Indian Coubcil of Medical Reasearch Apex body In India for formulation coordination and promotion of biomedical rese arch

One of the oldest medical research bodies in the world in 1911 set up the Indian Research Fund Association (IRFA) with the specific obj ective of sponsoring and coordinating medical research in india Re-designed in 1949 as ICMR Funded by Government of India through the ministry of health and family (MOHF) ICMR CODE This statement of Ethiucal guidelines for Biomedical Research on Human Participa nts shall known as the ICMR CODE and shall consist of the following Statement of General Principles on Research using Human Participants in Biomedic al research STatement of specific Principles on Research using Human Participants in specifi c areas of Biomendical Research General Stat5ement Medical and Research using Human beig as research participants must necessarily ensure that: Purpose: Should be directed towards the increase of knowledge Conducted : Mere means for betterment Evaluation: AT all stages of prop[osal These statements of General and Specific Principles may be varied amended, subst ituted and added from time to time Statement of General Principles Principles of essentiality Human participants is considered to be absolutly essential Due consideration Research has been o are external to Necessary for the ecies of all alternatives duly vetted and considered by a appropriate body of persons wh the particular research advancement of knowledge and benefi of all members of human sp

Staement of General Priciples Principles of voluntariness, informed consent and community agreement: Research Participants are fully apprised of the research and the impact and risk Right to abstain from further participation Research entails treating any community or group of person as a research partici

pant, these principles of voluntariness and informed consent shall apply mutatis mutandis Participant is incapable of giving consetnthe principle of voluntariness and inf ormed consent shall continue to apply Cardinal principles to be observed throught the research and experiment Ethics committe shall decide on the form of consent to be taken or its wavier ba sed on thhe degreee of risk involved Statement of General Principles Principles of non-exploitation renumerated for their involment Participants kept fully apprised of all the dangers Human participants should be selected so that the burdens and benefits of the se search are distributed without arbitrariness, discrimination or caprice In bult mechanism for compensation for the human participants through Insurance cover Providing for remedial action and comprehensive aftercare treatment during and after the research Statement of General Principles Principles of Privacy and confidentiality Identity and records of participants are kept confidential cannot be discolsed without consent in writing of the human participant concerne d or someine authorised on their behalf Principles of Precausion and risk manegement Due care and caution is taken research participants are put no known irreversible adverse Both professional and ethicsl ate statges Statement of General Princples Principles of professional competense conducted all the time by competant and qualified persons Act with total integrity and impartiality aware of , though training preferably , the ethical considerations to be borne i n mind Principles of accountability and transparency Experiment will be conducted in a fair , honest, impartial and transparent manne r Full and complete records of the research inclusive of data and notes are retain ed for purpose of post research moniotoring, evluation of the research, conducti at all stages to the minimum risk effects and generally benefits reviews of the research are undertaken at appropri

ng further research scrutiny by appropriate legal and administrative authority, if nessary STatement of Gebera Principles Principles of maximization of the public interest and of distributive justise Benefit all human kind and not just those who are socially better off but also t he least advantaged. Principles of institutional arrangements All the procedures required to be complied with and all institutional arrangemen ts required to be made in respect of the reearch and its subsequent use or appli cation are duly made in bonafide and transparent manner Statement of General Principles Principles of public domain Results are generally made known through scientific and other publications Principles of totality of responsibility Professional and moral responsibility Effect of research is duly monitored and constantly subject to review and remedi alaction at all stages of the research and experiment and its future use Statement of General principles Principles of compliance General and positive duty on all persons, conducting, associated or connected wi th any research to ensure that both letter and the spirit of these guidelines , as well as any other norms directions and guidelines 12 principles under statement on general principles are common to all areas of b iomedical research Ethical Review Procedures Emphasized under the statement of General Principles at item no. 5 (Precaution a nd risk minimization) Mandatory that all proposals on biomedical research involving human participants should be cleared Basic Responsibilities Ensure competent review of all ethical aspects of the project proposals Provide advise to the researchers on all aspects of the welfare and safety of re search participants Dual responsibility of review of both, the scientific content and ethical aspect s Basic Responsibilities Advisable to have seperate committees specify in writing the authority under which the committe is established

Special Situations Small institutions could form alliance with other IECs or approach registred IEC The institutional policy should be same To protect dignity, rights and well being TO ensure tat Universal ethical values and international scientific standards ar e expressed in terms of local community values and customs To assist in the developmnt and the education of a research community responsive tolocal health care requirements Composition Multidisplinary and multisectional in composition Independant and competant are two hallmarks Number of persons should be kept faily small (8-12 members) Minimum 5 members is required to form the quorum Chairman should be from the same institution Others: mix of medical/non-medical, scientific and non scientific persons. Composition 1. Chairperson 1-2 persons from basic medical science area 1-2 clinicians from various institus 1 legal expert or retired judge One social scientist/ representative of non-governmental voluntary agency one philosopher/ethicist/theologian One lay person from the community Member secretary

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