ICMR'S ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH.pptx

ICMR'S ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH

1. ICMR'S ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH Presented By: Hitesh S. Sonawane Course:1 st Yr M. Pharm (Regulatory Affairs) 1 Submitted to: Dr. Pankaj P. Nerkar (HOD Regulatory Affairs)

2. ICMR Indian Research Fund Association (IRFA) 1911 Indian Council of Medical Research (ICMR) 1949 2

3. CONTENT 3

4. INTRODUCTION The Indian Council of Medical Research (ICMR), New Delhi , the apex body in India for the planning , formulation , co-ordination , implementation and promotion of biomedical research, is one of the oldest medical research bodies in the world. 4

5. AIM AND OBJECTIVES ICMR promotes biomedical research in the country through intramural research (through its own Institutes / centre's) and extramural research (through grants-in-aid given to projects in non-ICMR Institutes. ICMR’S 26 National Institutes address themselves to research on specific health topic like TB Leprosy Cholera and Diarrheal diseases 5

6. STATEMENT This statement of Ethical Guidelines for Biomedical Research on Human Participants shall be known as the ICMR code and shall consist of the following:- (a) Statement of General Principle on Research using Human Participants in Biomedical Research. (b)Statements of Specific Principles on Research areas of Biomedical Research. 6

7. General Principles 7 Essentiality Professional competence Maximization of benefit Voluntariness Non-exploitation Institutional arrangements Social responsibility Transparency and accountability Ensuring privacy and confidentiality Totality of responsibility Risk minimization Environmental protection

8. STATEMENT OF General Principles PRINCIPLE OF ESSENTIALITY: Human Participation is essential PRINCIPLE OF VOLUNTARINESS: Right to abstain from further participation Before medical research person to informed about the agreement PRINCIPLE OF NON-EXPLOITATION: Payment should be given for their involvement. Participants must inform towards all danger. 8

9. PRINCIPLE OF PRIVACY AND CONFIDENTIALITY: Identity and records of participants are kept confidential. PRINCIPLE OF PRECAUTION AND RISK MINIMISATION: Do care and precaution is taken at all stages. Participants put to minimum risk PRINCIPLE OF PROFESSIONAL COMPETENCE: Conducted by the competent and qualified person. 9

10. PRINCIPLE OF TRANSPARENCY AND ACCOUNTABILITY: Experiment will be conducted in a fair, honest and transparent manner. PRINCIPLE OF MAXIMIZATION OF BENEFIT: Conduct the research in such way directly and indirectly maximize the benefits to the participants. PRINCIPLE OF INSTITUTIONAL ARRANGEMENTS: Take the responsibility to facilitate research by providing required infrastructure, manpower, funds and training opportunities. 10

11. PRINCIPLE OF SOCIAL RESPONSIBILITY: Avoid creation or deepening of social and historic divisions or in any way disturb social harmony in community relationships. PRINCIPLE OF TOTALITY OF RESPONSIBILITY: The professional, social and moral responsibilities compliant with ethical guidelines and related regulations are binding on all stakeholders directly or indirectly. PRINCIPLE OF ENVIRONMENTAL PROTECTION: Ensuring protection of the environment and resources at all stages of the research 11

12. GENERAL ETHICAL ISSUES Informed Consent Process Protects the individual’s autonomy to freely choose whether or not to participate in the research. It contains medical terminology in simple terms that can understand to the participant. Benefit-risk assessment Justify the risk, which is the probability of causing discomfort or harm anticipated as physical, psychological, social, economic or legal. 12

13. Compensation for Participation: It includes travel expenses, time spent, food supplies. Additional medical service. Conflict of interest: It is a condition where professionals judgement concerning primary interest such as participant welfare and influenced by secondary interest financial or non financial , personal , academic , political. 13

14. ETHICAL REVIEW PROCEDURE Basic Responsibilities To protect the dignity, rights and well being of the potential research participants. EC should ensure that privacy of individual participants data is protected. 14

15. COMPOSITION OF ETHICAL COMMITTEE Chairperson One-two from basic medical science One-two clinicians One legal expert or retired judge One social scientist One philosopher/ ethicist /theologian One lay person from the community Member secretary 15

16. TRAINING The EC members should 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 so that they become aware of their roles and responsibilities. 16

17. VULNERABILITY The word vulnerability is derived from the Latin word vulnarere which means ‘ to wound ’. Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their own interests because of personal disability; environmental burdens; social injustice; lack of power, understanding or ability to communicate or are in a situation that prevents them from doing. 17

18. REFERENCE https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Gudeilines_2017.pdf 18

19. THANK YOU