AHERF Organizes a National Conference on Evolving Roles of Ethics Committees in India

NEW DELHI, June 4, 2013 /PRNewswire/ --

Apollo Hospitals Educational And Research Foundation (AHERF) today organized a 'National Conference on Evolving Roles of Ethics Committees in India' at Delhi with the objective of increasing awareness, aligning all stakeholders on current state, discussing and identifying key changes required on the regulatory and industry front, identifying responsibility amongst stakeholders and charting out the roadmap to strengthen ethical conduct of clinical research in India.

In the recent past, India has witnessed great negativity around the conduct of clinical trials and the regulatory framework has been evolving to align itself with the changing scenario. There is obvious room for improvement in the framework and standards within which clinical trials are conducted in India. One key element in this improvement is the role of ethics committees. The one and a half days long conference provided a platform for the convergence of key stakeholders and facilitated an exchange of ideas through plenary sessions and panel discussions which resulted in a productive dialogue on ethics in clinical research. Further, as part of the conference, a hands-on workshop on ethics committee processes was conducted to impart education on ethics committee operations and best practices.

Dr.Roy Chaudhary said, "While the rapid expansion in the field of clinical research has been beneficial for the Indian population, it has also raised concerns that ethical conduct is often forgone when conducting clinical trials. The specter of unethical trials being frequently reported is a reflection of an ailing and substantially ineffective research regulatory system in India. The increasing awareness about ethical requirements in research, as well as the role of activists in questioning trial conduct when deemed exploitative, has resulted in a positive change to some extent. However, a lot still needs to be done. This requires a multi-faceted approach and involvement of all the stakeholders with an aim for more robust science, which incorporates a strong commitment to ethics."

Speaking on the occasion, Dr. Mubarak Naqvi, Senior Director, Clinical Study Unit, Sanofi said, "The mission and purpose of the healthcare industry is to address patients' needs by providing them with appropriate therapeutic solutions. To meet unmet medical needs of patients, clinical trials become a mandatory part of the drug discovery, development and marketing approval process. As medical practitioners and researchers committed to the safety and health of our patients, it is our responsibility to ensure that clinical trials are conducted with appropriate regulatory and ethics approvals and are in line with Good Clinical Practice (GCP) guidelines. Hence, the role of the ethics committees and the laws regulating their functioning become ever so critical to the future of clinical research."

The conference also witnessed the presence of various sites and institutions which are key stakeholders in the conduct of clinical trials. Dr. Sita Naik, Advisor to Chairman, Research Task Force, Apollo Hospitals, said, "Although ethics committees have been around for some time, there is a genuine lack of understanding of the issues involved by both the investigators and members. There is an urgent need to have training programs at various levels in order to increase the pool of competent ethics professionals. Programs like the present meeting, are aimed to widen the net and increase the awareness."

From another perspective, Mr. Seemant Jauhari, CEO, AHERF added, "Conduct of clinical trials is perhaps an inevitable component of the drug development process. The only option is to undertake it with great responsibility and the stakeholders should ensure their conduct with accountability governed by clear regulatory processes. However such processes must be balanced enough to allow effective yet efficient evaluation of studies in India. A well-focussed group, with wide representation of all stakeholders should champion this topic consistently and contribute to establishing benchmarks in ethical conduct of trials."

About Apollo Hospitals Educational And Research Foundation

Each Apollo Hospital, where clinical research activities are undertaken has an ethics committee to review and supervise all research activities. These ethics committees are constituted as per GCP guidelines and Schedule Y requirements. All the members have undergone several GCP trainings including workshops conducted by ICMR and the leading expert trainers in the industry. During the past decade and more, Apollo Hospitals Educational and Research Foundation (AHERF) has been successfully managing and supporting the functions of the ethics committees, organising meetings and running day-to-day operations.

AHERF spearheads research and educational initiatives for the Apollo Hospitals Group which comprises of 54 hospitals and is India's single largest integrated hospital chain. AHERF is active in promoting basic, clinical, epidemiological & translational research. AHERF is not only the single largest site solutions organization but also it leverages on its experience to train "industry ready" clinical research professionals.

With such an aspiration, AHERF is proud to champion the all important topic of "ethics" through a national conference on evolving role of ethics committees in India. We believe firmly that such endeavours shall catalyze the welfare of the principal stakeholder 'the research subject' and the ultimate beneficiary 'the human race'.

Primary Media Contact: Parul Chabbra, [email protected], 91-9810588410

Secondary Media Contact: Kusum Sahijpal, [email protected], 91-9999973090