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Institutional ethics committee.pptx

  1. U m a r F a r o o q u e S h a i k h 1 s t Y e a r M . S c C l i n i c a l R e s e a r c h Institutional Ethics Committee
  2. Learning Objective ▪ Introduction of Institutional Ethics committee (IEC) ▪ Composition of IEC ▪ Responsibilities of IEC ▪ Functions of IEC ▪ Maintenance of records IEC 2
  3. ▪ After the World War II, trial was conducted by 23 Nazi doctors and scientists at Nuremberg for the murder of concentration camp inmates who were used as research subjects. ▪ The code highlighted on the need for informed consent, prior animal work, qualified scientists, risk justification by anticipated benefits, avoidance of physical and mental suffering, death, or disabling injury. ▪ In Willowbrook Hepatitis Study (1956), children were deliberately infected with mild form of hepatitis, and consent was obtained from parents without informing about the risk invlove and giving the opportunity of school admission on participation in the study 3 Introduction : Evolution of Ethics Guidelines
  4. ▪ In 1963, Jewish Chronic Disease Study was conducted where cancer cells were inoculated in senile subject without proper explanation on risk. ▪ in view of the emerging situation, World Medical Association (WMA) General Assembly (Helsinki, Finland, 1964) developed a set of guidelines to safeguard the rights and well-being of subjects participating in clinical research. ▪ This is referred to as the Declaration of Helsinki and is revised from time to time, the last amendment in 64 WMA general assembly in Brazil, 2013. 4 Introduction : Evolution of Ethics Guidelines
  5. ▪ The declaration of WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.” ▪ The declaration specifically defines that the duty of the physician who are involved in medical research is to promote and safeguard the health, well-being, and rights of patients 5 Introduction : Evolution of Ethics Guidelines
  6. ▪ In a very shocking turn of events, unethical research conducted by the United States Public Health Service (Tuskegee Syphilis Study) surfaced in 1972. ▪ The sheer misconduct led the US government to set up ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the report (Belmont report) in 1979, which stressed on three basic ethical principles: autonomy, beneficence, and justice, and recently, two more pillars are added which includes confidentiality and honesty. ▪ In India Indian Council of Medical Research (ICMR) introduced “Ethical Guidelines for Biomedical Research on Human Subjects” last amendment on 2017. 6 Introduction : Evolution of Ethics Guidelines
  7. 7 Introduction : ICMR guidelines on IEC ▪ “It is mandatory that all proposals on biomedical research involving human participants to safeguard the welfare and the rights of the participants….” should be cleared by an appropriately constituted Institutional Ethics Committee (IEC) in India. ▪ The ethics committees are based at clinical or academic institutions and hospitals. ▪ Ethics committee ensures a competent review of all the ethical aspects of the project proposal submitted and does it free from any bias or external influence. In other country EC also knowns as ▪ Institutional Review Board (IRB) United States, ▪ Research Ethics Board (REB) Canada. ▪ Human Research Ethics Committee (HREC) in Australia
  8. ▪ Ethics Committees (EC) are multidisciplinary, independent groups of individuals appointed to review biomedical research protocols involving human beings to help ensuring the dignity, fundamental rights, safety, and well-being of research participants are protected. ▪ Number of persons: 7 -15 (Maximum of 15 members recommended) ▪ Quorum –minimum of 7 ▪ Chairperson. Out Side the Institution ▪ Member secretary. Associate of Institution ▪ One to two basic medical scientists (preferably one pharmacologist) ▪ One to two clinicians from various institutions 8 Composition of IEC
  9. ▪ One legal expert or retired judge ▪ One social scientist/representative of nongovernmental voluntary agency ▪ One philosopher/ethicist/theologian ▪ One lay person from the community . ▪ at least one member whose primary area of interest / specialization is nonscientific ▪ at least one member who is independent of the institution / trial site  Besides, there should be appropriate gender representation on the IEC.  If required, Subject experts may be invited to offer their views. 9 Composition of IEC
  10. Responsibilities of IEC  Safeguard the rights, safety, and well-being of all trial subjects  Reviews a proposed clinical trial within a reasonable time and document its views in writing  conducts continuing review of each ongoing trial at least once per year  Provide advice to the researchers on all aspects of welfare and safety of research participants  Ensures that information regarding payment to subjects(including the methods, amounts, schedule of payment) is set forth in the written informed consent form and any other written information is provided to the subjects 10
  11. Responsibility of IEC Members : Chairman ▪ A well-respected person from any background with prior experience of having served/serving in an EC. ▪ Conduct IEC meetings and accountable for functioning of the committee. ▪ Ensure active participation of all members (particularly non-affiliated, nonmedical) in all discussions and review. ▪ Handling of complaints against Investigators, IEC members, conflict of interest. ▪ Ratify minutes of mitting of the previous meetings. ▪ Review SAE reports with causality assessment and report accordingly. ▪ In case of anticipated absence of Chairperson and Vice Chairperson (optional) at a planned meeting, the Chairperson should nominate a committee member as acting Chairperson, or the members present may elect an acting Chairperson on the day of the meeting. 11
  12. ▪ Should be a staff member of the institution, 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 the institution. ▪ Organize an effective and efficient procedure for receiving, preparing circulating, and maintaining each proposal for review. ▪ Schedule IEC meetings . ▪ Organize IEC documentation, communication and archival. ▪ Arrange for training/refresher training of IEC members. ▪ Ensure SOPs are updated as and when required. ▪ Prepare for and respond to audits and inspections 12 Responsibility of IEC Members : Member Secretory
  13. ▪ Non-medical or medical person with qualifications in basic medical sciences. ▪ In case of EC reviewing clinical trials with drugs, the basic medical scientist should preferably be a pharmacologist. ▪ Scientific and ethical review on the intervention, benefit-risk analysis, research design, methodology and statistics, continuing review process, SAE, protocol deviation, progress, and completion report. ▪ For clinical trials, pharmacologist to review the drug safety and pharmacodynamics. 13 Responsibility of IEC Members : Basic Medical Scientist
  14. ▪ Should have a basic degree in Law from a recognized university, with experience. Desirable: Training in medical law. ▪ Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial Agreement (CTA), regulatory approval, insurance document, other site approvals, researcher’s undertaking, protocol specific other permissions. ▪ Interpret and inform EC members about new regulations if any. 14 Responsibility of IEC Members : Legal Expert
  15. Responsibility of IEC Members : Social scientist/ /social worker/ Philosopher/ethicist/theologian ▪ Ethical review of the proposal, ICD along with the translations. ▪ Assess impact on community involvement, socio–cultural context, religious or philosophical context, if any Serve as a patient/participant/ societal / community representative and bring in ethical and societal concerns. 15
  16. Responsibility of IEC Members : Lay person ▪ Representative of the community and aware of the local language, cultural and moral values of the community. Desirable: involved in social and community welfare activities. ▪ Assess on societal aspects if any 16
  17. Functions  Only members who participate in the IEC review and discussion should vote/provide their opinion or advise.  The IEC should perform its functions according to written standard operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement Maintaining current knowledge of application regulation, laws and institutional policies ▪ Conducting initial and continuing review of trials ▪ Determining the frequency of continuing review, as appropriate 17
  18. Functions ▪ Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IEC ▪ Specifying that no subject should be admitted to a trial before the IEC issues its written approval / favorable opinion of the trial. ▪ Specifying that the investigator should promptly report to the IEC. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects. ▪ Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial. 18
  19. Maintenance and recorded of IEC ▪ IEC retains all relevant records (e.g., written procedures, lists of occupations/affiliations of members, submitted documents, minutes of meetings, IEC Communication etc.) for a period of at least 5 years after completion of the trial and makes them available upon request from the regulatory authority ▪ IEC may be asked by investigators, sponsors, or regulatory authorities to provide copies of its written procedures and membership lists 19
  20. Mandatory Documents EC Should Review ▪ Protocol (for scientific rationale) ▪ Informed consent document (for the safety and welfare of research participants) ▪ Informed consent document’s vernacular translation ▪ Investigator brochure for information regarding clinical and nonclinical data of the investigational product ▪ Study advertisement for participant recruitment or any other written information to the patient ▪ Grants, payments, insurance documents. 20
  21. IEC changes as per new CT rules 2019 ▪ EC Application - Form CT-01, approval granted in Form CT-02 ▪ Constitution of EC : 1. One woman out of seven members 2. Preferably 50% external members - adequate age and gender 3. Any change - informed to CLA within 30 days 4. Any member not successfully completed training disqualified as member 21
  22. IEC changes as per new CT rules 2019 5. EC registration validity increased from 3 to 5 years. 6. EC approval - informed to CLA within 15 working days. 7. Site does not have its own Ethics Committee : obtain approval from independent EC or another site EC, locked with in same city or within radius of 50kms 22
  23. Thank You