Information about Ethics committee

This slide contain information about the ethics committee.

1. Ethics committee Presented by Ankit verma (B.pharma) Clinical research coordinator 11-Apr-20 20

2. Ethics committee-Clinical research In India the concept of ethics committee was in 1980 by ICMR. Indian council of medical research(ICMR) Provided the guidelines for the formation of ethics committee. EC formed as a group of members including medical or scientific professionals along with non medical or non scientific professional/ person. EC also known as Review board. EC designated for the purpose of protecting the rights ,safety and well being of the subjects participating in clinical research. The board is responsible for the reviewing and approving the clinical research study protocol or its amendments. No study will be conducted in human anywhere in india without having prior ethics committee approval.

3. Type of Ethics committee Two types of ethics committee available in india Institutional ethics committee Independent ethics committee

4. Institutional Ethics Committee: It is formed by an institution that is a hospital/Research centre. It reviews the documents/protocols submitted by that institution for conducting clinical trials. It provides an unbiased opinion/approval about the proposed study from the research subjects point of view. It also perform ongoing review of the approved study at appropriate time intervals. Ethics committee consist of minimum of seven members and maximum of 15 members including chairman and member secretary. Ethics committee chairman should be from outside the institution. Apart from the Ethics committee members, subject experts can also be invited for the EC meetings for their advice but they won’t voting rights for taking the decision about the proposed study protocol. It is mandatory to obtain EC approval letter before initiating the study.   

5. It is not a part of any institution or hospital or research centre. It is an independent body without having any relationship with the institution. It reviews the submitted protocols from institutions and give the approvals to conducting the studies. Most important point is, at present IEC can only give approvals to the Bio availability/ Bio equivalence (BA/BE) studies of approved drugs. Except from these two things, ICE will act as same as Institutional Ethics Committee. At present, nearly 660 Ethics committees registered with Central Drugs Standard Control Organization (CDSCO) in India . From this, approximately 530 are Institutional Ethics Committees and remaining (130) are Independent Ethics Committees. Independent Ethics Committees (IEC):

6. Some EC around world Research ethics committee in the united kingdom Medical research ethics committee in the nether land Comates de protection des personas in France Institutional ethics board in Canada Human Research ethics committee in Australia

7. Five codes of ethics Integrity Objectivity Professional competence Confidentiality Professional behavior

8. What is an EC/IRB An independent body Made of medical professionals and non medical members Protect the participant & provide public assurance

9. What authority does EC/IRB have! It is required by law It is mandated by national & international guidelines Established by the institutions highest body Mandated to act independently

10. Who all should members! Reasonable number of member Collectively have qualification and experience to review and evaluate the proposed research. Science Medical aspects E thics

11. Composition as per schedule y Chairperson. 1-2 basic medical scientists(preferably one pharmacologist). 1-2 clinician from variation intuition. One legal expert or retired judge. One social scientist/ representatitve of non- governmental voluntary agency. Lay person from community.

12. EC basic medical scientist Who can be a basic medical scientist? Scientific Specialized or professional knowledge of subject matter(pharmacology) Qualification of an expert(MD-pharmacology)

13. EC lay person Who can be a lay person . Non scientific Non-Specialized or professional knowledge of subject matter(in this case bio medical research, health/medicine) No qualification of an expert Should be form the community/society served by the hospital

14. Why a lay person! What is a lay persons perspective? Safeguard the public interest To contribute a user perspective or patient voice’ to professional discussion. Review the ICF for language & understanding.

15. EC legal person Who can be a legal person? Non scientific Professional qualification to prectise law as per the requirement of the country. An expert in given field of knowledge(legal) Specialized or professional knowledge of subject matter (in this case knowledge of medico-legal cases)

16. Why have a legal person! What is a legal persons perspective? Ensure EC decision do not contravene the law Ensure the legal rights of patients are protected Review ICF Review insurance Review CTA(clinical trial approval)

17. EC social worker Who can be a social worker? Non scientific Social worker engaged with a NGO An expert in given field of knowledge(bioethics) Specialized or professional knowledge of subject matter(in this case knowledge of public health policy an societal risk/impact)

18. Why a social worker! What does SW person do? Is any project likely to cause any social harm?( eg -discrimination) Review ICF from to protect rights of participants Language understandable and help in decision making No harm due to socio-economic vulnerability Culturally acceptable No risk due to social hierarchy No language to undue influence participation. In case of vulnerable participant, help EC determine measure enhance protection.

19. What is the purpose of EC/IRB review! The primary purpose of such review is- “assure the protection” Right Safety of the human subjects welfare

20. What does an EC/IRB do? Reviewing and providing opinion on- Trial protocol Suitability of the investigator(s) Suitability of facilities Methods and material used in obtaning and documenting informed consent of trial subject. “ Make sure everything's done ethically within reason, of course.”

21. Quorum requirement for EC meetings A minimum of five member presented in the meeting room. The quorum should include both medical, non-medical or technical or/ and non-technical member Minimum one non-affiliated member should be part in accordance with current CDSCO requirements. No decision is valid without fulfillment of the quorum.

22. Quorum requirement for EC meetings A minimum of five member presented in the meeting room. The quorum should include both medical, non-medical or technical or/ and non-technical member Minimum one non-affiliated member should be part in accordance with current CDSCO requirements. No decision is valid without fulfillment of the quorum.

23. Types of decisions by EC approved – with or without suggestions or comments; • revision with minor modifications/amendments – approval is given after examination by the Member Secretary or expedited review, as the case may be; • revision with major modifications for resubmission – this will be placed before the full committee for reconsideration for approval; or • not approved (or termination/revoking of permission if applicable) – clearly defined reasons must be given for not approving/terminating/revoking of permission.

24. Documents to be maintained by EC for record Type of documents Document specifics Administrative documents Constitution and composition of the EC • Appointment letters • Signed and dated copies of the most recent curriculum vitae of all EC members • Signed confidentiality agreements • COI declarations of members • Training records of EC members • Financial records of EC • Registration/accreditation documents, as required •A copy of national and international guidelines and applicable regulations • Regulatory notifications

25. • Meeting-related documents • Agenda and minutes • All communications received or made by the EC • SOPs Proposal-related documents One hard copy and a soft copy of the initial research proposal and all related documents Decision letters • Any amendments submitted for review and approval • Regulatory approvals • SAE, AE reports

26. • Protocol deviations/violations • Progress reports, continuing review activities, site monitoring reports • All correspondence between the EC and researchers • Record of notification issued for premature termination of a study with a summary of the • Final report of the study • Publications, if any

27. Meeting The Chairperson will conduct all meetings of the Institutional Ethical Committee. If for reasons beyond control, the Chairperson is not available, an alternate Chairperson will be elected by the members present from among themselves The Member Secretary will be responsible for organizing the meetings, maintaining the records and communicating with all concerned. He/she will prepare minutes of the meetings and get them approved by the Chairperson before communicating to members and Principle Investigator. Chairman & member secretary are responsible for implementing this SOP. The Member Secretary in consultation with the chairman may convene the IEC meeting once in every three month. Additional review meeting can also be held with short notice as and when required. All members will receive notification of meeting schedules in advance of the IEC meetings, all the proceeding and deliberation will be documented. Applicant investigator may be invited to present the proposal or elaborate on specific issue.

28. Reference 1. 2. https:// www.slideshare.net /mobile/azherkhan5916 /ethics-commitee-141264056 3. https:// www.icmr.nic.in /sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf 4. IEC PIMS SOP JAN 2016

29. Thank you & Q/A