Icmr guideline

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1. ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS Supervisor :- DR. rajesh kumar Assistant Professor KurukshetrA university, kurukshetra Presented by :- sachin jangra mPHARMA 2nd SEM Roll no. 03

2. ICMR Indian Research Fund Association (IRFA ) Indian Council of Medical Research(ICMR ) 1949

3. GUIDELINES….. Guidance on transfer of human biological material for research Dietary guidelines for Indians Ethical Guidelines for Biomedical Research on Human Participants

4. Indian council of medical research ( icmr ) Crest body of india for formulation ,coordination & promotion for medical research. One of oldest medical research bodies in india . Firstly organised as IRFA ( indian research fund association) then re-registered as ICMR Funded by the Gov. of I ndia through Ministery of Health & Family W elfare.

5. Continue….. Further widening of healthcare between developing & develped country. R&D help in diagnosis & therapy. India is projected as a global hub for clinical trail.

6. Icmr code Ethical Guidelines for Biomedical Research on Human Participants shall be known as the ICMR Code and shall consist of the following:- Statement of General Principles on Research using Human Participants in Biomedical Research. Statement of Specific Principles on Research using Human Participants in Biomedical Research

7. GENERAL STATEMENT Medical and related research using human beings as research participants must necessarily ensure that – Purpose of such research is that it should increase the knowledge of human condition in relation to the its social & envioment .

8. Continue… Such a research is not only conducted for the human who is under medical research but also for the betterment for the others . Such research must be subjected to a regime of EVALUATION at all stages of the proposal

9. Statement of General Principles Principles of essentiality:- Human participation is essential . Principles of voluntariness, informed consent and community agreement Right to abstain from further participation. Before medical research person to informed about the agreement.

10. Statement of General Principles Principles of non-exploitation Payment should be given for their involvement. Participants must inform towards all danger. Principles of privacy and confidentiality Identity and records of participants are kept confidential

11. Statement of General Principles Principles of precaution and risk minimisation :- Due care and precaution is taken at all stages Participants put to minimum risk. Principles of professional competence Conducted by the competent & qualified person.

12. Statement of General Principles Principles of accountability and transparency Experiment will be conduced in a fair , honest & transparent manner Principles of public domain Results are generally made known through the scientific and other publication.

13. Specific principle 1. Drug trials 2. Vaccine trials 3. Surgical procedures / medical devices 4. Diagnostic agents - with special reference to use of radioactive materials and X-rays 5. Trials with herbal remedies

14. Ethical Review Procedures Basic Responsibilities To protect the dignity, rights and well being of the potential research participants. To ensure that universal ethical values and international scientific standards are expressed in terms of local community values.

15. Composition The IECs should be disciplinary and multi-sectorial in composition . Independence and competence are the two hallmarks of an IEC. The number of persons in an ethics committee should be kept fairly small (8 - 12 members ). It is generally accepted that a minimum of five persons is required to form the quorum.

16. The composition may be as follows:- 1 . Chairperson 2. One - two persons from basic medical science area 3. One - two clinicians from various Institutes 4. One legal expert or retired judge 5. One social scientist 6 . One philosopher/ ethicist/ theologian 7. One lay person from the community 8. Member Secretary

17. TRAINING.. The EC members should be encouraged to keep level of all national and international developments in ethics through orientation courses on related topics by its own members or regular training organized by constituted body( ies ), so that they become aware of their role and responsibilities.

18. REGULATION IECs register under Biomedical Research Authority.

19. Selection of Special Groups as Research Participants ii. Children I. Pregnant or nursing women iii. Vulnerable groups

20. Record keeping

21. THANK YOU