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The Institute Review Board - Ethics Committee (IRB-EC) is intended to ensure a competent review of scientific and ethical aspects of the project proposals received. The EC will review new project proposals after the same has been reviewed and approved by the Scientific Review Committee of the Institute.

Composition

The Ethics Committee will comprise of 10 members to allow a quorum of at least 6-7 members at each review meeting as per ICMR guidelines in order to provide collective expertise ensuring a comprehensive review (scientific and ethical) of the projects submitted to it.

In addition to the medical experts, the committee will have:
     at least 1 member from a non-scientific field
     at least 1 member from outside the Institution

A list of members, their qualifications and affiliations will be maintained by the EC. A copy of the EC composition and operating procedure is to be made available to any member of the hospital / Institute for filing of research projects upon written request for the same to the EC

Responsibility


The IRB EC is set up to ensure that the research protocols that are carried out at Regional Cancer Centre, Trivandrum.

     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/expertice.
     include solely, patients who through their legally acceptable representative  have  given informed         consent for participation in the research study.

The Committee will review all new research projects and also the ongoing research projects at intervals appropriate to the degree of risk to the study subjects. The committee will maintain a list of projects submitted, approved/disapproved and the outcome of each project.

The Committee expects from the Principal Investigator:

      a report of the clinical trial on a 6 monthly basis or more frequently if so directed
      a report of each serious adverse event with regard to the study
      to be kept informed of amendments / revisions to any study-related document as well as patient safety         related information
      to be kept informed of study completion and discontinuation with reasons.
      to submit justification for approval to restart studies discontinued earlier

Procedures

     The applicant of the proposal (generally the Principal Investigator) is required to submit his / her       application letter and 11 copies of the following documents, 45 days before a scheduled meeting:

     1. Data sheet of HEC, RCC, TVM
     2. IRB- Scientific Committee Approval certificate
     3. Final Protocol with all amendments
     4. Investigator’s Brochure and any other safety information available
     5. Informed Consent Form and Patient Information Sheet in English, Malayalam and  the relevant          translated languages and their back - translations with appropriate  translational certificate
    6. Questionaaires
    7. Any other project- specific documents
    8. Current CV of the Principal Investigator

The Committee will meet ONCE in 3 months OR As And When Required. Advance notice will be sent out to the EC members 4 weeks before each meeting, along with the agenda.

   


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