|Year : 2015 | Volume
| Issue : 4 | Page : 421-424
Ethics in medical research: The difficulty of being good
Department of Community Medicine, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra, India
|Date of Web Publication||14-Jul-2015|
Department of Community Medicine, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Dr. D. Y. Patil Vidyapeeth, Pune, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Banerjee A. Ethics in medical research: The difficulty of being good. Med J DY Patil Univ 2015;8:421-4
Deviation from ethics in research can occur at any stage from the proposal of a research question to the publication of new knowledge.  In this editorial, few situations are discussed where ethical principles get overstretched and caution thrown to the winds in others. Some dilemmas faced by postgraduate students are narrated based on insights gained during informal discussions on dissertations over the past two decades.
In the Hindu epic tale Mahabharata, good behavior is not rewarded, the virtuous suffer banishment and deprivation while the wicked flourish in their palaces. Nor does the epic explains why the "good" person, who had a strong and persuasive case to make war, could win only by unfair means?  Perhaps because the good were weak they had to resort to unfair means to beat the strong. In the same manner when at a disadvantage whether as a student or faculty in a country where there are unrealistic academic expectations in research there is a temptation to be unethical since the good are left behind.
The temptation to deviate from research integrity starts from the time medical postgraduates start work on their dissertations as a prerequisite for degrees required by most universities. The student is supposed to choose his topic of interest. In most cases, the student is not equipped to do so due to lack of interest and inexperience in any particular topic. The guide in most cases takes the bite, which the student has to chew. To get the proposal accepted, there is a tendency to develop a flawless proposal. This often drives the guide to bite more than the student can chew. The acceptance of the dissertation proposal is the first objective with little realization of the difficulties inherent in implementing an ambitious proposal. Common pitfalls are a large sample size, random sampling methods (which are not feasible due to limited time and resources, including guides not conversant with research methods), and an obsession with significant P values, which often leads to data dredging and post-hoc generation of hypothesis. Sloppy research is unethical. As the deadline for the submission of dissertations approaches, there is desperation to complete the dissertations by hook or crook sometimes even resorting to outsourcing (particularly the statistical part). Once when a colleague advised a postgraduate student that a particular table with its obscure statistics (the meaning of which even the student could not explain) is redundant in the thesis and should be removed, the student protested saying that he has paid a hefty amount to the statistician for that particular table!!
Often remarks of the reviewers both at the proposal and the final submission stages do not help matters either. While these remarks may be theoretically sound, they overlook the practical difficulties the novice researcher faces due to limitations of resources and research experience. It would go a long way to promote research integrity in these formative years if the reviewers and guides of these postgraduate students have more realistic expectations from them. It should be appreciated that to carry out a theoretically sound research resources are needed which are rarely available to the postgraduate student. A more pragmatic approach would be for universities to introduce joint projects undertaken by a team of postgraduate students instead of individual theses, which may be sound theoretically but difficult to implement singlehanded. It is tempting for an individual student to stray from the path of research integrity. An added advantage would be the development of team spirit and teamwork so essential to tackle complex emerging problems in medical research. Since the work load would be shared there would be less temptation to indulge in dishonest practices besides the peer pressure to maintain high levels of integrity. Integrity should take precedence over perfection. It should be realized by the guides and reviewers of graduate research projects that a perfect study is beyond the capability of most students during their training. Integrity would be easier if research projects are broken down in smaller parts shared among a group of students. A poor man will steal to survive. A student with no resources would deviate from integrity to survive in an unrealistic academic world. In both instances, it is difficult to be good.
Recent amendment in regulations in many Indian Universities mandates that students should publish papers before they can appear for the final examination. This leads to the further temptation to indulge in unethical practices for the very simple reason that it is just not possible to publish in genuine peer-reviewed journals in the limited time available to the student. The student has to compulsorily publish his papers in "predatory journals" most of which publish anything within a couple of weeks as long as the author pays.  Publication in such predatory journal is a breach of publication ethics. On the other hand, if the student or faculty attempts publication in a proper peer-reviewed journal he or she is likely to miss his opportunity to take the examinations on time since publication in authentic journals takes time.
Among the faculty in academia, the stakes become higher and higher as career progresses. Most academic bodies stipulate that faculty carry out research which will decide their promotions and tenure. Besides, getting a proposal funded with its accompanying handsome grant is an end in itself for many academicians.
Most research is carried out ostensibly for the benefit of participants and mankind. The benefits of research should outweigh the risks to the participants. This sounds politically correct as it fulfills the ethical principle of beneficence. However, the pressure on academic faculty to do research is so great that most research may be undertaken for the benefit of the investigators. This conflict of interest sometimes makes it difficult to be good if one wants to advance one's academic career. There are instances, some well-established and others alleged when integrity in research has been compromised in order to promote one's academic career. The principle of beneficence (at least for the researcher!) is definitely apparent in the most medical research. Poor steal out of necessity. The rich steal out of greed. In the academic world there is greed to increase one's publication count which will advance one's academic career.
In acceptance of research proposals equity is the first casualty. Minor diseases of affluence get more funding than major diseases of poverty. As Bill Gates summed it up, "The malaria vaccine is the biggest need, but it gets virtually no funding, but if you are working on male baldness… you get more research funding……."  In other instances costly vaccine trials are promoted in poor countries, which would be benefited more by spending on basic sanitation and safe water supply needs. These trials also give an opportunity to investigators from poor countries to advance their careers. If held back by concerns of ethics of such trials they would be left behind in the academic rat race. The author was approached some time back by the Office of Medical and Scientific Justice, USA, to carry out the ethical evaluation of one such vaccine trial in a developing country. Throwing caution to the winds, all the principles of ethics were breached in this trial. 
Globalization driven by the information highway has facilitated high-pressure marketing of products related to health and disease blurring the boundary between pseudoscience and rigorous science. Before the advent of the information highway and instant media coverage of dubious research, even genuine research struggled for recognition. Often recognition came years after the death of the researcher. During their lifetime these researchers (ahead of their times and unintelligible to their peers), had to contend with anonymity and in extreme cases, disgrace.
The example which illustrates this situation best has to do with a practice which to the present day is well acknowledged but still not properly practiced. Two pioneers who identified the association between handwashing and hospital infections are Oliver Wendell Holmes and Ignaz Philipp Semmelweis.  Prompted by the death of a physician who had performed a postmortem on a woman who died of puerperal fever, Holmes concluded that physicians with unwashed hands were transmitting puerperal fever. His findings were published in a medical journal with very limited circulation and barely noticed. Later, Semmelweiss took up the study of high mortality rates in the clinics of Vienna General Hospital. He noticed that the First Clinic had a much higher mortality rate (10%) than the second clinic (<4%). Since in the first clinic doctors were conducting the deliveries (after conducting postmortems), while in the second clinic midwives were attending the childbirths, he concluded that doctors were responsible for the higher mortality in the first clinic. He explained that doctors were transmitting "cadaverous particles" to the patients they attended to in the first clinic. He insisted that doctors wash their hands with chloride of lime before entering the labor room. This practice when adopted dramatically brought down the mortality rate in the first clinic. However, his writings and books on the subject brought disgrace and humiliation instead of glory, since they ran contrary to the medical consensus of his times that diseases were transmitted by "miasma" or "bad air." Doctors also found it difficult to reconcile that they were responsible for more deaths compared to midwives. Ostracized by the medical community and dejected, he became an alcoholic and was confined to an asylum in 1865 where he was beaten to death.  He paid a heavy price for the courage of his convictions, which is essential for ethical research. Professionals form powerful associations, which promote the status quo sometimes under the garb of "medical consensus." Going against the current is not easy and can endanger one's academic career.
If doing ethical research was difficult during the life and times of Semmelweiss it is doubly so now. Original research challenges the status quo which does not make the maverick researcher easily acceptable amongst his peers. Peer-review, a process by which contemporary research proposals and papers submitted for publications are judged may be a barrier to innovative ideas. Peer-reviewers are "biased towards papers that affirm their prior convictions."  Add to this the lure of big money and prestige due to the sponsorship of research by industry.
One such example is the current controversy about the diet-heart hypothesis. It has been alleged that the diet-heart hypothesis has been maintained by prestigious and powerful scientists. Consequently organizations discouraged exploration of alternative hypotheses by not allocating funds to researchers who did not toe the line.  Researchers who interpreted data to fit a predetermined hypothesis were rewarded at the cost of those who created a new hypothesis that fitted their data.  Many (sometimes influenced subtly by industry interests) were lured to accept the diet-heart hypothesis promoted by cherry picking studies, which supported it. The story is long and complex, but the underlying themes include personal ambition and money.
Sometimes the efforts of investigators outside the medical fraternity whose careers are not endangered by challenging the "medical consensus" are in a position to bust the myth of "the emperor's new clothes." Major flaws in the diet-heart hypothesis have been revealed by years of meticulous investigation by science journalists , one of whom also published a peer-reviewed article for the prestigious British Medical Journal. 
There have been instances where research has caused harm to the study participants. The Tuskegee study started in the year 1932 in USA to study the natural history of syphilis. The participants were poor, illiterate African American men. When antibiotics for syphilis became available during the course of the trial the researchers withheld antibiotics from the trial participants, which could have cured the patients. In 1997, President Clinton formally apologized for the Tuskegee study. 
To ensure compliance of research ethics, regulations require that research with human participants be approved by the Institutional Ethical Committee (IEC). IEC ensures that research does not violate the principles of ethics. Although most IEC members may be researchers, they should also include legal experts, community members and social scientists to ensure a wider perspective. However, IEC lack the resources and expertise to ensure all aspects of ethics are complied with. Therefore, IEC can only be the minimum ethical standard for research. In the final analysis, the "judgment and character of the investigator" are the most crucial element for ethics in medical research. 
In spite of these compulsions, the editorial board of the journal requests the authors to maintain the highest ethical standards. From time to time we receive plagiarized manuscripts sometimes compelling us to retract published articles. This affects the reputation of the journal and the author. Besides, the "judgment and character of the investigator" can only ensure the authenticity of the data and the results. Integrity in research is more important than perfection. We regret we cannot oblige authors who are in a hurry to publish since proper peer-review, essential to maintain global standards, takes time. They should submit only "elective papers" to this journal. "Emergency papers" which may be required for appearing in the university examination or for promotions can be submitted to "predatory journals." We have the policy to nurture and encourage genuine authors to be ethical and good without much difficulty.
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