Ethics Committee
Independent, accredited and trained Ethics committee
The Ethics committee is independent from the institute and comprises of 9 members who are trained in ICH GCP. They have been appointed as per Drugs and Clinical Trials Rules,2019.
The JCDC Ethics committee is registered with the CDSCO and the registration number is: ECR/352/Inst/MH/2013
The EC is setup to ensure that the research protocols carried out
- - Are sound in scientific design, have statistical validity and are conducted according to the parameters of ICH–GCP as well as local regulatory requirements.
- - Do not compromise the safety, rights and well being of the patients participating in the research study.
- - Are conducted under the supervision of medical persons with the required experience/ expertise.
- - Include solely patients who, through their legally acceptable representative have given informed consent for participation in the research study.
- - The Committee can also be called upon to solve the ethical issues of Jehangir Hospital on request.
The Ethics committee meets at least once every month.
It requires the following electronically submitted documents at least 3 weeks prior to the meeting for approval
- - Final protocol with all the Amendments
- - Investigators Brochure and any other safety-related information available.
- - Informed Consent Form and Patient information Sheet in English and the relevant translated languages and their back-translations (optional) with appropriate translation certificates.
- - Any other project – specific documents
- - Draft Clinical Trial Agreement. – Clinical Trial Agreements should have a tripartite agreement between the sponsor/Investigating Institute, Principal investigator and JCDC on the other hand.