ETHICS & LAW OF CLINICAL RESEARCH TRIALS Including COVID-19 Trials

CONTENTS (IN Brief)

1. INTRODUCTION …………………………………………………….1-46

2. REGULATION OF CLINICAL TRIALS IN INDIA ………47-100

3. ETHICS COMMITTEES (ECS) ……………………………..101-128

4. BA/BE STUDIES; BIOMEDICAL & HEALTH RESEARCH; ACADEMIC CT ……………………………..129-139

5. INFORMED CONSENT: PARTICIPANT RIGHTS & RETENTION IN TRIAL ………………………………………..141-176

6. VULNERABLE POPULATIONS ………………………….177-199

7. RESPONSIBLE CONDUCT OF RESEARCH ……………201-225

8. BENEFIT SHARING & COLLABORATIVE RESEARCH ….227-250

9. PAYMENT AND COMPENSATION PROVISIONS/ POST-TRIAL ACCESS ………………………………………251-286

10. CLINICAL TRIAL RULES: A CRITIQUE …………….287-319

11. RESEARCH DURING HUMANITARIAN EMERGENCIES 321-357

12. COVID-19 PANDEMIC RESEARCH: NATIONAL
& INTERNATIONAL RESPONSE ……………………….359-395

13. HUMAN CHALLENGE TRIALS AND COVID-19 ….397-411

14. INTERNATIONAL HEALTH REGULATIONS (IHR)& WHO’S LEGITIMACY IN DISEASE OUTBREAKS …413-450
15. THE RISE OF LITIGATION IN CLINICAL RESEARCH
    TRIALS – I ………………………………………………………….451-494
16. THE RISE OF LITIGATION IN CLINICAL RESEARCH TRIALS – II ………………………………………………………..495-531

GLOSSARY ………………………………………………………………………. 533-578

REFERENCES/BIBLIOGRAPHY …………………………………………. 579-597

ABOUT THE AUTHOR

Ashok K. Jain is a well-known writer in the legal field for the past 25 years with over 50 titles to his credit. His works include diverse areas of law like ‘Law and Environment’, ‘Criminology Penology and Victimology’, ‘Cyber Law’, ‘Public International Law’, ‘Socio-Economic Offences’, etc. Deeply moved by the crime of female foeticide rampant in India, he wrote a book ‘The Saga of Female Foeticide in India’, which won him national and international acclaim. He was also associated with the World Wide Fund for Nature-India to get a book published by the organization titled ‘Rules and Regulations Relating to Medicinal Plants and Other Non-Timber Forest Produce in India.’

The author is interested in various socio-medico-legal issues concerning the country and the society at large. He is a science graduate from Delhi University, having a non-formal education in Psychology and Anthropology, along with a Doctoral degree in Law. The present book is a humble effort by him to motivate people towards an equal society by building an environment in which every stakeholder is given due recognition especially the ‘research trial subjects in developing nations.’