Ethics Committee
Independent, trained and active 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 ICH GCP guidelines. They include 3 doctors, a Pharmacologist, a lawyer, a layperson, a lady, a basic scientist and a social worker.
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 the Jehangir Hospital on request.
The Ethics committee meets every third Saturday of the month.
It requires 11 sets of the following documents at least 2 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
- Clinical Trial Agreement. – Clinical Trial Agreements should have a tripartite agreement between the sponsor/Investigating Institute, Principal investigator and JCDC on the other hand.