Re application by Dr Matthew Hope
[2012] QCAT 191
•19 April 2012
| CITATION: | Re application by Dr Matthew Hope [2012] QCAT 191 |
| APPLICANT: | Dr Matthew Hope (Applicant) |
| APPLICATION NUMBER: | CRL002-12 |
| MATTER TYPE: | Clinical research matters |
| HEARING DATE: | 28 March 2012 |
| HEARD AT: | Brisbane |
| DECISION OF: | C Endicott, Senior Member |
| DELIVERED ON: | 19 April 2012 |
| DELIVERED AT: | Brisbane |
| ORDERS MADE: | 1. The clinical trial “Traumatic Brain Injury or Sub Arachnoid Haemorrage and the relationship with Optic Nerve Sheath Diameter” is approved. 2. Approval is given for three (3) years or until revocation or expiry of the ethics approval, whichever is the sooner. |
| CATCHWORDS: | CLINICAL RESEARCH – where technique being studied on patients with impaired capacity – where information not provided to treating medical team – where consideration of the difference between clinical research and special medical research Guardianship and Administration Act 2000, ss 68, 72 and sections 12(1)(b), 12(2) and 13 of Schedule 2 |
APPEARANCES and REPRESENTATION (if any):
| APPLICANT: | Dr Matthew Hope |
REASONS FOR DECISION
Medical staff from the Gold Coast Hospital are conducting a study in patients with head injuries looking at a simpler measurement tool than the currently used computerised tomography (CT) scan to identify dangerous increases in pressure after a head injury. The study uses an ultrasound scan to demonstrate a recordable link between optic nerve diameter and pressure changes in the brain. A bedside non invasive test would greatly facilitate identification of time-critical patients and expedite their treatment.
The study is an observational study only. Patient specific information obtained from the ultrasound will not be released to the patient’s treating medical team during the study.
It is anticipated that patients with head injuries will not have the capacity to provide their consent to participation in this study when the ultrasound examination is intended to be conducted. Under the Guardianship and Administration Act 2000 (GAA Act) the tribunal can give consent to an adult’s participation in special medical research or experimental health care for an adult with impaired capacity.[1] However the tribunal’s consent is not required for an adult with impaired capacity to participate in clinical research approved by the tribunal. Clinical research as defined by the GAA Act is stated not to be special medical research or experimental health care.[2]
[1] Sections 68 and 72 of the GAA Act.
[2] Section 12(2) of Schedule 2 of the GAA Act.
Clinical research is defined in the GAA Act as medical research intended to diagnose, maintain or treat a condition affecting the participants in the research or a trial of drugs or techniques involving the carrying out of health care that may include the giving of placebos to some of the participants in the trial.[3] In practice, it can be difficult to distinguish between clinical research and special medical research.
[3] Section 13 of Schedule 2 of the GAA Act.
The difference between the concepts is important when dealing with patients with impaired capacity. Once clinical research is approved by the tribunal, the researchers need to obtain consent for participation from a person authorised by law (a health care attorney, a guardian for health care, a statutory health attorney for an adult). This is done by discussion with the authorised person at any time prior to enrolling the patient in the study.
Special medical research on the other hand requires consent to be obtained from the tribunal for each patient enrolled in the study. This process would take hours, if not days, to conclude for each patient and consideration of an application for consent can only occur during the hours when the tribunal is open for business. Patients with head injuries arrive at any time of the day or night in hospitals and without consent of the tribunal, patients could not be enrolled in special medical research.
The research in this study is time critical and could only usefully be conducted in the time shortly after a patient with head injuries first arrives in the hospital. At the hearing, Dr Hope appearing as the applicant confirmed that it would not be practicable to wait for the start of the tribunal’s business hours to seek consent for participation in the study in each case. By then pressure in the patient’s bran would have already been assessed by CT scan in most cases and essential treatment commenced and it would be otiose to then carry out another assessment of pressure in the brain.
This study would have clearly fallen into the clinical research category if the results of the ultrasound were to be provided to the treating team as part of the diagnostic information obtained during clinical examination of a patient with head injuries. However the study is observational in nature only and is directed to gaining knowledge from the ultrasound that will be used for research purposes and not for immediate clinical purposes as well. That aspect of the study raised concerns with the tribunal.
The concerns arose out of the practical difficulty in distinguishing between clinical research and special medical research as stated in paragraph 4. If the research is only intended to gain knowledge that can be used in the diagnosis of a condition that an adult with impaired capacity has or had had, then that research falls within the category of special medical research. However I was satisfied that despite being an observational study only, the research in this study did fall within the clinical research category of the GAA Act.
The study critically does more than seek to gain knowledge that can be used in a diagnosis. The study involves a technique that is intended itself to diagnose a condition affecting participants in the research. The fact that the information is not provided to the treating medical team during the study does not detract from the intention of the research: it is intended to diagnose a condition. In that way the study can be seen to fall within the category of clinical research that is able to be approved by the tribunal.
The study had received approval from an ethics committee, it did not involve any known substantial risk to participants, the ultrasound technique was a known safe and ethical procedure carried out in routine medical care and participation in the study was not adverse to the interests of patients who could not give their own consent to participation.
The tribunal accordingly approved the clinical trial entitled “Traumatic Brain Injury or Sub Arachnoid Haemorrage and the relationship with Optic Nerve Sheath Diameter” for a period of three years or until revocation or expiry of the ethics approval, whichever is the sooner.
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