ICMR Guidelines
ICMR stands for the Indian Council of Medical Research guidelines. These guidelines are mandatory and needs which is to be followed for all the biomedical research among the country as per the New Drugs and Clinical Trials Rules. ICMR has made a great contribution as a knowledge making agency and contributed in understanding various diseases of national importance such as malaria, tuberculosis, Japanese encephalitis, AIDS (Acquired Immunodeficiency Syndrome), Filariasis, Kala-azar, Leprosy and Poliomyelitis. In addition to this, ICMR has made widespread contributions in the areas of reproduction, nutrition, and maternal & child health, environmental health and occupational and research complimenting health systems. ICMR regional medical research institutes/ centers have been paying in tackling regional health problems further.
These guidelines have explained the three basic ethical principles which include: respect for person, justice, beneficence by instating twelve general principles as follows:
Principle of essentiality:
Research performed should be important for the progression of knowledge that benefits doctors, patients, and all others involved in aspects of health care and also for the environmental and ecological well-being of the planet.
Principles of voluntariness, informed consent and community agreement:
Participants involved in the research must be aware of the research nature and the probable results of the experiments and then must make independent choice without involvement of any influence of the treating doctor, whether to be part of the research or not. When the research treats persons as a research participant, those of voluntariness and informed consent must apply to the community and also to each individual member responsible of the research or experiment.
Principle of non-exploitation:
Participants involved in the research must be compensated for their involvement in the research or experiment. They must be made aware of all the risks involved in the irrespective of their social or educational levels and economic condition attained. Every protocol of research must be involved in the provisions of compensation for the human participants either through appropriate means to cover all predictable and hidden risks.
Principle of privacy and confidentiality:
Acquired significant data for research purpose must be kept confidential to prevent disclosure of any particular identity of the involved participant and must not be disclosed without valid legal and/or scientific reasons.
Principle of precaution and risk minimization:
Care and caution must be taken into consideration at all stages of the research and experiment to avoid research participant from any harm and adverse events. EC has to play an active role in minimization the risk.
Principle of professional competence:
Clinical research trials must be carried out only by competent, capable and qualified persons in their respective fields.
Principle of accountability and transparency:
The experiments conducted by the researchers should be always in honest, fair, impartial and transparent manner after all the full disclosure of his/her interests in research. The research data or the significant information should be retained subject to the principles of privacy and confidentiality for the tenure of minimum 5 years, by the appropriate legal and administrative authority, if needed.
Principle of institutional arrangements:
It is majorly required to consider that all institutional arrangements compulsory to be complete in respect of the research and its following use or applications must be duly made in transparent manner.
Principle of the maximization of the public interest and of distributive justice:
Research study results must be used for the human benefits, particularly the research participants themselves and/or the community not only to those who are socially better off.
Principle of public domain:
Research study results must be always made in the public through the publications or with other sources. Considerably, before the publications, the detailed significant information of the clinical trials must be made before the start of recruitment via the clinical trials registry which allows the free online access.
Principle of totality of responsibility:
All the working population in the research directly or indirectly connected should take the professional and moral responsibility.
Principle of Compliance: All those allied with the respected research work must comply by the guidelines relating to the detailed area of the research. In the process of conducting research ethically, one should follow these above 12 general principles imposed by the ICMR. Moreover, to follow these general principles one should be aware regarding the vulnerable population, informed consent process, post-trial access, therapeutic misconception, and structure and role of ethics committees. Furthermore, these concepts hold the specific significance in the emerging countries, as most of the participants in the research are uneducated and economically backwards, therefore they are discussed precisely in every organization with all the employees and laborers.
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