ABSTRACT
The importance of the regulation of healthcare research and the central role of
research ethics and research ethics committees (RECs) is best explained when
located against the backdrop of the chequered history of research involving
human participants. This history includes a number of controversial incidents
across a range of jurisdictions, such as the Nazi atrocities during the Second
World War, the Tuskegee Syphilis study (Shamoo and Resnik, 2003: 181-186),
and the now infamous Porton Down experiments (Evans, 2008). Such scandals
have led to law reform aimed at ensuring that ethical imperatives are properly
adhered to. The result is the development of a number of legal and regulatory
measures based on ethical principles and guidelines and designed to protect the
interests of human research participants. For example, in the United States it
was not until after the public hearings on the thalidomide disaster that the phar-
maceutical industry was legally required to publicly demonstrate the scientific
efficacy and safety of new drugs for human use. The outcome on this occasion
was the enactment of the 1962 Kefauver-Harris amendments to the Food, Drug
and Cosmetics Act 1938 (Rothmann, 1987), which enhanced the control of
the US Food and Drugs Administration (FDA) over research involving human
participants. European legislatures later followed, leading to the introduction of
legislative frameworks for the development of pharmaceutical products (Santoro,
2005: 12), which has culminated in the EU Clinical Trials Directive (2001/20/
EC) and the UK Medicines for Human Use (Clinical Trials) Regulations 2004,
SI 2004/1031 (‘Clinical Trials Regulations’). Many of these legislative instru-
ments contain detailed requirements for the conduct of research involving human
beings and the process of ethical review that should be undertaken prior to the
research commencing. Consequently, many of the functions of NHS RECs in the
United Kingdom are now prescribed by law, and predicated on ethical principles
and guidelines that resulted from the controversies of the past. It is therefore of
more than purely academic interest to trace the history of research ethics in order
to explain the background to the current legal position.
