Certificate course on ethics in clinical research concludes successfully

Certificate course on ethics in clinical research concludes successfully

Sachin JagdaleMumbai

Former Supreme Court Chief Justice M N Venkatachaliah had once said, “Biomedical research has acquired dimensions which are at once exciting and awesome. It raises some delicate and difficult issues of ethics which need to be dealt with sensitivity to human values and with great circumspection. While research which promises to mankind the great blessings of science should not be stifled by too restrictive an approach, however, great care should be taken to ensure that something does not go out of hand. Therefore, any system of ethical guidelines on research needs to be cognisant of, and informed by, a sensitive balance of the risks and benefits.”

As India is a favourite destination for clinical trials, the necessity of ethics while conducting clinical trials is all the more crucial. The concerned authorities have started making people aware of the ethical values regarding clinical trials by leaps and bounds. Department of infectious diseases and interdisciplinary research, Maharashtra University of Health Sciences (MUHS) had recently organised a certificate course on ethics in clinical research at Haffkine Institute, Mumbai. Dr Bhushan Gagrani, Secretary, Medical Education and Drugs Department was the chief guest at the event whereas Dr Mrudula Phadke, Vice Chancellor, MUHS, was the guest of honour.

In his inaugural speech, Gagrani said, “Training ethics committee members is a requirement of national and international guidelines. India is in the forefront of clinical research for pharma products and is contributing to new drug development globally. However, there is concern that illiterate patients may be forced to participate in clinical research. While clinical research is important and should be facilitated, the patients who participate in the clinical trial should not be harmed.” He adds, “Clinical research is important for developing new drugs, and also for understanding causes and epidemiology of diseases which is important for public health. MUHS has incorporated training in research in the syllabus for medical courses. The University has encouraged setting up of ethics committees in medical colleges as per Indian Council of Medical Research, Government of India requirement. The ethics committee needs to function as per national guidelines. If you establish good communication with citizens then clinical trials will be more comprehensive.”

Phadke narrated some of the mishaps that had happened in the past in relation to the administration of vaccines and how the knowledge of ethics in clinical research would have helped in that scenario. She said, “At this juncture, I recollect the first clinical trial that we undertook three decades ago in the Department of Pediatrics of the BJ Medical College, Pune. A vaccine manufacturing company’s Director gave me one bulb of Diphtheria, Tetanus and Pertussis (DTP) vaccine and told me to try it on infants and give my opinion about the vaccine. I took the bulb and gave the vaccine to babies, least realising

the importance of ‘parental consent’, the ‘voluntariness’ of it, the ‘informed’ part of it and so many things. The trial went well, probably because of the immense faith that the patients had in us, as we were counseling them inadvertently without knowing the ethical issues concerned and above all, it was just that we were lucky. Institutional Ethics Committees had not come into existence then.” According to her, times have changed now. Ethics in clinical research has assumed a big dimension and is rightly so. However, many teachers, researchers, students and sometimes members of the Ethics Committees of the colleges do not know their exact role. This certificate course will be immensely beneficial for them.

Dr Nilima Kshirsagar, Director Professor, Infectious Diseases and Interdisciplinary Research, MUHS, said, “Ethics is an important part of clinical research. Initial and ongoing training of ethics committee members is required as per National and International guidelines. MUHS has organised this two day certificate course on ethics in Clinical Research, the contents of which have been prepared by expert course committee members.

The faculty consists of professionals with years of experience. The course will be taught in lectures, case studies and interactive audience response system. Various topics ranging from informed consent procedure, ethical issues in clinical trials, observational studies, to ethics committees and review procedures will be discussed. We have participants from industry, academia, students, members of ethics committees and journalists.” She adds, “There have been tremendous advances in genetics, biotechnology, and molecular biology in past decade and new drugs are being developed using the knowledge and techniques from these basic sciences. There is an enormous need to carry out research in human subjects to ensure safety and efficacy of these products. While doing so, every effort is required to protect rights of the subjects participating in the studies. This university course on ethics in clinical research we hope will help in building the capacity of our ethics committees, and others engaged in clinical research, thus ensuring safety and well being of our subjects.”

Dr Abhay Chowdhary, Director, Haffkine Institute for Training, Research and Testing was also present for the event. He lauded the MUHS by saying that the course of ethics in clinical research was a great initiative.