“Now everybody can do their part to advance medical research.” This is the up-beat message emblazoned across the webpage Apple uses to promote its new ResearchKit app. An application designed to harvest various user data for use in large-scale medical trials.
On the face of it, this seems like a great idea.
If even a fraction of the hundreds of million iPhone users shared data on their health and activity levels, it could provide a mass of uniquely diverse data that would be invaluable to researchers. It could also directly benefit users – for example asthma sufferers could automatically be warned if they were in an area that had poor air quality.
Users could take place in medical surveys, signing their names with their fingers. They could even pick which surveys they want to participate in – and there’s the catch. Good Clinical Practice demands not only that the patient’s best interests are at heart but that they fully appreciate the details of the trial – how many are involved, personal risk, likely benefit, etc.
How is this going to be achieved with a group whose only defining feature is access to an iPhone?
In my circle of friends and colleagues, there are many iPhone users – some taking full advantage of the myriad possibilities offered by such an impressively powerful pocket computer and others barely mastering the on/off switch.
A lot of iPhones get passed on to children when their parent gets the latest model – is the trial signup going to transfer to the new model of phone with the user? Alternatively, will the research data reveal sudden inexplicable boosts in activity coupled with increasing junk food consumption?
Of course the rules of Good Clinical Practice are quite clear about gathering informed consent, and the particular rules that apply to children.
For example, consent forms should be tailored to the age of the patient, even if this means that one trial has several different forms. Each form should be approved by the local IEC. With the youngest patients, a parent or guardian should review and sign the forms.
And I’ve not even started on the subject of data protection.
I wonder how many people who sign up will realise that data protection rules are different for apps? Unlike the information they share with a doctor, data they share with an app or wearable device isn’t usually protected by federal medical privacy laws. The data can be sold, shared and stored in various ways they may not expect.
Don’t get me wrong – I think this is a great idea in principle. I’m just wondering how it’s all going to work in practice. Maybe I’m just bitter as I don’t own an iPhone…
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