Download - Research and ethical committee or IRB
4. RESEARCH AND ETHICS COMMITTE
Apollojames,Lecturer, Nandha college of pharmacy
ETHICAL COMMITTEE
An ethics committee is a committee formally designated to review and approve the initiation of a clinical research study involving human participants and to provide continuing review of the research study
Institutional Review Board = Ethics Committee
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ETHICAL COMMITTEE
COMPOSITION RESPONSIBILITIES OPERATION PROCEDURES RECORDS
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COMPOSITION
1. Chairperson2. 1-2 basic medical scientists.3. 1-2 clinicians from various Institutes4. One legal expert or retired judge5. One social scientist / representative of
non-governmental voluntary agency6. One philosopher / ethicist / theologian7. One lay person from the community8. Member-Secretary
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Responsibilities of an Ethics Committee
The responsibility of an ethics committee is to ensure the protection of the rights, safety and well-being of participants involved in clinical research
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REVIEW OF RESEARCH• Conduct initial review of research• Conduct continuing reviewDocumentation EC members review Protocol Informed Consent Forms Recruitment procedures (e.g.,
advertisements) Written information given to subjects Safety information CV of Investigator Information about payments to subjects Other documents can be requested
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REVIEW OF RESEARCH
Approval/favorable opinion Modifications required prior to
approval/favorable opinion Disapproval/negative opinion Termination or suspension of prior
approval/favorable opinion
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OPERATION
• EC members make decisions at announced meetings
• Quorum must be present• Only members independent of investigator
and sponsor can vote• Only members who participate in the
review and discussion can vote• Investigator can provide information but
cannot vote• Nonmembers with special expertise can
provide assistance
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PROCEDURES AND RECORDS Maintain a list of EC members Follow written procedures Retain records for at least 3 years after
completion of study
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