Ethics in publishing scientific research

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A SPECIAL SUPPLEMENT

CHRONICLE PHARMABIZ November 24, 2011

Ethics in publishing scientific research Bhupinder Singh and Rishi Kapil

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scientific research papers is the only way to keep science alive. A research paper, in this context, is verily an organized description of hypotheses, data and conclusions, intended to inform and instruct the reader. It has often been said that, “If one’s research does not generate papers, it might just as well not have been done”. The headway of a researcher, accordingly, is determined by the quantum and quality of publications he scribbles. Science is becoming increasingly advanced and its publication a lot trickier. Gone are those days when simple but planned laboratory studies uncovering a newer trait of a drug or of a drug formulation could be considered for publication in a renowned journal. Publication, in today’s ambiance of pharmaceutical UBLISHING

research, has become much more demanding and intricate than ever before. Research lately has also become highly equipment-intensive, involving voluminous data from sophisticated instrumentation like SEM, TEM, FTIR, MS, LCMS, NMR, XRD, DSC, etc. Projects are increasingly becoming more collaborative. Outcome of research is now considered far more vital than the genuine effort to obtain the same. Institutions are getting more aggressive in turning intellectual property into products. Who can publish “what and when”, is no longer a scholarly issue. “Publish, patent or perish” is the current buzz word. Commercialization of research findings tends to be the major issue when research funding from commercial entities, which generally control whether and how results are published, outweighs that from the gubernatorial agencies. The hallmarks of scientific research and publishing, i.e.,

moral ethics and integrity, are assigned high priority while publishing research findings. Research papers are more likely to be accepted, if the reviewers can trust the quality and genuineness of research. Kudos to those who tend to maintain their commitment and compliance to ethics while attempting intellectual objectives. Nevertheless, “to err is human”. There are countless “green” pastures and innumerable “soft” tools available to allure a scientist to “err”. Hence, he fumbles and at times, stumbles during the arduous, monotonous and wearisome journey to the destination. A “perilous” mind’s flight tends to invent and discover innumerable short cuts, deep-cuts and under-cuts to reach the target fast, howsoever. Elsevier (2008) claimed that more than 2,00,000 articles in Medline database are confirmed duplicates. Standards of ethical publications have been reported to be frequently violated by scientists from the

developing nations like China, Russia, Nigeria and India. With quantum and quality of publications being treated as the sole “yard stick” of research performance, every scientist is constrained to publish his work in high impact journals. A hurried pursuit to get tangible outcome from every research work that is published gives rise to such research malpractices every now and then. Researchers sometimes totally exaggerate their research findings to publish it in a periodical of high repute. Figure 1 provides a bird’s eye view of such conceivable malpractices which a research scientist may succumb to. Out of the listed academic manipulations, subtler

forms of unethical behaviour like plagiarism, self-plagiarism and falsification are being observed quite often in practice. Though most of these actions would violate different professional ethics codes or institutional policies too, yet these cannot per se be classified as “research misconduct”. Scientific (professorial) misconduct is the severest form of unethical practice as it is regarded as the violation of the standard codes of scholarly conduct and ethical behaviour in professional scientific research. In some cases, scientific misconduct may also constitute violations of the prevailing law, thus calling for penalties, but not always. Misconduct may also occur due to various institutional and environmental reasons like incenCONTINUED ON p 47X


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Researchers not serious about ethical norms

p 46X tives, constraints and pressures to publish or obtain grants, and career ambitions, in pursuit of profit, name or fame. Gross scientific misconduct is, however, reported to be quite rare in research practice. In any case, a course in research ethics here is likely to help people better identify with these stresses, sensitize people to ethical concerns, and improve ethical judgement and decision making. This helps to prevent deviations from norms even if it does not prevent misconduct. Hitherto, there has hardly been any evidence that science today has become ethically corrupt. Still, even infrequent misconduct can tantamount to severe blow on faith in science. If one considers an analogy of research manipulations with crime, it does not take many burglaries, assaults, rapes or even murders in a town to erode the community’s trust, and increase its phobia and paranoia. Many of the deviations that occur in research may occur because researchers simple do not know or have never thought seriously about some of the ethical norms of research. For instance, some unethical authorship practices probably reflect years of tradition in the research community that has not been questioned seriously until recently. If a drug company uses paid ghost-writerss to write papers “authored” by its pharma-employees, what is wrong about this practice of usingCONTINUED FROM

ghost-writerss in research? If the Director of a Research Centre is named as an author on every paper that comes from his Centre, even if he does not make any significant contribution, what could be unethical with that? That’s just the way it

is done, one might argue. The research community, by and large, concurs that high “ethical standards” are the worthy goals to uphold “research standards”. Even though universities, professional societies, and journal publishers have

publication policies and ethical guidelines outlining the standards that the researchers should comply with, no one is adequately prepared to deal with any potential dispute(s). Only few of the junior members of the scientific community

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who do most of the work, i.e., research scholars and postdocs, receive any explicit training on publication practices. Instead, they are expected to follow an old adage, “ethics are caught, not taught”. CONTINUED ON p 48X


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Scientists now more inquisitive about data than before

p 47X Ethics, verily, are a method, procedure, or perspective to decide how to act and analyse complex problems and issues. Teaching or instilling values of research ethics ideally suits during the primitive “impressionable” years at the level of a school, college, department, or even, home and a religious place. Despite its need, dissemination of research ethics has so far been overlooked in sciences, in general, and pharmaceutical and medical sciences, in particular. Scientists today are getting more and more inquisitive about the genuineness of pubCONTINUED FROM

lished data. Phenomena like whistle-blowing (i.e., raising concern in the media or the public on malpractice) are on the rise. The violations of research publication ethics are not merely restricted to the developing world, where there is relative scarcity of resources. There are myriad instances of research malpractices, of different kinds and gravity in the developed world too. Notwithstanding the fact that the grave wrongdoings are uncommon, the measures to protect science are utterly obligatory. Quite often, the situations when authors “agree to disagree”,

need to be dealt with by some responsible agencies. To cope up with this global issue, the Committee on Publication Ethics (COPE) has been set-up in UK with an aim to provides a forum for editors of academic journals to discuss issues relating to the integrity of the work submitted to, or published in, their journals. Several major publishers (including Elsevier, Wiley–Blackwell, Springer, Informa, Palgrave Macmillan and Wolters Kluwer) have signed up their journals as COPE members. ACS’s “Ethical Guidelines to Publication of Chemical Research” and

“Uniform Requirements for Manuscripts Submitted to Biomedical Journals” published by the International Committee of Medical Journal Editors, are other good models by other professional societies to curb the potential menace. Many government agencies, such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have exclusive ethics rules for funded researchers. “Research ethics” is most developed as a concept in medical research. The key agreements of “Declaration of Helsinki” and “Nuremberg Code” are vital milestones in instilling the needs of moral practices. Codes of professional conduct like “Code of Pharmaceutical Ethics” and the “Hippocratic Oath” have also been considered as concrete steps towards inculcating the ethical being esp. among the juveniles. “Ethical norms” are verily so universal that one might be tempted to regard them as simple common sense. On the other hand, if morality were nothing more than common sense, then why are there so many ethical disputes and issues in our society? There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research, such as knowledge, truth, and avoidance of error. Second, since research often involves a great deal of co-operation and co-ordination among people of different disciplines and institutions, ethical standards promote the

values essential for collaborative work, such as trust, accountability, mutual respect, and fairness. Third, many of the ethical norms help to ensure that researchers can be held accountable to the public. Figure 2 depicts a brief interrelation between research ethics and the major issues related with it. As depicted in the figure, it is always the responsibility of the researcher to ensure that the proposal submitted by him follows the ethical regulations and is cleared by the Institutional Review Board and Institutional Animal Ethics Committee. The proposal must be free from any kind of debriefing or deception, and must be prepared after adequate risk assessment and informed consent of the volunteers. Figure 2: Inter-relation between research ethics and major issues related to it Several measures can be taken in an endeavour to diminish the tendency of manipulating scientific research. Taking three decades of experience and abounding literature on the topic beside me, I have endeavoured to compile these ostensible measures together categorically. To facilitate their retention in the gray matter, I propose sixteenpoint “HAIL ETHICAL NORMS”, as enlisted in Box 1. Box 1: Some basic tenets to “contain” research manipulations and to “maintain” research ethics HAIL ETHICAL NORMS Honesty, i.e., sincerity in all CONTINUED ON p 49X


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Knowing and obeying laws & policies essential

p 48X scientific communications Animal Care, i.e., proper respect and care for animals during their use in research Integrity, i.e., keeping one’s promises, commitments and agreements, and striving for consistency of thought and action Legality, i.e., knowing and obeying relevant laws and institutional and governmental policies Ensuring Human Subjects’ Protection, i.e., minimizing harms and risks and maximizing benefits. Treating Colleagues with Respect, i.e., treating them fairly. Having Openness, i.e., sharing data, results, ideas, tools, resources. Increasing Competence, i.e., maintaining and improving your own professional competence through lifelong education and learning Confidentiality, i.e., protecting confidential communications, such as papers or grants submitted for publication, p e r s o n n e l records Always Publishing Responsibly, i.e. publishing in order to advance research and scholarship, not to advance just your own career. Leadership, i.e., helping to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions. Non-Discrimination, i.e., avoiding prejudice against colCONTINUED FROM

leagues or students on the basis of sex, race, ethnicity or other factors unrelated to their scientific competence and integrity Objectivity, i.e. striving to avoid bias in experimental design, data analysis, data interpretation, peer review,

personnel decisions, grant writing, expert testimony, and other aspects of research, where objectivity is expected or required Respect for Intellectual Property, i.e., honouring patents, copyrights, and other

forms of intellectual property; using unpublished data, methods, or results with requisite permission of the authorized persons Maintain Transparency, i.e., informing a collaborator of one’s intent to file a patent to

ensure one as the sole inventor Social Responsibility, i.e. striving to promote social good and prevent or mitigate social harms through research, public education, and advocacy. CONTINUED ON

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Ethics to be practiced while protecting intellectual property p 49X Most scientists are quite ethical, most of the times. They habitually wonder as to what is the need to undergo training in research ethics, as they distinctly know the difference between right and wrong. And they never fabricate or falsify data or plagiarize. Also, they usually believe that most of their colleagues are highly ethical in research. Accordingly, it is too early to foretell whether training and education in research ethics can help to reduce the rate of scientific misconduct. For that, one must first try to understand the plausible causes of misconduct. Researchers, who are morally weak, economically desperate, ignorant, insensitive, or psychologically disturbed, can easily succumb to the short-cut and unconscientious practices. A course in research ethics, in such cases, is quite unlikely to have any tangible impact. A holistic change in the mindset towards scrupulousness, nonetheless, would cut the ice. Ethics also need to be publicized and practiced while protecting intellectual property. Patenting increases incentives for faculty and universities to keep their findings secret for longer than they otherwise would. Scientific discoveries published in journals, theses, dissertations, public meetings, etc. cannot be patented. Some authorities may, however, patent such discoveries, but the credibility, worth and applicability of such patents becomes questionable. To conclude,though competition is indeed tough and enticements galore,that does not CONTINUED FROM

mean that one should succumb to these allurements and compromise with the ethics of scientific research and scientific publishing. As a rule, it is deemed that manuscript peer review system and self-correcting mechanisms eventually catch those who try to hoodwink the system. However, this science’s peer review system today is quite far from being perfect, as it is quite vulnerable to bamboozle. Fraudulent research,

accordingly, often enters the public record without being detected for years. Beyond doubt, it is the (ethical) attitude coupled with (innovative) aptitude that would determine the altitude (of accomplishment). And in this context, aptitude to conduct work is partly innate and partly acquired. The principled attitude can certainly be built and nurtured in the scientists. They must realize that sooner or later ethical violations

are exposed. Also, the employers and evaluators of the researcher’s work must understand the hiccups of equipment resources, infrastructural amenities, etc. Hence, they should not pressurize them to pursue publication in high impact journals only. From a scientist’s perspectives, there is absolutely no dearth of journals today, print or open access, where one can report the work not at par with the international standards. In a

nutshell, while conducting research and reporting it in journals, one must keep certain DO’s and DON’Ts in mind and practice to preserve the ethical being. Figure 3 enlists the same. Dr Bhupinder Singh Bhoop is Professor (Pharmaceutics & Biopharmaceutics)University Institute of Pharmaceutical Sciences, UGC Centre of Advanced Studies,and Rishi Kapil is Research Associate at UIPS, Panjab University, Chandigarh