chapter  1
16 Pages

Research ethics and law in context

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.