Role and responsibility of ec members

Role of Ethics committee members in clinical research.
Please give your suggestions if any needed.

1. Role and Responsibilities of EC members Mr. Vinendrasinh Parmar Ph. D Research Scholar 1

2. Outline Introduction Compositions Quorum Steps in EC Role and responsibilities References 2

3. INTODUCTION: IRB: ICH GCP 1.31: an independent body constituted of medical, scientific and non-scientific members whose responsibility to ensure the protections of right, safety, and well being of human subject involved in a clinical trial , or among other things, reviewing, approving, and providing continuing review of clinical trail protocols and its amendments, methods and material to be used in obtaining and documenting informed consent of the trial subjects. 3

4. Composition 8-12 members Chairperson One-two persons from basic medical science area One-two clinicians from various institutes One legal expert One social scientist/ representative NGO One philosopher/ ethicist/ theologian One lay person from community Member secretary 4

5. Quoram as per schedule Y Basic medical scientist Clinician Legal expert social scientist/ philosopher/ ethicist/ theologian Lay person 5

6. Steps in EC review: 6

7. Chairperson: Qualifications: A well respected person from any background with prior experience of having served/ serving an EC Role: Conduct an EC meeting and be accountable for independent and efficient functioning of the committee. Enumerate active participation of all members(particularly non-affiliated, non-medical, non-technical) in all discussion and deliberations Ratify minutes of the previous meetings 7

8. In case of anticipated absence of both chairperson and vice-chairperson at a planned meeting, a chairperson should nominated a committee member as acting chairperson or members present may elect an acting chairperson on the day of meeting. The acting chairperson should be non affiliated person and will have all power of chairperson for that meeting. Seek COI declaration from members and ensure quorum and fair decision making Handle complaints against researches, EC members, conflict of interest issues and requests for use of EC data etc. 8

9. Member secretary: Qualifications: Should be a staff member of the institution. Should have knowledge and experience in clinical research and ethics, be motivated and have good communication skills. Should be able to devote adequate time to this activity which should be protected by institution. 9

10. Role: Organize an effective and efficient procedure for receiving, preparing, circulating and maintaining each proposal for review. Schedule EC meeting, prepare the agenda and minutes. Organize the EC documentation, communication and archiving. Ensure training of EC secretarial and EC members. Ensure SOPs are update as and when required. Ensure adherence of EC functioning to the SOPs. 10

11. Prepare report and response to audits and inspections. Ensure completeness of documentation at the time of receipt and timely inclusion in agenda for EC review. Assess the need for expedited review / exemption from review or full review. Assess the need to obtain prior scientific review, invite independent consultant, patient or community representative. Ensure quorum during the meeting and record discussions and decision. 11

12. Basic medical scientist: Qualifications: Non-medical or medical person with qualification in basic medical science. In case of EC reviewing clinical trial with drugs, the basic medical scientist should preferably be a Pharmacologist. 12

13. Role: Scientific and ethical review with special emphasis on the intervention, benefit-risk, analysis, research design, methodology and statistic, continuing review process, SAE, protocol deviation, progress, and completion report. For clinical trials, pharmacologist to review the drug safety and pharmacodynamics 13

14. Clinician (s): Qualifications: Should be individual/s with recognized medical qualification, experience, expertise and training. 14

15. Role: Scientific review of protocol including review of the intervention, benefit-risk analysis, research design, methodology, sample size, site of study and statistics. On going review of protocol (SAE, protocol deviations, or violations, progression and completion of report) Review of medical care and facility, appropriateness of principal investigator, provision for medical care, management and compensation. Thorough review of protocol, investigator brouchure (if applicable), and all other protocol details and submitted documents. 15

16. Legal expert: Qualifications: Should have basic degree in Law from a recognized university, with experience. Training in medical Law. 16

17. Ethical review of proposal, ICD, along with transitions, MoU , clinical trial agreement (CTA), regulatory approval, insurance document, other site approvals, researchers understanding, protocol specific other permissions, such as , stem cell committee from stem cell research, HMSC for international collaboration, compliance with guideline etc. 17

18. Social scientist/ Philosopher/ethicist/theologian: Qualifications: Should be an individual with social/ behavioral science/ philosophy/ religious qualification and training and / or expertise and and be sensitive to local cultural and moral values. Can be NGO involved in health-related activities. 18

19. Role: Ethical review of the proposal, ICD along with the translations. Assess impact on community involvment , socio-cultural context, religious, or philosophical context, if any 19

20. Lay person(s) Qualifications: Literate person from the public or community. Has not pursued a medical science/ health-related career in the last 5 years May be representative of the community from which the participants are to be drawn Is aware of local language, cultural and moral values of community. Desirable involved in social and community welfare acivities 20

21. Role: Ethical review of the proposal, ICD along with translation. Evaluate benefits and risk from the participants perspective and opine whether benefit justify the risk Serve as a patient/ participant/ community representative and bring in ethical and societal concerns. Assess on societal aspects if any. 21

22. References: Schedule Y Ethical Guidelines for Biomedical Research on Human ICMR 22

23. Any questions? 23

24. THANK YOU…! 24