ICMR ethical guidelines for biomedical research .pptx

Icmr ethical guidelines and it’s parts

1. ICMR ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH Facilitated by – Dr. Mamta Bisnoi Dept. – Drug Regulatory Affairs. Delhi Pharmaceutical Sciences & Research University . Presented by – Himanshu Dhiran Roll No- 18/MRA/SPS/2021 1 st M. Pharm , Drug Regulatory Affairs.

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

3. INTRODUCTION The Indian Council of Medical Research (ICMR) issued the Policy Statement on Ethical Considerations Involved in Research on Human Subjects in 1980. Ethical Guidelines for Biomedical Research on Human Subjects was released in 2002 followed in 2006 and new guidelines were recently revised in 2017 as "National Ethical Guidelines for Biomedical and Health Research involving Human Participants” .

4. GUIDELINES Guidance on transfer of human biological material for research Dietary guidelines for Indians Cancer Management Guidelines Guidelines for Good Clinical Laboratory Practices Ethical Guidelines for Biomedical Research on Human Participants

5. DEVELOPMENT OF ICMR

6. SCOPE These guidelines are applicable to all biomedical, social and behavioral science research for health conducted in India involving human participants . The purpose of such research should be: directed towards enhancing knowledge about the human condition while maintaining sensitivity to the Indian cultural, social and natural environment. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results.

7. Sections of Indian council of medical research General Principles. General Ethical Issues. Responsible Conduct of Research. Ethical Review Procedures. Informed Consent Process. Vulnerability.

8. 1. STETEMENT OF GENERAL PRINCIPLES Essentiality. Voluntariness, informed consent and community agreement. Non- exploitation Social responsibility. Ensuring privacy & confidentiality. environmental protection Risk minimization. Professional competence. Maximization of benefit. Institutional arrangements. transparency and accountability.

9. 2.GENERAL ETHICAL ISSUES All research involving human participants should be conducted in accordance with the basic and general ethical principles as outlined in section 1. The researcher and the team are responsible for protecting the dignity, rights, safety and well-being of the participants enrolled in the study.

10. 2. GENERAL ETHICAL ISSUES Benefit-risk assessment Informed consent process. Privacy and confidentiality. Distributive justice. Payment for participation. Compensation for research-related harm . Ancillary (Supportive)care. Conflict of interest. Community engagement. Post research access and benefit sharing.

11. 3. Responsible Conduct of research . Values of Research . a. The scientist as a responsible member of society . b. Contemporary ethical issues in biomedical and health research. c. Sensitivity to societal and cultural impact of biomedical and health research. d. Mentoring. Policies. a. The protection of human participants. b. Animal experimentation.

12. 3. Responsible Conduct of research . Planning and conducting research – Specific Issues . a. Conflict of interest issues. b. Data acquisition, management, sharing and ownership. Reviewing and reporting research. Responsible authorship and publication. a. Authorship. b. Peer review.

13. 3. Responsible Conduct of research . Research misconduct and policies for handling misconduct. Registration with Clinical Trials Registry–India. Collaborative research. a. Ethical considerations in collaborative research. b. Responsibilities of ethics committees, researchers and institutions. c. International collaboration.

14. 4. Ethical Review Procedures . Terms of reference (TOR) for Ecs Special situations. Composition of an EC. Terms of reference for EC members Criteria for selection of members of an EC. Training . Roles and responsibilities of the EC. Submission and review procedures.

15. 4. Ethical Review Procedures . Full committee meeting. Review of multicentre research. Continuing review. Record keeping & archiving. Administration and management . Registration and accreditation of ECs

16. 5. Informed Consent Process . Requisites. Essential information for prospective research participants. Responsibility of researchers. Documentation of informed consent process. Electronic consent. Specific issues in Clinical trials. Waiver of consent. Re-consent or fresh consent. Procedures after the consent process. Special situations Consent for studies using deception

17. 6. Vulnerability. Principles of research among vulnerable populations. Additional safeguards/protection mechanisms. Obligations/duties of stakeholders Women in special situations. Children . Research involving sexual minorities and sex workers. Research among tribal population. Research involving individuals with mental illness or cognitively impaired/affected individuals.

18. 6. Vulnerability. Individuals who have diminished autonomy due to dependency or being under a hierarchical system. Patients who are terminally ill. Other vulnerable groups

19. REFERENCE https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf

20. THANK YOU