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. CHAPTER 2 HIsIoRY Many ag ~ cies and organizations have recently di ~ the policies and procedures that government, universities, and other~research organizations should develop to d~1 with complaints of scientific misconduct. However, insufficient attention has been given to identifying and encouraging practices that will promote responsible and honest science. The purpose of this report is to foster these practices and to identify next steps that can be taken by various components of the research system to improve the quality and integrity of research in the health sciences. Quality in this sense refers to the rigor with which experiments are designed and carried out, statistical anal. performed, and results accurately recorded and reported, with credit given where it is due. Integrity in research means that the reported results are honest and accurate and are in keeping with generally accepted research practices. Error is accepted ~ part of the price of doing experimental research, but responsible investigators assume that when errors are detected they will be corrected by the publication of new findings. Discussions of integrity and quality in research have led the research community and others to examine more closely the reliability and effectiveness of the current mix of formal and informal practices and procedures in promoting a healthy research environment. Many organizations are now seeking to define appropriate guidelines that should govern scientific research and the principles that should be observed by individual m castigators and trainees in day-to-day practice. Over the past decade misconduct in research has attracted increasing attention f ram the press, the public, the Congress, and the academic and research communities. This attention was initially drawn by a few highly publicized instances of data fabrication, plagiarism, and misrepresentation, such as the incidents involving John Long at Massachusetts General Hospital, Vijay So man at Yale University, and Mark Spector at Cornell University (Broad and Wade, 1982~. Because many of theme cases involved federal research funds and prestigious institutions, congressional hula rings were convened in 1981 to review the policy implications of scientific fraud (U.S. Congress, 1981). During these hearings, representatives of the scientific community claimed that incidents of scientific fraud were rare, that existing mechanisms were adequate to Bead with these events, and that there was no near for additional policies or procedures to ensure the integrity of federally funded biomedical research. Shortly after these hearings, new cases of serious scientific misconduct came to light. m e handling of these cases, involving John

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Darsee at Harvard Medical School, Marc Strauss at Boston University, and others, raised new questions about the ability of academic institutions to conduct Objective investigations of m~soonduct by their own faculty members or research staff. PROFESSIONAL AND UWIVERSIrY EITC~S In October 1981, the Association of American Universities (AAU) established a Committee on the Integrity of Research, chaired by William H. Danforth, chancellor of Washington University. The charge to the conic star: Incidents of m~soon~uct which raise concern about ~ntaaritY in scientific research have come to cur attention. such instances to be rare for such a large enterprise as university research, even rare occurrences are unacceptable. _ Although we believe m e AAU therefore recognizes a need for universities to collaborate with ~rofecciona' societies and related organizations in the _ ~ ~ . ~ , a ~ _ , _ exam m arlon or roe sources or suan problems and remeoles available to them (AAU, 1983). m e report of the A~U Committed on the Integrity of Research was published in 1982. It affirmed the principle of self-requlation in maintaining the integrity of the academic researr h process. m e committee concluded, however' that informal and quiet efforts to deal with intellectual dishonesty were no longer acoept~hie: "Although these methods may have generally worked well in the rant, experience suggests that it is now appropriate to give serious thought to better methods for preventing and detecting irregularities and to the manner in which universities deal with them" (AAU, 1983). m e A~U committee recommended that all academic research institutions develop policies and procedures to ensure a high standard of ethical behavior for researchers, to define mechanisms for dealing with suspected deviations four intellectual honesty, and to warn of available sanctions. m e report was approved by the AAU., the American Council on Education, an] the National Association of State Universities and land Grant Colleges. Ibe report was diss~minat~ to a broad audience of university administrators, p~vf~sional society ark government officials, and others;, but the sc~cie~r did not correct a systematic iffy to evaluate the response of the university unity to its rations. In January 1982, he Association of American Medical Colleges (AA =) appointed an ad hoc Committ^= on the M~ntenanoe of High Ethical Standards in the Conduct of Research. Chaired by Julius R. Krevans, then dean of the Medical School of the University of California at San Francisco, the AAMC committed reaffirmed the responsibility of research faculties and their institutions to maintain research standards and to 7

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investigate allegations of scientific m~s~r~ucL. The guidelines and rations set forth ~ e cc~mmi~ report were adopted by AAMC In June 1982 as a guide for the faculties of ~;c~1 schools and t~6hj~ hospitals to assist then in probing the integrity of the bill 1~ enterprise (AAMC, 1982~. The AAMC report reccmmended nine elements, including an explicit mechanism for dealing with allegations of misconduct; policies on openness of research; policies to assure that quality rather than quantity of publications be emphasized in prcmotion-decisions; and policies to ensure appropriate supervision of research teams. Despite these initiatives by professional organizations, only a small number of research institutions made a systematic effort in the - =rly 1980s to develop written policies or procedures to handle cases of scientific misconduct. A survey conducted from 1982-1984 by Penelope Greene and her colleagues at Harvard University reviewed the policies and prccedur-= adopted by universities following the ALEC report (Greene et al., 1985). Almost 500 institutions responded to the Greene survey. Of this number, about 25 percent (116) had adopt Ed rule= for dealing with allegations of misconduct; another 25 percent (124) had no such rules. More than half of the respondents indicated that they were formulating prcce~ur~ at the time of the survey. About half of the institutions that had adopted policies at the time of the Greene survey indicated that they had used the AAMC recommendations in developing their misconduct rules. Mast academic institutions appeared to believe that the problem of scientific misconduct did not deserve policy or procedural guidelines and that existing faculty disciplinary mechanisms were adequate to handle the problem if it Should arise on their campus. Other national organizations have since prepared materials to educate young scientists on the responsible conduct of research. The best known among these efforts is the report Honor In Science, published by the research honorary society Sigma Xi (Sigma Xi, 1986). m is 42-page booklet offers "practical advice to those entering careers In scientific research" and sets forth clearly and informally the basic principles of intellectual honesty In science. At the local level, a few universities formed faculty committees in the m~d-1980s to promote research integrity and to discourage scientific misconduct. The University of Michigan, for example, published a report of the Joint Task Force on the Integrity of Scholarship In June 1984. Entitled Maintaining the Integrity of Scholarship, the report defined the ethical obligations of scholarship, pressures that can discourage integrity in schol s hip, and steps to be taken to encourage integrity in scholarship and offered reccmmen~ations, guiding principles, and procedures for the university community. 8

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In September 1985, Donald Kennedy (1985), president of Stanford University, published a report titled.On Academic Authorship, which died the need to clarify the allocation of responsibility and credit for scholarly work and the factors That complicate determinations of appropriate authorship. Harvard Medical School released a set of guidelines in February 1988 for the performance of scientific research by all faculty, trainees and research staff at that institution (Tosteson, 1988~. _ . - , _ The Harvard gulOel mes have attracted national attention because they codify generally accepted research practices and set forth recommendations for supervision of research trainees, data recording and retention, responsible authorship, avoidance of endive publication Cacti. and individu~d laboratory written procedures. These recommendations are not promulgated as rules, but are Intense] to guide the development of written prooedurem for each research group affiliated with The Harvard Medical School, according to its dean, Daniel C. Io6teson. During the pant year, this IBM committee has learned of other professions] efforts to encourage research integrity and to improve the ability of academic institutions to handle incidents of scientific fraud an] research misconduct. The National Conference of Lawyers and Scientists, a joint project of the American Association for the Advancement of Science and the American For Association, is spore oring a series of workshops to evaluate the features of effective m~soon~uct policies and procedures for universities. Background papers commissioned for the NCIS workshops provide additional analysis of the significance of the publicly reported conic of scientific Discos duet and institutional efforts to handle these cases (ALAS, 1988~. A consortium of educational organizations under the leadership of AAU is also develc ping a framework, or Gel guidelines, for instit~tiorm1 policies arm pr~r~c to d-al wit research fraud (AAU, 1988) . ~ EELS One of the first efforts by a government agency to address The issue of scientific Tn~sconcluct was a workshop Torment in 1981 by the E= siclent's ~ emission for the Study of Ethical E = bl en; In M Medicine and Biomedical and Behavioral Research (U.S. President's Commission, 1982~. In response to reports of harassment of persons who raised concerns about scientific misconduct (these individuals are often called '~histle-blowers"), the commission cosponsored the workshop with ALAS and the organization Medicine in the Public Interest to review institutional experiences in handling reports of research fraud. The workshop report, Whistle blowing in Biomedical Research, provide= a study of He initial policies arid pros use by universities to investigate charges of scientific misconduct. 9

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We oversight Ire of the muse Science and Tec~noic~y niece hell] hirings on March 31-~r;1 1, 1981, to review institutional ex~rienaes in haywire f~PC of scientific fraud in bi~i~al Ah (U.S. C30r~ress, 1981~. Airy-Tentative prow Senator) Albert Gore, ye ~ittee received testifier fawn variants insti~cional representatives, inch Ehilip Hoer, then president of the National Academy of Sciences. me witches surest Bat the problem of scientific fraud had been greasy ~ggerat~ and that the cash that had surface were adeaaate1v at be existing self-r~ulatory Humanisms. _ _ _ _ Following continued press reports of cases of serious scientific misconduct, Congress enacted legislation In 1985 that required the U.S. Public Health Service (USERS) to develop procedures for investigating charges of scientific misconduct involving federally funded research activities (P.L. 99-158~. USPHS subsequently adopted interim guidelines (USOHHS, 1986) in July 1986 that required local research institutions to adopt misconduct guidelines as a condition of funding for grants and contracts awarded by the National Institutes of Hearth and other USE HS-funded research programs. _ In September 1988, USERS proposed draft regulations in the Federal Register further defining the responsibilities of USERS awardee and applies nt institutions for dealing with and reporting possible misconduct (USDHHS, 1988a). The notice of proposed rulemaking (NORM) states: Before 1980, instances of reported misconduct in EHS-funded research programs were infrequent. In recent years, however, there has been a small number of highly publicized instances of scientific sconduct....From what little we do know, it would appear that reported instances of scientific misconduct represent only a small fraction of the total number of research an] research training awards funded by EHS. Nevertheless, even a small number of instances of scientific m~soonduct is considered a threat to the continued public confidence in the integrity of the scientific process an] in the stewardship of Federal funds. The traditional safeguards such as peer review and guidance form professional organizations must be supplemented by explicit institutional oommitment to high ethical standards in research. The proposed rule sets forth The following definition for 'misconduct in science": "~1) fabrication, falsification, plagiarism, deception or other practices that seriously deviate freon those That are commonly accepted within the scientific community for proposing, conducting or reporting research; or (2) material failure to comply with federal requirements that Cared uniquely related to the conduct of research." The latter portion of this definition covers areas such as the federal regulations governing the handling of hazardous research materials, the use of animals or human subjects in research, and the use of recombinant-DNA materials. 10

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the proposed rule again affirms that the primary responsibility for detecting, investigating, reporting, and resolving allegations of scientific miscrnduot rests with awardee institutions. These institutions will now be require] to provide assurances that they have established appropriate procedures to review reports of misconduct in biomedical or behavioral research at their institution. m e proposed rule establishes minimum sban~ard5 for these procedures and requires the institutions to notify the funding agency when Bus conduct investigations are initiated. In the some issue of the Federal Reaisber announcing the proposed rule discussed above, the U.S. Public Hearth Service also published an advanced notice of proposed rulemakina (AVERS) in the development of fabure regulations protecting against scientific fraud or misconduct (USDHHS, 1988b). m e ANP~M invited public comment on several complex and oontravearsial aspects of scientific misconduct that m:g'ht be considered by the government in formulating new regulations. In particular, comments were solicited on the following topics: o definition of scientific misconduct; o responsibilities of awardee institutions; o responsibilities of the Department of Health and Human Services; o joint responsibilities of the department and awardee institutions; and gancrDmentwide policy on scientific misconduct. o A 60-day comment period was provided for the NERD, and 90 days were provided for comment on the ALARM. The pace of governmental interest in scientific misconduct picked up in 1988. In addition to the regulatory proposals discussed above, three oongressional hearings and an investigative study by the Office of the Inspector General in the Department of Health and Human Services focused on this topic. In April 1988, two separate House subcommitt~Pc held hearings to review regent allegations of scientific misconduct and the experience of NIH In investigating therm bases. Representative John Dingell, chairman of the House Energy and Commerce Committee, strongly criticized government agency performance, contending that the agencies inadequately an dressed key issues regarding disclosure, notification, and protection of whistle-blowers in these cases (U.S. Congress, 1988a). Representative Ted Weiss, chairman of the Human Resources and Intergovernmental Relations Subcommittee of the House Government Operations Committee, also held hearings to review similar charges and to explore the public health and safety questions that might arise as a result of fraudulent research (U.S. Congress, 1988b). 11

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Congressman Swiss convene] a strand day of hearings in September 1988 to pursue the=- issues and to examine conflict of interest charges in academic research (U.S. Congress, 1988c). The congressional hearings attracted~national media attention and highlighted congressional concerns about the appropriateness of the governments policy of relying upon local institutions to investigate charges of scientific mum conduct. In late September 1988, the Office of the Inspeabor General (OIG) of the Department of Health and Human Servicer rely a draft report on misconduct in scientific research pUSDHHS, 1988c). m e report included the results of a recent study of the extent to which NIH and its ~ grants== have developed policies and procedures to prevent! detect' and handle scientific muscorduct and a description of what selected grantee institutions have learned as a result of experiences with research fraud. m e draft GIG report recur mended that the Secretary of HHS establish inve ~ igatory and oversight functions independent of the research funding agencies and develop a more formal process to deal with scientific misconduct. The recommendations included additional notification requirements for the awardee institutions an] the development of alternative methods of detecting possible misconduct, including spot alerts of scientific data and specific reviews by editors of scientific journals. The GIG staff surveyed a random sample of FY 1986 NIH grantee institutions by telephone and also conducted site visits to nine such institutions that had experience with scientific misconduct cases. m e draft report concluded that although only 22 percent of NIH grantee institutions overall have policies and procedures to d-~1 with scientific misconduct, 93 percent of such grandson with 100 or more awards have such policies and procedures In place. The scientific misconduct procedures that are In place are generally not comprehensive, often failing to require notification to NIH. The report noted that 36 percent (17 of 47) of the grantee institutions with est~hlished pro endures reported cases of m~soon~uct that required their use. - Sixteen of the 34 ca~-m (47 percent) investigated by these 17 institutions were substantiated. Extrapolating from these figures, the GIG estimated that 95 scientific misconduct races (47 substantiated and 48 unsubstantiated) have been addressed by NIH grantee institutions. This estimate, as noted in the GIG report, is consistent with records maintained by NTH since 1982, which show that 102 cases have been investigated by its grantees and reported to the agency in that time period. Ihe GIG report (USDHHS, 1988c) emphasizes that, "Ihe estimate of 95 cases does not represent an estimate of the actual prevalence of scientific misconduct. In fact, our grants== were about evenly split on whether or not more misconduct occurs than is reported." 12

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OBSER;i~ Several strong themes have emerged in policy discussions about the appropriate nature of public and private institutional response to incidents of scientific fraud and research misconduct. First, government agencies, professional organizations, and research institutions have consistently affirmed that the primary responsibility for handling Chew- Marc should rest with awardee institutions, the ones doing the rose arch. Second, recent federal regulations have generated new requirements for research institutions to adopt explicit, written guidelines for handling al legations of scientific misconduct. Third, these misconduct guidelines and policy directives revere a need for additional mechanisms to encourage high ethical standards for research. m ere is wide variation among universities in their efforts to define appropriate standards for research, and pruf=mcional standards have remained ambiguous in some instances. The absence of formal stats or written guidelines for the ethical performance of him amnerat~ uncertainty beat the c~rit~r;~ for ~;=tinnn,;!::hinr' ~ . _ _ . . . . . . . prattle stat violate processions norTre al a~lvltl~ mat at simply part of the variation armed These norm. Ir~restigations of Marc of scientific fraud Mu ~ est that various factory in the research environment may contribute to the occurrence of scientific misconduct even though they are not the direct canes" of these occurrences. Examples include pressures to "publish or perish," an emphasis on competition and secrecy in research performance. and ^, r Inadequate Interaction of young researchers with their peers and mentors. There is concern that not only ethics, but also the quality of scientific research in general may suffer in this environment. These concerns have pivoted resewn h institutions, professional organizations, government agencies, and congressional oversight cc~nmi~ees to search for policies that will strengthen the ~n~riLv and quality of the research environnent. Over the research use of human and aniLrla1 subjects, these policy disa scions raise 9~cal questions abut the adequacy and _ _ ~ As In the case of public corKxrn ertectlveness or- the current se 't-regulatory system in assuring responsible research practices and preventing scientific misconduct. The purpose of this stay was to examine these questions and to propose ways to encourage high ethical stand adds in the conduct of research without damaging the freedom and creativity that have traditionally characterized American research. 13