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

1. 4. RESEARCHAND
ETHICS COMMITTE
Apollojames,
Lecturer,
Nandha college of pharmacy

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: ajamespharma@gmail.com
THANK YOU