IEC & Video recording in clinical trials.pptx

Institutional Ethics Committee

1. Institutional Ethics Committee (IEC) & Video recording in clinical trials Dr. Keerthi Rajan M Junior Resident - 2 Dept. of Pharmacology & Therapeutics King George’s Medical University

2. Learning Objectives What is IEC? Why it was formed? For clinical trials, BA/BE studies For biomedical or health research Responsibilities & functions IEC meetings Video recording in clinical trials

3. Introduction Independent body with medical, non-medical, scientific & non-scientific members For protection of rights, safety & well-being of human subjects Reviewing, approving and conducting continuous review of trial protocols & amendments To maintain 4 pillars of medical ethics

4. Person’s right to make choices and hold views There should be obligations of not to harm intentionally Treat and provide care equally to all patients All choices for a patients are made with the intent to do good Pillars of Medical Ethics

5. EC for clinical trials, BA/BE studies Minimum of 7 members 50% should be non-affiliated Safeguard rights, safety, well-being of participants Undergo training as specified by Central Licensing Authority (CLA) If any changes, to be intimidated within 30 days

6. Proceedings At least 5 members should be present Review of protocol/documents related to clinical trials, BA/BE studies One or more sub committees Subject experts can give opinions, but can’t do voting

7. EC for Biomedical & Health research In accordance with National Ethical Guidelines from ICMR Registration under rule 16 of NDCT rule 2019, with the Dept. Of Health research, MOHFW, GOI, as per rule 17 Members should have training certificate in human research and GCP, if not should submit within 6 months

8. Constitution Chairperson/Vice-chair Not affiliated to the Institute, have prior experience in an EC Member Secretary Affiliated to the Institute, experience in clinical research & ethics Basic Medical Scientist Medical/non-medical person knowledge & experience in research Clinicians Both affiliated & non-affiliated Legal expert Basic degree in law with experience Independent member Social scientist / Philosopher / Ethicist / Theologian / NGOs Lay person Literate person from community

9. IEC-KGMU Registration no. : ECR/262/Inst/UP/2013/RR-19 Present IEC members appointed on 22 nd March 2024 For a period of 3 years Prof. Hardeep Singh Malhotra is the present Member secretary Last IEC meeting held on 27 th November, 2024

10. Structure Name Designation Chairperson Dr. J. S. Srivastava Former deputy director, CDRI, Lucknow Senior Clinicians of University Dr. D. N. Upadhaya Prof., Dept of Plastic Surgery Dr. Sujita Kar Additional Prof., Dept of Psychiatry Prof. Rajeev Kumar Singh Prof. & Head, Dept of Pediatric & Preventive Dentistry Senior Clinicians (Non affiliated) Dr. Amit Goel Prof. & Head, Dept of Hepatology, SGPGIMS Dr. Pradeep Maurya Prof.(Jnr grade), Dept of Neurology, RMLIMS Dr. Ritu Karoli Prof.(Jnr grade), Dept of Medicine, RMLIMS

11. Basic Medical Scientist of the University Dr. Riddhi Jaiswal Prof., Dept of Pathology Dr. Kaleem Ahmad Additional Prof., Dept of Biochemistry Dr. Rahul Kumar Additional Prof., Dept of Pharmacology Basic Medical Scientist Non-affiliated Prof. Girdhar Gopal Agarwal Former Head, Dept. Of Statistics, Lucknow University Legal Expert Hon. Justice Ritu Raj Awasthi Chairperson, Law Commission of India Social scientist Mr. Jayant Krishna CEO, Foundation of Advancing Science & Technology Lay person Prof. Meenakshi Pahwa Former Prof., Dept. Of English, Lucknow University Member Secretary Prof. Hardeep Singh Malhotra Dean, Research & Development

12. Scientific review Ethical review Decision making process Documentation Responsibilities & functions

13. 1. Scientific review Done before ethical review Screening based on risk Expedited review - with minimal risk like study on drugs and devices already approved Full review - with more risk like those involving vulnerable population Exempted review - less risk like educational practices research

14. 1. Scientific review Periodic review - regular intervals of 6 months to 1 year Continuing review - for any new info, ADEs, regular follow-up Interim review - sub committee review in some special cases, then re examined by IEC Risk & benefits, privacy, confidentiality, justice issues are addressed

15. 2. Ethical review Scientific design and conduct of study Recruitment of research participants Care and protection of participants Informed consent process

16. 2.1. Scientific design & conduct of study Appropriateness of study design Methodology, sample size calculation Risk vs benefits, justification for controls, withdrawal criteria Monitoring & auditing conduct of the research Site facilities for emergencies Reporting & publication issues

17. 2.2. Recruitment of research participants Inclusion criteria Exclusion criteria Study population - demographic characteristics Means by which contact and recruitment are made Means by which full information conveyed

18. 2.3. Care and protection of participants Investigator qualification & experience Medical care to participants, medical supervision Voluntary withdrawal of participants Insurance & indemnity arrangements Confidentiality Conflict of interest if any

19. 2.4. Informed consent process Adequacy, completeness and understandability of written & oral information given Clear justification to include participants who cannot consent Assurance that participants will receive any new info if available Contact details for complaints or queries

20. 3. Decision making process If required, PI to present the protocol / offer clarifications Opinions of representative from interest groups Collective decision is made Outright approval, Approval with modifications, Resubmit with more info, outright disapproval

21. 4. Documentation Meetings must be minuted, approved, signed by chair All documents are strictly confidential Maintained till 5 years even after completion of study

22. Documents to be submitted Trial protocol Patient information sheet & Informed consent form Investigator’s brochure Principal investigator’s current CV Insurance policy/ compensation Investigator’s agreement with sponsor

23. Requirements of IEC meeting Minimum of 5 members Medical, non-medical, technical, non-technical Minimum 1 non-affiliated member One lay person Decision invalid if above criteria not fulfilled

24. Steps in IEC meeting

25. Video recording in clinical trials Audio Visual (AV) recording of informed consent made mandatory on 21 st Oct 2013 To ensure the participants are adequately informed About risks, benefits, challenges, chances of failure of investigational medicinal product (IMP) Recent guidelines effective from 1 st May 2019

26. Requirements for AV recording Principal investigator, Co-Investigator or any suitably qualified member is responsible Legally acceptable representative (LAR) if participant is unable to give consent for any reasons An impartial witness for entire process, if both are illiterate AV recording done wherever applicable

27. Requirements Conditions to be - Free from disturbance & comfortable Camera with - Good resolution, Sufficient memory, battery back up Show non-editable date & time Mike system, Computer/laptop with CD/DVD writer, External Hard disk

28. Process PI/Co-I and participant/LAR sit, introduce, language chosen Participant/LAR should state that they know about AV recording done Informed about purpose, treatment allotment, randomization, procedure, follow up, benefit/risks, compensation for participation/ study related Injury, nominee name and details, voluntariness and right to withdraw and contact for enquiries

29. Process Participant/LAR should read out all the statements mentioned in ICF Signing by both sides also recorded Recording checked for completeness, clarity The computer/laptop should be password protected Recordings transferred to CD/Hard disk, then archived

30. Summary IEC protects safety and well being of human participants in a research At least 7 members, 50% non-affiliated Present IEC KGMU from March 2022 Reviews and approves protocols Video recording mandatory for informed consent process

31. References Sarkar S, Srivastava V, Mohanty M. Postgraduate Pharmacology. 2nd ed. Hyderabad: Paras medical publisher; 2024. 287–291 p. Mathur R. Indian council of medical research 2017 national ethical guidelines for biomedical and health research involving human participants. 2017. Available from: www.icmr.nic.in New Drugs & Clinical Trial Rules, 2019 Available from: www.cdsco.gov.in ICMR-NIRRH Ethics Committee for Clinical Studies 5.0 Audio-Visual (AV) Recording of Informed Consent Process Title Available from: www.nirrch.res.in

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