The Law and Regulation of Clinical Research: Interplay with public and bioethics
  • Authors: Margaret Kabiru and Anne Njenga
  • ISBN: 9966 -01-080 - 1
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The Law and Regulations of Clinical Research: Interplay with Public Policy and Bioethics is the first book to critically analyse issues in clinical research from bioethical, policy and legal perspectives. It offers  detailed comparative study of international guidelines/regulations and national regulatory frameworks of five countries: Australia, Kenya, South Africa, United Kingdom and the United States of America.  The book proposes an alternative strategy as a policy option for fostering administrative reform in clinical research and advocates for the creation of an enabling environment through regulations that facilitate compliance with laid down standards.

                The book targets stakeholders who may be searching for ways of improving an existing regulatory framework for clinical research or developing an effective framework where none is in place.  Stakeholders  yearning for appropriate strategies that can be used to forge consensus in addressing the challenges posed by clinical research with find this book an invaluable reference. Those who are interested in regulatory reform of government and public institutions will undoubtedly find the book relevant for their work insofar as it directs their attention to formulating appropriate administrative policy in clinical research.

The Authors

Dr Pamela Andanda holds Bachelor of Laws (LLB) and Master of Laws (LLM) in Public Law from the University of Nairobi.  She also holds a Diploma in Legal Practice from Kenya School of Law, is an advocate of the high Court of Kenya and a Certified Public Secretary- CPS (K). She obtained her Doctorate (PhD) from the University of the Witwatersrand's School of Law where she developed a special interest in the teaching and research of biotechnology, bioethics, policy analysis, health law and regulation of biomedical research. She lectures research methodology, biotechnology & the law, mercantile law, sale and security at the University of the Witwatersrand's School of Law.

 Dr Andanda is currently working on an international research project on Genomics and Benefit Sharing with Developing Countries: From Biodiversity to Human Genomics (funded by the European Union's Science & Society unit under the sixth Framework programme); a joint project with other prominent international scholars from the United Kingdom, India, France, Lithuania and the Philippines. She is also currently a consultant with South African AIDS Vaccine Initiative's HIV/AIDS Vaccines Ethics Group (HAVEG) and has presented conference papers on biomedical research and biotechnology at national and international conferences.

Anne Njenga has a B. Ed (Hons) an in Educational Psychology. She worked at the Kenya Institute of Education between 1977 and 1997 where she was involved in research, curriculum development and training in BCD. She was a lecturer in Kenyatta University, Department of Early Childhood Education between 1997 and 2000. Currently she is the Training and Research Coordinator, Mwana Mwende ECDE Training Centre and also a consultant in early childhood development (ECD).