chapter  2
16 Pages

How did we get here? A brief history of research ethics

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.