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Promoting Integrity in Research
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International - Activity
4 Countries Describe Scientific Misconduct Procedures at Warsaw ConferenceVolume 7, No. 2, March 1999Representatives of four European countries reported on their efforts to develop administrative procedures for responding to allegations of scientific misconduct and promoting good scientific practices during an international conference held in Poland last November. The "Scientific Misconduct: An International Perspective" conference, held at The Medical University of Warsaw was attended by about 70 persons from Canada, Denmark, England, France, Germany, Norway, Poland, Sweden and the United States. Conference papers have been submitted to Science and Engineering Ethics. Daniel Andersen, the Danish Committee on Scientific Dishonesty (DCSD), reported that the committee closed 24 cases since it was established by the Danish Medical Research Council in November 1992. Scientific dishonesty was found in six cases and less severe deviations from good scientific practice in nine cases. Eighteen other cases were not considered pertinent by the committee. The DCSD is a national committee that covers research in the health sciences regardless of funding source. "Cases can be brought directly to the committee without involvement of the local research institutions and the committee actually discourages any attempts to conduct local inquiries or investigations," Andersen said. The committee is composed of seven experienced researchers in the health sciences appointed by universities, scientific societies, and other research institutions, and an experienced jurist, a High Court Judge, as chairman. Andersen continued, "The committee has a broad mandate, including case management, prevention of scientific dishonesty, and advancement of good scientific practice." Allegations received by the committee are sent to the respondent for comment. Those comments are then sent to the whistleblower for comment. Several rounds of comments may be needed before the committee can decide whether an investigation is warranted. If so, a subcommittee of three impartial experts is appointed and outside experts may be used. The involved parties may comment on the composition of the subcommittee, and they must receive all the information known to and used by the subcommittee. The subcommittee report also is given to the parties for comment. The report and comments are then forwarded to the committee for its decision. No information is provided to external parties (including the news media) until a decision is made. If dishonesty is found, the institution of the respondent is informed; sanctions are the responsibility of the institution. If dishonesty is not found, an abstract devoid of identifiers is printed in the committee's annual report. The involved parties are free to use the decision as they wish, but the committee does not inform any third parties about its decision. The DCSD has issued guidelines on authorship, collaborative agreements, and other areas. "It was not the intention to create quite new principles for good scientific practice. Rather, it was the intention to make explicit rules which already were well accepted by leading scientists but which had never been issued in a clear text," Andersen said. Laurence Schaffar-Esterle, INSERM, the primary agency for biological, medical and health research in France, reported that INSERM established a Committee on Scientific Integrity in June 1998 to develop procedures for preventing scientific misconduct and responding to allegations. To prevent scientific misconduct, Schaffar-Esterle said the committee is emphasizing good laboratory practices (GLP), especially research documentation that includes "the raw data, the modalities of any data processing, and explicit written descriptions of the methodological approach, including the methods of randomisation, the statistical treatment, and the quantitative or qualitative criteria related to selecting the experiments and the results." "In France," Schaffar-Esterle reported, "the legislative framework governing clinical trials and human subjects research has resulted in their generally excellent conformity with good clinical practices, thereby ensuring not only necessary respect for individuals but also the quality and reliability of the data. Laboratory research, however, does not always comply sufficiently with the rules of good laboratory practice." INSERM is developing a preliminary guide to GLP. The committee recommended that GLP be included in the evaluation of laboratories and researchers. The process recommended by the committee for responding to allegations of scientific misconduct in the 260 research laboratories operated by INSERM includes the appointment of a Scientific Integrity Officer who reports directly to the Director-General of INSERM and is assisted by regional correspondents. Allegations are reported to the Scientific Integrity Officer or the regional correspondents. Procedures include an inquiry followed by an investigation when warranted, separation of the investigative and adjudicative phases, maintenance of confidentiality, use of outside experts, imposition of sanctions, correction of the literature, restoration of reputations, punishment for bad faith allegations, and actions designed to prevent a repetition of the misconduct. Schaffar-Esterle said, "Even though each institution must remain responsible for responding to allegations of scientific misconduct within its doors, INSERM would like to see national, European, and international co-ordination about the methods of such response." Christoph Schneider, Deutsche Forschungsgemeinschaft (DFG), the major research funding agency in Germany, reported that the German Rectors' Conference (HRK) has drawn up model guidelines for procedures to deal with allegations of scientific misconduct that are based on the recommendations of the international commission on professional self-regulation in science established by DFG in June 1997. The HRK guidelines are available at http://www.hrk.de. After reviewing three cases that led to the creation of the international commission, Schneider said, "What the three cases have in common is that none of the institutions involved was prepared for dealing with the misconduct allegations when they were confronted with them. All necessary procedures had to be invented step by step during their implementation." He added, ". . . above all [there was in one case] the abominable situation of graduate students in the group faced with the choice of condoning, or actively participating in, their superiors' misconduct or leaving the group to face an uncertain future." Most universities and research institutes in Germany are expected to issue regulations on responding to allegations of scientific misconduct in the next year or two because the DFG General Assembly in June 1998 adopted the recommendations of its international commission, including one that ties eligibility for funding to the availability of internal procedures to safeguard good scientific practice, according to Schneider. Imogen Evans, Medical Research Council (MRC), the leading research agency on human health in England, outlined the policy and procedure adopted by the MRC in December 1997 that formally covers about 3,000 staff employed in MRC units. Evans said, "Those in receipt of MRC grants in universities and elsewhere are expected to operate under similar policies." The policy and procedure will be evaluated after 2 years. Evans said the MRC procedure was designed to (1) comply with employment law, (2) embody the principles of natural justice towards those who are the subject of an allegation, (3) protect whistleblowers, and (4) achieve an appropriate balance between confidentiality and publicity. "The emphasis throughout is not only on impartiality and thoroughness but also on reasonable speed in reaching just conclusions; a protracted inquiry is in no-one's best interests," she said. Evans continued, "The MRC is also convinced that it is equally important to achieve a working culture that fosters integrity. Thus education and training in good research practices are fundamental to the prevention of research misconduct." |
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