Abstract
In early March 2015, Apple announced a set of apps referred to as “ResearchKit” – designed to connect medical researchers directly with participants and to harness the data already collected by Apple’s “HealthKit”. Broadly, these combine data already recorded (such as using the built-in gyroscope as a pedometer) along with data entered by the user, and then make that data available to specific projects.
The aim here is noble – to facilitate medical research on a wider scale, but a number of ethical concerns have already been raised:
Privacy – Apple themselves seem acutely aware of the potential privacy issues, having noted in their keynote that the data will not pass through to their hands. However, Apple is not the only source of privacy concerns – given the potential amount of data it may be hard to anonymize appropriately.
Research on minors – concerns have also been raised about whether these apps can properly exclude children from being research subjects – with some of them allowing you to change your stated age until you qualify for the research project.
End-user agreements are not consent forms, and likewise there is a distinction between how people treat and react to end-user agreements (i.e. scroll to bottom and click through as fast as possible) and how we expect an informed consent processes to be handled.
Each of these issues is probably resolvable through technical solutions – for example, quizzes to assess how well the participant has comprehended the information are already implemented in some apps and might reduce the concerns about how we commonly treat electronically presented information.
I want to focus on another concern, though – how ethics approval might be required and handled. Thus far, each of the apps using ResearchKit has IRB approval in the US. This is fine as far as it goes, but the use of these apps brings up jurisdictional issues that are at least challenging. This is because the apps can be downloaded internationally (even if they are region-specific it is straightforward to set up a foreign ITunes account – I myself have accounts in the UK, US, NZ and Australia) and also because the device with the research app on it can itself travel internationally with its user.
Of course, jurisdictional issues are nothing new – international research has long faced questions about where and when ethical review should occur. Also, online research has continually faced this issue; however, the potential scale of the issue here is different because millions of people have Apple devices and thousands have signed up for ResearchKit. This complicates the approval and jurisdictional issues because, while many projects can be relatively contained, it would seem difficult to do in this case. So, for example, if a research participant from the US travels to Australia and continues to participate in the research, does that render the researcher in breach of the National Statement in Australia since they do not have the relevant permission to conduct research in Australia?
Now in practice, of course, I suspect we will continue to do what we always do with regard to the questionable ontology of online facilitated things – i.e. ignore them and treat them as if they occur right here. Nonetheless, this calls into question both whether we can regulate these large-scale research projects and perhaps just how harmonized our research regulatory systems need to be internationally to be effective.
This issue of Research Ethics presents an array of challenging issues in cutting-edge research, ranging from cluster randomized trials to assent with children. We start with an empirical piece exploring the attitudes of clinical researchers to the use of advanced directives in the research context. We then move to a framework for assessing research assent protocols. Some of the difficulties in early study ending are then raised. This is followed by a fascinating discussion of the use of metaphor as a research tool. Finally, we report on the Ottawa Statement on Cluster Randomised Trials.