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Ethics committee
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- 2. 1. What constitutesan EC? 2. What is its authority? 3. Who all are members? 4. What are their roles? 5. What does EC review? Understanding EC!
- 3. Institutional Review Board(IRB) An independent body constituted of medical, scientific, and non scientific members, whose responsibility it is to ensure the protection of the rights, safety, and wellbeing of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
- 4. Research EthicsCommittee (REC) in the United Kingdom Medical Research Ethics Committee (MREC) in the Netherlands Comités de Protection des Personnes (CPP) in France Institutional Review Board in United States Research Ethics Board (REB) in Canada Human Research ethics committee (HREC) in Australia Some EC/IRB around world
- 5. What is anEC/IRB! An independent body Made of medical professionals and non- medical members Protect the participant & provide public assurance
- 6. What authority doesEC/IRB have! It is required by law It is mandated (give someone authority) by national & International guidelines Established by the Institutions highest body Mandated to act independently
- 7. Who all shouldbe members! Reasonable number of members Collectively have qualifications and experience to review and evaluate the proposed research Science Medical aspects Ethics
- 8. ChairpersonMember Secretary PI Legal Expert Basic Scientist (Post Grad.) MedicalSpecialist (Post Grad.) Lay person Social Worker/ Theologist/ philosopher External Subject Expert Inside the institution Outside the institution Composition as per Schedule Y
- 9. EC- Basic Medical Scientist Whocan be a Basic Medical Scientist? Scientific Specialized or professional knowledge of subject matter (Pharmacology)* Qualification of an expert (MD- Pharmacology)*
- 10. EC- Lay Person Who canbe a lay person? • Non Scientific • No Specialized or professional knowledge of subject matter (in this case bio medical research, health/medicine)* • No qualification of an expert • Should be from the community/society served by the hospital
- 11. Why a layperson! What is a Lay person’s perspective? Safeguard the public interest To contribute a user perspective or ‘patient voice’ to professional discussions Review the ICF for language & understanding
- 12. EC- Legal Person Who canbe a legal person? Non Scientific Professional Qualification to practice law as per the requirements 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)
- 13. Why have alegal person! What is a Legal person’s perspective? Ensure EC decisions do not contravene the law Ensure the legal rights of patient are protected Review ICF Review Insurance Review CTA (Clinical trail approval)
- 14. EC- Social Worker Who canbe 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 and societal risk/impact)
- 15. Why a Socialworker! What does a 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 will 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 cases of vulnerable participants, help EC determine measures to enhance protection
- 16. What is thepurpose of EC/IRB review! The primary purpose of such review is – “ Assure the protection” Rights Safety Welfare of the human subjects
- 17. What does anEC/IRB do? Reviewing and providing opinion on- • Trial protocol • Suitability of the investigator(s) • Suitability of facilities • Methods and material used in obtaining and documenting informed consent of trial subjects
- 18. • First patientin • Number of subjects recruited/ withdrawn • Investigator to promptly report- o Deviations from protocol o New safety information o Any increased risk to participants/ unanticipated problems o Serious & unexpected AE o Complaints from subjects What does the EC/IRB do?
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