Tiêu đề 8. ETHICAL GUIDELINES IN CLINICAL RESEARCH.pdf ✅

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].