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Research and ethical committee or IRB

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Research and Ethical committee- which gives the idea regarding its definition, committee members details, their function etc.,

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Research and ethical committee or IRB

  1. 1. 4. RESEARCHAND ETHICS COMMITTE Apollojames, Lecturer, Nandha college of pharmacy
  2. 2. 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 AJ
  4. 4. COMPOSITION 1. Chairperson 2. 1-2 basic medical scientists. 3. 1-2 clinicians from various Institutes 4. One legal expert or retired judge 5. One social scientist / representative of non- governmental voluntary agency 6. One philosopher / ethicist / theologian 7. One lay person from the community 8. Member-Secretary AJ
  5. 5. 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 AJ
  6. 6. REVIEW OF RESEARCH • Conduct initial review of research • Conduct continuing review Documentation 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 AJ
  7. 7. REVIEW OF RESEARCH  Approval/favorable opinion  Modifications required prior to approval/favorable opinion  Disapproval/negative opinion  Termination or suspension of prior approval/favorable opinion AJ
  8. 8. 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 AJ
  9. 9. PROCEDURES AND RECORDS  Maintain a list of EC members  Follow written procedures  Retain records for at least 3 years after completion of study AJ
  10. 10. For enquiries: ajamespharma@gmail.com THANK YOU