Clinician perspectives on patient consent for metagenomic next-generation sequencing of blood samples for the diagnosis of infection in clinical practice.

Introduction. Pathogen diagnostics based on metagenomic next-generation sequencing (mNGS) are now in clinical use. mNGS can identify unexpected pathogens or organisms of unclear significance and generate human genomic data. Given these features, it has been suggested that patients should provide specific informed consent for mNGS.Gap Statement. There is limited published guidance on the appropriate form of consent for clinical infectious disease mNGS to guide clinical implementation and current practice varies.Aim. To inform a pilot of mNGS for returning travellers delivered at a reference laboratory for use by specialist infection clinicians, we sought clinician perspectives on the form of consent required for mNGS and the information patients require to make an informed decision.Methodology. A national survey of infection specialists provided clinicians' opinions.Results. If consent for an infection screen including blood-borne virus testing had already been provided, only a minority of surveyed clinicians (22 out of 124, 18%) thought that mNGS should be discussed before it was performed on pre-existing blood samples.Conclusion. Most of the UK infection clinicians surveyed did not think that mNGS of blood from returning travellers required discussion before being performed when patients had already consented for infection diagnostics to find the cause of their illness. However, clinicians felt that patients should be aware of the potential for additional testing and wanted information on mNGS to be readily available.With the increasing availability of clinical infectious disease mNGS, engagement of non-specialist clinicians and patients is required to confirm the generalizability of these perspectives. The model of consent used for clinical infectious disease mNGS should be ethically adequate in addition to being acceptable to patients and clinicians.