GCP

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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 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

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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 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

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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

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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

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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

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REVIEW PROCEDURESRecord Keeping

• Minutes of all IEC Meetings with Chairpersons
  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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REVIEW PROCEDURESSPECIAL CONSIDERATIONS

• Research involving children, pregnant lactating
  women
• Vulnerable subjects
• Those with diminished autonomy
• Commercialisation of research
• International collaboration

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Thank You