Hi Rowley You do not need NRES approval for this study as you rightly state. If the study is linked with an academic institution you can apply for ethical approval using their processes. Are these underwriters in the NHS or another organisation?? I can't really suggest anything other than to produce a document that asesses risk in a sensible way to submit along with the study protocol? BW Sue On 26/12/2013, Rowley Cottingham <[log in to unmask]> wrote: > I need to undertake a study using normal volunteers. As they are not > patients, we are not covered by standard NHS indemnity. The underwriters > are > struggling to make an assessment of risk and hence premium. Our risk > analysis suggests that the risk to any individual of any harm is low, and > significant harm infinitesimal. Can anyone give any advice on what we can > say to the underwriters? > > Kindest regards, > > > Rowley. > -- Suzanne Mason Professor of Emergency Medicine EMRiS group School of Health and Related Research University of Sheffield Tel: 0114 2220694 0114 2714972 (NHS Secretary: Jill Bishop)