Research Fraud, Misconduct, and the IRB

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  • Research Fraud, Misconduct, and the IRBAuthor(s): Stephen HilgartnerSource: IRB: Ethics and Human Research, Vol. 12, No. 1 (Jan. - Feb., 1990), pp. 1-4Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563681 .Accessed: 14/06/2014 05:09

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    January/February 1990

    Volume 12 Number 1 January/February 1990

    Research Fraud, Misconduct, and the IRB by Stephen Hilgartner 1

    Cohort-Specific Consent: An Honest Approach to Phase I Clinical Cancer Studies by Benjamin Freedman 5

    Protecting Human Subjects from Harm Through Improved Risk Judgments by Eric M. Meslin 7 UPDATE 11 ANNOTATIONS 12

    Research Fraud, Misconduct, and the IRB by Stephen Hilgartner

    Research fraud and misconduct have ascended to the top of the science policy agenda. Major scientific organizations, such as the American Association for the Advancement of Science and the Insti- tute of Medicine, have recently issued reports on the topic. Prestigious jour- nals, such as Science, Nature, and the New England Journal of Medicine, have run numerous articles or editorials on misconduct. Several Congressional committees have held controversial hearings. The Department of Health and Human Services recently issued final regulations on investigations of alleged misconduct.' And a wide range of policy

    Stephen Hilgartner, a sociologist, is assistant professor of social medicine at the Center for the Study of Society and Medicine, College of Physicians and Surgeons, Columbia University.

    proposals are being debated at confer- ences and scientific meetings.2 Given all this attention, it is natural that members of Institutional Review Boards (IRBs) and others would begin to ask whether, when, and how IRBs should become involved in this issue.

    Amid the current heated debate, it is useful to recall that ten or twelve years ago scientific fraud and misconduct received almost no attention. The recent rise of the misconduct problem on the science policy agenda has been accom- panied by major shifts in beliefs and perceptions. In my overview of the misconduct issue, I will not be evaluating the validity of these beliefs, but instead will concentrate on changes in people's notions about misconduct and on the emergence of a new definition of the

    problem.3 How have ideas about scien- tific fraud and misconduct changed? How have conceptions of the causes of dishonesty in research shifted? And how have notions of appropriate solutions evolved? These questions serve as background to the main focus of this article-the role of IRBs in problems of fraud and misconduct.

    Changing Conceptions of the Misconduct Problem

    Only a decade or so ago most scientists and science watchers believed that serious dishonesty in science was not a major problem. This "traditional" view emphasizes the most extreme offenses, such as fabricating or plagiarizing data. It also narrowly focuses on the deviant individual, the perpetrator. Misconduct, in the traditional view, is seen as a problem of individual pathology-the compulsive liar, the cheat, the psycho- path. It is a problem of the psychology or moral failure of individuals.4

    The traditional view of misconduct also holds that scientific fraud is extremely rare and attributes this low incidence to the institutional norms of science,5 which require honest reporting of research findings. Further, the tradi- tional view holds that in those cases where someone actually does fake data, detection is probable, especially if the results are important. The scientific community's control mechanisms, such as peer review and replication, are deemed capable of detecting fraud. Finally, the traditional view holds that once detected, cases of gross dishonesty will be communicated to other scientists rapidly; punishment is, if not sure and swift, certainly likely and severe.

    The traditional view of scientific misconduct paints a comforting picture of a problem of very narrow scope. The harm caused by the few cases that do occur is minimal. Also, because respon- sibility is focused on the individual perpetrator, the wider scientific commu- nity is absolved of blame.

    During the 1980s the traditional view has come under increasingly severe attack. First, many observers have lost confidence in the claim that scientific misconduct is extremely rare. One count of cases of serious misconduct found 14 cases between the years 1950 and 1979, and 26 cases between 1980 and 1987.6 If most of the cases that occurred are included in these figures, then the incidence is indeed low in comparison with the number of prac- ticing scientists. But because of nagging doubts about the efficiency of detection, one cannot rule out the possibility that many instances of fraud have not been detected.7 In order to be counted in such

    A publication of The Hastings Center, 255 Elm Road, Briarcliff Manor, NY 10510 @ 1990

    1

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  • 2

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    totals, a case must not only occur, but it also has to be noticed, reported, investigated, confirmed, and finally, disclosed in the media or through some other kind of public announcement. It is therefore possible that large numbers of cases are missed. Consequently, there has been ongoing debate about whether the known cases represent a few "bad apples," on the one hand, or the "tip of the iceberg," on the other.8

    Along a second dimension, a broader range of unacceptable practices is receiving attention. The most egregious and extreme offenses-e.g., fabrication of data and plagiarism-still dominate discussion of scientific misconduct, but there is also increasing concern about a variety of unacceptable or dubious practices that, while less serious, are almost certainly more widespread. These include listing "honorary authors" who contributed nothing substantive to publications that bear their names, failing to mention that a paper relied on historical controls, neglecting to disclose conflict of interest when reviewing manuscripts, giving the work of co- authors only a cursory review before "signing off" on it, publishing the same data repeatedly without notifying jour- nal editors, or using misleading statis- tical techniques. There is also concern about researchers nonrandomly assign- ing patients in supposedly random clinical trials, and even about researchers handling data negligently.9 Clearly, the extent to which some of these practices should be labeled mis- conduct is the subject of intense debate, and many observers have pointed out the importance of distinguishing between fraud, which is never accept- able, and error, which is inevitable in science. But nevertheless, recent discus- sions have moved away from a black- and-white distinction between deception and truth and toward a spectrum of practices of varying shades of gray.

    At the same time, notions of who and what is responsible for the problem of scientific misconduct have also grown broader. Here it is useful to distinguish between three kinds of responsibility: causal responsibility, moral responsibil- ity, and political responsibility.' Causal responsibility refers to beliefs and assertions about the etiology of a problem. Moral responsibility accrues to those who are blamed for the problem. Political responsibility concerns who is responsible for "doing something" about the problem.

    Turning first to causal responsibility, the causes of misconduct are now often seen as extending beyond the patholog- ical individual to include many features of the way scientific research is organ-

    ized. Misconduct has been attributed to pressure to publish, competition for funding, inadequate supervision of trainees, deficiencies in the peer review system, infrequent replication, inade- quate procedures for keeping records or retaining data, and the diffusion of responsibility for jointly authored works." This is not a complete list, but even so, it includes mechanisms that operate at several organizational levels in the scientific community--from particular laboratories to the undergrad- uate and graduate training programs, to the structure of the grant system, to journal peer review. One can lay these levels out in a spectrum with the causal mechanisms ranging from being nar- rowly focused on the individual to pointing to increasingly large and broadly based scientific institutions. In recent years, causal responsibility for misconduct has been attributed to a widening spectrum of scientific actors.

    Sometimes one hears still broader explanations that attribute scientific misconduct to things happening outside the scientific community. It is perhaps inevitable in an era of insider trading scandals and criminal indictments of top presidential aides that people would sometimes argue that scientific miscon- duct is merely a symptom of a broader moral decay in society, rather than a phenomenon peculiar to science.

    Theories about causality are obviously closely related to ideas about moral and political responsibility, and notions of moral responsibility have also broadened. The individual perpetrator still retains most of the blame, but increasingly the blame is shared with a number of others: the co-author who fails to check carefully the data under- lying a paper, the referee who gives a manuscript a cursory review, the "research czar" who neglects his or her lab. In addition, universities and medical schools have sometimes reluctantly investigated allegations, and some observers have extended the blame to those institutions. In the moral drama of scientific misconduct, the patholog- ical cheat still plays the lead role, but there is a large supporting cast.

    Conceptions of political responsibility for the problem have also broadened. In the traditional view of misconduct, no one needed to "do something" about the problem because a problem barely existed; the control mechanisms already in place seemed adequate. Today, in contrast, participants in the misconduct controversy are intensely debating a wide range of possible solutions. The overall trend in these proposals is toward requiring more extensive changes. People have put forward numerous

    ideas, but there are four general, although sometimes overlapping, orientations.

    The first of these reflects what might be called a 'law enforcement" perspec- tive, focusing on detection, deterrence, and punishment. This approach emphasizes the efficient and just inves- tigation of allegations,'2 swift and severe punishment, and what amounts to a witness protection program, safeguards to prevent retaliation against whistleblowers.'3

    A second perspective takes an "over- sight" approach. It emphasizes improv- ing routine quality assurance in science by intensifying routine scrutiny of research results, data, and laboratory practices. Here one finds proposals that institutions adopt policies concerning the recording and retention of data.14 Another oversight approach would require routine data audits to determine whether the data underlying a paper are verifiable and reproducible.'

    Another orientation takes an "educa- tional approach," emphasizing the training of researchers and the profes- sional socialization of researchers. Here one finds concern that research ethics need to be articulated more clearly during graduate education. The pro- posed reforms include providing for more intensive interaction between senior scientists and their students, and emphasizing education in good research practices and the ethics, as well as the methods, of research.'6

    Finally, a fourth perspective stresses the "reward system," seeking to change the rules of the game regarding aca- demic appointments, promotions, and grants in ways that will reduce the incentives for people to cheat or to cut corners in research. One well-publicized example is that of the Harvard Medical School, which has issued guidelines suggesting that departments should base promotion decisions on the quality of publications rather than on their sheer number. As an example, Harvard guidelines state that some have sug- gested that no more than five papers should be reviewed for appointment as assistant professor, no more than seven for associate professor, and no more than ten for full professor."7

    Needless to say, such schemes have engendered considerable controversy, since many of them would involve major changes in the way research is con- ducted in the United States. The pro- ponents of such changes believe them necessary to ensure the integrity of research and to preserve public confi- dence in science. Others fear that such proposals will intensify bureaucratic regulation of science, stifle creativity,

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  • January/February 1990

    and threaten the autonomy of the scientific community. They worry that government regulation of misconduct will pave the way for increased political control over science.18

    The Limited Role of the IRB

    In the context of this debate about misconduct, let me turn to a second set of questions: What is the appropriate role of the IRB in addressing research fraud and misconduct? Under what circumstances, if any, ought the IRB to concern itself with research miscon- duct? These questions must be consid- ered in light of the fundamental missions of the IRB, which are, first, to protect the rights and interests of human subjects, and, second, to assure that research involving human subjects is conducted in an ethically legitimate way.

    I propose the following guiding prin- ciple for considering whether and when the IRB should address misconduct: research misconduct is an IRB issue only when it is related to its fundamental missions; the IRB should not expand its missions to include misconduct as an area of additional concern....

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