There are total of more than 850 registered independent and institutional ethics committees. All registered ethics committees have to go through accreditation process which was introduced recently by NABH and responsibility is assigned to quality council of India (QCI) to accredit all registered ethics committees in India. An ethics committee is a committee dedicated to the rights and well-being of research subjects, also known as an Institutional Review Board but there are some little difference between Independent Ethics Committee(IEC) and Institutional Ethics committee (IRB) like IRB direct attached with site or institution and IEC usually independent. For starting any clinical trial, the approval of the ethics committee is crucial as without that the DCGI will not provide his sanction for beginning the study in the country.
The ethics committee should review and accord its approval to a clinical trial as per Schedule Y, the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding rights, safety and well-being of the trial subjects. In case of the clinical trial related injury or death, the ethics committee shall review the serious adverse events reports and recommend for providing compensation.
Keeping in view the registration and accreditation requirement of Ethics Committee, this course has been framed to provide a basic understanding about the functioning and responsibility of Ethics Committee. Further this course will also be helpful to all stakeholders involved in clinical trial to comply with the necessary requirements,
This Course has following modules:
- Regulation and Guidelines for Ethics Committee in India
- Accreditation and Registration of Ethics Committee in India
- Composition of Ethics Committee
- Standard Operating Procedures of Ethics Committee
- Functioning of Ethics Committee
- Submission of Clinical Trial Dossier to Ethics Committee
- Records Maintained by Ethics Committee
- Review and Approval Process of Ethics Committee
- Responsibility of Investigator Towards Ethics Committee
- Application to DCGI for registration of Ethics Committee