Citizen Science and DIY Diabetes: Ethical and Regulatory Challenges of Patient-led Innovation

The first of our Centre for Health Law Science and Policy events for 2020

Dr Rachael Dickson and Professor Muireann Quigley from Birmingham Law School will be presenting their paper “Citizen Science and DIY Diabetes: Ethical and Regulatory Challenges of Patient-led Innovation”- abstract is attached.

Citizen Science and DIY Diabetes
Ethical and Regulatory Challenges of Patient-led Innovation

Abstract

Healthcare technology innovation in diabetes management is a slow process, resulting in a community of ‘loopers’ emerging. Tired of waiting for commercial companies to produce effective, accessible products, loopers are constructing DIY ‘artificial pancreas’ systems (APS) to better manage their diabetes by connecting their insulin pumps to their glucose monitors using either a small computer or their smartphones.

These practices raise ethical and legal challenges for both clinicians and users. There is an almost complete lack of ethical or legal guidance for clinicians who provide care to patients using DIY artificial pancreas systems (APS). This results in significant uncertainty with regards to their ethical and legal obligations in providing appropriate care. Correspondingly, there appears to be a lack of awareness amongst loopers that there may be legal implications of altering the functioning of their insulin pumps. Looping falls outside the usually tightly regulated medical device environment, raising a number of legal and regulatory questions. For example: are those who create and use DIY systems liable for device malfunction? What impact does looping have on the legal and ethical responsibilities of clinicians and the NHS towards loopers?

We don’t aim to answer such questions in this paper, but instead problematize and analyse the DIY diabetes movement as an aspect of ‘citizen science’. Citizen science is “understood broadly as the participation of non-professionals at any phase of scientific research” (Fiske et al. 2019). The types of activities captured by citizen science include “include volunteer monitoring, community science, and participatory research . . . [as well as] technology-supported projects where crowdsourcing techniques [which] are applied to scientific data or analysis” (Wiggins & Willbanks 2015).

Up until now, most discussions regarding citizen science have often focused on areas such as genomics, where citizen scientists are involved in genetic sequencing or working towards creating biomarker-based tests for rare diseases, or data collection, where the patients are leading projects to improve understanding of particular health conditions. In a number of respects DIY APS represents a much more complex, treatment-oriented (and potentially problematic) example of citizen science. Using citizen science as a lens for enquiry, in this paper we explore some potential ethical and regulatory challenges of patient-led innovation. We argue that while DIY APS generally represents a welcome democratisation of diabetes management. However, there are a number of pressing concerns which need to be addressed regarding the growing use of an essentially unregulated medical technology.