Constitution, Training, Registration/Re-Registration and Management of Institutional Ethics Committee (IEC)/Institutional Review Board (IRB)/Independent Ethics Committee (Ind.EC)
As per the Good Clinical Practices Guidelines, the sponsor and/or investigator should seek the opinion of the Ethics Committee to conduct clinical trials in hospitals/site. The concerned Ethics Committee will be responsible for assessing the suitability of the Protocol, methods, and documents to be used in enrollment of the Subjects, ensuring Informed Consent documentation as well as Adverse Event reporting.
The Ethics Committees review the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the study with the approved protocol till it is 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, have a dedicated team under our Sites Management Operation (SMO) who work with hospitals / private nursing homes / institutions to set up their Ethics Committee as per the statutory requirements like selection of the ideal team members, registration, drafting SOPs, and templates, etc. We also conduct necessary GCP training and certifications, as well as help them manage their Ethics Committees on an ongoing basis.
Keeping in mind the pivotal role of Ethics Committees in Clinical Research, we strive to prove that our intervention ensures to raise the performance standards of the concerned Ethics Committee to meet its objectives.