Education and training on international guidelines and standards of clinical trials is needed to maintain the culture of ethics in the field of clinical research, said Dr K Rosaiah, Governor of Tamil Nadu.
Inaugurating a conference on ‘ethics in clinical research and research methodology’ at Sri Ramachandra University in Chennai, the Governor said exploitation of human beings in clinical trials cannot be allowed and tolerated. “Unethical conduct of clinical trials, plagiarized research publications and substandard research projects are damaging our image. This menace can be weeded out of our universities, hospitals and research laboratories only through maintaining proper ethical standards,” he added.
According to him, the value of clinical research in India had exceeded $300 million in 2010 and expected to cross $400 million in two years. But, both the underdeveloped and the developing nations are not able to make much headway and gain international recognition due to lack of national quality standards, internationally acceptable research methodologies and absence of professional ethics. These deficiencies have also been reflected in the quality of research publications and patented products and processes.
Lack of ethics is also visible in biomedical research, drugs and pharmaceuticals research and clinical trials of international character, the Governor said.
Dr Rosaiah congratulated Sri Ramachandra University which signed an memorandum of understanding (MoU) with CITI (Collaborative International Training Initiative) of Miami University, USA for offering training modules to young researchers. Later, he released a CD containing India specific GCP modules and conference proceedings.
Dr Sergio Litewka, director of International operations for the University of Miami Ethics Programmes and international director for the CITI programme said that research misconduct erodes trust on the scientific enterprises. The consequences of misconduct are dire, not only for institutions, investigators and universities but also for individuals and communities. Because of the increasing number of international collaborative scientific activities, scientific fraud is becoming a global concern. Academia, therefore, has a crucial role in creating and supporting educational models for supporting the responsible conduct of research and preventing research misconduct, he said.
In his welcome address, Dr S P Thyagarajan, Professor of Eminence and Dean Research, SRU said testing new drugs and pharmaceuticals on humans need to follow certain internationally adopted ethical principles grouped as protection of human rights, autonomy to participate or withdraw from any trial and benefit to the volunteers need to outweigh risks. Towards this end the SRU – CITI collaboration has organized this international conference aimed at catching researchers when they are young, and provide them knowledge, skills and attitude about ethical principles and practices.
Vice Chancellor Dr JSN Murthy said the SRU – CITI programme comprising different modular courses will be useful to anyone interested in doing research related to human subjects and research using laboratory animals.