A clinical trial is an important element of research in the field of medicine and science. Before any treatment protocol, or medicine or any practice related to the patient is brought into mainstream practice, it is essential that the trials have proved it's impact. One of the most fundamental ethical principles in human experimentation is that the experimenter should not subject the participants in the experiment to any procedure they would not be willing to undertake themselves. The shocking incidents of clinical trials performed on inmates in jail during the dark period of the Nazis was exposed in the Nuremberg trials. Many people subjected to these trials either died or suffered permanent impairment. This forced the world to think of ethical considerations before subjecting anyone to any test. Thus, the first International Statement on the ethics of medical research using human subjects namely, the Nuremberg Code was formulated in 1947.
The United Nations through the World Health Organization has taken several steps since 1948 to revise and frame guidelines for medical research. The guiding principles have been that purpose of research should be directed towards increase of knowledge of human condition in a manner conducive to and consistent with their dignity and well-being under conditions of professional fair treatment and transparency. The Indian Council of Medical research brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 and revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'. It's latest version was released in 2006 and consists of 2 important elements
(a) Statement of General Principles on Research using Human Participants in Biomedical Research
(b) Statement of Specific Principles on Research using Human Participants in specific areas of Biomedical Research
Over the years, India has become a hotspot for clinical trials thanks to the huge diversity in population, large patient pool for several conditions, strong pharmaceutical market (growing at the rate of 13-14% for the last 5 years according to a McKinsey report on the potential of the pharma market), environment for doing business, focus on improvement in quality of medical education and it's strategic location.
Sankalp India Foundation is a voluntary organization working for blood emergencies, thalassemia management and Bone Marrow Transplants. As an organization pioneering quality, safety and access in the fields of blood transfusion medicine and bone marrow transplantations Sankalp India Foundation regularly undertakes many research activities. The organization places utmost value to human ethics, hence a need was felt that all the research proposals of the organization involving human subjects are to be examined and reviewed by a duly constituted Institutional Ethics Committee (IEC).
We are happy to inform that an Institutional Ethics Committee for Sankalp India Foundation (IEC-SIF) is being formed with well qualified professionals on board. The SOP is framed and the guiding principles for the committee can be summarized as (taken directly from the ICMR guidelines)
- Principles of essentiality
- Principles of voluntariness, informed consent and community agreement
- Principles of non-exploitation
- Principles of privacy and confidentiality
- Principles of precaution and risk minimization
- Principles of professional competence
- Principles of accountability and transparency
- Principles of the maximization of the public interest and of distributive justice
- Principles of institutional arrangements
- Principles of public domain
- Principles of totality of responsibility
- Principles of compliance
The committee may review different types of research studies, including, but not limited to, the following:
- clinical trials
- epidemiological research
- social science research
- research on medical records or other personal information
- research on stored samples
- health systems research
- implementation research
The committee is in the process of being registered with the drug controller department and shall be operational from the month of May 2017.
- Establishing institutional ethics committees: challenges and solutions - a review of the literature.
- McKinsey report on growth of Indian Pharma Industry