Ethics Committee Constitutions
per the Good Clinical Practices Guidelines, the sponsor and /
or investigator should seek the opinion of the Ethics Committee
regarding suitability of the Protocol, methods and documents to
be used in recruitment of Subjects and obtaining their Informed
Consent including adequacy of the information being provided to
the Subjects. The Ethics Committees are entrusted not only with
the initial view of the proposed research protocols prior to initiation
of the projects but also have a continuing responsibility of regular
monitoring for the compliance of the Ethics of the approved programmes
till the same are completed. Such an ongoing review is in accordance
with the Declaration of Helsinki and all the international guidelines
for biomedical research.
at Consortium Clinical Research,
with our expertise ensure to guide the hospitals / private nursing
homes / independent bodies to set up their Ethics Committees that
would meet the statutory requirements (including the selection of
ideal team members, drafting their SOPs and templates, etc.) and
most importantly train the Ethics Committee members in the GCP guidelines
and in their individual and teams’ roles and responsibilities.
the big picture in purview, we strive to prove that our intervention
ensures to raise the performance standards of the concerned Ethics
Committees to meet its objectives in the Clinical Research environment.