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JOURNAL REVIEW  
Year : 2014  |  Volume : 4  |  Issue : 2  |  Page : 74-76
Ethical misconduct and corruption in medical research


Senior Lecturer, Department of Oral Pathology, Meenakshi Ammal Dental College, Alappakam Chennai, Tamil Nadu, India

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Date of Web Publication9-Jan-2015
 

How to cite this article:
Padmapriya T. Ethical misconduct and corruption in medical research. J Educ Ethics Dent 2014;4:74-6

How to cite this URL:
Padmapriya T. Ethical misconduct and corruption in medical research. J Educ Ethics Dent [serial online] 2014 [cited 2021 Jan 20];4:74-6. Available from: https://www.jeed.in/text.asp?2014/4/2/74/148992


Medical research is an affluent field that thrives to safeguard and enhance the health of the world population and hence the scientific community involved in medical research are entrusted with the morality of ethical conduct in their experimentation and studies.The cases of fraud and misconduct prevail at an alarmingly increasing rate in the medical research, the cause of which seem multifactorial like procuring sponsorship from pharmaceutical companies,personal greed of some scientific professionals,etc. The scientific research fraternity can combat this problem by reformative strategies like establishing more number of effective official regulatory bodies for research monitoring, incorporating ethics in to the curriculum both at student level and all along the carreer course of the scientists to restore the research integrity.It is a time of call for the whole of scientific community to awaken and act unitedly in this battle against fraud and deciet in the research field especially when we have an obligation to protect the world that we seek to benefit through our research.


   Fraud and Deceit in Medical Research Top


Umran Sarwar and Marios Nicolaou

J Res Med Sci Nov 2012;17:1077-81.

The field of medical research which is considered to be the corner stone has the ability to influence the physical and psychological well-being of the world population. It is henceforth mandatory that such an affluent field be genuine and bias free in the very interest of the people is striving to help. There still has been an alarming rise in cases of misconduct and fraud in the medical research and though this has resulted in many organizations to combat the issuing problem, fraud and deception seems to be under-reported. A strong reason for the difficulty in identification of such cases and inability to prevent the continuing of the same such problem appears to be the lack of a single global definition for fraud and misconduct that is universally acceptable in relevance to the international nature of the research and publication.

The consensus conference on misconduct in biomedical research in UK has defined misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standard. The COPE, the UK committee on public ethics describes misconduct as the intention to cause others regard as true that which is not true. The ORI, office of research integrity, USA defines research misconduct using the FFP model (fabrication falsification and plagiarism).

The lack of funding for research seems to be one of the main reasons leading to commit such deception to reach their goals and also failure of senior authors to supervise the work holds them accountable for the resulting misconduct. On investigating such fraud the research organizations should act promptly facilitating timely retraction of publication of such fraudulent research to avoid dissemination of untruthful information in the medical literature. An underlying desire to be successful in science and fear of failure also cause researchers to resort to misconduct. Pharmaceutical companies securing grants and finances for drug research, professional careerism are also reasons causing the research misconduct. There has been the trend for career progression and eligibility for funding in research to be based on number of publications rather than regarding the quality of the publication or journal. Implementation of research ethics education at the very student level, thereby, targeting them as potential researchers will ensure both a scientific career based on integrity for the scientists and a solution to the prevailing misconduct in research.


   Ethics in Clinical Research Top


Silvio Garattini*, Vittorio Bertele'

J Hepatol 2009;51:792-7.

Research and development of drugs are primarily governed by pharmaceutical industries that sponsor them. Hence there is a high risk of bias that can be involved in clinical trials of drugs sponsored by them, so that newer such drugs can be approved and marketed for their benefit.

The random clinical trial despite being the best available method to check the efficacy and safety of new drugs has many flaws inherently prevalent in the design of its methodologies. Despite Helinski's declaration against choice of placebo when effective drugs are available, many RCTs continue the use of placebo inappropriately. There is disparity in the selection of study population in most clinical trials as the age limits of the study groups do not usually match that of the people for whom the drug is developed. Also about 50% of the drugs that are being prescribed to children or adolescents have not been subjected to RCT. Most RCTS are also designed with unnecessary and inappropriate emphasis on composite or surrogate endpoints rather than the definitive outcome of the drug, only to promote an otherwise ineffective or even a harmful drug. A practice of selective publication of positive trials and selective reporting of outcome of trials is known to exist misleading to improper perception of efficacy of the drug concerned. There have been instances of adverse reactions kept undeclared in reports for approval and marketing of some drugs which can actually be more harmful than of use. An example of such a serious case was that of coxibs which were considered as better anti-inflammatory due to their lower gastric toxicity and it took many years later to realize that it had a risk of causing MI and heart failure.

As a measure to minimize the bias involved in RCT, it is suggested that at least one pivotal phase III study to be conducted by clinicians independently without any influence of pharmaceutical companies. Ethical committees need to be more cautious and critical of inappropriate studies designed purposely to suit the commercial benefits of the drug industry and not of patient needs. Scientific societies will have to adopt more stringent measures to curb selective publishing. A critical attitude and approach are needed towards the industry to make them oblige with producing drugs with an adequate safety and added value as well.


   Monitoring Research: An Obligation Unfulfilled Top


Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass, Myriam Skrutkowska

Can Med Assoc J* 1995;152:12.

In Canada, a national and surgical adjuvant breast and bowel project (NSABP) based in US, a study was conducted between 1977 and 1990. A researcher involved in the project was reported to have falsified some of the data of the trial along with some other serious violations. Occurrence of such research fraud undermines the trust of the public that hold on medical research. The local institution involved with research through their REB should ensure proper monitoring of research, especially those involving human subjects. The guidelines of Medical Research Council of Canada along with the concepts of research monitoring are discussed and explained that are applicable for administrators and REB's members in developing institutional policies on research. The research monitoring are not just a police work, but in are actually quality assuring mechanisms and are essential towards enhancing authenticity in research.

Four categories in research monitoring are discussed in this article. The annual review being the first of the category demands institutions to submit a report every year after the approval of research protocol not only after beginning but also during the course at the conclusion of the study. In cases of research studies with possible serious adverse drug reactions, mortality or morbidity, special committee need to be established to monitor the data and ensure safety or more frequent reports from researchers may be required.

Consent monitoring warrants, the REB to ensure that informed consent be obtained and documented in a rightful manner. In studies with issues involved in either competence or voluntary participation of the subjects, it is advised to appoint an advocate, who should be during the consent, in negotiations of the research.

Monitoring for adherence to protocol includes the periodic and consistent assessment of the research protocol followed in during the course of research to ensure that only approved procedures are followed. The approach uses self-monitoring by researchers along with experts within or outside the institution. Direct monitoring by a member of REB is also required in cases of exemption.

Monitoring the integrity of data requires the pharmaceutical companies and clinical trial cooperative groups to conduct procedural audits to monitor the quality and integrity of the research data. The REBs also need to conduct regular review of the audit procedures proposed by the pharmaceutical companies or the clinical trial cooperative groups.

Monitoring of continuing research necessitates the affirmed commitment of the research community towards ethical conduct of experimentation involving humans. Such institutional programs established by the REBs to review the research are paramount in regaining the public trust in medical research

Barriers to Considering Ethical and Societal Implications of Research: Perceptions of Life Scientists.

Jennifer Blair McCormick, Angie M. Boyce, and Mildred Cho

AJOB Prim Res 2012;3:40-50.

An empirical study was done between 2005 and 2007 to investigate the attitude of scientists towards ethical and societal implications of their work. The study involved series of phone interviews, focus groups and a national survey of life scientists at biomedical research institutions. The analysis of the data revealed four main barriers which scientists face in considering the ethical and social implication of their research.


   Lack of Awareness Top


Results show that there is a certain lack of awareness prevalent amongst researchers about the ethical and social importance of their work. A plausible explanation for this alarming attitude could be due to the lack of clarity in what defines an ethical concern and as a result of which they neglect to consider the social effect of their work as they assume their work is not related to such societal context.

[TAG:2]Lack Of Relevance [/TAG:2]

Life scientists those being well aware of the societal and ethical importance of research seemed to be of opinion that such consideration not to be relevant to their particular work and it is especially the case when their experimentation does not involve humans as research subjects.


   Higher Personal Thresholds and Self Confidence Top


Researchers seemed to be overconfident about their capability of handling ethical dilemmas on their own. Even when an issue demands outside expertise, such as seeking bioethicist, the participants disclosed an unwillingness to approach them, they felt that the bioethicists would always disapprove newer techniques and hence only deter their scientific experimentation.

The study results suggest that increased educational efforts are necessary in making ethical and social considerations as a vital part of scientific research, importantly in both at the start of the academic career and throughout the professional progress of the researchers which make them be more ethically aware and socially responsible. The ethics consultants and their institutions have to be aware of these potential constraints prevailing in the scientific community in considering the ethical and social perspective of their research, in so, as to serve them more fruitfully. This study provides an empirical data which will help in creating future mechanistics that would facilitate the researchers in actively considering ethical, policy and social issues of their work so as to minimize the negative implications of their research.


   Suspected Research Fraud: Difficulties of Getting at the Truth Top


Caroline White, Freelance medical journalist

BMJ Jul 30, 2005;331:281-8.

Misconduct in research isa major problem faced by the research community and also upon suspicion of such a fraud when the editor wants to investigate in to possible cases of fraud, as they are deemed to go through a lengthy and costly process on their own. This article gives a detailed account of the investigation of the case of Singh, an Indian researcher by Smith the BMJ editor. It provides an insight in to the various natures of obstacles in the way of exposing a research fraud.

RB Singh published a randomized clinical trial in BMJ on the dietary interventions to prevent further heart attacks in April 1992. At the time, The study was cited 225 times. Later the same year, he submitted another which gave rise to many doubts about the reliability of the data. The article also lacked in reference as compare to the previously published article despite having many similarities between the two trials including that of the study participants. Also other aspects of the trial got published in another journal, the American Journal of Cardiology. The BMJ editor, Richard Smith decided for a joint investigation and sought financial help from American Journal of Cardiology which also published Singh's studies but was refused . Smith went ahead with it, despite the odds, and asked Dr. Paul McKeigue, a professor of genetic epidemiology at University College Dublin, to review manuscripts of Singh. He also asked Singh to supply with the raw data related to the manuscripts to be reviewed by Dr. Evans, a world statistical expert. The review of the manuscripts clearly pointed the inconsistencies and errors in the paper which justify the retraction from publication. The highlight was that singh kept insistently sending his further works to BMJ disregarding their judgment. His manuscripts reviewed by many different reviewers held no difference of opinion regarding the possible lack of genuine of the work. After 5 years of his first paper accepted by BMJ with no chance of further publication in BMJ and none of his manuscript accepted, he stopped sending manuscripts to BMJ but continued publishing else were. Meanwhile, review of the raw data he had supplied verified as data fabrication. Smith took the case to the Human Rights Commission of India which forwarded the case to the Indian Medical Council. After the lack of any initial response, only on Smith's persistent and repeated letters, the council replied that it was not within their authority to take any disciplinary action against Singh and also stated that only the Human Rights Commission can do anything about it as they had taken up the issue. BMJ could not find a legitimate authority to convict the author publicly and was assured by many Indian sources that it was impossible to get any regulatory body within India to bring justice to the case as they would only feel that it was not their responsibility and rather that of the international journals which had published his works. So BMJ under Smith's editorial ship decided to publish the saga of Singh's investigation solely to make readers aware of the questionability of his studies to prevent detriment to patients and the scientific community. Smith feels that it would alert the world with such cases of fraud and help in finding ways to resolve them. Inspite of some of the authors works being held with such wide felt doubt by the research community as they continue in publishing their increduious works and will have to be prevented from it, at least for the sake of the public.

Top
Correspondence Address:
Dr. T Padmapriya
Senior Lecturer, Department of Oral Pathology, Meenakshi Ammal Dental College, Alappakam Chennai, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7761.148992

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