ABSTRACT
When new healthcare interventions, including pharmaceutical products, are being
investigated for their potential use in human applications it is inevitable that they
will need to be tested on human beings. This book concerns the regulation of
research involving human participants, human tissues and data pertaining to the
health, welfare and social care of individuals. It will assess the ethics and law
that govern the conduct of healthcare research, taking account of biomedical and
pharmaceutical research, as well as studies that are more concerned with social
and practical issues associated with the provision of care. The central focus of the
work will be the role and responsibilities of research ethics committees (RECs)
in relation to the process of the ethical review of research involving human par-
ticipants. It will therefore be relevant to RECs operating in the NHS, social care
organisations and universities, as well as some private sector organisations. A
close examination of the operation of RECs will be conducted to assess the legal
and regulatory mechanisms that confront them in the practical conduct of their
work. Through this, the extent of the potential legal liability of RECs and their
members will be investigated and placed in context. In so doing the book aims to
join up the dots and make connections between the theoretical philosophical and
ethical principles that underpin the review process and the relevant law, regula-
tion and guidance that pertain in practice.
