ETHICAL ISSUES DURING CLINICAL TRIALS WIKI:
In Clinical Research it is most important to focus on the ethical issues during clinical trials. During clinical trials the individual is expose to risks and burdens for the benefit of society in large.so the ethical guidelines were formulated. The Nuremberg code was the first international code laying ethical principles for clinical research. Later WHO formulated guideline in the form of declaration Helsinki in 1964. Then after discovery ofTuskee’s syphilis study, US laid down its guidelines for ethical principles in Belmont Report. In the year 2000 the Indian council of medical research had laid down the ethical guidelines for Biomedical Research on human subject which were received in 2016. Its gives twelve general principles those should be followed by all biomedical researches working in the country.
PRINICIPLES OF ETHICAL GUIDELINES:
1. Principle of essentiality:-The research which were carry should be essential for the wellbeing of the society.
2. Principles of voluntariness, Informed consent and community agreement:- The research participant should be aware of the nature of the research and probable consequences of the experiment and he should not take any decision and the influence of the treating doctor. It is also applicable when we take commodity as research participants.
3. Principle of non-exploitation:- The participant should be aware of all the risks irrespective of their social and economic condition or educational levels attained.
4. Principle of privacy and confidentiality:-Without a valid reason all the data acquired for research purpose should be kept confidential to prevent participant’s identity being exposed.
5. Principle of precaution and risk minimization:-To prevent research participant from any harm and adverse events, At all stages of experiment and research due care and caution should be taken.
6. Principle of professional competence: – The experiment and research should be carried only by a qualified person in that field.
7. Principle of accountability and transparency:-The researcher should be transparent in conducting experiment and he should keep all the data correctly.
8. Principle of maximization of the public interest and of distributive justice:- The result of the research should be used for the benefit of the society irrespective of participants.
9. Principle of institutional arrangements:-All the institutional arrangement should be made in respect to the research. Its applications and use are made in a transparent way.
10. Principle of public domain:-Through publications the results should be made public.
11. Principle of totality of responsibility: Each and everyone involved in research are responsible for any outcome.
12. Principle of compliance:-Whoever associated with the research work should follow the guidelines related to the specific area of research.
In order to conduct any research ethically we should follow all these twelve principles laid down by Indian council for medical research.
In order to follow these principle one should be aware of the informed consent processes, population therapeutic misconceptions, Post trial asses and structure and role of Ethics committees. In developing countries like India most of the research participant under educated and economically backwards, these concepts hold special importance.