulent clr intended to deliberately mislead,then misrepresentation represents as little as 2% to 3%of research effort an~l probably a much smaller percent-age among surgical :.cientists.

An assumption exists that much of this misrepresen-tation is related to a publish or perish atmosphere andis concentrated amo]rlg young physicians who need toproduce to climb an "academic ladder." As a matter offact, equal numbers ,:>f identifiable episodes of scientificfraud occur in the biomedical community among senior,well-established individuals, who are no longer tenure-hungry assistant professors.

The capability of the peer-reviewed medical journalprocess to identify fraud is most limited, particularly ifthe data presented aTe internally consistent. This hasbeen addressed by others, and it would be extraordinar-ily unlikely for the editorial review process of most sur-gical journals to identify experiments that were neverdone or results that were "adjusted."

Some issues regarding coauthorship, however, can be

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variations on a theme do magnify the doubt of the sur-gical-editorial cornmunity regarding an individual'swork. Indeed, the very group that a young surgeon maybe most anxious to impress includes those who becomemost alert to such conducto

Mundane issues, and 1 believe they are mundane, re-lated to precise referen,::e accuracy and statistical valid-ity will be refined over the years ahead to increasinglevels of reliability. The obligations of coauthorship,even as we speak, are rapidly escalating; one must, as isso often the case in American medicine, only look to thecourts to see the remarkable example of product liabil-ity in which one publisher of air route maps is being heldliable for an erroneous publication that may have led toan airplane crash and a death. 1 cannot see this happen-ing in the short term to the surgicalliterature and to ourbiomedical journals. On the other hand, a single prece-dent-setting award could overturn that sense of fairness.

To encourage critique, anonymity of reviewers seemswise; the same process applied to authorship does notappear to alter the ac(:eptability of manuscripts; mostjournals openly provide such information to reviewers.My conviction is that ft:w people try to magnify the sur-gical world's impression of their work by repeated pub-lications of strikingly similar material. 1 would suggestthat in the broad field of general surgery, those individ-uals represent about 2~) of the academic cornmunity andonly a slightly larger proportion of submitted work.Most authors are eX1:raordinarily conscientious andbend over backwards to reference their own work,related material, and often, in covering letters, call theeditor's attention to su(:h similarities and stress how thecurrently submitted m,anuscript may be different.

1 would interpret this entire movement toward accu-rate publication as a sllbstantial step in the right direc-tion and feel that, although peer review will always re-main imperfect, it wiJ.l surely continue to be refinedfurther over the intemlediate termo

"Office oíScientmc Integrity-National Approachto Quality Assurance," Barbara Williams, PhD, se-nior scientist, Office oí Scientmc Integrity, NationalInstitutes oí Health, lJS Public Health Service. TheOffice of Scientific Intt:grity was established in 1989 inresponse to concerns from Congress, the press, and thescientific cornmunity that the existing system for inves-tigating allegations of scientific misconduct was not ef-fective. The Office of Scientific Integrity (OSI) was cre-ated to monitor, and, if necessary, conduct inquiries andinvestigations into allegations of scientific misconduct inresearch and in research training supported by thePublic Health Service" Additional missions are to pro-mote the responsible conduct of science by mutualcooperation between the OSI and research institutions,

to enhance the quality of research and research training,and to lower the incidence of scientific misconduct. It isOUT belief that by inculcating the principIes of respon-sible conduct of science and rigor in adhering to theseprincipIes, early in research careers, the occasional butextremely unfortunate and expensive instances of sci-entific misconduct can be lowered. We hope to foster anenvironment that lessens cutting corners, the "little sins"of research. OUT fundamental principIe is a commitmentto truth: letting data speak for themselves, keeping anempirical mind, and telling it all, as messy as it marseem. Science is a process of discovery. If a researcher'sview of data is colored, that researcher will miss whatis being revealed and mar mislead others. It is essentialto plan education and prevention programs and to de-velop standards in many related afeas, including dataretention and authorship practices.

The NIH are developing internal policies and proce-dures. The Assistant Secretary for Health, Dr. JamesMason, is personally interested in drafting this docu-ment, and OUT internal policies will be available as amodel for other institutions in the near future.

The OSI uses scientists as case workers. This ensuresa basic understanding of the scientific model underlyingthe issues. We are proactive, but we consider ourselvescolleagues with the scientific community. We feel thatmisconduct in science is properly a professional scien-tific matter. The primary responsibility for conductinginquiries and investigations and for establishing pre-ventive programs lays with the institutions. Severalstudies and models mar be used in developing programsfor the responsible conduct of science; some of these arethe "Report on Responsible Conduct in Research inHealth Sciences,"14 the Association of American Med-ical Colleges' "Framework for institutional policies andprocedures to deal with misconduct in research,"15 anda book by Sigma Xi, "Honor in Science,"16 which werecommend dispersing to junior members as they comein laboratories.

The Final Rule,9 42 CFR Pan 50, was published inthe Federal Register on August 8, 1989, and wasrepublished in the NIH Cuide far Crants and Cantractsin September 1989. It is the document that sets forth theresponsibilities of awardee institutions for dealing withand reporting possible misconduct in science. This doc-ument provides that all institutions that apply for Pub-lic Health Service research funds submit an assuranceto the OSI that adequate procedures and policies are inplace for dealing with allegations of misconduct in sci-ence.

Th; definition of scientific misconduct in the FinalRule is "fabrication, falsification, plagiarism, and otherpractices that seriously deviate fram those that are com-

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son, confidentiality has been breached, there mar be anecessity to take action to clear the names of the peopleinvolved.

The OSI adheres closely to the principIe that, once anallegation of scientific misconduct is made, the processmust be completed; no bargains mar be made, no signedagreements mar be made to drop the case. lt must bepursued to the end, even if the subject of the inquiry orinvestigation moves to another institution.

The person bringing the allegations, those personswho conducted the research, and those persons who haverelevant knowledge of the research or of the suspectedmisconduct must be interviewed. The proceedings of theinvestigation must be documented in detail. We recom-mend that all interviews be taped and that a copy of thetranscript or the relevant portion of the transcript beprovided to the interviewees for comment. One of thefinal requirements of the OSI process is that individu-als be provided with the portion of the report that de-scribes their involvement and that they have an oppor-tunity to comment. A word-by-word transcript is thebest documentation of the proceedings for deliberation;it is very difficult for an interviewee to argue with a

transcript.lt mar be difficult for the members of the investiga-

tional panel to determine misconduct. For instance,improper data selection mar not render a clear-cutjudgment of misconduct. The administration of the in-stitution mar need to take the lead in making the finaldetermination.

Lastly, the report must come to the OSI. The OSI hasrigorous standards regarding the report and mar needto ask for further information or documentation after thereport is received. The staff of the OSI can, in certainways, assist individual s and institutions faced with anallegation of scientific misconduct: extramural expertconsultation, planning assistance for the inquiry or in-vestigative process, and interinstitutional coordinationin the event that an investigator has moved to or collab-orated with researchers at other institutions.

lf the OSI has questions about a case, we will workwith the institution toward resolution. When our ques-tions are satisfied, the OSI will forward a report of aninvestigation, with any recommended Public HealthService sanctions, to the head of the appropriate agency ,who then forwards the agency recommendation to theOffice of Scientific lntegrity Review. Decisions aboutsanctions are made by the Assistant Secretary forHealth, unless the recommendation is for debarment, inwhich case it is forwarded for a debarment hearing. Wewish to work together with research institutions to pre-vent misconduct and to fairly resolve allegations of mis-conduct, when they arise.

monly accepted in thl~ scientific community for the pro-posing, conducting, ;!nd reporting of research." Thisdefinition explicitly excludes honest scientific error anddifferences in interpretation of data. It also excludesanimal and human welfare issues, which are covered bythe Office for ProteCltion from Research Risks, and fi-nancial canteros, which are also handled by anotheroffice. Because the O~;I is responsible for administrativeinvestigations, the de1inition does not use the termfraud.It is possible, however, that criminal prosecution canfollow from a case.

The Final Rule provides for a two-step process,which generally begins at the institution. When an al-legation of scientific Inisconduct is received, the institu-tion has a 60-day period in which it must conduct aninquiry to determine whether there is substance to theallegation. If a full iw..estigation is warranted, it must becompleted within 120 days. The principIes in the FinalRule for conducting inquiries and investigations includethoroughness, fairnes:s, timeliness, and objectivity. Thestandard for thoroughness is extremely rigorous. TheprincipIe of faimess is for both the person who hasbrought forth the allc~ations and for the subject of theinquiry and investigation. Once allegations of scientificmisconduct have beeI11 brought to the attention of the in-stitution, certain procedures are initiated to ensure aproper investigation éLDd to protect the involved individ-uals. These procedures include immediate data acqui-sitian, strict confidentiality, and the promise of a com-

plete investigation.AlI potentially relevant primary material must be se-

cured immediately Cln receipt of an allegation. It ishelpful to remember that, if the work was performedwith the support of thle Public Health Service, the insti-tution has primary responsibility for the data. Thus, theinstitution has not OIJlly the right but the responsibilityto secure the data. This ensures the integrity of thedata for examinatioID and protects the investigatorfrom any charge oí altered data. The investigatorhas, of course, the right to reasonable supervised access,but the primary data must be held at all times undercustody of the instit\Jltion. Another issue to consider isthe Tole of attomeys in the inquiry and investigation

process.Confidentiality for all involved individuals, both the

person who carne fo,rth with the allegations and thesubject of the inquiry and investigation, is of prime im-portance during this process. Attention must be paid totheir particular vuln¡erabilities within the institution,especially during thl~ inquiry and investigation. If afinding of misconduC1 occurs, proper disclosures mar bein order. If no misconduct is found, individual s must beproperly protected. In the latter case, ir, for some rea-

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SUMMARY

The symposium was concluded with a question andanswer period, which :served to clarify and further em-phasize the aforementioned issues. Many concerns ofcoauthorship responsibilities, due process, and potentialsanctions were discussed. Moral and ethical issuesreflecting the extent or punishment, reporting of mis-conduct to hospital s and specialty boards, and the almostassured litigation and counter-litigation were ap-proached with considerable apprehension and concern.

Misconduct in scienc:e will clearly be monitored moreclosely than in the pasto Increasing coauthorship re-sponsibility, conscientious senior investigator supervi-sion, and institutional cooperation will provide theframework to discourage dishonesty in science and en-courage proper educati,onal development of both youngand established investigators in a milieu of scientific in-

tegrity.

This surnrnary was prepared by Constantine Mavroudis,MD.

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