Bioethics at research in the human being
Gonzalo Herranz
department of Bioethics, University of Navarra
congress Mexican Bioethics
National Academy of Medicine and high school of Humanism in Health Sciences
Universidad Anáhuac, Mexico, 26 March 1993
Congress Unit of the National Medical Centre
Obtaining informed consent and the establishment of ethics committees for the research
2. The ethics of righteousness
The ethos of the academic publication
Acknowledgements
The ethics of human experimentation is a very broad and diverse field. To deal with it in reasonable detail would take many hours. Given the time available available, I will limit myself, in the first part of my speech, to briefly outline a few general points, and then go on to consider in some detail two subjects that seem to me to be particularly in need of comment: the informed consent of the experimental subject, and the ethics of publishing the work of research. I do so on the assumption that the status of the ethics of research in Mexico does not differ substantially from that in Spain.
- The ethics of research in humans has, to begin with, a fascinating history. In it, the moral rectitude and altruism of researchers have written splendid pages. But it is also a story, very human, perhaps too human, of occasional weaknesses and miseries, of doctors who have succumbed to the temptation to objectify man, to turn him into an animal at laboratory. It is, above all, the history of a growing concern for respect for the dignity of man as a subject of experimentation. Throughout this history, the academic community has demonstrated a splendid capacity for amendment and rectification.
- The Ethics of research has an immense and extremely varied panorama of problems to study: our ignorance in Medicine is still massive. Ignoring the solution to a problem, the so-called null hypothesis, is the essential ethical requirement for any clinical essay . And if it is unethical, on the one hand, to make research merely repetitive, there is a certain moral obligation to investigate those problems that remain to be clarified and that are not trivial. We are certainly free to choose our field of work, but we should do so, if possible, in priority areas, from which the most benefit for mankind can be derived. I believe that, in planning the research, we should not overlook the truly essential question that John Paul II speaks of in point 15 of Redemptor hominis: whether man, as man, in the context of the scientific progress we are contemplating, is really becoming better, more spiritually mature, more aware of the dignity of his humanity, more manager and more open to others.
- There is, therefore, an ethical obligation to push the frontiers of science. There is a duty to investigate. Active, for the researcher, which has to try to dispel ignorance. Passive, for the subject, who, out of solidarity and love for science, has to collaborate in this gain of knowledge. The research often results in immediate and direct services to man, in the form of technologies that make existence more pleasant and dignified. But knowledge does not need to be useful to be good. Pure science is also a good worthy of great appreciation, it is a universal good. In any case, human experimentation thus appears to us as an exercise in solidarity. Every subject of experimentation should be informed of this "great" aspect of research.
- Ethics imposes unquestionable methodological requirements on the research on man. The researcher makes use of an infinite number of procedures: some of them barely touch the humanity of the patients; others require invasive techniques that subject the human body and soul to risks that are not always easy to calculate. For this reason, the skill of researcher, as the designer and material realiser of its experimental project , is another of its ethical requirements : by its very nature, shoddy experimentation, badly designed, carried out without skill technique or rigorous control of details, that which neglects the scrupulous and punctual annotation of the findings, that which is presented in a deficient manner, is unethical by its very nature.
To be scientific, the knowledge gained through experimentation must be generalisable. It is therefore a fundamental ethical requirement to pay serious attention to the very close relationship between statistics and ethics. This is where the quality of biomedical experiments often hangs in the balance. The preparatory work of estimating the size of the sample is essential: the experimenter can never forget that he is working with human beings when calculating the issue of patients or healthy volunteers to be included in the essay he is planning, in order to ensure that its conclusions are statistically significant and have probative force. Research carried out on an insufficient issue of experimental subjects is unethical, as its conclusions lack evidential value. And the behaviour of the experimenter who uses an excessive issue of subjects is equally incorrect. His conclusions do not become more valid, but his miscalculation not only subjects part of his own experimental subjects to unnecessary risks, but, by delaying the publication of his results, he deprives others of the potential benefit of his research. It also wastes money needlessly.
- Above all, ethics imposes on the experimenter a strong commitment to respect man, his life and his physical and moral integrity. He cannot, therefore, plan or carry out his experimentation lightly. The ethics of respect obliges the experimenter to make a reasonable estimate of the risks and benefits of research, to calculate and describe them, to weigh them up, to optimise the benefit/risk ratio as far as possible, and to take the necessary precautions and preventive or rescue measures to prevent accidents or unforeseeable events from causing serious harm to the experimental subjects, or, in the event of such harm occurring, to compensate for it.
- There is, in medicine, a rule of great moral value which is the principle of non-discrimination: the physician must treat all his patients equally. There is, however, one exception to this injunction: that of showing respect that is proportionate in its intensity to the weakness or defencelessness of the patient. The good clinical experimenter has the clear notion that the subjects he studies are not equal, that there are important differences between them. Sometimes he or she does research on patients who could benefit directly from the procedure, diagnostic, therapeutic or preventive, tested: the research is somehow integrated into the patient's medical care. There is a strong risk of abuse here, when the doctor researcher acts on patients who trust him submissively. At other times, he does so on subjects, healthy or sick, who will derive no benefit from the experimentation, apart from the moral satisfaction of contributing to the good of humanity.
Sometimes experimentation is carried out on adults who are in full possession of their capacity to judge and decide about the experimentation and their participation in it; sometimes on subjects who, for various reasons, lack either the capacity to judge or the capacity to decide freely. These subjects should not be marginalised from the potential benefits of experimentation. However, the participation in experimentation of subjects who belong to the so-called vulnerable groups must be surrounded by certain special precautions to prevent any possible abuse. This circumstance has prompted the development of one of the most interesting chapters of the Ethics of Human Experimentation, which deals with the specific problems of research on incompetent or vulnerable subjects: minors, the mentally ill, certain elderly people, prisoners, pregnant women, embryos and human foetuses, or people who in some way have a relationship of dependence with the experimenter.
- For the protection of human subjects, the ethics of experimentation has a rich body of doctrine on obtaining informed consent. This fundamental requirement has a solid legal basis. But it is, above all, an ethical gesture. If it ceased to be so and became a mere formalism, a routine management assistant, human experimentation would be degraded to become a veterinary essay . On this capital point, I will deal in some detail in a few moments.
- The ethics of experimentation must be present as an illuminating light, from the very beginning, in the genesis and development of trials on human beings. It must be present in the thinking and action of the manager of the experiment, but also through specific bodies which, depending on the place, time and circumstances, are called Institutional Ethics Committees for Biomedical research , Clinical Trials Committees, Institutional Review Committees, of varying composition and attributions: always with a consultative function, but also, sometimes, with very broad discretionary powers. A large part of the doctrinal and practical enrichment of the ethics of human experimentation is due to the reflection and work of these committees, which are responsible for a serious examination of the nature, objectives and methods of the research projects submitted for their opinion, approval and supervision. These Committees have to discern whether a research is original and seeks to broaden our knowledge, or whether it is repetitive and motivated, in the author, by prevalently personal or commercial interests. They must act even-handedly in their dual advocacy on behalf of science and the patient by scrutinising thoroughly whether the risks and drawbacks of essay reasonably outweigh the calculated benefits. Moreover, they must seek to reduce the risks by offering, if available, alternative modes of research, by modifying the composition of the groups, or by proposing more favourable conditions of inclusion/exclusion of experimental subjects. Above all, the Committees must be guardians of human dignity and prevent any abuse, moral, psychological or physical, of the patients or subjects studied.
- An important aspect of the ethics of research has to do with safeguarding the privacy of patients. Firstly, by taking care of professional secrecy: medical records cannot, for example, be used for epidemiological research, but methods must be applied that make it impossible to identify each individual patient, for which coding or encryption procedures should be used. Secondly, respecting each patient in his or her specific individuality: he or she cannot be treated as if he or she were an element without identity staff, a issue of a group. There is an ever-present risk, in the application of experimental treatment, of losing sight of the identity staff of the experimental subject. It should always be borne in mind that blinding methods, whether single or double, seek the maximum objectification of the results, not the annulment of the patient as a being staff. In essay, everyone must be called by his or her own name. A procedure researcher can never deprive a patient of the human attention or of valid therapeutics.
Veatch has developed a theory of clinical research in the first part of his work The Patient as Partner, in which he develops the idea that the subject of research is an equal, a peer, who amicably accepts the doctor's invitation to participate in the common business of extending the field of our knowledge.
- It is understood, from this perspective, that the relationship researcher/experiment subject has to have the gentleness and dignity of the relationship between a host and his guest, not that of a master and a servant. This idea of the patient as a volunteer who agrees to cooperate provides an excellent basis for respecting his freedom: an indication from him that the experiment should not be continued is tantamount to an order, since it is assumed that only for serious reasons does the guest wish to terminate the relationship. The guest who freely accepts the invitation has a moral obligation not to behave capriciously, since, at the moment he is invited to participate in the experiment, the researcher will have communicated to him the importance and moral value of the research in which he is going to collaborate. Neither can the researcher turn the guest into a captive, nor can the guest behave capriciously.
- The ethics of experimentation has some problems still to be studied and clarified: the ethical legitimacy of the random distribution of subjects between experimental and control groups and the choice of the best models to carry it out; the ethical justification of establishing control groups without treatment or with placebo treatment; the use of lies or the total or partial concealment of the truth as part of the experimental procedure ; the ethical principles of the policy of research; the existence of areas forbidden to scientific research, and many more.
- Finally, there is an extensive chapter on the ethics of publishing experimental work. Publication is the final phase of the research task: without publication, there is no proper publication research. internship As this is something that concerns us all, I will refer to it at greater length in the final part of my lecture.
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After this brief enumeration of some of the salient points of the ethics of human experimentation, I shall comment in some detail, in the time remaining, on two issues which, as I said, seem to me to be of more immediate interest: the obtaining of informed consent, on the one hand, and the ethics of publication, on the other.
Obtaining informed consent and the establishment of ethics committees for the research
In the history of human experimentation, as I have already said, great advances have been made in reaction to great mistakes or failures. Ethics, in a rudimentary but effective form, was already present at the beginning of scientific experimentation on man. Claude Bernard, at the very beginning of experimental medicine, already spoke with precision of his ethical requirements . We do not know much about what happened in the long period before the Second World War. Its history is yet to be made. There were not many opportunities for testing then, nor had the technique of experimental research on man been formalised. Nor had the sensitivity of doctors and the public to topic been awakened. Some of the episodes that we know of do not leave the pioneers of experimental surgery and medicine in a very good light. It was undoubtedly a time marked by harsh paternalism or indifference.
The beginning of The Ethics of Experimentation is well marked: it is a long excerpt from the judgement of the Nuremberg Trial against Nazi war criminals, including SS doctors, who were accused and convicted of having carried out atrocious experiments on concentration camp prisoners. Today we call this part of the judgement the Nuremberg Code. The Code states once and for all that science, not even good science, is not enough to guarantee the moral rectitude of the research. Natural science alone is incapable of resolving the ethical question. All experimentation must be subject to the universal rule of respect for man.
It is in the interest of all of us to look more deeply into this idea, as we often forget it. To do so, it is a good idea to reconsider the strong text of the Code. I will read some of its passages:
"The voluntary consent of human subjects is absolutely essential. This means that the person concerned must have the legal capacity to consent; must be at status such that he or she can exercise full freedom of choice, unimpeded by force, fraud, deceit, intimidation, promise, or any other form of coercion or threat; and must have sufficient information and knowledge of the elements of the experiment so that he or she can understand what he or she is deciding. This last element requires that, before accepting an affirmative response from an experimental subject, the researcher must have made known to the subject the nature, duration and purpose of the experiment; the methods and means by which it will be conducted; the inconveniences and risks that can reasonably be expected; and the effects on his or her health or personality that might result from participation in the experiment.
The duty and responsibility to assess the quality of consent rests with each and every individual who initiates, conducts, or collaborates in the experiment. It is an obligation staff that cannot be delegated to another with impunity".
These are demanding words. The experimenter has to take the subjects he or she is going to study seriously, and also, and very significantly, must take himself or herself seriously. No participant in experiments - be it the sponsor, the director or a simple assistant - can claim that the ethics of the experiment is not his or her own business: everyone bears equal responsibility for it. Nuremberg established for all time that it is neither legally nor ethically valid to relieve one's own conscience of guilt by claiming that one acted in compliance with orders from superiors. In the ethics of human experimentation, every experimenter, regardless of his or her place on the organisational ladder, is fully manager of the subjects he or she treats; he or she is the protector of their human dignity.
It has been said that this fundamental rule of the Nuremberg Code is almost impossible to comply with in many experimental situations that are considered ethically acceptable, and that it would therefore have to be modified. I think not: when it comes to enumerating principles, it is better to overdo it than to underdo it. Routine wears away the sharp edges of norms. Firm formulas are needed to put things back on track. The basic doctrine of Nuremberg is valid and must remain formulated in its original intensity.
In fact, the Nuremberg Code was insufficient to eradicate abusive experimentation. Twenty years after its promulgation in the late 1960s, some allegations of wild experimentation were made public, showing that the spirit of Nuremberg had been forgotten. The 1966 Beecher Ethics and Clinical Research article and Pappworth's book, Human guinea pigs: Experimentation in man, which appeared the following year, provoked a strong reaction in scientific opinion. The World Medical Association ( association ), which had promulgated the mild Declaration of Helsinki in 1964 to guide physicians in research on human subjects, reinvigorated it eleven years later in Tokyo by including in it the requirement for the involvement of an independent committee to evaluate and approve research projects: Basic Principle 2: The project and mode of conduct of any experimental procedure on human subjects should be clearly stated in the protocol of the experiment, which should be given to an independent and specifically appointed committee to review, comment on and provide guidance on the experiment.
The essential thing in human experimentation, the Helsinki declaration tells us, is to comply with the ethical requirements , regardless of the legal-administrative procedures required in each country. But are these requirements actually complied with? Is the borderline of free and informed consent, which is a moral line we should never cross, sincerely respected? Do the Committees actually act? Is their presence real and active, are their opinions authoritative, are they rationally based? Judging by what is published (I can affirm this with respect to Spain), neither the respect for the person of the experimental subject nor the regulatory function of the Ethics Committees of research seems to be very valid. In order to give some realism to my assertions, I have made an elementary tasting of the Mexican bibliography . I reviewed the clinical research papers published in the Revista Médica del high school Mexicano de la Seguridad Social, the first one offered to me by the librarian. I reviewed volume 29, from 1991. The status here does not seem very different from Spain: in the research articles published, there is hardly any mention of the intervention of the Ethics committee of research in the approval and control of the experimental protocol (one article out of 16). The criteria for inclusion and exclusion of experimental subjects and many other methodological details are sometimes described in detail, which is commendable. But obtaining informed consent is rarely (3 out of 16) mentioned, and never in detail, as if this element of the experimental procedure were of no interest or intrinsically incapable of innovation or adaptation to specific situations. I do not question (I want to make it clear: I am not accusing anyone) that administrative rules are complied with and that patients and healthy volunteers sign the form consent form presented to them. My doubts concern whether the delicate and humane process of obtaining free and informed consent has all the ethical intensity it requires; whether the effort to make the information offered intelligible is persistent. This is essential to respect the dignity of the participants in the experiment. And human dignity is the same for a degree scroll university student and an illiterate peasant.
Judging by what has been published, the Committees seem to be reduced to decorative instances of routine approval. There is reason to believe that ethical safety mechanisms routinely work or do not work at all. Experiments are diluted in ordinary medical care, disguised as ordinary treatment.
This is what the silence of the publications seems to proclaim. It is unreasonable to think that authors forget the ethics of experimentation only and casually at the time of publication. The good researcher does not omit, when describing the methods or reporting his observations, any part of his work which, besides being an essential part of the process researcher, has required considerable time and effort. The manner in which consent was obtained cannot be regarded as unimportant. The failure to mention it in the published articles is probably due to the fact that it has not been given due attention or has been omitted. And the seriousness of the case is that it is not only at the stage of the realisation of work: it is also at the stage of its assessment publishing house . I assume that all members of the committee publishing house of a biomedical journal, and all experts capable of evaluating research papers, and many of the readers of these journals, know the rule of the committee International Association of Medical Journal Editors (the so-called group of Vancouver) included in the requirements of uniformity for originals submitted to biomedical journals, which states:"When publishing on experiments on human subjects, it must be stated whether the protocols applied have followed the ethical standards of the committee of research Clinical of the institution where they were made or the guidelines of the Declaration of Helsinki". Without this requirement, no work should be accepted for publication. The Revista Médica del high school Mexicano de la Seguridad Social repeats almost verbatim the same rule, and, as if that were not enough, reminds us that it is also a legal obligation. One of its Instructions to Authors states:"When reporting the results of experiments on humans, indicate whether the procedures were in accordance with the standards of the committee on Human Experimentation of the Institution in which they were performed, the Helsinki Declaration of 1975, or the agreement of the administrative office de Salubridad y attendance published in the Diario Oficial of Tuesday 26 January 1982, pages 16 and 17".
In the future, more attention should be paid to procedure to obtain informed consent and to its accredited specialization, and eventual description, in published works. What matters, in the end, is not so much to comply with legal or procedure publishing house standards, but to practice the ethical principle of respect for persons. We still have a long way to go before all researchers are imbued with the idea that, in the research on man, respect for persons is the prevailing value, since, as the Helsinki Declaration reiterates, the interests of science and society must never take precedence over the interests of the individual. It does not seem that the interests of the researcher, or his lack of time, or his determination to lengthen the list of his publications, or his conviction that the value of the essay he performs can trample on the human rights of the patient, can take precedence over the interests of the individual.
Hopefully, through a happily synergistic effect of ethics and law, many biomedical researchers will overcome the mentality, psychologically fixed in adolescence, that only hard science matters, and open themselves to the ethical, and not just the administrative, imperatives of research, namely that researcher and subject are moral persons who, persuaded of the value of science, respond freely (and almost always affirmatively) to fulfil the general duty to do research and to volunteer to be the subject of research. In my opinion, it is part of the work and vocation of the researcher to be an educator, and not only an experimenter. The research should have a humanising effect on doctor-patient relations and on the general atmosphere of the hospital through the internship of respect for people. The slightest trace of human cowardice must be removed from our care institutions.
Let us turn now to our final point: the ethics of publication. Biomedical publishing is an intrinsically ethical activity. There is no stage of development - from the initial decision to publish and the listing of co-authors, to the completion of the process publishing house and proofreading - where certain, and sometimes complex, ethical questions need to be answered.
This is logical, as biomedical publishing has always fulfilled two highly responsible functions. On the one hand, each published work is an element that is added to the body of medical science and is disseminated among professionals: it therefore ends up influencing, to a greater or lesser extent, opinion and professional conduct. On the other hand, the published article is the result of the author's effort staff and sample of his scientific or professional quality, which contributes to his prestige and to determining his place on the professional or academic ladder.
The ethics of publishing has never been of greater concern than it is today. In recent years, a few high-profile cases of scientific fraud have pricked the conscience of the research community and taught us a lot about the bad arts of biomedical publishing, about the specific criminality of perverse authors.
I am going to refer mainly to the ethics of the author, leaving aside the ethics of the process publishing house.
There are three levels at which the moral quality of the author is put to test : First, a lower level, where small but significant things are taken care of or neglected; this is what can be called the deontology of style. Then there is the middle level of the ethics of rectitude, which leads the author to ask himself about the motives that lead him to publish, whether his article really has something valuable and worthy of being statement. Finally, the upper layer of the ethics of truthfulness, which prohibits different forms of scientific fraud.
Deontology is the doctrine of reasonable standards. The first thing to do when preparing to write a article is to consult the author guidelines of the journal in which you plan to publish. In this context, biomedical journals are obliged to promulgate publication standards that are informed by rationality and respectful of authors. These standards are detailed, they regulate many details: And yet they are gladly accepted, because, at bottom, they are the result of a very mature and considered deliberation on how to do things well and with the utmost simplicity. It is the author's ethical duty to know in detail the details because they are, at bottom, as many manifestations of ethical respect for people: for those who make up the committee publishing house and the readers.
It is often required, for example, that the manuscript be typed, double-spaced, on DIN A4 sheets, numbered consecutively in the top right-hand corner. This may seem a pure formality, but the author cannot ignore the fact that a manuscript presented on good paper, in a clean and neat subject font, is not simply more elegant (which is, in a way, an ethical manifestation of respect): a neat manuscript is, above all, easier to read and, therefore, easier to understand and to criticise. Double spacing and wide margins are a necessity for those who evaluate or review work to make corrections and recommendations; making it easier for evaluators is a morally good thing. No one can comfortably study a manuscript if he or she does not loose his or her pages: if the author forgets to number them, he or she will force the reviewer or the printer, in case they are out of order, to a laborious task of reconstruction. Failure to comply with such simple and easy to comply with rules is sufficient reason for refund to send the manuscript to the author to remedy the omissions. All these obligations to take care of form are, in essence, duties to protect substance. There is nothing ethically indifferent on the Information for Authors page.
But the ethics of style has to do, above all, with the way in which the message of article is conveyed. The author who is sensitive to the ethics of style ensures that the features of scientific essay are present in his writing: clarity, conciseness, order, precision, substantiation, reasonableness, and a logical succession of sentences, paragraphs and sections. The good author feels obliged to offer his readers a text that is comprehensible on the first reading, because he has eliminated from it, throughout the essential process of revising it repeatedly, obscure sentences, excess words, ambiguous expressions, exaggerated grade , empty sentences, structural monotony, and argumentative weakness.
The author gradually discovers that the effort to conform to the Instructions financial aid makes him more orderly, more critical of himself, to give greater precision to his concepts, the right force to his expression, the due rigour to his thought. He will discard some ideas because he discovers that they were simply unprovable intuitions that do not stand up. He will modify tables or graphs to make them more demonstrative and realistic, free of bias in favour of his own desires. The Results section of article "reports, not interprets, the observations made".
2. The ethics of righteousness
The impulse to do research ideally comes from the desire to search for truth, to verify or falsify an original hypothesis, to contribute to the elevation of human existence, or simply to contribute one more grain of sand to the body of science. In everyday reality, researcher is often driven by impulses which, although acceptable, are of a lower ethical category: to fulfil the contractual obligation to do research, to maintain one's academic rank, to move up in the professional degree program , to obtain economic benefits. When the need to publish is exacerbated by the sometimes terribly disturbing pressure of the fierce struggle to rise through the ranks, a risky status occurs.
When the motives for publishing are self-serving, researcher runs the risk of publishing research fictitious or routine, without ambition or originality. When one publishes to extend one's publication list, it is easy to fall into certain ethical errors: article without interest and without results, falsified authorship, plagiarism and repeated publication.
Articles without originality, without interest, without results are a plague of the biomedical bibliography . issue The number of biomedical journals published in the world continues to grow, especially those that support the medical-pharmaceutical advertising , which offer authors thousands and thousands of pages in which to write. It is possible today to publish articles that nobody is interested in and nobody reads, so that authors can dispense with any effort to give them quality and content. And, what is more serious, nobody reads them either when they are presented as test merits in merit competitions, since, unfortunately, the judges who judge them tend to follow the lazy and simplistic criterion of equating greater merit with greater issue publications. This is why so much is published so routinely. More modern ways of assessing merit, such as, for example, the impact index of published articles, are also not absolutely reliable.
We do not know the extent of the phenomenon of fictitious authorship. We do know that it takes three main forms. Fragmented publication, which increases the issue of published works by using the trick of giving the press a article in the form of minimum publishable units. Repeated publication, in which the same observations are republished, with or without the addition of new data or new and convoluted interpretations. Authorship inflation, which consists of giving place as co-author to someone who has not contributed substantially to the creation of article. This conduct responds to a mercantile notion of what it is to be an author: the condition of author is bought, sold and exchanged. In the lightness with which merits are evaluated, many have come to the conclusion that merit is extensible and does not diminish when the issue of those who sign a article grows: making someone a co-author can be a way of compensating services or damages, or of relieving tensions between the components of a group or, above all, a procedure of creating merits: it is enough to constitute groups whose members are linked to each other by the commitment to sign each of them on the works produced by all of them.
Plagiarism is extremely difficult to detect, unless a massive amount of copied material is contained in a article. Small-scale plagiarism is undetectable, unless computerised text comparison systems are available. It is impossible to be original all the time. In our ordinary life there is more or less deliberate mimicry: we all speak the same language, profess common notions, borrow ideas and take them on loan. But, in the scientific article , when we are referring to the ideas of another, we have to recognise that, by means of the quotation in quotation marks or the bibliographic reference letter , those words or those ideas belong to the other, not to us. In all scientific writing, it is inevitable that there is a certain Degree of textual copying: of successful expressions, of thematic architecture. But what is inadmissible is to copy entire periods, or to imitate paragraph by paragraph the architecture of a article; in a word, to plagiarise.
To curb this subject of abuses, publishers, especially the committee International Association of Medical Journal Editors, have been developing rules to try to prevent or at least hinder them. They have established criteria for accepting co-authorship, for dignifying the acknowledgements section, for assessing the originality or repetitiveness of each article in a series on a common theme. The International committee has done much to define the ethics, and not just the style, of biomedical publications. Its requirements on Uniformity is a must-read.
The publication ethic imposes a duty on researcher to communicate truthfully about data and to carefully avoid concealment or misrepresentation. The vast majority of researchers faithfully fulfil this commitment to truthfulness and thus contribute to the clean and trusting environment in which scientific communication takes place. Truthfulness is a non-negotiable value in science. However strong the rivalries between individuals or groups may be, and however tense the struggle between one and the other to go first and furthest, the scientific research is a chivalrous sport, in which creativity, hard work and criticism compete, but from which the foul play of fraud or falsification is radically excluded. It has been said that cheating in science is like trying to build a building using dynamite: it doesn't work result.
And yet, in the last 20 years, the academic community has been struck by an epidemic of publication fraud. The names of Summerlin, Long, Alsabti, Soman, Strauss, Darsee, Slutsky and Berger, are among the list of the falsifying researchers who have been accused of being "traitors to the truth" or "prophets of lies". In science, cheating may bring fleeting notoriety, but the mystification cannot last: traitors, when discovered, are banished from academic community. Their articles, retracted by themselves or denounced as false by their colleagues, form an accursed bibliography , which cannot be cited.
Faults against the accuracy of publication form a wide and varied spectrum. Its venial forms, careless or negligent errors, are not easy to distinguish from inadvertent and unintentional errors. In writing, mistakes can be made when copying data, or ambiguities can be made when expressing judgements. It is not easy to tell, on laboratory or in the clinic, where familiarity with the problem under investigation reaches and where carelessness or negligence begins. There are many gradations between erroneous judgement, conditioned by an inexperienced or benignly biased view of the problem, and serious and deliberate distortion of scientific judgement leading to falsification or fabrication data.
The essay of the scientific article contains in its own structure ethical points of least resistance. Because, at some point in his work, the researcher has to transform his raw data - he cannot publish them all - into abbreviated expressions. He has to summarise them in tables, translate them into the abstract language of statistics, or represent them graphically. Any article of research entails a certain measure of refinement of the data observed. An ambitious and unscrupulous researcher may be tempted to suppress, change or invent data to make his conclusions possible, or simply more elegant or more convincing. There are flaws in the design experiment that can be found if one looks for them (inadequate controls, subgroups with too small a issue of cases, inappropriate statistical methods, poorly chosen scales to measure differences between groups), but only indirectly can one suspect that the author has manipulated the data or presents them in a selective way.
The ethos of the academic publication
The environment in which biomedical science is cultivated and published needs to be ethically invigorated: a clean environment, where more emphasis is placed on honesty and objectivity than on obtaining brilliant results. In academic and professional promotion, the issue of published work needs to weigh less, and its quality more.
The good researcher should only feel pressured by the accuracy and precision of his findings. He wants and welcomes criticism from his colleagues before publishing them. His commitment is to study the phenomena, not to obtain ego-gratifying results. Facts are sacred; the notebook of laboratory, a holy book, whose pages, numbered like those of a notarial deed, may be stained with reagents, but they can never be fudged. Negative results, if they are true results, are as good science and as worthy of publication as those of the opposite sign, for they are a piece of truth. Making a contribution to science is not about proving that one is superior or luckier than others.
Even with the utmost care, it is impossible not to occasionally make a mistake when observing, annotating, transcribing or refining data. Fortunately, unintentional errors are rare and minor. Nor are errors of interpretation of much importance. A scientist," said Medawar, "who is reasonably inventive and imaginative will almost certainly make errors in matters of interpretation.... If his mistakes are confined merely to that field, he will never do much harm, nor need he lose much sleep. That is a matter of ordinary administration in science. The thing is of little consequence, for where one imagines wrongly, another will imagine rightly. But if the error is about a fact - if the scientist says that litmus paper has turned blue when, in fact, it had turned red - then he has good reason to lose sleep (...) Because such an error subject makes it very difficult, even impossible, for others to interpret the fallacious scientist's findings correctly: that is, they will not be able to devise a reasonable hypothesis to accommodate them."
When an error has crept into the published results that the author discovers later, the fix is easy: report it to the journal as soon as possible. The academic community is grateful. Moreover, public confession of the error not only forgives the sin, but brings the wrongdoer back into a state of grace, earns him prestige, and his honesty is praised. The research, Relman has written, "is fraught with error. In the ordinary course of things, the most important errors are discovered in later work. In a sense, a good deal of progress in biomedical research consists of discovering and rectifying errors, as new theories and better methods allow researchers to reanalyse previous findings. There is nothing reprehensible in good faith error, if it is accompanied by a willingness to look for it and to confess it".
This is the genuine ethos of science, which is lived by the vast majority of those who cultivate it. The few who resort to various forms of unethical publication not only degrade themselves, but also tarnish science and endanger it. The academic community cannot disappoint the public trust, which is a condition for the achievements of the research to be accepted without reticence, and for the business scientific to continue to receive from society the financial aid necessary for its further development and expansion. The sponsors of research and editors of scientific publications continue to bear the all-important responsibility for keeping the ethos of science pure.
The epidemic of fraudulent scientific publications has so far had a salutary effect. It has been said that the service to science that the falsifiers have done with their errors is greater than what they would have done if they had devoted their whole lives to honest research , for they have made everyone more sensitive to the ethical demands of publishing. Every cloud has a silver lining.