Avent

[2011] QCAT 598

CITATION: Avent [2011] QCAT 598

PARTIES: Minyon Avent
(Applicant)

APPLICATION NUMBER: CRL022-11

MATTER TYPE: Clinical research matters

HEARING DATE: 15 November 2011

HEARD AT: Brisbane

DECISION OF: Ron Joachim, A/Senior Member

DELIVERED ON: 15 November 2011

DELIVERED AT: Brisbane

ORDERS MADE: 1.    The application is dismissed

CATCHWORDS:

Clinical Research – where comparative assessment of healthcare already proven to be beneficial is not medical research

Guardianship and Administration Act 2000, s 13, schedule 2

APPEARANCES and REPRESENTATION (if any):

APPLICANT: Minyon Avent

REASONS FOR DECISION

1. On 5 October 2011 the Tribunal received an application for approval to conduct clinical research.  This application was from Minyon Avent from the Royal Brisbane and Women’s Hospital at Herston.  The clinical research is a pilot study of pharmacokinetic and phamacodynamic assessment of monotherapy versus combination therapy for the management of gram negative bacteraemia.

1. The Tribunal considers this application under the definition of clinical research outlined in section 13 of schedule 2 of the Guardianship and Administration Act 2000. Section 13 of schedule 2 defines clinical research as medical research intended to diagnose, maintain or treat condition affecting the participants in the research or a trial of drugs or techniques involving the carrying out of healthcare that may include giving of placebos to some of the participants in the trial. Subsection 1(A) states however a comparative assessment of health care already proven to be beneficial is not medical research.

1. The study seeks to investigate the optimal dose of antibiotic or the combination of antibiotics in patients with gram negative infections.  It is a comparative study because it is comparing the use of different types of antibiotic therapy.  In other words this is a comparison of treatment known to be beneficial. 

1. The Tribunal spoke to the applicant on 15 November 2011 who confirmed the comparative nature of the study. 

1. The Tribunal is therefore of the view that the study proposed does not fit the definition of clinical research as defined in the Act.  This does not mean of course that the trial can not proceed.  It simply means that the approval of this Tribunal is not necessary.

1. The enrolment of people with impaired decision making capacity can still occur with the approval of an attorney under an Enduring Power of Attorney for personal matters or a guardian appointed by this Tribunal or a statutory health attorney as defined in the Powers of Attorney Act1998.