ETHICS COMMITTEE
PRIYADARSHINI J. L. COLLEGE OF PHARMACY
Electronic zone building, MIDC, HINGNA ROAD
NAGPUR-440016
2022-2023
Presented By
Swapnil S. Tirmanwar
Sr.no Content
1. Introduction
2. Composition
4. Responsibilty
5. Function
INTRODUCTION
• An ethics committee is a body responsible for ensuring that
medical experimentation and human subject research are carried out
in an ethical manner in accordance with national and international law.
• Ethics committee is also known as IRB or ERB.
• The ethical & scientific standards for carrying out biomedical research
have been developed & established in international guidelines such as
WHO & ICH for good clinical practices.
COMPOSITION OF EC
• 1 Chairperson
• 1 Member secretary
• 1-2 basic medical scientists (preferably one pharmacologist)
• 1-2 clinicians from various institutes
• One legal expert or retired judge
• One social scientist
• One philosopher
• One lay person.
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.
FUNCTIONING OF THE EC
• The EC should function in accordance with the written SOPs that
provides detailed guidelines about the EC procedures.
• The PI and not the Sponsor communicates and deals with the
ethics committee.
THANK YOU…

Ethics committee research methodology presentation

  • 1.
    ETHICS COMMITTEE PRIYADARSHINI J.L. COLLEGE OF PHARMACY Electronic zone building, MIDC, HINGNA ROAD NAGPUR-440016 2022-2023 Presented By Swapnil S. Tirmanwar
  • 2.
    Sr.no Content 1. Introduction 2.Composition 4. Responsibilty 5. Function
  • 3.
    INTRODUCTION • An ethicscommittee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law. • Ethics committee is also known as IRB or ERB. • The ethical & scientific standards for carrying out biomedical research have been developed & established in international guidelines such as WHO & ICH for good clinical practices.
  • 4.
    COMPOSITION OF EC •1 Chairperson • 1 Member secretary • 1-2 basic medical scientists (preferably one pharmacologist) • 1-2 clinicians from various institutes • One legal expert or retired judge • One social scientist • One philosopher • One lay person.
  • 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.
  • 6.
    FUNCTIONING OF THEEC • The EC should function in accordance with the written SOPs that provides detailed guidelines about the EC procedures. • The PI and not the Sponsor communicates and deals with the ethics committee.
  • 7.