Fraud in Medical Research: An International Survey of Biostatisticians

Fraud in Medical Research: An InternationalSurvey of Biostatisticians

Jonas Ranstam, PhD, Marc Buyse, ScD,Stephen L. George, PhD, Stephen Evans, MSc,Nancy L. Geller, PhD, Bruno Scherrer, PhD,Emmanuel Lesaffre, PhD, Gordon Murray, PhD,Lutz Edler, PhD, Jane L. Hutton, PhD,Theodore Colton, PhD, and Peter Lachenbruch, PhD,for the ISCB Subcommittee on FraudMalmo University, Malmo, Sweden, (J.R.); International Institute for Drug Development,Brussels, Belgium, (M.B.); Duke University, Durham, North Carolina (S.L.G.); MedicinesControl Agency, London, UK (S.E.); National Heart, Lung and Blood Institute, Bethesda,Maryland (N.L.G.); Institut de Recherche Jouvenail, Paris, France (B.S.); BiostatisticalCentre, Leuven, Belgium (E.L.); University of Edinburgh, Edinburgh, UK (G.M.); GermanCancer Research Centre, Heidelberg, Germany (L.E.); University of Newcastle, Newcastle,UK (J.L.H.); Boston University, Boston, Massachusetts (T.C.); and the Food and DrugAdministration, Rockville, Maryland (P.L.)

ABSTRACT: The characteristics of scientific fraud and its impact on medical research are ingeneral not well known. However, the interest in the phenomenon has increased steadilyduring the last decade. Biostatisticians routinely work closely with physicians andscientists in many branches of medical research and have therefore unique insight intodata. In addition, they have methodological competence to detect fraud and could beexpected to have a professional interest in valid results. Biostatisticians therefore arelikely to provide reliable information on the characteristics of fraud in medical research.The objective of this survey of biostatisticians, who were members of the InternationalSociety for Clinical Biostatistics, was to assess the characteristics of fraud in medicalresearch. The survey was performed between April and July 1998. The participationrate was only 37%. We report the results because a majority (51%) of the participantsknew about fraudulent projects, and many did not know whether the organization theywork for has a formal system for handling suspected fraud or not. Different forms offraud (e.g., fabrication and falsification of data, deceptive reporting of results, suppres-sion of data, and deceptive design or analysis) had been observed in fairly similarnumbers. We conclude that fraud is not a negligible phenomenon in medical research,and that increased awareness of the forms in which it is expressed seems appropriate.

Address reprint requests to: Jonas Ranstam, PhD, Malmo University, School of Health and Society,SE-20506 Malmo, Sweden; (E-mail: [email protected]).

Received December 1, 1999; accepted June 12, 2000.

Controlled Clinical Trials 21:415–427 (2000) Elsevier Science Inc. 2000 0197-2456/00/$–see front matter655 Avenue of the Americas, New York, NY 10010 PII S0197-2456(00)00069-6

416 J. Ranstam et al.

Further research, however, is needed to assess the prevalence of different types of fraud,as well as its impact on the validity of results published in the medical literature. ControlClin Trials 2000;21:415–427 Elsevier Science Inc. 2000

INTRODUCTION

The public awareness of scientific fraud has increased remarkably sincethe late 1980s when a controversy made front-page news, instead a paperinvestigated for fraud had as coauthor a Nobel laureate [1]. During the 1990sscientific fraud was disclosed on numerous occasions [2]. In fact, it was recentlysuggested that fraud now is “endemic in many scientific disciplines and inmost countries” [3]. However, the clandestine character and consequentiallack of reliable information make it difficult to study scientific fraud. Thecharacteristics and frequency of scientific fraud, therefore, are generally un-known, and its impact on medical research is unclear.

Biostatisticians routinely work closely with physicians and scientists in manybranches of medical research and have unique insight into data. In addition,they have the methodological competence to detect fraud and could be expectedto have a special professional interest in the validity of results. Biostatisticianstherefore could provide unique and reliable information on the characteristicsof fraud in medical research.

The objective of this study was to assess the characteristics of fraud inmedical research by surveying members of the International Society of ClinicalBiostatistics (ISCB).

MATERIAL AND METHODS

The ISCB is an international society for biostatisticians, which, in April 1998,had 442 members in 31 countries on six continents. Most of the members (69%)were from the European Union, of whom 80 lived in the United Kingdom, 54in Germany, and 39 in Sweden. Forty-three members lived in the United States.Eighteen countries had fewer than ten members each (Table 1). The ISCB hasa subcommittee on fraud, which was set up following the expression of concernsboth about fraud and inappropriate responses to it.

In April 1998 a questionnaire designed for anonymous response was mailedto all members with an accompanying letter inviting participation in the survey.An electronic version was also opened on the ISCB home page on the internet.No prepaid return envelopes were used and no formal reminders were distrib-uted. However, a reminding notice appeared in the May 1998 ISCB newsletter.The deadline for response was the end of July 1998.

Mailed responses were sent to the survey office in Lund, Sweden. Twopersons independently entered the data into separate Microsoft Access data-bases. The two completed datasets were then cross-checked, and all discrepanc-ies investigated and data corrected if necessary. Web responses were adminis-tered at the ISCB permanent office in Fredensborg, Denmark, and after thedeadline were sent as an ASCII file to Lund for amalgamation with theother responses.

The questionnaire (see appendix) was designed cooperatively by membersof the ISCB Subcommittee on Fraud and contains 31 items divided into two

Fraud in Medical Research 417

Table 1 ISCB Members on April 1, 1998, in Response Rate OrderCountry Members Responders Response Rate (%)

Not stated – 11 –Hong Kong 2 0 0Israel 3 0 0Portugal 1 0 0Russia 3 0 0Slovenia 1 0 0Hungary 29 3 10Norway 7 1 14Japan 9 2 22Italy 21 5 24Switzerland 16 4 25Sweden 39 11 28France 24 7 29Austria 10 3 30Denmark 20 6 30Spain 13 4 31USA 43 15 35Finland 5 2 40Germany 54 22 41UK 80 34 43Belgium 14 6 43Canada 8 4 50Cuba 2 1 50Malaysia 2 1 50South Africa 2 1 50Australia 7 4 57Netherlands 20 12 60India 1 1 100Ireland 2 2 100Mexico 1 1 100New Zealand 1 1 100Singapore 2 2 100Total 442 163 37

sections, one on age, sex, position, nationality, etc., and the other on experiencewith and opinions on scientific fraud. Prior to the actual survey the question-naire was pilot-tested on a small number of ISCB nonmember biostatisticiansin the United States and in the European Union and was revised in accordancewith the experiences from this pilot study.

In the questionnaire, fraud was defined as a deliberate attempt to misleadothers in the design, conduct, analysis, or reporting of a study. Furthermore,it was stressed that careless or incompetent research was not necessarily consid-ered fraud; an “intention to cheat” was required. In addition, the responderswere specifically asked not to characterize poor methodology and borderlinepractices as fraud when replying to the questionnaire.

The sign test was used to evaluate the difference in subjectively estimatedprevalence of fraudulent projects between epidemiological papers and papersfrom clinical trials. Spearman’s rank correlation coefficient was used to investi-gate a potential relation between national response rates and prevalence ofstatisticians having been engaged in fraudulent projects.


Table 2 Distributions of Age, Sex, and Type of Employer

Sex MultipleSingle Employer Typea

EmployerAge Males Females Governmentb University Privatec Typea

<29 4 3 0 2 5 030–39 26 13 1 21 12 540–49 52 12 6 29 19 950–59 36 10 11 17 13 5>60 7 0 1 3 3 0

Totald 125 38 19 (29) 72 (91) 52 (77) 19a One member did not disclose his employer.b Regulatory and other governmental agencies.c Including pharmaceutical/biotechnology/device company, contract research organization, otherprivate company, and self-employed.d Total number of employment responses within parentheses. Thirty-five members had multipleemployments; 19 members were employed by more than one type of employer; some membershad more than two employers.

RESULTS

One hundred sixty-three members and three nonmembers completed ques-tionnaires. We report here information from the 163 members who responded.The response rate for members was 37% (see Table 1). Several respondersexpressed their concern about anonymity (nationality, age, and sex could iden-tify them). Eleven members also declined to disclose their nationality. Mostresponders mailed or faxed their questionnaires to the survey office; only 23(14%) used the Web.

Table 2 shows the distribution of the responders by age, sex, and type ofemployers. Nineteen members had governmental employment, 72 university,52 private, and, while 35 members reported multiple employment, 19 membershad multiple employer types. Counting responses rather than responders, ofthe 29 responses stating governmental employer, six stated employment by aregulatory agency and 23 by “other governmental.” Ninety-one responsesstated employment by a university. Private employment was stated by 77responses. Of these, 41 responses stated employment by a pharmaceutical/biotechnical/device company, 18 by a contract research organization, 8 by“other private company,” and 10 responded that they were self-employed.Comparison of responders and nonresponders was not possible because ISCBdoes not record these demographic data in its membership records.

Table 3 gives a summary of the main results. A clear majority (126 responders;76%) considered career and power to be the main motive for fraud, not financialreward. One hundred four (65%) members considered the impact of fraud onthe progress of medical science to be a major problem (27 members) or some-what important (77 members). One hundred and three responders (63%) re-ported that the organization in which they worked did not have a system forhandling suspected fraud, or that they did not know if this was the case, ordid not reply to the question.

Eighty-one responders (51%) knew of at least one fraudulent project in theirproximity during the last 10 years. Forty-three responses indicated that the


Table 3 Summary of ResultsAspect of Fraud Number (%)

Consider the main motive for fraud not financial but career and power 126 (76)Believe the impact of fraud on the progress of medical science to be important

or a major problem 104 (65)Do not know if the organization they work for has a system for handling

suspected fraud or not, or do know that such a system does not exist 103 (63)Know of at least one fraudulent project in the proximity during the last

10 years 81 (51)Have been engaged in a project in which fraud took place or was about to

take place 49 (31)Have been requested to support fraud 20 (13)Have participated as an expert in a formal investigation on suspected fraud 19 (12)

fraud had been related to fabrication or falsification of data and 31 to suppres-sion or selective deletion of data, whereas 16 and 32 indicated deceptive designor analysis and deceptive reporting of results, respectively.

Forty-nine responders (31%) reported having been engaged in a project inwhich fraud took place or was about to take place. In 14 cases the responderintervened to attempt to prevent the fraud from occurring; in 11 cases theresponder reported it to a relevant person or organization; in 10 cases theresponder was not aware of the fraud as it happened or did nothing to preventit. Fourteen responders reported other actions or did not reply to the question.Information was not obtained on whether an attempt to prevent fraud was suc-cessful.

Twenty responders (13%) had been requested to support fraud themselves.In 3 cases this concerned fabrication or falsification of data; in 11 cases suppres-sion or selective deletion of data; and in 7 and 12 cases deceptive designor analysis and deceptive reporting of results, respectively. Eight of the 20responders reported that the attempted fraud eventually was changed intoacceptable practice.

Nineteen responders (12%) had participated as an expert in a formal investi-gation on suspected fraud.

The subjectively estimated prevalence of fraud in published reports wassomewhat greater for epidemiological studies than for clinical trials (interpo-lated median values 0.80% and 0.69% respectively; p 5 0.047).

Response rates appeared to be lower in countries with higher frequency ofstatisticians having participated in fraudulent projects (rs 5 20.41, p , 0.001).

DISCUSSION

This survey of biostatisticians found that knowledge of fraudulent projectsis surprisingly common. Although only 163 of the 442 members (37%) re-sponded to the survey, 81 (51%) reported that they knew of at least one fraudu-lent project in their proximity in the past 10 years. Even if these 81 responsesincluded all episodes of fraud known to the 442 ISCB members, the prevalenceestimate of ISCB members knowing of fraudulent projects in their vicinity inthe past 10 years would be 18%. Although the overall low response rate to this


survey limits its generalizability, the high proportion of respondents knowingabout fraudulent projects provided the primary motivation for this report.

The prevalence of persons knowing about fraudulent projects among biostat-isticians in the current survey is greater than that among the members ofthe American Association for the Advancement of Science (AAAS) who weresurveyed in 1994. In a random sample of 469 researchers and administratorsin universities, industry, and government, 27% reported that they knew of atleast one fraudulent project over the last 10 years [4]. The participation rate inthe AAAS survey was similar (31%) to ours. If all episodes of fraud knownto AAAS members had been reported, the prevalence estimate would havebeen 8%.

The proportion of participants knowing about fraudulent projects is alsosubstantially greater than that in a 1992 Norwegian survey of 152 medicalprincipal investigators whose study protocols had been assessed by ethicscommittees. In that study also 27% of the responders knew about one or morecases of scientific fraud [5]. However, that study focused on ethical issues ingeneral rather than on fraud; the response rate was also substantially higher(70%).

Low frequencies of fraudulent data sets are suggested in reports based onaudits of multicenter trials: 0.4% in a British report [6] from a study with 1000participating general practitioners and 0.25% in a US report [7] of data auditsfor clinical trials. Since such investigations focus on fraud shown by actualdata, they cannot be directly compared with anonymous surveys, which focuson intentions rather than on data and in which no evidence needs to be pre-sented. Hence, the discrepancy in fraud prevalence as reported from surveysand from audits may not be as great as it appears. Furthermore, we includedquestions on deceptive analyses and reporting in our survey, and this is unlikelyto be studied in audits. However, considering only fabrication and falsificationof data, our results still suggest a high prevalence of fraudulent projects.

There are several explanations for the high proportion of responders whoknew of the occurrence of fraud, other than the low (37%) response rate.Biostatisticians are often privy to confidential data and are knowledgeableenough to understand their implications. Therefore they may be in a uniqueposition to observe scientific transactions in the prepublication stages. Second,because of their technical knowledge, biostatisticians may be harsh judges ofscientific collaborators’ optimistic interpretation of data. In our instructions weattempted to distinguish between fraud and carelessness, and we requestedthat poor methodology and borderline practices not be considered fraud. How-ever, our instructions might have been ambiguous, and we cannot be sure thatthe responders were not overzealous in what they considered to be fraud.

Third, we cannot be certain that the reported episodes of fraud were at allimportant, or that the same episode was not reported by multiple respondents.However, the latter does not seem likely because of the diverse countries oforigin of the responders.

The negative ecological correlation between participation rate and frequencyof statisticians having been engaged in projects in which fraud took place orwas about to take place could suggest that the 51% prevalence of statisticiansknowing of fraud in their proximity overestimated the proportion of ISCBmembers who knew of fraudulent projects. It is plausible that those who were


ever involved in a significant episode of fraud responded to the questionnaire,while those without such an experience did not.

Discussions of fraud have in the past often focused on clinical trials. Reasonsfor this may be that results of clinical trials have more direct medical conse-quences than epidemiological studies and that regulatory authorities controlthe conduct trials. However, our survey seems to suggest that fraud might bemore prevalent in epidemiological studies than in clinical trials. A possibleexplanation for this finding may be the more controlled nature of the clinicaltrial, which makes it less amenable to fraud [8].

The impact of fraudulent research has been discussed previously [9]. Itappears that the scientific community quickly recognizes and avoids citationsfrom work known, or suspected, to be fraudulent. This further stresses theimportance of control systems that reveal fraudulent publications as soon aspossible. The low proportion of biostatisticians who reported working for orga-nizations with systems for handling suspected fraud reiterates the need formore such systems. The low number of biostatisticians who reported havingparticipated as experts in formal investigations on fraud may suggest that fewinvestigations of fraud occur.

If we were to do this survey again, we would use prepaid return envelopes.We had hoped that allowing replies through the World Wide Web could savethe cost of postage, but that did not prove to be the case. We would also askmore specific questions on the exact nature of any fraudulent episodes to whichthe responders had been exposed.

We believe that it is important to change the general attitudes toward fraudin medical research. Improved education, emphasizing ethical standards inresearch, and more and better systems for handling suspected fraud could beexpected to play roles in prevention. However, more research in this field isnecessary to determine which educational, organizational, or administrativemeasures actually prevent fraud. In addition, low participation rates appearto be a major problem in many surveys. Survey techniques and procedurestherefore might have to be specially developed to improve validity and reliabil-ity in this field.

The International Society for Clinical Biostatistics (ISCB) covered costs for printing and mailingof the questionnaires of this survey. The full results of the study were presented at the ISCBmeeting at Dundee, Scotland, UK, August 24–28, 1998, and are available from the first author. Theviews expressed in this paper are those of the authors, not necessarily of the organizations withwhich the authors are affiliated.

REFERENCES1. US Committee on Energy and Commerce. Scientific fraud and misconduct in the

National Institutes of Health biomedical grant programs: Hearing before the Com-mittee on Energy and Commerce. 100th Cong; 1st Ses.: 12 April 1988. Washington,DC: U.S. Government Publishing Office, 1988.

2. Lock S. Research misconduct: A resume of recent events. In: Lock S, Wells F, eds.Fraud and Misconduct in Medical Research. London: BMJ; 1996.

3. Fulford P. Fraud and plagiarism. In: Williamson A, White C, eds. Committee on Pub-lication Ethics. The COPE Report 1998. London: BMJ; 1998.

4. Hamilton DP. In the trenches doubts about scientific integrity. Science 1994; 255:1636.


5. Jacobsen G, Hals A. Medical investigators views about ethics and fraud in medicalresearch. J R Coll Physicians London 1995; 5:405–9.

6. Hone J. Combating fraud and misconduct in medical research. Scrip Magazine1993; March:14–15.

7. Cancer and Leukaemia Group B. A successful system of scientific data audit forclinical trials. JAMA 1993; 270:459–464.

8. Buyse M, George S, Evans S, et al. The role of biostatistics in the prevention, detectionand treatment of fraud in clinical trials. Statist Med 1999; 18:3435–3451.

9. Garfield E, Welljams-Dorof A. The impact of fraudulent research on the scientificliterature. The Stephen E. Breuning case. JAMA 1990; 263:1424–1426.

APPENDIX

ISCB Subcommittee on Fraud: Survey on Fraud in Medical ResearchDear colleague,

Medical research activities have increased greatly in the last 50 years. Thismay explain why fraud and misconduct have attracted increasing attention inmedical research. However, due to its clandestine character, very little is actu-ally known about the general nature and prevalence of scientific dishonesty.Current systems and efforts to detect and prevent fraud and deception fromtaking place therefore may be unsuitable.

Statisticians have a unique position in medical research: We probably takepart in more medical projects than representatives from any other single disci-pline. Furthermore, we usually have complete insight into the empirical supportof a project, from raw data to results and conclusions. In addition, we have themethodological ability to suspect and detect fraud and deception. On August 29,1996, the International Society of Clinical Biostatistics (ISCB) approved a specialsubcommittee to investigate the role of biostatistics in the prevention, detection,and treatment of fraud in clinical trials. Dr. Marc Buyse, Belgium, is chairmanof the subcommittee and Dr. Jane Hutton, UK, its secretary. Members are Dr.Lutz Edler, Germany; Prof. Stephen Evans, UK; Dr. Nancy Geller, USA; Prof.Stephen George, USA; Prof Emmanuel Lesaffre, Belgium; Prof. Gordon Murray,UK; Dr. Jonas Ranstam, Sweden; and Dr. Bruno Scherrer, France. Prof. TheodoreColton and Dr. Peter Lachenbruch, both USA, are observers.

The subcommittee is now conducting a survey of ISCB members with thepurpose of describing the magnitude and character of this problem as envisagedby these members and of describing the statistical community’s opinion aboutscientific fraud and professional integrity of statisticians. The results of thesurvey will be presented at the ISCB meeting in Dundee and in a manuscriptto be submitted to a suitable scientific journal.

You are hereby invited to participate. It is important that as many ISCBmembers as possible take part in the survey. It takes no more than 15 minutesto complete the questionnaire; please give us this much of your time. It is wellknown that unpleasant incidents are easily forgotten. Please think carefullyabout each question before responding, especially questions 14 and 19. Thesurvey is based on complete anonymity. No registration of participants’ identitywill be made. This means that there is no way for the survey office to knowif you return multiple copies of the questionnaire; please return one only.


An electronic version of the questionnaire can be found on internet at theISCB home page http://www.ISCB-homepage.org. The questions can be re-plied to directly on the home page. However, to avoid contamination fromnonmembers, you will be requested to present a password to reach the question-naire; use “SB3681.”

Please reply before June 30, 1998, either by World Wide Web or by mail tothe survey office at Erdeven Medical Statistics, PO Box 746, SE-22007 Lund,Sweden (fax: 146 46 146868). For questions and comments on the survey, pleasecontact Dr. Jonas Ranstam at the survey office (e-mail [email protected]).

Brussels and Lund, April 1998

Dr. Marc Buyse Dr. Jonas RanstamChairman Survey organiser

Section I

First a few questions about yourself:

1. Are you a member of ISCB?(a) Yes(b) No

2. Have you ever participated in a medical project?(a) Yes(b) No (if so, skip section II)

3. What is the main area of biostatistics that you are professionally activein? Select one alternative only.(a) Theoretical statistics(b) Applied statistics(c) Other(d) I am not professionally active in statistics

4. If you answered a, b, or c to question 3, in what branch of biostatisticsare you active? Select as many alternatives as appropriate.(a) Randomised clinical trials(b) Nonrandomised clinical investigations(c) Laboratory experiments/preclinical studies(d) Epidemiology/public health/postmarketing surveillance(e) Other

5. What kind of organisation(s) are you presently employed by? Select asmany as appropriate.(a) Regulatory agency(b) Other governmental(c) University(d) Pharmaceutical/biotechnology/device company(e) Contract research organisation(f) Other private company(g) I am self-employed

6. What is your present position?(a) Statistician(b) Physician/scientist


(c) Administrator(d) Other

7. What is your function? Select as many alternatives as appropriate.(a) I perform statistical analyses(b) I oversee statistical analyses(c) I give statistical advice as needed(d) I design clinical trials (nonstatistical aspects)(e) Other

8. How old are you?(a) under 30(b) 30–39(c) 40–49(d) 50–59(e) 60 or older

9. What is your sex?(a) male(b) female

10. In what country do you live? Please specify.

Section II

This section contains questions on scientific fraud. In this survey a deliberateattempt to mislead others in the design, conduct, analysis, or the reporting ofa scientific study is considered scientific fraud. Please note that intention isrequired; careless and incompetent research may cause severe problems butisn’t necessarily fraud. Also please note that false claims on a researcher’scontribution, violation of rights of individuals participating in a study, andundisclosed financial interests indeed constitute scientific misconduct, butshould not be considered fraud in this study.

Fabrication of data should be considered fraud if the purpose is to changethe apparent outcome of a study (e.g., by increasing the sample size or effect, orby decreasing the variance). Imputation of missing values to facilitate balancedanalyses, however, is not necessarily fraudulent, but not reporting this in afinal report may be. Similarly, ignoring multiple comparisons may be fraud ina confirmatory trial, but not necessarily in an exploratory study.

Note: A grey area rather than a clear line often separates acceptable practicesfrom unacceptable ones. Please do not characterize poor methodology or bor-derline practices as fraud when replying below.

11a. In a report from an audit of US leukaemia trials presented in theJournal of the American Medical Association (1993;270:459–464) the fraudprevalence was 0.25%. What is your opinion about the prevalence offraud in all clinical trials undertaken?(a) The prevalence is less than 0.25%(b) The prevalence is about 0.25%(c) The prevalence is greater than 0.25% but less than 1%(d) The prevalence is greater than 1% but less than 5%(e) The prevalence is greater than 5%(f) Don’t know


11b. Now consider all clinical trials published in the biomedical literature.What is your opinion about the prevalence of fraud?(a) The prevalence is less than 0.25%(b) The prevalence is about 0.25%(c) The prevalence is greater than 0.25% but less than 1%(d) The prevalence is greater than 1% but less than 5%(e) The prevalence is greater than 5%(f) Don’t know

11c. Now consider reports of epidemiological studies which appear in thebiomedical literature. What is your opinion about the prevalence offraud?(a) The prevalence is less than 0.25%(b) The prevalence is about 0.25%(c) The prevalence is greater than 0.25% but less than 1%(d) The prevalence is greater than 1% but less than 5%(e) The prevalence is greater than 5%(f) Don’t know

12. What is your opinion about the impact for fraud in the progress ofmedical science?(a) Negligible(b) Somewhat important(c) Major problem(d) Don’t know

13. What do you think is the main reason for fraud in medical sciences ingeneral? Select one alternative only.(a) Financial(b) Career, reputation, and power(c) Other

14. Do you know of any project in your personal proximity in which fraudor deliberate deception occurred during the last 10 years?(a) No(b) Yes

15. If you answered (b) to question 14, what was the nature of the fraud?Should you know of more than one fraudulent project, please refer tothe most recent one. Select as many alternatives as appropriate.(a) Fabrication of falsification of data(b) Suppression or selective deletion of data(c) Deceptive design or analysis(d) Deceptive reporting of results(e) Other

16. Have you been engaged in a project in which fraud was about to takeplace or did take place?(a) No(b) Yes

17. If you answered (b) to question 16, what was the nature of the fraud?Should you know of more than one fraudulent project, please refer tothe most recent one. Select as many alternatives as appropriate.(a) Fabrication of falsification of data(b) Suppression or selective deletion of data


(c) Deceptive design or analysis(d) Deceptive reporting of results(e) Other

18. If you answered (b) to question 16, how did you react? Should you knowof more than one fraudulent project, please refer to the most recent one.Select the most appropriate alternative only.(a) I interfered to prevent it from happening(b) I reported it to a relevant person or organisation(c) I knew about it but did nothing(d) I was not aware of it at the time it happened(e) Other

19. Have you ever been requested to support fraud or deliberate decep-tion yourself?(a) No(b) Yes

20. If you answered (b) to question 19, what was the nature of the fraud?Should you have been requested more than once, please refer to themost recent occasion. Select as many alternatives as appropriate.

(a) Fabrication of falsification of data(b) Suppression or selective deletion of data(c) Deceptive design or analysis(d) Deceptive reporting of results(e) Other

21. If you answered (b) to question 19, did any of the following occur?Should you have been requested to support fraud or deliberate deceptionmore than once, please refer to the most recent occasion. Select as manyalternatives as appropriate.(a) I was offered to be a coauthor(b) I was offered a promotion(c) I was offered money(d) I was offered something else(e) I was threatened with dismissal(f) I was threatened with being exposed to slander(g) I was threatened with losing money(h) I was threatened with physical violence(i) I was threatened with something else(j) Another inducement or threat was offered(k) The matter was dropped(l) The fraud or deliberate deception was changed into acceptable

practice22. Does a system for handling suspected fraud exist at your organisation?

Select one alternative only.(a) Yes, a formalised system(b) Yes, an informal system (discussion, education, meetings)(c) No(d) Don’t know

23. Does a committee for handling suspected fraud exist at your organi-sation?(a) Yes


(b) No(c) Don’t know

24. Have you ever participated as a statistical expert in a formal investigationof suspected fraud?(a) Yes(b) No(c) Cannot answer

25. What is your experience regarding statisticians’ actual responsibilitiesin medical research today? Select one alternative only.(a) The statistician has an overall shared responsibility(b) The statistician is responsible for selection of methods and statisti-

cal results(c) The statistician is responsible for his/her own calculations only(d) The statistician has no responsibility at all

26. What is your opinion about the statistician’s responsibilities in an idealmedical research project? Select one alternative only.(a) The statistician should have an overall shared responsibility(b) The statistician should be responsible for selection of methods and

statistical results(c) The statistician should be responsible for his/her own calculations

only(d) The statistician should have no responsibility at all

27. What is you opinion about the statistician’s responsibilities in a multiau-thor publication on a medical research project when the statistician is acoauthor? Select one alternative only.(a) The statistician should have an overall shared responsibility(b) The statistician should be responsible for selection of methods and

statistical results(c) The statistician should be responsible for his/her own calculations

only(d) The statistician should have no responsibility at all

28. Do you think that it would be appropriate for a society like the ISCB totake actions to counteract fraud?(a) Yes(b) No(c) Don’t know

29. If you answered (a) to question 28, by doing what? Select as manyalternatives as appropriate.(a) Developing guidelines(b) Establishing committees(c) Approaching the editors of journals(d) Other means

30. If you answered (d) to question 29, please specify.31. If you wish to comment on this survey or expand on any reply, please

do so here.

Thank you very much for participating.

Documents

Fraud in Medical Research: An International Survey of Biostatisticians