"It is vital that the conduct of science itself is based on the highest ethical considerations" - Enric Banda, Secretary General, European Science Foundation (1)
INTRODUCTION
Scientific research, comprising diverse and multifaceted activities, include a wide range of intellectual and practical endeavours. These include theoretical studies, experimental work and surveys, as well as the verification, further analysis and extension of earlier work. The objective is always to extend human knowledge and our understanding of the physical, biological and social worlds.
Progress in science depends on trust and it is vital that the ethics and integrity of science are beyond question. Scientists must have confidence in the results of other scientists. Also, society has to trust the honesty and motives of scientists and the integrity of their results. Scientific integrity is at the heart of the trust on which scientific communication and collaboration depend. Scientific integrity demands that those engaging in research and scholarship should at all times, and without exception, accept the highest professional standards with a critical, open-minded approach in the whole range of scientific work, including experimental design, generating and analysing data, publishing results, and acknowledging the direct and indirect contributions of colleagues, collaborators and others. Also, frankness and fairness with regard to the contributions of colleagues, absolute honesty at all stages in scientific enquiry and personal responsibility are of fundamental values to uphold the sientific integrity.
Science has had a tradition of informal self-regulation to ensure that the highest professional standards of integrity are maintained. However, over the past 20 years there are increasing pressures on scientists to produce results quickly what in turn creates temptations to short-cut proper procedures, derived from: competition between scientists for scarce research and schoolarship funds; often ultimative desire some public funding agencies attach to the utilitarian value of science; and the emphasis on publications as measures of quantity and quality of scientific work, has sharpened the focus on outputs, as well as challenging traditional academic values of freedom of thought and action.
Last, but not least, the ethical issues always inherent in social science and clinical research, where people are the subjects, and increasingly posed by advances in biomedical and biotechnological research, have added to the problem. In today's more inclusive society, these issues are now widely held to be too important, at best, to be left to informal and private debate within the scientific community, or, at worst, neglected by scientists.
All above points have turned a spotlight on issues of scientific integrity and professional standards and put pressure on the scientific community to strengthen the process of self-regulation and make it more visible. So good practices in the design, conduct, interpretation and reporting of scientific research and scholarship are the gatekeepers of integrity of science. They are the prerequisites of mutual trust within the global scientific community and of greater trust between scientists and the public. Where there is a climate of trust, the results of science are more likely to be accepted, exploited or applied, for the benefit of humankind.
Good scientific practice (GSP)
History
The cases of alleged scientific misconduct which have become famous in the USA between 1978 and the end of the 1980s have attracted enormous public attention what was the major factor which caused a large number of committees to engage both in the phenomenology and in fundamental deliberations of "scientific fraud and misconduct" (2) from the beginning of the 1980's. In the late 1980's, biomedical research witnessed some of the first initiatives in codifying Good scientific practice (GSP) and establishing procedures for dealing with misconduct. In the mid-1990s the UK Medical Research Council (MRC) produced a series of reports on the ethics of biomedical and clinical research, on entific practice and on procedures for inquiring into allegations of scientific misconduct (3). The Danish Committee on Scientific Dishonesty (DCSD), was founded in 1992 at the Initiative of the Danish Medical Research Council and has been working under the umbrella of the Danish research ministry since 1996 (4). Well-publicised case of scientific misconduct in Germany - the Herrmann-Brach affair, an unusually serious case of scientific misconduct (5) has led the Executive Board of the Deutsche Forschungsgemeinschaft (DFG - German's Ministry of Science) to appoint an international commission with the mandate - Commission on Professional Self Regulation in Science, chaired by the President, to explore causes of dishonesty in the science system, to discuss preventive measures, to examine the existing mechanisms of professional self regulation in science and to make recommendations on how to safeguard them. Proposals for Safeguarding Good Scientific Practice (GSP) together with following recommendations, were given on January, 1998 (6). Scientific activities in many fields are governed by legal and professional norms, and by codes of conduct like the Declaration of Helsinki (7) and the GSP recommendations are in no way designed to replace these norms and regulations, but they are aimed to supplement them by a set of basic principles and to develop and extend ethical norms of science (8).
Above GSP document contained the accompanying justification and commentary with suggestions for their implementation. They are followed by a short overview of the problems in the scientific system discussed by the commission, and of institutional regulations in other countries which were helpful for drawing up the recommendations.
GSP document
GSP in research and scholarship is essential for the integrity of science. It sets internationally valid benchmarks for quality assurance, which enable replication and further studies by other scientists. Also, it provides safeguards against scientific dishonesty and fraud. Good practice, thus, nurtures trust within the scientific community and between science and society, both of which are necessary for scientific advance.
GSP embraces all the procedures and practices that are necessary for planning, conducting and reporting research and scholarship within a framework of scientific integrity. By providing a common currency, good practice facilitates the vital, external processes of peer review, verification and repeatability. This enables other scientists to judge the validity of new contributions to knowledge and understanding. Standard methodologies for collecting and interpreting information also reduce the individual bias that might be introduced, perhaps unwittingly, by a scientist's personal background and values. And the audit trail created by GSP provides quality assurance and a valuable buttress against scientific misconduct and fraud.
To be effective, GSP have to be made explicit in written guidance or codes. There also have to be managerial procedures for implementing them and monitoring processes to ensure compliance. The DFG's international Commission presented a comprehensive report with an analysis of the issues along with 16 recommendations covering principles and operation of GSP, as well as procedures for investigating allegations of scientific misconduct. These recommendations were used as an excellent basis for developing a set of common internationally accepted standards defined through GSP.
It is recommended that Universities and independent research institutes should formulate rules of GSP in a discussion and decision process involving their academic members. These rules shall be made known to, and shall be binding for, all members of each institution. They shall be a constituent part of teaching curricula and of the education of young scientists and scholars.
General statements
Rules of GSP include following principles for the fundamentals of scientific work (in general, and specified for individual disciplines as necessary), with uncontested respect that freedom and responsibility - of each scientist and scholar individually as well as of the institutions of science - are inseparable from each other:
- observing professional standards,
- documenting results,
- consistently questioning one's own findings,
- practising strict honesty with regard to the contributions of partners, competitors, and predecessors,
- cooperation and leadership responsibility in working groups,
- mentorship for young scientists and scholars,
- securing and storing primary data,
- scientific publications.
GSP document points to the possible essential causes of scientific misconduct:
- any form of fraud, such as fabricating or falsifying data or records;
- piracy or plagiarism;
- sabotaging the work, records or protocols of other scientists;
- breach of confidence as a reviewer or supervisor, and
- complicity in such actions by fellow scientists.
Institutions of science Institutions of science are under obligation to provide organizational structures which should guarantee working conditions that allow all their members to observe the norms of GSP. Heads of institutions carry the responsibility to ensure that a suitable organizational structure is (and is known to be) in place, that goals and objectives will be set and progress towards them can be monitored, and finally, that mechanisms for resolving conflicts are available. Scientists
On the other hand, in science as in all other fields, adherence to fundamental values is particular to each individual. Every scientist and scholar is personally responsible for his or her own conduct. But whoever is responsible for directing a unit also carries responsibility for the conditions therein. Members of a working group must be able to rely on each other. Mutual trust is the basis for the conversations, discussions, and even confrontations which are characteristic of groups that are dynamic and productive. A researcher's working group is not only his or her institutional home base; it is also the place where, in conversations, ideas become hypotheses and theories, where individual, surprising findings are interpreted and brought into a context.
Young researchers
GSP recommends the special attention on vital importance of ensuring that every younger member of the group - graduate students in particular, but also advanced undergraduates and younger postdocs - receives adequate training and supervision. Each one must have a senior partner primarily responsible for his or her progress. A healthy communication within a group and high quality supervision are the best means to prevent younger or more experienced group members from slipping into dishonest practices. Leading a group includes the responsibility to guarantee such conditions at all times. Scientific misconduct
According to GSP recommendations universities and research institutes are responsible to establish procedures for dealing with allegations of scientific misconduct. They must be approved by the responsible corporate body. Taking account of relevant legal regulations including the law on disciplinary actions, they should include the following elements:
- a definition of categories of action which seriously deviate from GSP and are held to be scientific misconduct, (the fabrication and falsification of data, plagiarism, or breach of confidence as a reviewer or superior);
- jurisdiction, rules of procedure (including rules for the burden of proof), and time limits for inquiries and investigations conducted to ascertain the facts;
- the rights of the involved parties to be heard and to discretion, and
- rules for the exclusion of conflicts of interest; sanctions depending on the seriousness of proven misconduct, the jurisdiction for determining sanctions.
Authorship
A special attention in GSP is paid to the authorship and the criteria for authorship, because publications are the primary medium through which scientists give an account of their work, but also it is the most frequent cause of conflicts and scientific misconduct. Through a publication, authors (or groups of authors) make a new finding known and identify themselves with it; they also assume the responsibility for its content. Authors of an original scientific publication shall be all those, and only those, who have made significant contributions to the conception of studies or experiments, to the generation, analysis and interpretation of the data, and to preparing the manuscript, and who have consented to its publication, thereby assuming responsibility for it. Some scientific journals demand that this be documented through the signatures of all authors. Others ask for a written statement to this effect by the corresponding author as the person responsible for a manuscript as a whole and in all its details. Where not all authors can assume responsibility for the entire content of a publication, some journals recommend an identification of individual contributions. With this definition of authorship, other contributions, including significant ones, such as:
- the responsibility for obtaining the funds for the research,
- the contribution of important materials,
- the training of co-authors in certain methods,
- involvement in the collection and assembly of data,
- directing an institution or working unit in which the publication originates, are not by themselves regarded sufficient to justify authorship.
Publications
Publications - scientific papers, monographs, thesis, etc. - are the most important "products" of research, but even in fields where intensive competition requires rapid publication of findings, quality of work and of publications must be the primary consideration. Findings, wherever factually possible, must be controlled and replicated before being submitted for publication. Wherever achievement has to be evaluated - in reviewing grant proposals, in personnel management, in comparing applications for appointments - the evaluators and reviewers must be encouraged to make explicit judgements of quality before all else.
Although, it may have seemed logical, when comparing achievement, that measure of scientific productivity as the number of products, i.e. publications, per length of time is correct, the length of publication lists have to be complemented by additional criteria like the reputation of the journals in which publications appeared, quantified as their "impact factor", etc. For such purposes, today a variety of instruments are available (9) - bibliometry, scientometry, etc. However, they require specific expertise in their application. It is widely accepted that the representative list of publication should consists of papers (often not more than 5-10), selected by their authors as the best examples of their work according to the criteria by which they are to be evaluated. GSP recommend to abuse like the so-called salami publications, repeated publication of the same findings, and observance of the principle of the LPU (least publishable unit).
Ombudsman
Within GSP it is recommended to appoint an independent authority in the form of an Ombudsman (or a small committee) and equip it with the necessary resources for exercising its functions. Its mandate should be to advise and assist scientists and scholars in questions of GSP and its impairment through scientific dishonesty, and to give an annual public report on its work what among above, would support public confidence in GSP by demonstrating the attention which science and scholarship give to their own self regulation. GSP in Europe
At a European strategic level, there are several possible initiatives which are proclaimed to be taken to strengthen approaches to scientific integrity and GSP across Europe.
With its extensive membership in 23 countries, the European Science Foundation (ESF) is uniquely placed to play a pan-European role in promoting, developing and further improvement of GSP in Europe (10). Several ESF member organisations and some individual research institutions and universities have already published guidelines, or codes, for GSP across the full range of the natural and social sciences, engineering and the humanities. However, to be fully effective ESF point that such codes have to be more widely adopted by European universities and research institutions, observed by all researchers and scholars and monitored for compliance. ESF commits itself:
- to support and promote vigorously the concepts and principles of GSP in research and scholarship; and
- to promote the principle that the selection of scientists by academic institutions should be transparent, based primarily on criteria of scientific quality, creativity and promise, without discrimination on grounds of sex, race, political opinions or cultural backgrounds.
The current debate about a European Research Area (ERA) introduces a favourable political dimension and creates a window of opportunity for action directed to affirmation of GSP. Therefore, ESF believes that the following conclusions and recommendations set out a basis for further action at European level on this important topic:
- national academies should draw up national codes of GSP in research and scholarship, where these do not yet exist;
- national academies should initiate discussions on the most appropriate national approach to procedures for investigating allegations of scientific misconduct (where this has not yet been done), whether by means of an independent national body, formal procedures in each university and research institution, or by other means.
- research-funding agencies should consider ways of making an institution's eligibility to apply for research grants conditional on that institution having adequate policies for GSP and procedures for investigating scientific misconduct.
- organisations that employ scientists should act as responsible employers with clear, fair and robust guidelines for GSP, coupled with effective and transparent management procedures for implementing these guidelines and for investigating allegations of scientific misconduct.
- finally, it is important to consider whether there is a need for any pan-European structures to reinforce national arrangements, for example, by maintaining a college of eminent scientists who might serve on local or national committees investigating scientific misconduct, or by setting up an Ombudsman system to provide a third party for counselling "whistle blowers" in the scientific community.
GSP in our scientific institutions
In our country legal norms and norms in science do not include the necessity of the preparation and acceptance of GSP, but considering above European trends it is obvious that it will be one of the obligatory condition for implementing our science and Universities in international scientific community. So, it is expected (11) that our national authorities, first of all Ministry of Science, Development and Technology of Serbia will be the leader for both, implementation of GSP in our legislature as well as in our scientific practice.
Our scientific community already recognized ongoing European initiatives and at the moment two our scientific Institutes: Institute for Oncology and Radiology of Serbia and Institute for Medical Research had accepted GSP (12, 13), prepared with the written permission of DFG, on the base of internationally accepted recommendations. The Scientific Committees of these Institutes have appointed Ombudsmans as regulated by GSP (14). Also, some of our scientific journals: Archive of Oncology (15) and Bulletin of Hematology (16) as well as Societies: Yugoslav Society of Immunology and Medical Academy of Serbian Medical Association made activities (17) related to development affirmation and approval of principles of GSP.
LITERATURE
1. Banda E. Foreword. European Science Foundation Policy Briefing, 2000: Good scientific practice in research and scholarship, Foreword. Available at: http://www.esf.org
2. An extensive summary in: Panel on Scientific Responsibility and the Conduct of Research. Committee on Science, Engineering and Public Policy. National Academy of Sciences. National Academy of Engineering. Institute of Medicine: Responsible Science. Ensuring the Integrity of the Research Process, (Vol. 2.), Washington D.C.: National Academy Press, 1992-93.
3. Medical Research Council: Principles in the Assessment and Conduct of Medical Research and Publicising Results. London: MRC 1995
4. Danish Committee on Scientific Dishonesty: Guidelines for Data Documentation, in: DCSD Annual Report 1994, Kobenhavn: The Danish Research Councils 1995
5. Koenig R. Panel Calls Falsification in German Case 'Unprecedented', Science1997; 277: 894
6. Deutsche Forschungsgemeinschaft. Recommendations of the Commission on professional self Regulation in Science: Proposal for safeguarding Good Scientific Practice. Available at http://www.dfg.de
7. World Medical Association Declaration of Helsinki: Adopted by 18th World Medical Assembly, Helsinki 1964 as amended by the 52nd World Medical Assembly, Edinburg, Scotland, October 2000.
8. Bok D. Beyond the Ivory Tower. Social Responsibilities of the Modern University, Cambridge, Mass.: Harvard University Press 1982 9. European Science Foundation Policy Briefing, 2000: Good scientific practice in research and scholarship, Foreword. Available at: http://www.esf.org
10. Vučković-Dekić Lj. VII. Vrednovanje naučnika u: Etika naučnoistraživačkog rada u biomedicini (eds: Vučković-Dekić Lj, Milenković P, Šobić V), Akademija medicinskih nauka - SLD, Medicinski fakultet, Beograd, 2002
11. Vučković-Dekić Lj. Safeguarding Good Scientific Practice. The experience of Yugoslavia and other European countries. Arch Oncol 2001;2 (Suppl) 30-31
12. Institute for Oncology and Radiology of Serbia. Good Scientific Practice -Ethical codex of science. January 26, 2001
13. Institute for Medical Research Good Scientific Practice - Ethical codex of science. February, 2001
14. Stojanović N. Good Scientific Practice - Ombudsman. Arch Oncol 2001;2 (Suppl) 38
15. Vučković-Dekić Lj. Archive of Oncology makes it clear that it is strictly committed to Good Scientific Practice (Editorial) Arch Oncol 2001;9:1
16. Vučković-Dekić Lj. Good Scientific Practice - Duty of all scientists (Editorial) Bilt Hematol 2001; 29:1
17. Etika naučnoistraživačkog rada u biomedicini (eds: Vučković-Dekić Lj, Milenković P, Šobić V), Akademija medicinskih nauka - SLD, Medicinski fakultet, Beograd, 2002