GCP ETHICS COMMITTEES Ravi Rengachari Vector Control Research
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GCP & ETHICS COMMITTEES Ravi Rengachari Vector Control Research Centre PONDICHERRY
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, 30 Sep 2000
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
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) (
Appointment ¨ Authority by which appointed ¨ Membership requirements ¨ Terms of Reference ¨ Conditions of appointment
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
An IEC should demonstrate ¨ Competence ¨ Efficiency ¨ Independence ( from political, institutional, professional & market influences) ¨ Consistency
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
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
REVIEW PROCEDURES ¨ Submission of Application (? Deadlines) ¨ Decision making process ¨ Interim Review ¨ Record Keeping ¨ Special Considerations
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
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
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
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
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
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
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.
REVIEW PROCEDURES SPECIAL CONSIDERATIONS ¨ Research involving children, pregnant & lactating women ¨ Vulnerable subjects ¨ Those with diminished autonomy ¨ Commercialisation of research ¨ International collaboration
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