Year : 2017 | Volume
: 62 | Issue : 4 | Page : 371--372
Ethical issues pertinent to current clinical research environment in India
Nilay Kanti Das
Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal; Member of Institutional Ethics Committee of Human Research, Medical College, Kolkata, West Bengal; Coordinator of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology, India
Nilay Kanti Das
Department of Dermatology, Bankura Sammilani Medical College, Bankura, West Bengal; Member of Institutional Ethics Committee of Human Research, Medical College, Kolkata, West Bengal; Coordinator of Dermatology Clinical Trials Special Interest Group, IADVL Academy of Dermatology
|How to cite this article:|
Das NK. Ethical issues pertinent to current clinical research environment in India.Indian J Dermatol 2017;62:371-372
|How to cite this URL:|
Das NK. Ethical issues pertinent to current clinical research environment in India. Indian J Dermatol [serial online] 2017 [cited 2020 Mar 28 ];62:371-372
Available from: http://www.e-ijd.org/text.asp?2017/62/4/371/210073
Medical science is an evolving subject, and the evolution comes by way of research. It is noteworthy that research is a must in understanding the disease pathology, development of new drug, designing new management strategy, and in other word for serving the humanity in better and proper way; nevertheless, it is also true that research should bring no harm to the study participants.
Research has two important pillars such as researchers and research participants; and it is a dedication from both of them that yields new information leading to the advancement of science. Mutual respect on behalf of both is an essential element for successful research, but unfortunately, an air of mistrust has developed in recent times, and ethical concerns are raised globally regarding conduct of clinical trials. It need not be overemphasized that this trust is the most important factor for good clinical research, and the series of articles in the symposium would through light on issues which can bridge the breached trust. In India, there were events and reports in media about the incidents where ethics was compromised, and the guardian of ethics and the ethics committee were at flaw  that insinuated the failing ethical standard of clinical trial environment. The Drug Controller General of India took cognizance of the fact and imperatively the regulatory environment in India has become very strict henceforth.
It is noteworthy that to reestablish the misplaced trust; it is extremely important that Good Clinical Practice (GCP) guidelines are followed while conducting clinical research. GCP has evolved over the past few decades since the development of Nuremberg Code (condemning the Nazi human experimentations) when humanity has witnessed how atrocities can be brought upon humanity in the name of science. World War II incidents were the eye-opener but what followed thereafter (Willowbrook Hepatitis Study, Jewish Chronic Disease Study, Tuskegee Trial, and more) revealed that the mindset of researchers had not changed and humanity has not learned from previous mistakes. The unscrupulous nature of these studies also teach us that ethics can also be breached not only in clinical trials but also in noninterventional studies too; thus furthermore raises the alarm that if mere observational studies can be so immensely unethical, then how vulnerable can be a participant in an interventional study!
Ethics revolves around one single motto of “do no harm” and a doctor–researcher has dual responsibility and has to serve two major roles; one as researcher who would look at ensuring a flawless study design and more importantly as a treating doctor upon whom a patient has placed his/her trust knowing that the doctor would do the best for him/her. Here, rises the issue of “therapeutic misconception” when a patient approaches a doctor for the best possible treatment, and the doctor-turned-researcher recruits him/her in a study without proper explanation of the fact that a treatment modality in a research is yet to be validated as the best possible treatment.
Indian Association of Dermatologists, Venereologists and Leprologists Academy has set up a “Special Interest Group: Dermatology Clinical Trials” to look after and facilitate clinical trials in dermatology, and it is the effort of this group to make the clinical trials not only scientifically sound but also ethically healthy too.
The present symposium is an attempt to highlight the history and evolution of ethics in clinical research, the two important pillars namely, ethics committee and informed consent process and also the ethics of safety reporting in the study participants.
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