Research and ethical committee or IRB

Research and ethical committee or IRB

• 1.
  4. RESEARCHAND ETHICS COMMITTE Apollojames, Lecturer, Nandhacollege of pharmacy
• 2.
  ETHICAL COMMITTEE An ethicscommittee 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
• 3.
  ETHICAL COMMITTEE  COMPOSITION RESPONSIBILITIES  OPERATION  PROCEDURES  RECORDS AJ
• 4.
  COMPOSITION 1. Chairperson 2. 1-2basic 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.
  Responsibilities of anEthics 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.
  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.
  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.
  OPERATION • EC membersmake 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.
  PROCEDURES AND RECORDS  Maintaina list of EC members  Follow written procedures  Retain records for at least 3 years after completion of study AJ
• 10.
  For enquiries: [email protected] THANKYOU