Practical Challenges for Commercial Enterprises in the Ethics Review Process for Digital Health Research: Document Analysis and Interview Study

Introduction The rapid evolution of digital health interventions has created challenges in navigating the ethics approval process for commercial enterprises. Recognising the need for processes that balance ethical considerations with the specifics of digital health research, this study aimed to describe what happens when enterprises seek ethical review in the UK and propose strategies for a smoother process. Methods Inductive thematic analysis was conducted on thirty-two ethics review documents (29 to an NHS Research Ethics Committee, 3 to an ethics committee at a higher education institution) submitted by digital health developers with commercial sponsors and ten semi-structured interviews with digital health enterprise representatives. Results Ethics committees raised an average of 4.3 action points per submission. We identified five broad themes around committees’ concerns: ethical commitments in care; study design; digital health research peculiarities; data governance; document quality and completeness. Interviewees reported a range of experiences. Here, we identified six broad themes: submission and protocol revisions; the dynamic between parties; application time and procedures; acumen and practicality in digital health; support and guidance from RECs; enterprise expertise and resources. Conclusion We suggest strategies for applicants to achieve a favourable decision, such as evidence-based study designs and participant support for better inclusion and equity, and identified specific pitfalls to avoid, such as lack of justification for data governance procedures. We recommend that UK research ethics committees provide adapted guidance and foster collaboration through open communication and mutual understanding, to facilitate a smoother approval process in digital health research.