Introduction

1.1 The Association of the British Pharmaceutical Industry (ABPI) established a committee in 1969, under the Chairmanship of Sir Charles Stuart-Harris, to investigate and advise on medical experiments involving pharmaceutical company staff volunteers. The report of this Committee, issued in 1970, set a standard of practice for member companies to provide safeguards for staff volunteers in drug studies. These published guidelines also acted as a basis for volunteer studies organised outside the pharmaceutical industry. However, research practices and opinions have inevitably changed during the past eighteen years, and these are not fully reflected in the 1984 updated commentary on the 1970 Stuart-Harris report.

1.2 In October 1986 the Royal College of Physicians published a report entitled ‘Research on Healthy Volunteers’. The Association subsequently set upa Working Party to reconsider its own position, to review current guidelines related to volunteer studies, and to draft new ones. These guidelines take account of the conclusions reached by the Royal College of Physicians. The membership of the Working Party is shown in Appendix D.

1.3 In its 1970 report and the 1984 Update, the ABPI referred to staff and human volunteers, but did not define the term volunteer. Key elements in the definition of a non-patient volunteer are that the individual cannot be expected to derive therapeutic benefits from the proposed study, is not known to suffer any significant illness relevant to the proposed study, and whose mental state is such that he is able to understand and freely give valid consent to the study. This definition embraces the term ‘healthy volunteer’.