1. GCP & ETHICS COMMITTEES Ravi Rengachari Vector Control Research Centre PONDICHERRY

2. 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

3. 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

4. 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)

5. Appointment  Authority by which appointed  Membership requirements  Terms of Reference  Conditions of appointment

6. 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

7. An IEC should demonstrate  Competence  Efficiency  Independence ( from political, institutional, professional & market influences)  Consistency

8. 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

9. 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

10. REVIEW PROCEDURES  Submission of Application (?Deadlines)  Decision making process  Interim Review  Record Keeping  Special Considerations

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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.

18.  Research involving children, pregnant & lactating women  Vulnerable subjects  Those with diminished autonomy  Commercialisation of research  International collaboration REVIEW PROCEDURES SPECIAL CONSIDERATIONS

19. Thank You