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
