Ethics committee research methodology presentation

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.

The responsibility of an ethics committee is to ensure the protection of the rights, safety and well-being of participants involved in clinical research.

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.

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  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.

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 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.

6. 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.

7. THANK YOU…