One of challenges of conducting exposome research with volunteers is how to organise and manage participant consent over the long term. This issue of participant facing governance is being explored by the EHEN Ethics and Law Working Group in an online questionnaire to find out how researchers working with data cohorts are addressing consent and participant facing governance in practice.
In this first EHEN opinion piece, Daniel Groos, coordinator of the EHEN Ethics and Law Working Group, explores the issue of participant facing governance in relation to the Danish consumer cohort, which is a pilot study linked to the Human Exposome Assessment Platform (HEAP) – one of the nine Horizon 2020 projects in the EHEN network. Daniel works for Lygature, a HEAP consortia partner providing advice and guidance on legal, ethical and privacy issues linked to exposome research, both on a national and international level
Statens Serum Institut (SSI), a Danish public health institute, participates in the HEAP project with the Consumer Cohort Project. That project investigates how food and daily supermarket products (e.g. cleaning products) can affect the health of Danes. This is done, after their consent, by forwarding to the SSI the consumer receipts which participants already download to a commercial app to monitor their spending. The research is carried out by the Department of Infectious Disease Epidemiology and Prevention of SSI.
The Danish consumer cohort is exemplary for how diverse datasets are used in exposome research.
The method of utilizing consumer food purchase data in investigating outbreaks is a method which has the potential to uncover multiple factors that may not emerge in patient interviews and surveys. Further, digital receipts are helpful as they can serve as an objective and automatically traceable digital marker for individual consumer choice behaviour, and do not require consumers to manually log their meals.
However, such research also poses challenges, which are examined below.
Sphere transgressions
The fact that the research takes place within a public-private sphere demands attention, as citizens generally are favourable to public health research but tend to dislike sharing their data if it (indirectly) results in financial profit for commercial parties. In this instance, it should be noted that the data are already generated by a commercial company. The issue of sphere transgressions (private parties gaining influence in public spheres) is in that sense inverted; in this case, it is SSI which takes the leap into a different sphere.
On the hand, people sceptical of such commercial apps would be unlikely to participate in the first place and the fact that the SSI uses them for research might give a certain legitimacy to the app of which a public organisation should steer clear. Whether it is problematic in this particular case should be examined.
Consent
The transfer of purchase information from the company to SSI takes place on the basis of consent of the participants. The wording of the participant information makes clear that the consent is formulated in a broad manner. Although the Danish data protection authority has authorised the data processing, whether the consent has the specificity required by the EDPB remains doubtful.
The consent procedure has certain elements of consent for governance, as consent is in essence granted to the research team to use and analyse the data in an ethically and legally sound way. Information is given on the meaningfulness of the study for participants, the data management, and the benefits of the research for the wider society. However, in the longer run, more participant engagement may be needed to transform the consent procedure to fully realize a model of consent for governance.
Real world implications
The study website currently makes clear that participating in the research can increase our knowledge of how our lifestyle and surroundings affect our health, but doesn’t give an indication about the real-world application of the study findings.
Regarding food-borne disease outbreaks, the research outcomes could be decisive in compelling public authorities to undertake action to protect citizens’ health. Other applications and possible outcomes could be more controversial.
A study on consumer patterns using a different method, found that becoming unemployed leads to less healthy food intake which gets worse when the unemployment lasts longer. The authors recommend that these findings should be taken into account in future welfare reforms.
Hence this type of research raises questions about citizen’s own responsibility for health or whether the outcomes should be translated into policy recommendations in a very different field than health protection. Special attention should go to the vulnerabilities and inequalities of the groups associated with, for example, ’unhealthy habits’. Considering the potential outcomes of the research, the question is to what extent researchers carry responsibility to clarify the social benefits and to take measures to ensure benefit sharing and equitable access.
The research may also help empower consumers by enabling identification of healthy or climate friendly choices and perhaps change focus from price only to more balanced priorities; the app as your personal lifestyle coach. That would potentially mean another sphere transgression. There are no concrete plans in that direction. However, if the participants would be targeted with this information, this would only be acceptable as an option with their additional consent.
Conclusion – the case for broad consent
Given the challenges of fostering trust and enhancing participant engagement while also providing research output, a broad form of consent together with participant facing governance is advised.
In the consumer cohort, participant engagement is realised in a rudimentary form. Given the status of the SSI it might be in an excellent position to implement such engagement, perhaps gradually. The results of the previously mentioned online questionnaire might be helpful in giving examples of what works in practice.
