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SPIN . 1 SUMMED Several strong themes have emerged in policy dicr~==ions about the appropriate nature of public and private institutional responses to incidents of scientific fraud and research musoonduct. First, government age ~ ies, professional organizations, and research institutions have consistently affirmed that the primary responsibility for handling these In should rest with awards institutions, the ones doing the research. Second, recent federal regulations have generated new D~qUirementS for research institutions to adept explicit, written guidelines for handling allegations of scientific misconduct. m ird, these mum conduct guidelines and policy directives revere a need for additional mechanisms to encourage high ethical standards for DeS~arCh m ere is wide variation among universities in their efforts to define appropriate standards for De Perch, and professional standards that govern various research practices have remained ambiguous in some instances. The absence of formal standards or written guidelines for the ethical performance of research has gene rater uncertainty about the criteria for distinguishing practices that violate professional norms from activities that are simply part of the variation around these norms. . . .. Investigations of cases of scientific fraud suggest that various factors in the research environment may contribute to the occurrence of scientific misconduct even though they are not the direst causes of these occurrences. Examples include pressures to "publish or perish," an emphasis on competition and secrecy in research performance, and 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 prampbed research institutions, professional organizations, government agencies, and congressional oversight committees to search for policies that will strengthen the integrity and quality of the research environment. As in the case of public concern over the research use of human and animal subjects, these policy discussions raise fundamental questions about the adequacy and effectiveness of the current self-regulatory system in assuring responsible research practices and preventing scientific misconduct. _ . _ . . . . PURPOSE OF THE STUDY AND APPROACH The purpose of this study was to examine these questions and to propose ways to encourage high ethical standards in the conduct of research without damaging the freedom and creativity that have traditionally characterized American research institutions. A workshop 1

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was a prc*uctive means for the IOM study committee to gather information and perspectives abcut standards and practices that affect the conduct of research in the health sciences. More than 100 clinical and basic research scientists, government and university officials, professional society officers, journal editors, and members of the press attended the workshop, held in September 1988 in Washington, D.C. An agenda and list of participants are include d as appendices to this report. AMOS AND EINDIN;S In meetings before and after the workshop, the committee arrived at assumptions and findings that.formed the basis for their policy proposals and final recommendations contained in this report. In the absence of definitive data documenting the integrity of existing research practices and the level of misconduct in health sciences research, the committee relied upon expert Opinion. These assumptions and findings may not be shared by all members of the research community indeed, they were not shared by all workshop participants- but they quickly emerged as a consensus of the committee. These assumptions and findings deserve explanation and clarification because they form the foundation for this report. O Scientists develop and maintain quality and accuracy in research practice by self-regulation, extensive reliance on each investigator's professional Standards' and the traditions and collegiality that characterize research institutions. o A variety of informal and formal practices and prom cures exist in the academic research environment to assure and maintain the high integrity of research conduct. O Few academic institutions have established explicit standards for responsible research practices, such as guidelines for the recording and retention of research data or for inclusion as an author. The committee believes that the absence of explicit institutional standards allows the research system to tolerate substandard activities by a small number of individual investigators who fail to observe generally accepted practices. Furthermore, the absence of a mechanism to enforce standards leads to a perception that the institution or the profession is unwilling or unable to correct abusive practices. O There are very few courses of instruction dedicated to communicating professional standards and the ethics of research practice to young scientists. o m e culture of the American university is distinguished by traditions and styles of governance that assume professional integrity and that place great value on the independenoe and collegia~ity of individual faculty. 2

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o Investigations of a ~11 number of publicly report cast of scientific fraud and ocher r~a~ m~saor~c suggest that a mix of factors ~i~ed to this deviant behavior. He of these was an ur~healt~y ~ environ Cat failed to disparage (or even tolerated) sloppy or careless r ~ arch Eta ~ ar do. Although the committee believes that serious misconduct in science is rare and is ultimately a manifestation of individual deviance, it concludes that institutions fail to detect and correct early deviant behavior primarily because of an excessively permissive research environment that tolerates careless= practices. m e committee also believes that substandard practices are encouraged by funding pressures and an overemphasis on publication as the main means of achieving status and recognition for scientific advancement and research support. o Increasing budgetary and competitive press Yes in science demand that local research institutions and government research fenders develop standards to ensure responsible research practices to ensure the integrity of the academic research enterprise. O Effective institutional reforms to improve integrity and responsible research practices require better understanding of the key factors that influence professional development and performance in ienoe. INS In developing recommendations, the committ== sought to define appropriate rifles for government, universities, rPc=~rch institutions, prof-=cion~1 organizations, and scientific journals that would stimulate local institutional and professional efforts without creating an unjustifiable regulatory burden on the research a G ity. These recommendations represent the steps that the committee believes are most appropriate for action at this time in seeking to promote integrity in health sciences research. Recommendations for the National Instituter of Health 1. The National Institutes of H~a1th should establish an office to promote responsible research practices. This office should be coordinated with an expanded NIH effort to evaluate instibutiona~ investigations of misconduct in scientific research. The primary function of the office should be to foster ~ ~ of high professional standards of research applicant institutions. and monitor the development practice by all grantee and 2. By 1992, NIH should require all grantee and applicant institutions to provide assurances that they have adopted policies and procedures to encourage responsible research practices. Research applicants should affirm their familiarity with these policies and 3

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proc dares and should also:prcpose how They plan to store research data in the course of their study. 3. NIH should not implement random data audits as a mechanism for ensuring He responsible conduct of investigator-initiat^~ research. 4. NIH should adopt professional standards to ensure responsible research practicer by its intramural scientists. 5. NIH should adopt policies to limit the number of publications that can be considered as part of any grant application, in order to - emphasize quality over quantity. Recr~=E~.oations for Universities and Other Research Centers 6. Universities, medic schools, and other research organizations should adopt guidelines to clarify the expectations of each institution about the prof==cion~1 standards to be observed by investigators in the conduct of research. 7. Universities should provide formal instruction In good research practicum. This instruction should not be Amity to formal courses, but it should be incorporated into various places in the undergraduate and graduate curricula for all science students. 8. Universities should designate one or more administrative officers or faculty members to promote responsible research practices within the institution. The institution should also provide mediation and counseling services for faculty, staff, and students who wish to express concerns about professionally questionable Lrain~ng or research practices. 9. Universities and other research institutions should strengthen the integrity and quality of research by modifying incentives and academic guidelines in order to reduce the pressure for excessive publication. 10. Academic departments and research units Should monitor the supervisory and training practices of their faculty and research staff to ensure that adequate oversight is provided for young scientists. 11. Academic departments and research units should adopt authorship policies to improve the publication practices of their faculty, staff, and students. Recommendations for Professional and Scientific Organizations and Journals 12. Professional and scientific organizations representing the research community should develop educational and training activities 4

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and materials to improve the integrity of research. These organizations Should schist universities in identifying substandard research and training practices that Promise the integrity or quality of research. 13. Scientific journals Should develop policies to promote responsible authorship practices, including procedures for responding to allegations or indications of misconduct in published research or reports submitted for publication. 14. The National Academy of Sciences should pursue the issues and findings develc~ed by the Institute of Medicine in this report and examine their relevance and application to cipher fields of scientific research. 15. An interdisciplinary committee should be convened to study the issue of rights and responsibilities of all relevant parties to research data and to prepare model guidelines for data sharing and data arctic. 16. There are many issues that deserve further analysis to enhance institutional and policy efforts to discourage scientific misconduct and to improve the integrity and quality of research. The committee recon mend s that professional and scientific organizations initiate studies to understand and encourage responsible research practices.