HIRANI Cluster Innovation Manager, Sean O’Connor hosted a webinar recently along with the Mindset programme and Health Innovation Network South London to speak about ethics in the development of VR and XR interventions for mental health.
“A key message from the webinar was that ethical review should not be seen as a barrier to innovation. Used well, it helps innovators create interventions that are well designed, person-centred, credible and more likely to succeed in real-world mental health settings.
“We spoke about the importance of:
• involving patients, service users and people with lived experience early through meaningful PPI and co-design
• recognising that ethics review is concerned with ethical issues, recognising risk, participant protection and proportionality, rather than methodological peer review
• innovators working closely with research and clinical teams to develop evidence, consent processes and monitoring arrangements
• understanding the critical difference between supervised and unsupervised interventions, particularly in relation to distress, withdrawal, safeguarding and clinical responsibility
• clearly explaining what the technology senses, what it infers from those signals and how it may adapt the experience
• considering accessibility, inclusion and data minimisation from the earliest stages of development
• being transparent about commercial involvement, including who owns the technology, who accesses the data, how intellectual property is managed and whether commercial interests could influence study design, interpretation or future use.
“One question captured a key part of the discussion:
Who is responsible when an adaptive VR or XR system changes the intervention?
The developer, researcher, clinician and organisation may all have responsibilities, but those responsibilities must be clearly defined. Shared responsibility should not become diluted responsibility.
“An important point for innovators was that the therapeutic potential of VR is closely linked to its ability to create a strong sense of presence and generate emotional, behavioural and physiological responses that resemble real-world experiences. Those same features that may support therapeutic change are also linked to the highest risk with immersive interventions.
Discussions also reinforced that a promising intervention is not enough. Innovators should always have an implementation model or framework in mind.
That means considering:
- where the intervention will sit within care pathways
- who will supervise or support its use
- how it fits clinical workflows
- what evidence commissioners and procurement teams will require
- what training, technical support and governance are needed
- how the intervention will be funded, maintained and updated
- whether the commercial model is sustainable beyond a pilot or grant-funded study
“A product can be safe, acceptable and technically impressive, yet still fail if it does not fit real services, budgets, responsibilities and procurement routes. Implementation, adoption and sustainability should therefore shape development from the beginning,” said Sean.
#VR #XR #MentalHealthInnovation #DigitalHealth #ResearchEthics #PPI #CoDesign #ResponsibleInnovation #Implementation #Commercialisation #Procurement #MindsetXR #HIRANI
