Workshop on Capacity Building of Ethics Committees for Clinical Research in India 08 April 2015, PIMS, Puducherry

Transcription

1 Objective: To strengthen the knowledge about the requirements for ethical conduct, review of study documents, statistical fundamentals, and reporting and analysis of serious adverse events during clinical trials in accordance with the good clinical practices and current regulatory requirements in India, thereby making Ethics Committee accreditation ready. Expected Outcomes: By the end of this workshop, the participants will: 1. Understand the ethical principles governing clinical research 2. Understand the individual roles and responsibilities of different members of the EC 3. Understand how to review a protocol and informed consent documents prior to approval according to the individual expertise 4. Understand the need for and processes for accreditation of ECs Target Audience for the Workshop: o All ethics committee members from medical instititutions/hospitals Page 1 of 9

2 Course Director: Guest of Honour: Course Co-directors: Dr. J P Muliyil Former Principal, Christian Medical College, Vellore. Chairperson, CReATE Steering Committee. TBD Dr. Y. K. Gupta Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India. Head, CReATE centre for Pharmacovigilance. Dr. Urmila Thatte Secretary, Forum for Ethics Review Committees in India (FERCI). Head, CReATE centre for Ethics. Dr. L. Jeyaseelan Professor and Head, Department of Biostatistics, Christian Medical College, Vellore. Head, CReATE centre for Data Management. Dr. R. M. Pandey Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India. Dr. J P Muliyil Workshop Faculty Former Principal, Christian Medical College, Vellore. Chairperson, CReATE Steering Committee Dr. Y.K. Gupta Dr. Vasantha Muthuswamy Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India. Head, CReATE Centre for Pharmacovigilance President, Forum for Ethics Review Committees in India (FERCI) Retd. Senior Deputy Director General and Chief of the Division of Basic Medical Sciences, Traditional Medicine and Bioethics, and the Division of Reproductive Health and Nutrition, of the Indian Council of Medical Research, New Delhi Vice President, Forum for Ethics Review Committees in India (FERCI). Former Deputy Director General Senior Grade (ICMR). Page 2 of 9

3 Dr. Urmila Thatte Dr. RM Pandey Dr. L. Jeyaseelan Dr. Vijay Prakash Mathur Dr. Shoibal Mukherjee Dr. Siddharth Deshpande Dr. Prafull Mohan Dr. Pooja Gupta Mr. Alishan Naqvee Secretary, Forum for Ethics Review Committees in India (FERCI) Head, CReATE centre for Ethics. Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India. Professor and Head, Department of Biostatistics, Christian Medical College, Vellore. Head, CReATE Centre for Data Management. Additional Professor, Pedodontics and Preventive Dentistry, Centre for Dental Education and Research. Member Secretary- Institute Ethics Sub Committee All India Institute of Medical Sciences, New Delhi Independent Professional & Research Consultant Assistant Professor, Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai. Senior Resident, Department of Pharmacology, AIIMS, New Delhi Assistant Professor, Department of Pharmacology, AIIMS, New Delhi Partner at Lex Counsel, Law Offices Moderator for the workshop: Dr. Vivek Ahuja Director- Research & Development, PATH, India Page 3 of 9

4 Workshop Agenda Day 1- April 06, 2015 (Monday) Session 1: Workshop Begins Time Topic Speaker :30 Assemble in the conference hall 08:30 08:40 Welcome address Dr. JP Muliyil 08:40 08:50 Welcome address Dr. Anil J Purty Professor of Community Medicine & Registrar, PIMS, Puducherry 08:50 09:05 Introduction to the workshop Dr. YK Gupta 09:05 09:15 PATH in India Dr. Vivek Ahuja Session 2: Regulations and Guidelines for Clinical : Focus on requirements and responsibilities Session Chair: Dr. JP Muliyil 09:15 10:00 Guidelines and regulations for clinical research in India Dr. Y K Gupta 10:00 10:30 Conflict of Interest Dr. Vasantha Muthuswamy 10:30 11:50 Group Exercise: Identifying the Role and Responsibilities of each member of an Ethics Committee Briefing by Faculty (~5 min) Group exercise (~20 min) Discussion (~55 min) Participants will be divided into 10 groups and each group will be assigned a role. Each group will be given an anonymized protocol to review and asked to list the documents that are required to be reviewed in the next EC meeting as per their defined roles in the EC. (1. basic scientist/pharmacologist, 2. clinician (pediatrician who is also the PI), 3. clinician Dr. Urmila Thatte and Page 4 of 9

5 (endocrinologist), 4. lay person, 5. lawyer, 6. member secretary, 7. chairperson, 8. legal person, 9. social worker and 10.Secretariat - Describe your role during initial review of the protocol till it is approved - Identify at least one document which your roles should definitely review This exercise will also include to identify what is expected from principal investigator of the study. Tea will be served during the session. Session 3A: Regulations and Guidelines for SAE (Serious Adverse Event) in India Session Chair: Dr. YK Gupta 11:50-12:15 Legal angle in clinical research Mr. Alishan Naqvee Group exercise (Case studies) on Causality assessment (Case studies/narratives will be shared and participants will mark their causality assessment, following which these will be discussed) Dr. Pooja Gupta 12:45-13:00 Demonstration of pharmacovigilance software for ECs Dr. Prafull Mohan 13:00-14:00 Lunch Session 3B: Regulations and Guidelines for SAE (Serious Adverse Event) in India Session Chair: Dr. YK Gupta Group exercise (Case studies) to determine compensation in clinical trial (Case studies/narratives will be shared and participants will mark their causality assessment, following which these will be discussed) Dr. Prafull Mohan 14:45 15:15 Tea Break Session 4: Principles of Good Clinical Practice (GCP) Session Chair: 15:15-15:45 Principles of Good Clinical Practice Dr. Shoibal Mukherjee Page 5 of 9

6 15:45 16:30 Interactive session (Queries from participants will be addressed by panel on stage) On stage Panel: Dr. Shoibal Mukherjee Dr. YK Gupta Dr. Urmila Thatte Dr. L Jeyaseelan Dr. RM Pandey 16:30 17:00 Role of sub-committee in handling SAE Dr. Vijay Prakash Mathur 17:00 17:15 Homework: Review of case studies pertaining to various aspects of ethical research. (Each participant will be given a print of case studies and asked to review and list their comments to be presented in Day 2. Participants will be divided into groups [as divided earlier] and a presenter will be identified by each group). End of Day 1 All participants Time Event 19:00-21:30 Dinner for all participants at Hotel Ocean Spray Page 6 of 9

7 Day 2- April 07, 2015 (Tuesday) Time Topic Speaker Session 5: Three Parallel Sessions Parallel Session: 1.Technical person: Biostatistics 2. Legal person: Requirements for legal review 3. For Layperson, Social worker and other nontechnical persons: Ethical review of protocol and informed consent document Session Chair: Dr. Shoibal Mukherjee 9: Speaker: Dr. L Jeyaseelan Impact of study design on statistical analysis and sample size calculation 09:45 10:30 Presenter: Dr. L Jeyaseelan Dr. RM Pandey Practical exercises for reviewing protocols with respect to biostatistics 10:30 10:45 Presenter: Dr. L. Jeyaseelan Software Demonstration Biostatistics and Data management Speaker: Mr. Alishan Naqvee Topics covered: 1. Clinical trial Agreement, 2. Indemnification, 3. Insurance and other laws governing clinical research Q&A Speaker: Dr. YK Gupta Topics covered: How to do an ethical review of protocol and informed consent document by a lay person. Risk vs. benefit Enrollment process. Confidentiality Medical management of SAE Subject compliance Inducement Q&A 10:45-11:15 Tea Break Session 6: Review of a Research Protocol Session Chair: Dr. JP Muliyil Page 7 of 9

8 Ethical and scientific review of a protocol. Group exercise: Review of a case studies pertaining to various aspects of ethical research. 5 min each presentation by Group Presenter and discussion 13:00-14:00 Lunch Dr. YK Gupta Dr. Urmila Thatte Session 7: Informed Consent Process Session Chair: Dr. Vasantha Muthuswamy 14:00-15:00 Video presentation: Appropriate and inappropriate consenting process 15:00-15:30 Case Studies: Informed Consent Form (Relevant case studies pertaining to ICF will be presented). Dr. Siddharth Deshpande Dr. Pooja Gupta Dr. Prafull Mohan 15:30 16:00 Tea Break 16:00-16:30 Post approval continued oversight of the study: Responsibilities of and Ethics Committee 16:30-17:00 Demo of Software for Ethics Dr. Siddharth Deshpande End of Day 2 Page 8 of 9

9 Day 3- April 8, 2015 (Wednesday) Time Topic Speaker Session 8: Accreditation of Ethics Committee Session Chair: Dr. Vasantha Muthuswamy 09:00 09:30 Background of accreditation of ethics committees, sites and investigators Dr. YK Gupta 09:30-10:00 Mechanism of accreditation 10:00 11:45 Group Exercise: Requirements for Standard Operating Procedures Hands on assessment of anonymized SOPs of participating ECs by the participants. Each group will review an anonymized set of SOP and identify the gaps. These will be discussed. 11:45 12:00 Post workshop questionnaire Dr. Urmila Thatte and 12:00-12:15 Vote of Thanks 12:15 Lunch followed by journey back End of Workshop Page 9 of 9