The University of Hull and East Riding Fertility Services Ltd (The Hull IVF Unit)

Introduction East Riding Fertility Services Ltd (ERFS Ltd.) operates the Hull IVF Clinic, a private li ited co pany !hich provides a nu "er o# assisted conception techni$ues, including in%vitro #ertilisation (IVF), #ro the &o en's and Children's Hospital at Hull Royal In#ir ary, (nla"y Road, Hull. )he co pany is a distinct legal entity and contracts !ith its clients to provide the services it o##ers #or a #ee or "y !ay o# other consideration. It has no legal or #inancial connection !ith the *niversity o# Hull Ho!ever, a nu "er o# individuals !ho !or+ in the IVF unit and carry out !or+ on its "ehal# are also e ployed $uite separately "y the *niversity o# Hull. )he purpose o# this docu ent is to clari#y !here responsi"ility #or in,ury to patients arising #ro treat ent in the IVF clinic lies. Fertility services / assisted conce tion (ll services and treat ents provided "y the Hull IVF *nit to its clients are the responsi"ility o# East Riding Fertility Services Ltd. (ny techni$ues or !or+ carried out "y individuals !ho also hold contracts !ith the *niversity o# Hull are "eing carried out in the course o# e ploy ent "y ERFS Ltd and not the *niversity o# Hull. )he co pany should ensure that it has ade$uate inde nity insurance to eet the cost o# clai s ade "y clients !ho su##er in,ury as a result o# negligent treat ent received. )here is no re$uire ent to have insurance cover #or in,uries #or !hich it is not to "la e !here no negligence is involved. It is also desira"le #or individual clinicians to have -edical .e#ence *nion (-.*) insurance !hich is capa"le o# covering the individual and the e ploying co pany #or clai s ade directly against the . *niversity o# Hull sta## do not have any involve ent in the IVF *nit in their capacity as e ployees o# the university. /one o# the university insurance policies provide cover #or the Hull IVF *nit. Research 0ccasionally, it ay "e that a e "er o# sta## or a post%graduate student o# the *niversity ay !ish to carry out a clinical trial in the IVF *nit. ( clinical trial is any procedure, techni$ue, intervie!, $uestionnaire, analysis !hich re$uires ethical approval. Ideally, the ERFS Ltd, should act as sponsor and agree to supervise the trial and "e responsi"le #or any lia"ility arising #ro har to the patient 1 volunteer. )his should particularly "e the case !here ERFS Ltd !ill "ene#it #ro the results o# the research. (lternatively, the appropriate /HS )rust ay "e prepared to provide inde nity su",ect to the approval o# their Research and Ethics depart ent. I# ho!ever, the *niversity o# Hull !ishes to ta+e on responsi"ility #or the trial then this ay "e possi"le. )he Insurance 0##ice !ill need to receive, !ith good notice, a copy o# the Ethics Co ittee application #or and a re$uest that inde nity "e provided #or either negligent or non negligent har . 2y !ay o# clari#ication, the di##erence "et!een the t!o types o# inde nity is solely due to !hat happens a#ter an in,ury is alleged. &ith the #or er, it is #or the patient to prove that the in,ury !as caused "y so eone's negligence and in the latter case it is only necessary to prove that an in,ury has occurred. )here is no distinction "et!een !hether the in,ury is caused "y a de#ective protocol or "y de#ective delivery o# the protocol, that is to say, the practical side o# the trial. In all cases !here the trial involves assisting !ith or altering in any !ay the process o# conception or any involve ent !ith a person !ho is +no!n to "e pregnant needs speci#ic !ritten approval #ro the insurer "e#ore the trial starts. It is good practice to get approval #or all trials re$uiring *niversity o# Hull inde nity in the IVF *nit. 0"viously, the trial ust "e approved "y the Ethics Co ittee.

Finally, it should al!ays "e the case that there is a clear distinction "et!een any procedure "eing carried out as part o# treat ent and procedure !hich is the clinical trial. (t the si plest level, a patient !ho is having IVF ay "e as+ed to provide a "lood sa ple as part o# that process and at the sa e ti e part o# that "lood ay "e used #or the purposes o# the trial. )he *niversity !ould not e3pect any pro"le resulting #ro the vena puncture in those circu stances to "e covered "y our clinical trials insurance. !onclusion )here is a clear distinction "et!een the !or+ o# the Hull IVF *nit and the *niversity o# Hull. East Riding Fertility Services Ltd have sole responsi"ility #or in,ury to clients 1 patients in their care and should a+e appropriate insurance provision accordingly. In the event that the *niversity o# Hull has "een as+ed to provide cover #or an ethically approved clinical trial #or !hich it has its insurers speci#ic sanction, then it !ill deal !ith clai s received as agreed.