Ethics in clinical drug trial research in private practice.
BACKGROUND
Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process.


METHODS
Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed.


RESULTS
The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards.


CONCLUSIONS
Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.
Beran
R G
RG
University of New South Wales, Griffith University.
Beran
M E
ME
D001315:Australia; D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D008485:Medical Audit; D011331:Private Practice