Ethics in Clinical Research

rd_ethics_ct_teaserMedicine is scientifically different in comparison to mathematics/physics. Each patient varies from the other. A treatment that works for a majority of the patients might not work for a few.

Hence, the practice of medicine is experimental in nature. At the same time, treatments that are common must also be assessed to conclude if they are helpful for distinct patients. Medical research must look into this aspect.

The other function is the development of new treatment methodologies, including drugs, medical devices and surgical instruments. Though, progress has been made in the recent past, the working of the human body still remains a mystery (the reasons for diseases and the method of curing). The answers to all the issues are through medical research.

Medical research also aims at examining a gamut of issues related to human well-being – disease type, financial capability, quality of the healthcare delivery system, sociology, legal, and ethics.

All medical practitioners utilize the outcomes of medical research during their clinical practice. In order to stay relevant, medical practitioners must stay abreast with existing research in the field of specialization based on the Continuing Medical Education/ Continuing Professional Development programs, medical journals, and by communicating with SMEs.

A medical practitioner need not directly get involved in research work, but should be able to interpret the outcomes of research. Hence, expertise in research methods is mandatory to facilitate an efficient medical practice.

A clinical trial is a widespread method of research. A drug must be tested for safety/effectiveness before regulatory bodies can validate it for usage. The process starts in the laboratory and is followed by testing on animals. Once the results are positive, the four phases of clinical research are as follows:

Phase One

Performed on a small sample of physically well-being volunteers. This is to determine the amount of drug needed to generate a reaction in the human body (the body’s ability to process the drug and determine any side-effects).

Phase Two

Conducted on a set of patients affected by the disease for which the drug has been developed. The objective is to decide if the drug is able to cure the disease and conclude if there are any detrimental side-effects.

Phase Three

It is the clinical trial wherein the drug is administered to many patients while being correlated to another drug (for the same disease).

Phase Four

It happens after the drug has been licensed/ marketed. Initially, the drug is evaluated for side-effects that cannot be identified in the previous phases. The drug manufacturing company would like to get a response from the patients.

Currently, the key procedures of research ethics are documented. At the end of World War II, several medical practitioners were sentenced by a special tribunal at Nuremberg, Germany.  This judgment known as the Nuremberg Code became the basis for research ethics today. One of the principles of the code is the need for patient’s approval to act as a research subject.

The World Medical Association (1947) has established stringent ethical guidelines for the medical practitioners. Based on extensive research, the WMA endorsed a group of principles for research & experimentation professionals in 1954.

The 101 Medical Ethics Manual – Principal Features of Medical Ethics Manual were updated over a ten-year period, and became the Declaration of Helsinki (DoH) in 1964. Upon further revision in 1975, 1983, 1989, 1996, 2000 and 2008, it turned out to be a brief synopsis of research ethics.

Other documents on research ethics that have been created in recent times include Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993), revised in 2002, the Nuffield Council on Bioethics (UK), and the Ethics of Research Related to Healthcare in Developing Countries (2002).

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