Title 8. ETHICAL GUIDELINES IN CLINICAL RESEARCH.pdf ✅

PHARMD GURU Page 1 GENERAL INTRODUCTION:  Refers to statement of general principles in biomedical research involving human participants.  This statement is also known as ICMR code.  ICMR code consists of: 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. These statements and principles may be varied, amended, substituted and added from time to time. GENERAL STATEMENT: Medical, and related research, using human beings (as research participants), should ensure that: 1) The PURPOSE of research should be directed towards the increase of knowledge about human condition, and for the betterment of all. 2) The research is CONDUCTED is a conductive manner. The dignity well-being, transparency and fair professional treatment should be maintained. 3) EVALUATION must be done at all stages ensuring the safety of human life. GENERAL ETHICAL PRINCIPLES: All research involving human subjects, should be conducted in accordance with three basic ethical principles, namely "respect for person, beneficence & justice". The present guidelines are directed at the application of these principles to research involving human subjects. a) RESPECT FOR PERSONS : Respect for Persons includes at least two fundamental ethical considerations namely: 1) Respect for autonomy: It includes the idea that an individual is free to choose, and to act. Both rational capacity and freedom from constraint are necessary ETHICAL GUIDELINES IN CLINICAL RESEARCH
PHARMD GURU Page 2 elements. "Respect for persons" include respecting the decisions of autonomous beings. 2) Protecting for those with impaired (or) diminished autonomy: It means recognition by the Commission, that these people are not capable of self determination at all times, and in all circumstances. b) BENEFICENCE : Beneficence includes the ethical obligation to maximize benefits and minimize harms and wrongs. c) JUSTICE : Justice in the ethics of research involving human subjects, the principle primarily refers to distributive justice, which means equitable distribution of both burden and benefits of participation in research. TWELVE BASIC PRINCIPLES: (Common to all areas of biomedical research) 1) All biomedical researches on human subjects should be absolutely essential after a due consideration of all alternatives for the advancement of knowledge and human beings - [Principle Essentiality]. 2) The concept of voluntariness and informed consent shall apply to the community as a whole, and to each individual member who is subject of research - [Principle of voluntariness and informed consent] 3) Irrespective of the socio-economic status and educational levels, research subjects should be fully apprised of all risks, arising. as a result of research - [Principle of Non-exploitation]. 4) The identity of records of human subjects of research should be kept confidential, and should not be disclosed without valid scientific and legal reasons - [Principle of privacy and confidentiality]. 5) Due care and caution is taken to ensure that research subjects are put to minimum risks/no irreversible risks [Principle of precautions and risks minimization]. 6) The research is conducted at all times by the competent & qualified persons [Principle of professional competence].