Research and ethical committee or IRB

Download Research and ethical committee or IRB

Post on 25-May-2015




0 download

Embed Size (px)


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


<ul><li> 1. 4. RESEARCHAND ETHICS COMMITTE Apollojames, Lecturer, Nandha college of pharmacy </li></ul> <p> 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 3. ETHICAL COMMITTEE COMPOSITION RESPONSIBILITIES OPERATION PROCEDURES RECORDS AJ 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. 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. 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 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. 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. For enquiries: THANK YOU </p>