Standard treatments, “Delayed consent” & clinical trials

Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (ADRENAL Trial) [2015] NSWCATGD 23 was a decision made on 19 June 2015 but apparently the reasons were published online only recently.

The trial commenced operation in NSW in 2012, but it was suspended in January 2015 following earlier decisions of NCAT in other matters.

The applicant’s primary submission was that the ADRENAL trial ought not be considered a ‘clinical trial’ within Part 5 of the Guardianship Act. In the applicant’s view, ADRENAL involves the comparison of two widely accepted, standard forms of critical care treatment and, as such, does not involve the testing of new drugs or treatments or the experimental study of new applications. The applicant submitted that this type of study was not intended to be the subject of the clinical trial provisions that were introduced into the Guardianship Act by the Guardianship Amendment Bill 1998.(see [7]).

Put more simply, the applicant’s primary argument was that the Tribunal should adopt a construction of the term ‘clinical trial’ so as to exclude studies of standard treatments (see [99]).

At [94], based on the evidence presented, the Tribunal was satisfied that the hydrocortisone arm of the ADRENAL trial, administered in accordance with the Study Protocol, reflects an existing, accepted treatment for septic shock. At [95], the the Tribunal was also satisfied that the placebo arm of the trial, administered in accordance with the Study Protocol, reflects accepted treatment for septic shock namely treatment in accordance with the accepted principles of therapy for the treatment of septic shock without the administration of hydrocortisone.

The conclusions reached by the Tribunal were at [125]:

A textual reading of the provisions relating to clinical trials in Part 5 of the Guardianship Act has led the Tribunal to the conclusion, on balance, that the definition of ‘clinical trial’ in section 33(1) of the Act, despite the breadth of the definition in that section and the language used in the definition of ‘special medical treatment’ in the same definitional section, should be interpreted as excluding trials of a currently accepted treatment for the condition in question. An examination of the provisions in section 45AA(2) supports this narrower view of the definition of ‘clinical trial’.

and at [127]:

Whether a drug or technique to be tested in a trial is a currently accepted treatment for a condition or whether it is properly regarded as new or experimental treatment will be a matter that needs to be considered on a case-by-case basis as the question of what is an accepted, established treatment may be open to interpretation.

Delayed consent issue: no legal basis

The evidence before the Tribunal indicated that the ADRENAL trial is one in which participants are likely to be incapable of providing informed consent as they are ‘often unconscious, sedated, intubated and too ill to understand information relating to clinical trial participation (at [16]).

In circumstances where it was not possible or practicable for the patient or the person responsible to provide consent in a timely manner, the Study Protocol provided that ‘delayed consent’ may be sought from the patient or person responsible, in that:

Patients who recover sufficiently to understand the explanation of the study will be asked to provide verbal or written consent (according to local HREC requirements) to continue with the study procedures as soon as possible or be offered the chance to withdraw. If the patient chooses to withdraw from the study procedures, they will be asked for permission to use their study-related data and for permission to collect and use outcome data.

The applicant  note that the rationale for the incorporation of a delayed or deferred consent protocol was informed by the NHMRC Guidelines, however in written submissions  the applicant accepted that ‘there is no legal basis for delayed consent in respect of receiving medical treatment in New South Wales: (at [23]-[24]). The tribunal implied at [32] that the Sydney Local Health District Human Ethics Review Committee who approved the Study Protocol may wish to revisit the delayed consent format.

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