illustrated eye with data inside

Working with the INSIGHT Health Data Research Hub: part 3

Thu Dec 17, 2020
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The ODI is working with eye-health charity AAAMD on a data-sharing initiative: INSIGHT. Find out about the INSIGHT Data Trust Advisory Board – the group of stakeholders providing oversight and scrutiny of the initiative’s data management

by Walter Pasquarelli


The INSIGHT Health Data Research Hub aims to unlock new insights in disease detection, diagnosis, treatment and personalised healthcare. To do this, it brings together and makes available anonymised data – from eye scans and images, and advanced analytics – to NHS, academic and industry researchers.

We’re working closely with the eye-health charity Action Against Age-related Macular Degeneration (AAAMD) to convene a group of public, patient and other stakeholders to provide meaningful oversight and scrutiny over how INSIGHT manages data.

In our previous post, we described some of the initial decisions that were made about this group’s role and how it would function. In this post, we’ll talk about what the group – the INSIGHT Data Trust Advisory Board, or ‘INSIGHT DataTAB’ – now looks like in practice.

The group’s role

The INSIGHT DataTAB is responsible for:

  • assessing and providing recommendations on individual applications to access the data made available by INSIGHT.
  • developing and iterating the criteria for assessing the applications.
  • providing feedback on the overall procedure for granting or denying requests to access INSIGHT data.

When the hub receives an application from a researcher to access data, it will process the request to check that it is technically and legally feasible. If it is, the application will be passed to the INSIGHT DataTAB to review. The group will review the application using a set of assessment criteria that it is currently developing itself (once agreed, the criteria will be published on the INSIGHT website).

Following its deliberations, the INSIGHT DataTAB will provide one of four possible recommendations back to the hub to say that the application should be: granted; granted with further conditions; deferred pending receipt of additional information or clarification; or denied.

The INSIGHT DataTAB will convene quarterly to review the batch of applications that have been received in the preceding three months. The minutes and recommendations from these meetings will be published openly. Over time, the group might choose to consider only applications that are novel or contentious, especially if the volume of applications grows considerably or if many prove to be similar in nature.

The full terms of reference for the group can be found here, and we expect the group to begin reviewing applications in early 2021.

Representation

Any group designed to oversee data sharing and use is only as strong as the diversity of its membership.

To understand who should be on the INSIGHT DataTAB, we began by attending events where patients were sharing their attitudes and expectations around the use of data, including a workshop organised by UseMyData in Leeds where members of patient advisory groups shared their personal experiences. We also spoke with organisations like Understanding Patient Data to test some of our thinking and highlight our blind spots.

Most importantly, we presented an early outline of our plans for the INSIGHT DataTAB to a panel of patient and public representatives at a workshop organised by Moorfields Eye Hospital. The workshop was vital in challenging some of our assumptions and in particular, in determining whose views should be represented on the group we were about to convene.

To try to ensure that the group would reflect a wide range of views, we thought about its diversity in terms of its members’ experiences and their characteristics. For example, we were keen to ensure that the opinions, experiences and perspectives of patients with sight-threatening conditions were represented, as well as those with experience in health data research and regulation. We also wanted to make sure the group was diverse in terms of geographical coverage and characteristics protected by the Equality Act 2010, such as age, ethnicity and sex.

We then worked closely with AAAMD, different patient and public representative groups and the hub’s existing Patient and Public Involvement and Engagement teams to recruit members with these different experiences and characteristics. These members joined in private capacity representing their individual experiences and capacities. View the list of initial members of the INSIGHT DataTAB here.

As we reflected in a recent article for the website ‘Understanding Patient Data’, when bringing together any group, reflecting the diversity of the population you’re sampling from is hard. While we’re delighted with the group that we’ve brought together, we will actively seek to understand whether its membership should evolve over time – for example, based on feedback from its members about voices they feel are missing from the process.

Why the group is a not a ‘data trust’

The INSIGHT DataTAB is very real. It has a set of members onboard, an agreed terms of reference and the hub is committed to receiving its recommendations. With a more theoretical lens, we also set out to use this work to test our thinking around ‘data trusts’.

At the ODI, we describe that data trusts provide independent, fiduciary stewardship of data. They are an approach to looking after and making decisions about data in a similar way that trusts have been used to look after and make decisions about other forms of asset in the past, such as land trusts that steward land on behalf of local communities. They involve one party authorising another to make decisions about data on their behalf, for the benefit of a wider group of stakeholders.

With data trusts, the independent person, group or entity stewarding the data takes on a fiduciary duty. In law, a fiduciary duty is considered the highest level of obligation that one party can owe to another – a fiduciary duty in this context involves stewarding data with impartiality, prudence, transparency and undivided loyalty.

As we described in the second post in this series, while the INSIGHT DataTAB is responsible for providing oversight of the hub’s stewardship of eye scans and other ophthalmic health data, University Hospital Birmingham and Moorfields Eye Hospital remain, as data controllers, legally accountable for the data and liable for any risks associated with sharing it. We didn’t think it was appropriate for the INSIGHT DataTAB members to take this accountability away from the hospital staff, nor try to formalise a fiduciary obligation around the members’ duties.

With guidance from BPE Solicitors, we therefore decided that the INSIGHT DataTAB members should be bound by a memorandum of understanding, which outlines their role, responsibilities and commitments.

In short, the INSIGHT DataTAB does not currently provide independent, fiduciary stewardship of data, so we do not consider it to be a data trust.

We will, however, continue to explore the concept through our work with INSIGHT. In the long run, in its quest for sustainability, the hub may choose to establish itself as a distinct organisation with dedicated staff. In this case, it could incorporate similarly to UK Biobank, which was set up in 2006 to steward genetic data and samples from around 0.5m people, and takes the form of a charitable company with a board of directors that act as charity trustees under UK charity law and company directors under UK company law.

As we’ve written in the past, UK Biobank seems to put into practice much of David and Richard Winickoff’s earlier academic proposal of ‘The Charitable Trust as a Model for Genomic Biobanks’, and to us, provides the independent fiduciary stewardship of data we see as central to the idea.

In our next blog post, we’ll share more about how the INSIGHT DataTAB is developing its own data access criteria.