Year : 2018 | Volume
: 20 | Issue : 2 | Page : 93--95
Ethics in medicine and research: Responsibilities of a medical scientist
Sougat Ray1, Sheila Samanta Mathai2,
1 Department of Community Medicine, INHS Asvini and SSO (Health), HQWNC, Mumbai, Maharashtra, India
2 Department of Pediatrics and Director, Institute of Naval Medicine, INHS Asvini, Mumbai, Maharashtra, India
Surg Capt Sougat Ray
Department of Community Medicine, INHS Asvini and SSO (Health), HQWNC, Mumbai, Maharashtra
|How to cite this article:|
Ray S, Mathai SS. Ethics in medicine and research: Responsibilities of a medical scientist.J Mar Med Soc 2018;20:93-95
|How to cite this URL:|
Ray S, Mathai SS. Ethics in medicine and research: Responsibilities of a medical scientist. J Mar Med Soc [serial online] 2018 [cited 2019 Jun 18 ];20:93-95
Available from: http://www.marinemedicalsociety.in/text.asp?2018/20/2/93/249771
In the 4th century BC, Hippocrates directed physicians “to help and do no harm.” Ethics in health care follow the same principle of first doing no harm to the patients. However, with unrestricted advances in medical experimentations during the wars and beyond, the scope of ethical issues in health care and research underwent a huge transformation leading to human rights violation and injustice. We witnessed the landmark discovery of penicillin during the Great War, but the benefits were stained by its unethical use. The infamous Nuremberg trials by the Nazi doctors and the Tuskegee trials by doctors in the United States are well-known examples of unethical medical practices. These practices gave rise to the Declaration of Helsinki, which focused on obligations of the physicians toward research participants and the Belmont Report, widely regarded as one of the first guidelines on bioethical principles for medical professionals, the latter stressed on respect for persons, beneficence, and justice.,
Bioethics is regarded as a philosophical discipline which encompasses social, judicial, and environmental issues. In bioethics, we try to examine a specific problem or a clinical case, and with the use of certain values, facts, and logic, decide what should be the best course of action in the interest of the patient. It might be easier to decide between right and wrong in most cases, but in circumstances, where a judgment is needed to be made between “two rights” or between two value systems (e.g., patient's versus doctor's), medical ethics becomes extremely challenging. Due to these basic conceptual complexities, medical ethics has been widely debated worldwide. Though there are various explanations of scientific misconduct, defining and practicing good scientific practices is not a straightforward task.
In this editorial, we intend to delve into the practice of medical ethics and discuss a few of its important facets, bringing out the challenges and best practices to be followed by medical students, doctors, and researchers. Practicing and following medical ethics builds an effective and accountable health-care system at all levels as has been highlighted in the Sustainable Development Goals, particularly Goal 16.
Medical Ethics in Medical Education
From the very beginning of their careers, medical students must to hone their skills on patients to learn medicine. However, the ethical dilemma remains as to whether or not patients benefit from this process. It is a common practice to provide little or no information to patients regarding the role of medical students and trainee doctors during the informed consent taken for conducting clinical examination or invasive procedures. “Ghost Surgery” is a term applied to the practice of allowing resident doctors to perform procedures without specific consent of patients. It is well known in medicine that even the most proficient doctor had to have a “ first time” with an invasive procedure on a patient. Meaningful consent from patients for participation in the training of medical students and resident doctors is necessary but rarely done. Studies have also shown that 86%–93% of patients would prefer to be given information regarding the role of residents in their management. The principle of beneficence is also to be applied, which requires that, even before patients are asked to participate in research or education, doctors and teachers must first decide whether the overall balance of risks and benefits justifies their participation.
Responsible Conduct of Research and Scientific Integrity
Trust in science depends heavily on the assumption that the origin and content of scientific ideas will be treated with respect. An action which willfully compromises scientific integrity by fabrication, falsification, or plagiarism in proposing, performing, reviewing, or in reporting results is scientific misconduct. Fabrication and falsification might introduce spurious results into research records, while plagiarism might breach the trust of scientific colleagues. It may be tempting to “adopt” an interesting idea from an article, but researchers are obliged to give credit to the originator. Proper citation adds to the value of a research article. Authors should strive to cite the original paper rather than a more recent paper based on an earlier article. In order to collect and present research data responsibly, researchers must include a description of the procedures used to generate data, sufficient to allow reviewers and readers of the scientific paper to evaluate not only the validity of the data but also the reliability of the methods used to derive that data. A study by Fanelli found that 1.97% (n = 7, 95% confidence interval: 0.86–4.45) of researchers falsified or fabricated data and up to 33.7% admitted to some or the other questionable research practices.
Authorship Issues in Medical Journalism
Authorship is assigning credit for work done and needs to be done appropriately. Sometimes, a name is included as an author even though that person had little or nothing to do with the content of the paper. Such “honorary,” “guest,” or “gift” authors dilute the credit due to those who have actually participated in the research. Similarly, “ghost” authorship is when a person who writes a paper is not listed among the authors. This may have been done for a monetary price, a practice which should be strongly discouraged. Practices such as responsible peer review are thus important tools to prevent these unethical practices.,
Role of Clinical Practice Guidelines
Medical malpractice adds to the cost of health care which includes high insurance premiums, expenses for damages to patients, litigation fees, and the practice of defensive medicine. Following standard clinical practice guidelines is, therefore, prudent whenever applicable. Standard treatment protocols are prepared after sound systematic reviews and discussions within expert groups and hence form a legal standard. They have a high impact on medical litigation.
Ethics in Pharmaceutical Industry
Ethical issues in the pharmaceutical sector have been highlighted for long. A recent Cochrane review showed that sponsorship of drug trials by the drug manufacturers leads to more favorable results and conclusions than sponsorship by other sources. Drug sales have been found to be maximized by faking clinical trials, irrespective of health outcomes. The entire process of carrying out a randomized, controlled, inferiority trial of a new drug, statistically analyzing and writing up the results, and submitting articles to specific journals where such articles are published against a massive price tag is performed with a commercial intention by the pharmaceutical company seeking to market a product.
In 2004 when the US National Cholesterol Education Program (NCEP) revised its definition of “high cholesterol” by lowering the threshold, millions more people became eligible for statins overnight. It is said that the decision was not based on any new scientific data but rather the increasingly popular notion that “lower is better.” The move sparked a furor when it was revealed that eight out of nine members on the NCEP guideline committee had direct financial ties to statin manufacturers. The issue of the use of statins vis a vis its role in inducing side effects, especially Type 2 diabetes and muscle cramps, still remains debatable with the protocol of its use getting modified with alarming frequency, the latest being in November 2018. Famously known as “the Monsanto papers,” another example of corporation's maleficence and collusion with US regulatory agencies came to light in 2017 when it was found that the company used ghost writing, interference in peer-review process, and creation of an academic website to defend glyphosate (RoundUp), a herbicide, which was later found to be carcinogenic.
Military Medicine and Ethics
Medical ethics begins and ends in the “patient–physician relationship,” and there is no exception to this rule. However, battlefield situations have seen gross deviations from the principles of medical ethics, mostly on the recommendations of the military commanders. Perhaps, the best known example was the decision by the commanders during World War II of providing penicillin to troops suffering from sexually transmitted disease first, rather than to those seriously injured, so that the former could return to combat early. In the first Gulf War, controversy had erupted on the use of the then experimental drug, pyridostigmine, for pretreatment in case of a possible chemical warfare on soldiers without their informed consent. Participation of physicians in prisoner interrogation in the war on terror and force-feeding has been raking up controversies. Use of selective serotonin-reuptake inhibitor for soldiers with posttraumatic stress disorder, and also in anxiety and depression, so that they can return to the battlefield earlier than otherwise, has also been debated. Even in peace, the role of the military doctor as to whether or not to make a patient fit for all duties as a soldier is often questioned.,
In the modern era of medical technology, debates and controversies on bioethics include artificial intelligence in health-care system, end-of-life decisions, organ trafficking, genome cloning, stem cell research, genetic engineering, and the recent in vitro fertilization technology of mitochondrial replacement therapy, where the future baby's mitochondrial DNA comes from a third party when the mother carries genes for mitochondrial disease.
Medical science related technology have progressed at an extremely fast pace in the last two to three decades. However, concerns of its social, legal, and environmental impact on the human race have raised several debates and controversies. Bioethics was born to cultivate and foster social responsibility of this advancement of science that might affect not only our present and future conditions, but also our future generations. For this, global standards and regulations on bioethics have been developed and are required to be implemented by all health-care workers so that the society at large may enjoy its benefits.
|1||Mandal J, Ponnambath DK, Parija SC. Bioethics: A brief review. Trop Parasitol 2017;7:5-7.|
|2||The Belmont Report. Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html. [Last accessed on 2018 Nov 18].|
|3||United Nations Department of Economic and Social Affairs. Sustainable Development Goal 16. Sustainable Development Knowledge Platform; 2017. Available from: https://www.sustainabledevelopment.un.org/sdg16. [Last accessed on 2018 Oct 28].|
|4||Thirumoorthy T. The ethics of medical education – The ethical and professional issues in teaching and learning medicine. Ann Acad Med Singapore 2017;46:331-2.|
|5||Porta CR, Sebesta JA, Brown TA, Steele SR, Martin MJ. Training surgeons and the informed consent process: Routine disclosure of trainee participation and its effect on patient willingness and consent rates. Arch Surg 2012;147:57-62.|
|6||Jagsi R, Lehmann LS. The ethics of medical education. BMJ 2004;329:332-4.|
|7||Horner J, Minifie FD. Research ethics I: Responsible conduct of research (RCR) – Historical and contemporary issues pertaining to human and animal experimentation. J Speech Lang Hear Res 2011;54:S303-29.|
|8||Fanelli D. How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data. PLoS One 2009;4:e5738.|
|9||Office of Research Integrity PHS Policy on Instruction in the Responsible Conduct of Research; 2001. Available from: http://www.ori.dhhs.gov/html/programs/rcrcontents.asp. [Last accessed on 2018 Nov 16].|
|10||Committee on Science, Engineering, and Public Policy. On Being a Scientist – A Guide to Responsible Conduct in Research. 3rd ed. Washington DC: National Academies Press, National Academy of Sciences; 2009.|
|11||Ruhl DS, Siegal G. Medical malpractice implications of clinical practice guidelines. Otolaryngol Head Neck Surg 2017;157:175-7.|
|12||Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database Syst Rev 2017;2:MR000033.|
|13||Lexchin J, Kohler JC, Gagnon MA, Crombie J, Thacker P, Shnier A, et al. Combating corruption in the pharmaceutical arena. Indian J Med Ethics 2018;3:234-9.|
|14||Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 2018 Cholesterol Clinical Practice Guidelines: Executive Summary. Circulation 2018. [Epub ahead of print].|
|15||McHenry LB. The Monsanto papers: Poisoning the scientific well. Int J Risk Saf Med 2018;29:193-205.|
|16||Annas GJ. Military medical ethics – physician first, last, always. N Engl J Med 2008;359:1087-90.|
|17||Puetz TW, Youngstedt SD, Herring MP. Effects of pharmacotherapy on combat-related PTSD, anxiety, and depression: A systematic review and meta-regression analysis. PLoS One 2015;10:e0126529.|