The demise of a planned randomised controlled trial in an urban Aboriginal medical service

To the Editor: I am responding to a recent editorial by Jamrozik1 commenting on a study proposed by Sibthorpe and colleagues to assess a brief intervention for hazardous use of alcohol by Indigenous people in an urban setting.2

After two unsuccessful attempts to recruit participants, the study was discontinued and funds returned to the National Health and Medical Research Council (NHMRC) in 1998. Sibthorpe et al identified their difficulties as primarily the result of having overestimated the number of suitable participants, for a number of complex reasons.

Jamrozik's criticisms rest disproportionately with the NHMRC and are based on procedures and processes in effect in 1996 and 1997, yet they are informed by contemporary knowledge and wisdom. This seems somewhat anomalous.

In 2000, the NHMRC revised its system for assessing research applications. This involved several developments which would have had a direct impact on the assessment of this application had they been instituted in 1996. Some of these include:

• the introduction of panels comprising 11 experts in the domain of the application;

• the introduction of the Indigenous Health Research Panel (IHRP), which provides advice on cultural appropriateness, community consultation and methods in applications with an Indigenous component (most members are Indigenous people); and

• the opportunity for IHRP to make stipulations upon which funding is contingent.

Also of significance was the establishment of the Research Agenda Working Group (RAWG), which oversaw the formulation of intervention-based criteria. Colloquially known as the "Darwin criteria", these principles ensure that all Indigenous research design has:

• sufficient Indigenous community consultation and participation;

• transferability (of the methods to other settings); and

• sustainability (of resulting changes).

The NHMRC was disappointed that the study by Sibthorpe et al did not proceed and did not result in usable data to inform a significant problem. However, it is also important to recognise that unanticipated outcomes, which can often lead to other, very positive results, are an integral part of the learning process.

The NHMRC has supported Australian health and medical research since 1936. It has a strong commitment to ensuring the continuing evolution of its procedures and practices. The new systems implemented in 2000 were designed to ensure the continuing tradition of funding high quality, relevant and applicable research.