GCP & ETHICS COMMITTEES

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 PROCEDURESMandate • 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 PROCEDURESDecision 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 PROCEDURESDecision 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 PROCEDURESInterim 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 PROCEDURESRecord 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 PROCEDURESRecord 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. REVIEW PROCEDURESSPECIAL CONSIDERATIONS • Research involving children, pregnant & lactating women • Vulnerable subjects • Those with diminished autonomy • Commercialisation of research • International collaboration

19. Thank You