ETHICS COMMITTE

AND ITS RESPONSIBILITIES

MEANING AND DEFINITION

WHAT ETHICS MEANS ? It is the branch of philosophy that deals with morals or right and wrong DEFINITION: Ethics are the principles and guidelines that help us to uphold things we value. Ethics in research are important you are young to conduct and experiment. It should be applied on all stages of research such as in planning ,conducting and evaluating a research. Thus research ethics educates and monitors a scientist conducting a research to ensure a high ethical standards.

HISTORY OF CLINICAL ETHICS COMMITTEE

Origin : From the term medical ethics Author : THOMAS PERCIVAL in 1803 coined the term medical ethics Cause : Nazi and Tuskegee syphilis experiments Establishment : In 1974 By : THE RESEARCH ACT Governed by : 21 CFR 56 and/or 45 CFR 46

ETHICS COMMITTEE
Independent body Levels : Institutional/Regional/National/Supranational Constitute : Group of scientific and Non-scientific members Size : The Ethics Committee shall consist of a maximum of 6 members . Skills : Members shall have qualifications and expertise in key areas of the work of the Ethics Committee.

NEED FOR ETHICS COMMITTEE

To protect human subjects To check for ethical values : 1. 2. 3. 4. 5. 6. BENEFICENCE NON-MALEFICENCE AUTONOMY JUSTICE DIGNITY (confidentiality) TRUTHFULNESS & HONESTY (informed consent) 7. NO INFLUENCE /COERSION JUSTICE

WHERE DOES THE ETHICS COMMITTEE WORK

General : In every PROFESSIONAL FIELD

Medical terms :

General/Government hospitals
Private hospitals Organisations

When DOES IT WORK ?

Prior the trial begins :
Review the trial Decide upon the trial

During the trial :

Continue reviewing Check/monitor for adverse events

End of the trial :

Review of report ecord keeping

ETHICS COMMITTEE

INDEPENDENT ETHICS COMMITTEE (IEC/IRB)

CENTRAL ETHICS COMMITTEE (CEC)

SIMILARITIES IN IRB/IEC
They are two sides of the same coin :
Ethics Committee Functions Procedures Composition

THEY ARE ALSO REFERED AS ETHICS REVIEW BOARD TWINS

DIFFERENCES IN IRB/IEC
IRB
Members are attached Institutions/ Organisation

IEC
Independent or more than one organisation

Review project of the Institutions

Review project of all the applicant

Meetings are in the institution premises

Meeting venue is decide by members

Usually termed in U.S. and other countries

Usually called in India

CENTRAL ETHICS COMMITTEE

The Policies & SOP of CEC has been designed herein based on Indian GCP & ICHGCP these guidelines and other applicable laws. The CEC will function to review and accord approval for a clinical trial protocol and will have the responsibility to safeguard the rights, safety and well being of all trial subject.

The CEC will function as per the policies and SOP document and will maintain a
record of the proceedings and will be accountable for adhering to the regulation governing the supervision of research in human subjects.

MEMBERS
Number : at least 5-7 (sometimes 7-12)
At least 1 from non scientific area i.e. layman

At least 3 from scientific area; e.g. : 3 doctors

At least 1 lawyer

Person independent of the trial can vote

Expertise are allowed to assist

RESPONSIBILITIES
RIGHTS SAFETY & WELL-BEING DECISION

EMERGENCY

PAYMENT

DOCUMENTATION

QUALIFICATION

PROCEDURES
Review & maintain information of the investigator & subject

Scheduling and conducting meetings

Conduct and continue reviewing of trial Decide frequency of continuing review (usually in between 12 months) Specifications

DOCUMENTS
1. PROTOCOL
2. INFORMED CONSENT FORMS 3. RECRUITMENT PROCEDURES

4. NAMES AND ADDRESSES OF THE INVESTIGATOR & SUBJECT

5. CASE REPORT FORMS 6. TRANSLATION FORMS

7. QUALIFICATION OF THE INVESTIGATOR

8. PRECLINICAL DATA 9. SAFETY INFORMATION 10. FINANCE 11. APPROVAL REPORTS e.g. DCGI Approval

DECISION MAKING PROCESS

Approval/rejection / partial approval On vote basis In presence of quorum Attendance must be reported All the reports must be written/documented

RECORD KEEPING
The committee must retain the relevant records
At least for 3 years, usually outside India And for a period of 15 years in India The condition and confidentiality of the records must be maintained

Records must be submitted to concerned authorities,

whenever asked for

IMPORTANCE OF THE ETHICS COMMITTEE

No trial is conducted without the approval from ethics committee Every step needs approval

LIST OF SOME ETHICS COMMITTEE

K.E.M ETHICS COMMITTEE
NAIR HOSPITAL ETHICS COMMITTEE NIZAM HOSPITAL ETHICS COMMITTEE

JASLOK ETHICS COMMITTEE

List of National Ethical committees : http://apps.who.int/ethics/nationalcommittees/NEC_full_web.pdf

Indian Cooperative Oncology Network