Ethics Committee Training & Certification Process initiated by Clinotek India, Bangalore

BANGALORE, India - April 5, 2013 - PRLog -- Clinical Research Industry is growing at a significant pace in India since 2004 - 2005. Addressing many concerns and pitfalls observed during this time, Drug Regulatory and Licensing Authority of India, DCGI has released a new notification vide GSR No. 72(E) dated 08-02-2013 inserting a Rule 122DD, in Schedule 'Y' with other amendments. According to this new rule, Registration of Ethics Committees in India is mandatory to review and accord approval to Clinical Trials. Mr. Nagendrappa M H, CEO of Clinotek India has said that it is a good move by DCGI, considering a lot of scenarios where protection of rights, safety and wellbeing of clinical trial participants was given least priority though it is one of the most important considerations according to ICH - Good Clinical Practice Guidelines practiced throughout the world, .

Mr. Nagendrappa has also said that Ethics Committees play a significant role in ensuring safety and wellbeing of clinical trial participants. He expressed that it is the lack of proper knowledge and training in Ethics Committee Members that is making the committees ineffective in ensuring protection of rights and safety of the trial subjects. So the members of Ethics Committees are highly recommended to have a proper training in essentials of clinical research, ICH - GCP guidelines, Declaration of Helsinki, Nuremberg Code, safety guidelines, reporting guidelines etc.

To take Clinical Research Industry one step further in India, Clinotek India - Center for Advanced Clinical Research Studies based in Bangalore, India has initiated a customised training program for Ethics Committees. Clinotek India has already provided training to Ethics Committee Members in one of the leading Dental Colleges in Bangalore, India. Clinotek India is also facilitating the process of registration of Ethics Committees by providing required assistance to streamline the activities of Ethics Committees in India. Mr. Nagendrappa M H who trained Ethics Committee Members was confident that the training program has given enough knowledge to Ethics Committee Members to start working with better confidence and can get even closer to subjects in protecting their rights, safety and wellbeing.

Mr. Nagendrappa concluded stating that, Ethics Committees can become more effective and helpful both for the trial participants and DCGI to improve the safety of trial participants in India. Clinical trial participants may expect to get timely compensation for any trial related injury they may suffer during their participation in clinical trials.