Transcript GCP & ETHICS COMMITTEES

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, 30Sep 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
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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
Thank You