Ethics & Law of Clinical Research Trials Including Covid-19

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. This book is an attempt to highlight the ethical and legal issues in relation to clinical trial and research in India with an emphasis on research during humanitarian emergencies taking into account the recent COVID-19 pandemic and the national and international response thereto.

Much of clinical research and trial law and litigation are comparatively recent, the book provides recent as well as historical context, underlying areas of concern with respect to human subjects participation, relevant rules, regulations and guidelines (national as well as international) on the subject.

India is a 'proud' hub of global clinical trials with a robust fast-track regulatory regime. During the COVID-19 pandemic, India did face a multitude of problems but it came up with an array of vaccines and, in fact, achieved the 'one billion COVID-19 vaccine doses milestone. Nevertheless, besides a balanced regulatory oversight, it requires a "strong protection regime" for the trial participants at par with that prevailing in the developed nations.

This book is a key resource for clinical investigators, institutional administrators, institutional review boards, medical/law students. researchers, policy-makers, attorneys, judges and layman especially participants of clinical trials.