As 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. We 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. Keeping 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. |
