Health research in the digital age: what are the ethical considerations?
Current health studies produce a very patchy picture. Health studies are traditionally based on data collected from healthcare providers who collect data from sick patients; these studies only include those populations who have access to healthcare or who decide to go to the doctor in the first place. Such studies mostly include information about specific diseases and miss out information on behaviours, wellness factors such as stress-levels and sleep, and other factors that can influence a person's health. Is digital health research a solution?
Backed through Nesta's Centre for Social Action Innovation Fund, 100 for Parkinson's is a new citizen science initiative led by uMotif. The research study aims to recruit several thousand participants (people with Parkinson's, family, friends and interested public) to use the uMotif self-management app for 100 days, and philanthropically donate their data to drive patient-focused research on how self-management can help improve health outcomes, particularly in Parkinson's Disease.
As with any health research study, there are certainly ethical considerations for large-scale, citizen science, digital health research initiatives, such as 100 for Parkinson's. As a nascent but developing field, there are already a number of papers that describe these ethical considerations, including risks to individual rights such as privacy and autonomy, to the wider conversation around people's obligations to contribute to the common good.
So how is uMotif navigating research and ethical considerations for their 100 for Parkinson's initiative?
uMotif's top tips for developing a digital health research plan
- Focus on developing a strong project protocol: Preparing for an ethics assessment begins with the project protocol. I recommend using the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines and checklist to write the protocol. It is an international initiative that aims to improve the quality of clinical trial protocols by defining an evidence-based set of items to address in a protocol. For extra learning there is a free module from the BMJ on how to write and publish a protocol. Once the protocol is ethically approved, register it on a clinical trials registry, for example the ISRCTN registry.
- Find an academic partner: This is a critical step to help shape a good protocol and draft the documents needed for ethics approval. Ethics approvals in the UK are through two routes: through the NIHR or through a university ethics board. If you are working within the NHS you will need to go through a centralised process with the NIHR IRAS system. An academic clinician can be a good partner here since they will know the ethics processes that are applicable in the NHS. Our project is based outside the NHS so we chose a university partner - The Liverpool School of Tropical Medicine - to help us with the ethics and research aspects of the project.
- Work with all partners including patient groups at every stage: Depending on the theme you are working on, it really helps to reach out to relevant patient groups, academics and companies quite early in the project. We shared our proposal and sought input from our key supporters – including patient groups and clinicians - on the project protocol, research questions, website design and copy, and formulating principles for data access. They are part of the steering group for the project too.
- Seek advice from others who have done similar projects: Digital health research, also called digital epidemiology, is a relatively new area. Reaching out to others who have done similar work is vital. We are in regular touch with Sage Bionetworks as they have pioneered the Participant Centered Toolkit for E-consent, a key element of any research project.