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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