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GCP & ETHICS COMMITTEES Ravi Rengachari Vector Control Research Centre PONDICHERRY
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If you are a member of an Ethics Committee…………………. Determining what is ethical goes beyond merely following prescriptions and requires moral reasoning: consideration of all relevant aspects of the case in its context, weighing and balancing competing moral requirements, and developing justifiable conclusions. Benatar & Singer, BMJ, 321, 30Sep 2000
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COMPOSITION OF THE IEC (ICMR Guidelines 2000) Multi-disciplinary, multi-sectoral Minimum 5 members, preferably not more than 12- 15, ( Balanced age & gender distribution) Quorum of 5 at least (? 50%) Chairperson from outside the Institute Member Secretary from within
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COMPOSITION OF THE IEC (ICMR Guidelines 2000) Suggested mix: Basic medical scientists, clinicians, legal expert, social scientist/ NGO rep, philosopher/ethicist/theologian, Lay member Additional members co-opted as per need ( specialists, specific communities, patient groups etc)
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Appointment Authority by which appointed Membership requirements Terms of Reference Conditions of appointment
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Responsibilities of an IEC To protect the dignity, rights and well being of potential research participants To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs To assist in the development and education of a research community responsive to local health care requirements
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An IEC should demonstrate Competence Efficiency Independence ( from political, institutional, professional & market influences) Consistency
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REVIEW PROCEDURES Mandate Review new proposals –Risk / benefit assessment –Consent procedures, confidentiality, justice issues to be looked into Evaluate progress of ongoing studies ( annual, more frequently if required); (see that no harm is caused to research subjects) Assess Final Reports ( look at post-trial benefit issues, commercialisation etc) NOTE: IEC should have SOPs for each of the above ? Multi-centre Trials
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BASIC ETHICAL REVIEW PROCEDURES Scientific review must be done before ethical review All biomedical research proposals involving human subjects must be reviewed and cleared by an appropriately constituted IEC or IRB, before initiating the studies Review only in formal meetings and not through circulation IEC should also continuously monitor the study to ensure that ethical guidelines are followed
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REVIEW PROCEDURES Submission of Application (?Deadlines) Decision making process Interim Review Record Keeping Special Considerations
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REVIEW PROCEDURES What to look for in an Application ?Format Project protocol in full ( justification for study, objectives, methods, I/E criteria, recruitment procedures, statistical considerations, Consent Forms/procedures, Safety information on interventions to be used) CV of investigator(s); Institutional facilities Source of funding for study; agreements relating to publication of results Confidentiality procedures
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REVIEW PROCEDURES What to look for in an Application Data Handling Procedures Procedures for handling adverse events Proposed arrangements for compensation/ reimbursements Clearances from Regulatory Authorities Willingness to comply with national/international GCP protocols Statement on probable ethical issues, and how these will be addressed
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REVIEW PROCEDURES Decision making process Decision by consensus, to be communicated in writing, and in detail Conflicts of interest to be addressed, if any Reasons for decision to be recorded Reversing a decision or discontinuing a trial possible, if good & sufficient reasons exist. Consider any amendments to protocol, adverse events, new information likely to influence study etc
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REVIEW PROCEDURES Decision making process Investigator &/or patient /interested parties may be asked for inputs Subject experts may be invited, and opinions recorded. Decisions to be taken only in the absence of non-members. Minutes
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REVIEW PROCEDURES Interim Review How & When? Each IEC to decide for itself, the procedure & mechanism Why? To re-examine a proposal To check if there is any valid scientific or ethical reason to suspend or terminate a study Expedited Review
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REVIEW PROCEDURES Record Keeping Documents to be dated, filed & preserved Constitution & composition of the IEC CVs of all members SOPs of the IEC National & International Guidelines Copies of protocols submitted to IEC All correspondence with IEC members & investigators reg: application, decision and follow-up Agenda of all IEC meetings
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REVIEW PROCEDURES Record Keeping Minutes of all IEC Meetings with Chairperson’s signature Copies of decisions communicated to applicants Record of notifications issued for premature termination of a study with reasons Final Reports of studies with microfilms,CDs and video recordings. Records to be maintained for at least 15 years ( if not permanently), after completion/termination of study.
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Research involving children, pregnant & lactating women Vulnerable subjects Those with diminished autonomy Commercialisation of research International collaboration REVIEW PROCEDURES SPECIAL CONSIDERATIONS
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Thank You
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