National Ethical Guidelines for Biomedical and Health Research Involving Human Participants

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Foreword I am very pleased that the ICMR ethical guidelines for research have been revised which were last brought out in 2006. ICMR has always been leading in developing ethical standards for human research in the country. These guidelines are well recognized in India and a number of other countries also.

Preface Medical profession is probably the oldest one to prescribe ethical guidelines. Such guidelines for practically all aspect of professional conduct were provided both in Caraksamhita and Susrutasamhita. Rapid advances in the whole field of biomedical sciences have added newer responsibilities and complex dilemmas for medical persons-both practitioner and researchers. It would be correct to say that every advance in medical science results in added moral responsibility. ICMR has always been on the forefront to set the standards for ethics in biomedical and health research. The Council brought out a policy document in 1980, which was revised in 2000 and further revised in 2006. The latest version of guidelines has addressed the newer emerging ethical issues keeping in view the social, cultural, economic, legal and religious aspects of our country. Ethics is a subject of discussions and debates and each and every word and line in the revised guidelines have been deliberated upon by a group of experts and have gone through a process of consultation and debate before it has been finalized. The new expanded document has separate sections on Responsible Conduct of Research, Informed Consent Process, Vulnerability, Public Health Research, Social and Behavioural Sciences Research for Health, Biological materials, Biobanking and Datasets, International Collaboration and Research during Humanitarian Emergencies and Disasters. The guidelines also highlight the need for capacity building in the area of ethics in order to improve the ethical conduct of research. These Guidelines are a result of in-depth discussions and debates, involving the diverse stake-holders and also the public. The ICMR ethical guidelines are well respected not only in India but a number of other countries. The new "National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017" will serve as a guide to answer and meet the challenges and concerns raised by the emerging ethical issues.

Acknowledgement We acknowledge with gratitude the inspiration and patronage of Dr Soumya Swaminathan, Director General ICMR and Secretary Department of Health Research, to update and revise the ICMR Ethical Guidelines for Biomedical Research on Human Participants 2006. The dynamic efforts and contributions of the Advisory Group consisting of Dr Vasantha Muthuswamy (Chairperson), Prof SD Seth, Dr Nandini K Kumar, Prof N K Arora and Prof Urmila Thatte are gratefully acknowledged. Special thanks are due to all the members of the 14 subcommittees who drafted the initial write up as well as all contributors who devoted their time and efforts towards these guidelines. The team of experts that was chosen provided a perfect blend of knowledge, experience and skill to prepare different sections of these guidelines. The inputs of stakeholders from all parts of the country in providing their valuable comments and suggestions in the Regional and National Consultation meetings and web based Public Consultation are duly acknowledged. The support from WHO - country office for India in their technical inputs and jointly hosting the consultation meetings in Bangalore and New Delhi is deeply appreciated and acknowledged. Special thanks are due to a team of very motivated persons especially Dr Rajib Hazam and Dr Kalyani Thakur who knew their job and provided technical and secretarial support and also assisted in coordination and communications involved in undertaking this exercise. This involved a very large number of consultations with experts and stakeholders who provided comments during face to face as well as online consultations. We are thankful to Dr Prashant Mathur, Director, National Center for Disease Informatics & Research (NCDIR), Bengaluru for guiding and facilitating the process. The administrative support extended by Mr Shyam Singh and Mr Santosh Saini from ICMR Headquarters and Mr N M Ramesha and Mr C Somasekhar from NCDIR, Bengaluru along with many others is duly recognised.

Introduction The code of conduct for physicians was well laid out in traditional Indian systems of medicine and do no harm was the underlying universal principle besides other principles applicable to the prevalent culture and the class systems of the society. The Indian Council of Medical Research (ICMR) issued the Policy Statement on Ethical Considerations Involved in Research on Human Subjects in 1980. Due to rapid advances in biomedical science and technology, new ethical dimensions emerged which necessitated further updation of these guidelines. Subsequently the Ethical Guidelines for Biomedical Research on Human Subjects was released in 2000, followed by the revised Ethical Guidelines for Biomedical Research on Human Participants in 2006." In the meantime, the Central Drugs Standard Control Organization (CDSCO) also released the Indian Good Clinical Practice Guidelines (2001) for clinical trials and revised Schedule Y of the Drugs and Cosmetics Act, 1940, in the year 2005 with several amendments in the Rules under Drugs and Cosmetics Act in the year 2013. ICMR and the Department of Biotechnology (DBT) jointly brought out Guidelines for Stem Cell Research and Therapy in 2007 and a further revision in 2013 which is now revised as National Guidelines for Stem Cell Research, 2017."