Does Waiver of Informed Consent in Low-Risk Randomised Controlled Trials Improve Research Inclusion? Insights from a Review of the UK Health Research Authority Confidentiality Advisory Group Register

Low-risk pragmatic trials improve clinical services. Informed consent is gold standard to ensure ethical research. However, its implementation can impact participation of underserved groups who face disproportionate barriers around communication, health and research literacy, and limited availability for burdensome processes. Carefully considered application of waived consent may overcome barriers to inclusive participation. However, an understanding of when waived consent has been used, whether it supported inclusion research, and lessons that can be learnt, is lacking. We reviewed the UK Health Research Authority Confidentiality Advisory Group (HRA CAG) database for non-emergency individually randomised trials that were granted a waiver of consent. Nine trials were identified; these aimed to boost cancer screening uptake in deprived or underserved populations. Waived consent enabled inclusive research approaches for evaluating interventions such as culturally tailored screening kits and barrier-reducing tools. Further research is needed on patient perspectives and ethical safety in these consent models.