Case story

Making a DVD for Informed Consent Processes

The Kanyini Vascular Collaboration is a partnership between the George Institute for International Health, Baker IDI Heart and Diabetes Institute, and 10 primary health care services in Central Australia, New South Wales and Queensland. It aims to identify and overcome barriers to best practice chronic disease care for Aboriginal and Torres Strait Islander people.

Ricky Mentha is an Indigenous Research Fellow at Baker IDI in Alice Springs, and works with principle investigator Alex Brown. Ricky talks about making a DVD for use as part of the informed consent process for a clinical trial of a combination polypill.

‘The team decided to make  the DVD here in Central Australia because of the English and Medical language barriers, because of the contextual situation of remoteness and chronic disease prevalence in Central Australia, and generally [because] people’s awareness of research is limited. The informed consent DVD will be used in conjunction with the traditional means of getting informed consent, where you sit down with a piece of paper and go through it with potential participants. Now [people will] have an audio visual aid as well.

We wanted the DVD to come from the community, so we collaborated with the Indigenous research team at Tangentyere Council and tapped into their expertise. We basically said ‘We need to inform your community [so people can decide] whether they want to participate in the study or not. This is the information we want to put in it and these are all the vital ethical considerations. You guys come up with how we go about doing it, who gets involved, what language is spoken.’

We developed this script … We give history of the issues we’re trying to research and how we can improve access and health outcomes for people, but that we need to study 300 people from central Australia.  Alex Brown gives the background information on the DVD. Then we set a scene up [to show] someone being recruited through the Health Service … [It shows that] the person can in fact say ‘no’ and walk away and that recruiting process stops, or ‘yes, you want more information’, and someone will come and sit down with you and go through the paperwork and explain it a bit more clearly.

We give the information [about] what … we’re going to be doing, ringing up people or going out and doing home visits once they’ve signed up.  And [we explain that] people get put into a control group that just stays on their normal medication, [or another group] get this new polypill with four medicines in one tablet.  And we follow up and do four interviews over an 18 month period.  We’re not trying to use medical terms and we’re trying to inform people of the process so people can make that choice. We make the whole research process very clear throughout the DVD and then people will be able to make a decision … to participate or not in the Polypill trial.

It’s being edited now with voice-over into five [Central Australian] languages and also there’s an English version. We don’t know yet - we haven’t tested it - but we think the DVD will assist people to make a decision whether they want to be part of the study or not.

Just by asking and engaging a lot of people in [making] this DVD people are hearing about the Polypill. People seem excited about the potential of cutting down on their medications, and participate in the study, so word has spread throughout the community… We have the opportunity to measure the improvements to their quality of life through this study.

The Kanyini Vascular Collaboration studies are described at: www.kvc.org.au/