Gaining NHS ethical approval from the perspective of a biomedical engineering team

Abstract

Gaining ethical approval to conduct collaborative research in the NHS is transitioning. The process of gaining ethical approval from a Research Ethics Committee was viewed as cumbersome within the UK. This viewpoint fuelled continuous improvement of the approval system, most recently implemented by the Health Research Authority. This paper documents an 8-month process of gaining ethical approval, under Proportionate Review, to recruit NHS patients, by an academic biomedical engineering laboratory. Within the field of prosthetic healthcare technology, the multidisciplinary laboratory adopted co-design principles to establish an effective relationship with clinicians to collaboratively gain approval. The challenges and recommendations of acquiring such approval are presented in this paper, including time commitment, project management, strategic networks and stakeholder engagement. The authors believe that academic biomedical engineering research is ideally situated to collaborate with the healthcare sector. By forging a collaborative approach, biomedical engineering can lead in the translation of technology from early stage research to clinical adoption. This vision will be facilitated by gaining an understanding of the NHS ethical approval process. The paper provides insight to this regard, with the aim of informing academic, research management and healthcare domains of this transitioning field of work.