NHS:@0.082761:0.061818:0.114869:0.061818:0.114869:0.050328:0.082761:0.050328:0.011438:0.012500:0.008170
 Indemnity Several health authorities and trusts have independently developed forms of:@0.115278:0.061818:0.680686:0.061818:0.680686:0.050341:0.115278:0.050341:0.001961:0.005441:0.008170:0.008170:0.007255:0.012712:0.008170:0.004542:0.004542:0.008170:0.000719:0.008742:0.007026:0.007925:0.007026:0.005229:0.007026:0.004542:0.004085:0.008448:0.007435:0.007435:0.004542:0.004542:0.008480:0.003186:0.007255:0.008170:0.004265:0.008170:0.008170:0.005441:0.004542:0.004542:0.004542:0.007255:0.006356:0.004575:0.007255:0.008170:0.008170:0.003856:0.004542:0.005261:0.008170:0.006356:0.004542:0.006356:0.004395:0.008007:0.007255:0.007859:0.007255:0.004510:0.004542:0.008170:0.008170:0.007059:0.008170:0.007255:0.007941:0.008170:0.007255:0.007941:0.004542:0.004542:0.008170:0.004559:0.008170:0.007435:0.008170:0.007435:0.004542:0.008170:0.008170:0.007255:0.008170:0.003480:0.005441:0.008170:0.005441:0.012892:0.006356:0.004428:0.008987:0.005441
indemnity agreement. However, difficulties have arisen when different :@0.340768:0.079369:0.807190:0.079369:0.807190:0.067891:0.340768:0.067891:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004575:0.007026:0.008170:0.005147:0.007255:0.006961:0.012418:0.007255:0.007859:0.004542:0.004085:0.005016:0.011797:0.008170:0.011797:0.007042:0.008170:0.007026:0.005441:0.004085:0.005098:0.008170:0.004542:0.005441:0.005441:0.004542:0.007075:0.008170:0.004542:0.004281:0.004542:0.007255:0.006176:0.004739:0.007925:0.007255:0.007859:0.007255:0.004085:0.007533:0.005441:0.004542:0.006601:0.007255:0.008350:0.003105:0.012173:0.008415:0.007516:0.008415:0.003513:0.008170:0.004542:0.005261:0.005441:0.007255:0.005196:0.007255:0.008170:0.004346:0.004085
authorities have required varying terms of indemnity and this has, on :@0.340768:0.096667:0.795098:0.096667:0.795098:0.085189:0.340768:0.085189:0.007255:0.008170:0.004265:0.008170:0.008170:0.005441:0.004542:0.004542:0.004542:0.007255:0.006356:0.004085:0.008170:0.007255:0.007859:0.007255:0.004510:0.005441:0.007255:0.008170:0.008170:0.004542:0.005441:0.007255:0.008170:0.003235:0.008415:0.007435:0.005441:0.008366:0.004542:0.008448:0.008333:0.003513:0.004542:0.007255:0.005441:0.012712:0.006160:0.004657:0.008987:0.005964:0.002696:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004575:0.007255:0.008170:0.008170:0.003856:0.004542:0.008170:0.004542:0.006356:0.004085:0.008170:0.006944:0.006356:0.003775:0.004739:0.008170:0.008333:0.004085
occasion, impeded the progress of clinical research within the NHS.:@0.340768:0.114217:0.782925:0.114217:0.782925:0.102740:0.340768:0.102740:0.008007:0.007255:0.007042:0.007255:0.006144:0.004542:0.008170:0.007958:0.004085:0.004657:0.004542:0.012712:0.008170:0.007255:0.008170:0.007435:0.008170:0.003513:0.004542:0.007958:0.007255:0.004085:0.008350:0.005441:0.008170:0.008366:0.005441:0.007255:0.006356:0.006356:0.004412:0.008905:0.005964:0.002778:0.007255:0.004542:0.004542:0.008007:0.004542:0.007255:0.007075:0.004542:0.004363:0.005441:0.007255:0.006356:0.007418:0.007255:0.005441:0.007484:0.008170:0.003186:0.012092:0.004542:0.004771:0.008415:0.004542:0.008448:0.003105:0.004542:0.007958:0.007255:0.004085:0.011373:0.011356:0.008742:0.004085
Particular difficulties may arise in large multi-centre trials involving many NHS :@0.340359:0.131831:0.866830:0.131831:0.866830:0.120354:0.340359:0.120354:0.009085:0.007418:0.005441:0.004542:0.004804:0.007255:0.008350:0.004542:0.007255:0.005686:0.004085:0.007843:0.004542:0.005261:0.005441:0.004363:0.007255:0.008170:0.004346:0.004542:0.004363:0.007255:0.006356:0.004608:0.012418:0.007026:0.008007:0.004657:0.007255:0.005163:0.004542:0.006160:0.007255:0.004918:0.004542:0.008448:0.003513:0.004542:0.007059:0.005441:0.007958:0.007255:0.004592:0.012712:0.008170:0.004363:0.004542:0.004542:0.005441:0.007255:0.006977:0.008170:0.004542:0.005441:0.007255:0.004085:0.004542:0.005441:0.004542:0.007255:0.004542:0.006356:0.004575:0.004542:0.008170:0.007958:0.008170:0.004542:0.008170:0.004542:0.008170:0.008170:0.004085:0.012712:0.006879:0.007925:0.007925:0.004330:0.011438:0.011520:0.008824:0.004085
bodies when it is clearly desirable to have standardised terms of indemnity to :@0.340033:0.149381:0.847631:0.149381:0.847631:0.137904:0.340033:0.137904:0.008170:0.008333:0.008170:0.004739:0.007255:0.006356:0.004363:0.011797:0.008170:0.007484:0.008170:0.003595:0.004739:0.004739:0.004085:0.004248:0.006127:0.004330:0.007255:0.004542:0.007075:0.007255:0.005245:0.004542:0.008170:0.004526:0.008170:0.007255:0.006356:0.004363:0.005441:0.007255:0.007974:0.004542:0.007059:0.004330:0.004542:0.008170:0.004526:0.007843:0.007026:0.007925:0.007026:0.005147:0.006356:0.004346:0.007255:0.008170:0.008170:0.007255:0.005441:0.008170:0.004542:0.006356:0.007255:0.008170:0.003562:0.004542:0.007255:0.005441:0.012908:0.006356:0.004265:0.008987:0.005964:0.002696:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004248:0.004248:0.007516:0.004085
provide equal protection to all participants in the study.:@0.340359:0.166679:0.700245:0.166679:0.700245:0.155202:0.340359:0.155202:0.008170:0.005441:0.008170:0.008170:0.004542:0.008170:0.007255:0.004657:0.007255:0.007941:0.008007:0.007255:0.004542:0.003807:0.008170:0.005441:0.008448:0.004542:0.007467:0.007435:0.004542:0.004542:0.008480:0.008333:0.003186:0.004330:0.007843:0.005065:0.007255:0.004346:0.004542:0.003464:0.008170:0.007255:0.005245:0.004542:0.004542:0.007255:0.004542:0.008170:0.007255:0.008170:0.004542:0.006356:0.004346:0.004820:0.008497:0.003186:0.004542:0.007958:0.007255:0.004918:0.006127:0.004248:0.007680:0.007680:0.007680:0.004085
9. :@0.290605:0.201528:0.306046:0.201528:0.306046:0.190051:0.290605:0.190051:0.007598:0.003758:0.004085
Responsibility for deciding whether a particular company-sponsored research :@0.340441:0.201528:0.851977:0.201528:0.851977:0.190051:0.340441:0.190051:0.010899:0.007075:0.006356:0.008170:0.008170:0.008170:0.006356:0.004363:0.008170:0.004542:0.004542:0.004542:0.004542:0.008170:0.004379:0.005441:0.008529:0.005637:0.003922:0.008170:0.007255:0.007255:0.004363:0.008170:0.004542:0.008170:0.008170:0.004085:0.011797:0.008170:0.007255:0.004542:0.008170:0.007255:0.005621:0.004085:0.007255:0.003529:0.008170:0.007255:0.005441:0.004706:0.004542:0.007255:0.008170:0.004706:0.007255:0.005654:0.003513:0.007255:0.008170:0.012712:0.008170:0.007255:0.008170:0.008399:0.005441:0.006356:0.008382:0.008170:0.008333:0.006356:0.008170:0.005441:0.007484:0.008170:0.004085:0.005441:0.007255:0.006356:0.007255:0.007255:0.005441:0.007255:0.008170:0.004085
proposal should proceed within the NHS rests with the Health Authority or :@0.340358:0.219078:0.834492:0.219078:0.834492:0.207601:0.340358:0.207601:0.008170:0.005637:0.008170:0.008170:0.008170:0.006356:0.007255:0.004542:0.004722:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.003513:0.008170:0.005441:0.008366:0.007255:0.007255:0.007467:0.008170:0.004085:0.011797:0.004542:0.004820:0.008170:0.004542:0.008366:0.003186:0.004542:0.007958:0.007255:0.004085:0.011618:0.011797:0.008791:0.005065:0.005441:0.006895:0.006356:0.004542:0.006176:0.004330:0.012092:0.004542:0.004771:0.008415:0.003105:0.004542:0.007958:0.007255:0.004085:0.012271:0.007435:0.007435:0.004542:0.004542:0.008562:0.003595:0.011601:0.008170:0.004542:0.007958:0.008170:0.005441:0.004281:0.004542:0.008170:0.004085:0.008170:0.005441:0.004085
Trust within which the research would take place, after consideration of :@0.340766:0.236376:0.815031:0.236376:0.815031:0.224899:0.340766:0.224899:0.009984:0.005441:0.008350:0.006356:0.004755:0.003595:0.011797:0.004788:0.004542:0.008366:0.004542:0.008170:0.003219:0.012092:0.008333:0.004542:0.007549:0.008333:0.003105:0.004542:0.007958:0.007255:0.004592:0.005637:0.007255:0.006356:0.007467:0.007255:0.005441:0.007484:0.008170:0.003350:0.011797:0.008170:0.008382:0.004542:0.008170:0.003627:0.004542:0.007255:0.008170:0.007075:0.004330:0.008170:0.004542:0.006977:0.007255:0.007255:0.003873:0.005065:0.007255:0.005441:0.004542:0.007435:0.005441:0.003627:0.007255:0.008170:0.008350:0.006356:0.004542:0.008170:0.007484:0.005441:0.007255:0.004542:0.004542:0.008170:0.008366:0.003513:0.008660:0.005801:0.004085
ethical, clinical, managerial, financial, resource, and legal liability issues. The :@0.340766:0.254241:0.851959:0.254241:0.851959:0.242764:0.340766:0.242764:0.007255:0.004265:0.008007:0.004542:0.007059:0.007026:0.004542:0.004085:0.005016:0.007026:0.004330:0.004542:0.007958:0.004542:0.006977:0.007255:0.004346:0.004085:0.005392:0.012712:0.006977:0.008170:0.007026:0.008007:0.007255:0.005163:0.004542:0.007059:0.004542:0.003873:0.004657:0.005441:0.004281:0.008170:0.007255:0.007941:0.007255:0.004346:0.007255:0.004542:0.003889:0.005147:0.005441:0.006977:0.006356:0.007941:0.008007:0.005441:0.007255:0.006993:0.004085:0.004984:0.007255:0.008170:0.008170:0.003856:0.004542:0.007059:0.008170:0.007255:0.004346:0.004330:0.004542:0.004363:0.007255:0.008170:0.004542:0.004542:0.004542:0.004542:0.008170:0.004085:0.004542:0.006144:0.006356:0.007778:0.007255:0.006062:0.004085:0.005392:0.009559:0.007843:0.006944:0.004085
NHS :@0.340358:0.270994:0.369600:0.270994:0.369600:0.261812:0.340358:0.261812:0.009438:0.009268:0.007268:0.003268
body is responsible for securing an appropriate indemnity agreement :@0.369443:0.271539:0.822923:0.271539:0.822923:0.260062:0.369443:0.260062:0.008170:0.008170:0.008333:0.008170:0.004739:0.004248:0.005964:0.004739:0.005441:0.007255:0.006356:0.007990:0.008170:0.008170:0.006127:0.004542:0.008170:0.004281:0.007255:0.004265:0.005441:0.008529:0.005637:0.004330:0.006356:0.007255:0.007059:0.008170:0.005441:0.004542:0.007990:0.008170:0.003840:0.007255:0.008431:0.003513:0.007255:0.008170:0.007941:0.005441:0.008170:0.008170:0.005441:0.004542:0.007255:0.004542:0.007255:0.004657:0.004542:0.008170:0.007958:0.007255:0.012435:0.008170:0.004330:0.004542:0.008170:0.004608:0.007255:0.008170:0.005245:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.004085
and should maintain a register of all clinical studies undertaken under its :@0.340766:0.289090:0.817809:0.289090:0.817809:0.277612:0.340766:0.277612:0.007255:0.008170:0.008170:0.004673:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.012712:0.007255:0.004542:0.008170:0.004542:0.007255:0.004542:0.008170:0.003595:0.007435:0.004085:0.005441:0.007255:0.008170:0.004542:0.006356:0.004542:0.007255:0.005703:0.003513:0.008905:0.005964:0.002778:0.007255:0.004346:0.004542:0.004085:0.007255:0.004542:0.004542:0.007958:0.004542:0.007059:0.007255:0.004542:0.005033:0.006356:0.004265:0.007925:0.007925:0.004542:0.007059:0.006356:0.004085:0.008170:0.008350:0.008170:0.007435:0.005441:0.004542:0.007500:0.008170:0.007255:0.008350:0.003595:0.008333:0.008333:0.008170:0.007598:0.005441:0.003627:0.004330:0.004248:0.005964:0.004085
auspices with an indication whether  is a company-sponsored study and, if :@0.340766:0.306640:0.837809:0.306640:0.837809:0.295163:0.340766:0.295163:0.007255:0.008170:0.006356:0.007958:0.004542:0.007255:0.007075:0.006356:0.004265:0.012092:0.004542:0.004771:0.008415:0.003513:0.007598:0.008497:0.003105:0.004542:0.008366:0.008170:0.004542:0.007255:0.007484:0.004542:0.004542:0.008170:0.008170:0.003660:0.011797:0.008382:0.007255:0.004542:0.008170:0.007255:0.005441:0.004085:0.010866:0.004248:0.005964:0.004739:0.007435:0.004085:0.007255:0.008170:0.012712:0.008170:0.007255:0.008170:0.008170:0.005441:0.006356:0.008170:0.008170:0.008170:0.006356:0.008170:0.005441:0.007255:0.008170:0.004265:0.006127:0.004542:0.007876:0.008007:0.008007:0.004330:0.007026:0.007843:0.007843:0.003922:0.005065:0.004984:0.006046:0.078418
it :@0.578822:0.306095:0.589933:0.306095:0.589933:0.296913:0.578822:0.296913:0.003922:0.003922:0.003268
so, with confirmation that an indemnity agreement is in place. If for any :@0.341158:0.324254:0.814688:0.324254:0.814688:0.312776:0.341158:0.312776:0.005882:0.007598:0.003758:0.005147:0.011797:0.004706:0.004542:0.008366:0.003513:0.007255:0.008350:0.008170:0.005441:0.004542:0.005441:0.012712:0.007255:0.004542:0.004542:0.008170:0.008170:0.003235:0.004739:0.008333:0.007255:0.004755:0.003922:0.007761:0.008742:0.003513:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004575:0.007255:0.008350:0.005441:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.003905:0.004248:0.005964:0.004739:0.004820:0.008497:0.003105:0.007925:0.004542:0.006977:0.007255:0.006961:0.004085:0.005392:0.006046:0.006127:0.001961:0.005719:0.008578:0.005719:0.003513:0.006944:0.007925:0.007925:0.004085
reason it is considered that the model form of indemnity is not appropriate or :@0.340750:0.341489:0.847613:0.341489:0.847613:0.330011:0.340750:0.330011:0.005441:0.007255:0.007484:0.006356:0.008350:0.008170:0.003595:0.004739:0.004739:0.003922:0.004248:0.005882:0.004739:0.007255:0.008170:0.008170:0.006356:0.004363:0.008170:0.007255:0.005441:0.007255:0.008170:0.003905:0.004542:0.008170:0.007255:0.004706:0.003595:0.004542:0.007958:0.007255:0.004918:0.012712:0.007958:0.008170:0.007026:0.004542:0.003873:0.005441:0.008529:0.005441:0.013186:0.003513:0.008905:0.005964:0.002778:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004575:0.004542:0.006078:0.004657:0.008170:0.008170:0.004542:0.003873:0.007255:0.008170:0.007941:0.005441:0.008170:0.008170:0.005441:0.004542:0.007255:0.004542:0.007255:0.004657:0.008170:0.005147:0.004085
that amendments are required, the NHS body involved should seek legal :@0.340342:0.359101:0.816975:0.359101:0.816975:0.347624:0.340342:0.347624:0.004739:0.008415:0.007255:0.004755:0.004085:0.007255:0.012435:0.007255:0.008170:0.007941:0.012712:0.007059:0.008170:0.004542:0.006356:0.004542:0.007026:0.005229:0.007026:0.004657:0.005441:0.006977:0.008170:0.008007:0.004542:0.005441:0.007010:0.008170:0.004085:0.004493:0.004542:0.007958:0.007255:0.004085:0.011797:0.011585:0.008905:0.003922:0.008170:0.008170:0.008333:0.008170:0.004820:0.004542:0.008170:0.008170:0.008170:0.004542:0.008170:0.007255:0.008170:0.004330:0.006356:0.008170:0.008170:0.008170:0.004542:0.008170:0.004297:0.006356:0.007042:0.007255:0.007941:0.004085:0.004248:0.007026:0.007925:0.007255:0.004346:0.004085
advice on the form or amendments proposed.:@0.340750:0.376650:0.634377:0.376650:0.634377:0.365173:0.340750:0.365173:0.007255:0.007941:0.008007:0.004542:0.007059:0.007255:0.004592:0.008415:0.008497:0.003105:0.004542:0.007958:0.007255:0.004592:0.005441:0.008170:0.005441:0.013056:0.003595:0.008415:0.005637:0.003922:0.007255:0.012712:0.007255:0.007990:0.008170:0.012712:0.006977:0.008170:0.004542:0.006356:0.003807:0.008007:0.005441:0.007958:0.008007:0.008007:0.006356:0.006961:0.008170:0.004085
10. :@0.295245:0.411503:0.318203:0.411503:0.318203:0.400025:0.295245:0.400025:0.007598:0.007516:0.003758:0.004085
Even when the model form of indemnity is agreed, the NHS body should satisfy itself :@0.340343:0.411503:0.906438:0.411503:0.906438:0.400025:0.340343:0.400025:0.010212:0.008415:0.007516:0.008415:0.003105:0.012173:0.008415:0.007516:0.008415:0.003105:0.004542:0.007958:0.007255:0.004592:0.012712:0.007958:0.008170:0.007026:0.004542:0.003873:0.005441:0.008448:0.005441:0.013186:0.003595:0.008905:0.005964:0.003105:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004657:0.004248:0.005882:0.004739:0.007255:0.007859:0.005441:0.006977:0.007255:0.007859:0.004085:0.004657:0.004542:0.007958:0.007255:0.004085:0.011797:0.011503:0.008905:0.004330:0.008170:0.008170:0.008333:0.008170:0.004820:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.006356:0.007042:0.004542:0.004363:0.006356:0.005245:0.008007:0.004330:0.004542:0.004771:0.006618:0.007516:0.004542:0.005752:0.004085
that the company sponsoring the study is substantial and reputable and has appropriate :@0.340343:0.429116:0.909248:0.429116:0.909248:0.417639:0.340343:0.417639:0.004542:0.008170:0.007255:0.004788:0.004085:0.004330:0.008007:0.007255:0.004510:0.007255:0.008170:0.012353:0.008170:0.007255:0.007941:0.008170:0.005065:0.006356:0.008170:0.008170:0.008170:0.006356:0.007958:0.005441:0.004542:0.008170:0.007990:0.003513:0.004542:0.008170:0.007255:0.005196:0.006356:0.004346:0.007925:0.007925:0.007925:0.004085:0.004542:0.006356:0.004624:0.006356:0.008170:0.008170:0.006144:0.004542:0.007255:0.007974:0.004542:0.004542:0.007255:0.004542:0.004085:0.007255:0.008170:0.008170:0.004085:0.005441:0.007026:0.008170:0.008007:0.004542:0.007255:0.008170:0.004542:0.007255:0.004592:0.007255:0.008170:0.008170:0.003856:0.007925:0.007026:0.006356:0.004592:0.007255:0.008170:0.008170:0.005245:0.008170:0.008170:0.005229:0.004542:0.007059:0.004542:0.007255:0.004085
arrangements in place (for example insurance cover) to support the indemnity. The NHS :@0.340752:0.446665:0.918938:0.446665:0.918938:0.435188:0.340752:0.435188:0.007255:0.005245:0.005441:0.007255:0.008170:0.008170:0.007255:0.012484:0.007255:0.008170:0.004542:0.006356:0.004085:0.004886:0.008578:0.003105:0.008170:0.004542:0.007059:0.007255:0.007255:0.004526:0.005441:0.005441:0.008170:0.005703:0.003513:0.007255:0.007941:0.007255:0.012353:0.008170:0.004330:0.007255:0.004265:0.004542:0.008170:0.006078:0.008170:0.005441:0.007059:0.008170:0.007255:0.007042:0.004739:0.007255:0.007859:0.008007:0.007255:0.005082:0.005441:0.004085:0.004542:0.007745:0.005065:0.006356:0.008170:0.008170:0.008170:0.008170:0.005441:0.004542:0.003105:0.004542:0.007958:0.007255:0.004592:0.004542:0.007794:0.007925:0.007026:0.012418:0.008170:0.004248:0.004542:0.007958:0.004085:0.005392:0.009722:0.007925:0.007255:0.004085:0.011291:0.011356:0.008742:0.004085
body will carry full liability for any claims in negligence if the indemnity is not honoured :@0.340016:0.463962:0.920245:0.463962:0.920245:0.452485:0.340016:0.452485:0.008170:0.008170:0.008333:0.008170:0.004085:0.011520:0.004542:0.004542:0.004542:0.003775:0.007255:0.006961:0.005441:0.005261:0.008007:0.003922:0.005441:0.008170:0.004542:0.004542:0.003611:0.004542:0.004542:0.007092:0.008170:0.004330:0.004542:0.004542:0.004314:0.008170:0.003431:0.005719:0.008578:0.005719:0.003186:0.007255:0.007859:0.008007:0.003922:0.007255:0.004346:0.007255:0.004346:0.012418:0.006356:0.003856:0.004820:0.008578:0.003105:0.008170:0.007255:0.008170:0.004346:0.004542:0.008170:0.007255:0.007974:0.007255:0.007042:0.003922:0.005147:0.006209:0.001961:0.004542:0.007958:0.007255:0.004085:0.004542:0.008170:0.008170:0.006912:0.012500:0.008007:0.004542:0.004363:0.008007:0.004330:0.004248:0.005964:0.004248:0.008170:0.008170:0.004542:0.003464:0.008170:0.008170:0.008170:0.008170:0.007925:0.005441:0.007059:0.008170:0.004085
and there is not supporting insurance.:@0.340752:0.481513:0.583971:0.481513:0.583971:0.470035:0.340752:0.470035:0.007255:0.008170:0.008170:0.003856:0.004542:0.007958:0.007255:0.005245:0.007255:0.004592:0.004542:0.006078:0.004739:0.008170:0.008007:0.004542:0.004363:0.006356:0.008170:0.008170:0.007941:0.008170:0.005229:0.004542:0.004542:0.008170:0.008170:0.003824:0.004542:0.007876:0.006127:0.008007:0.005441:0.006977:0.008007:0.007255:0.006879:0.004085
11. :@0.295245:0.516364:0.318203:0.516364:0.318203:0.504886:0.295245:0.504886:0.007598:0.007516:0.003758:0.004085
Where a clinical study includes patients or subjects within several NHS bodies, for :@0.340752:0.516364:0.885458:0.516364:0.885458:0.504886:0.340752:0.504886:0.015425:0.008170:0.007042:0.005441:0.007059:0.004739:0.007435:0.003922:0.007255:0.004346:0.004542:0.008170:0.004281:0.007255:0.007255:0.004363:0.004657:0.006127:0.004542:0.007876:0.008007:0.008007:0.004330:0.004542:0.008170:0.007255:0.004542:0.008170:0.008170:0.007255:0.006356:0.004085:0.007958:0.007255:0.004346:0.004542:0.007255:0.008170:0.004542:0.006356:0.004755:0.008415:0.005637:0.003922:0.006356:0.008170:0.007859:0.004542:0.006977:0.007255:0.004346:0.006356:0.004265:0.011797:0.004788:0.004542:0.008366:0.004542:0.008170:0.004085:0.006356:0.007255:0.007990:0.007255:0.005245:0.007255:0.004542:0.003889:0.011601:0.011601:0.008905:0.004085:0.008170:0.008170:0.008170:0.004542:0.007059:0.006356:0.004085:0.004673:0.005441:0.008170:0.005441:0.004085
example in a multi-centre clinical trial,  is necessary for each Authority or Trust to :@0.340752:0.533914:0.888382:0.533914:0.888382:0.522437:0.340752:0.522437:0.007255:0.007941:0.007255:0.012353:0.008007:0.004542:0.007255:0.004085:0.005033:0.008824:0.003513:0.007516:0.003922:0.012712:0.008170:0.004542:0.004542:0.004346:0.005441:0.007255:0.006993:0.008170:0.004542:0.005261:0.007255:0.004673:0.007255:0.004542:0.004542:0.008007:0.004542:0.007255:0.007075:0.004542:0.004085:0.004363:0.005441:0.004363:0.007255:0.004265:0.004085:0.004085:0.011520:0.004542:0.006356:0.004379:0.008170:0.007255:0.007042:0.007255:0.006144:0.006356:0.007255:0.005180:0.008170:0.004085:0.005719:0.008415:0.005637:0.003922:0.007255:0.007255:0.007255:0.008170:0.004085:0.011797:0.008170:0.004346:0.008170:0.008170:0.005229:0.004542:0.004363:0.008170:0.004248:0.008415:0.005637:0.003595:0.009984:0.005441:0.008170:0.006356:0.004542:0.003905:0.004248:0.007516:0.004085
it :@0.599167:0.533369:0.609951:0.533369:0.609951:0.524187:0.599167:0.524187:0.003634:0.003882:0.003268
complete an appropriate indemnity agreement with the sponsoring company.:@0.340752:0.551527:0.840098:0.551527:0.840098:0.540049:0.340752:0.540049:0.007255:0.008170:0.012435:0.008170:0.004542:0.007059:0.004542:0.007059:0.004739:0.007516:0.008497:0.003595:0.007255:0.008170:0.008170:0.005245:0.008170:0.008007:0.005441:0.004542:0.007010:0.004542:0.007255:0.004624:0.004542:0.008170:0.007958:0.007255:0.012435:0.008170:0.004330:0.004542:0.008170:0.004608:0.007255:0.008170:0.005245:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.003873:0.012092:0.004542:0.004771:0.008415:0.003105:0.004542:0.007958:0.007255:0.005000:0.006356:0.008170:0.008170:0.008170:0.006356:0.008170:0.005441:0.004542:0.008170:0.008170:0.003529:0.007026:0.007925:0.012337:0.008007:0.007255:0.007859:0.008007:0.004085
12. :@0.295245:0.586376:0.318203:0.586376:0.318203:0.574899:0.295245:0.574899:0.007598:0.007516:0.003758:0.004085
Where independent practitioners, such as general medical practitioners, are engaged in :@0.340752:0.586376:0.910768:0.586376:0.910768:0.574899:0.340752:0.574899:0.015425:0.008170:0.007042:0.005441:0.007059:0.004739:0.004542:0.008170:0.007958:0.007255:0.008170:0.007255:0.008170:0.008170:0.007255:0.008170:0.004542:0.003431:0.008170:0.005441:0.007059:0.007255:0.004542:0.004542:0.004542:0.004542:0.007990:0.008170:0.007255:0.005245:0.006356:0.004085:0.005408:0.006356:0.008170:0.007451:0.008170:0.003595:0.006863:0.006046:0.004739:0.008007:0.007255:0.008170:0.007042:0.005441:0.007059:0.004542:0.004608:0.012712:0.007255:0.007974:0.004542:0.007255:0.007075:0.004542:0.004085:0.008170:0.005261:0.007255:0.007042:0.004542:0.004542:0.004542:0.004542:0.008170:0.007974:0.007255:0.005441:0.006176:0.004085:0.005065:0.006944:0.005229:0.007026:0.004739:0.007255:0.008170:0.008170:0.007255:0.008170:0.006977:0.008170:0.004085:0.004820:0.008333:0.004085
clinical studies, Health Authorities should seek to ensure that such studies are the subject :@0.340752:0.603926:0.920572:0.603926:0.920572:0.592448:0.340752:0.592448:0.007255:0.004346:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.004297:0.006127:0.004330:0.007925:0.007925:0.004542:0.006895:0.006127:0.003922:0.003513:0.012173:0.007516:0.007516:0.004739:0.004542:0.008611:0.003595:0.011601:0.008170:0.004542:0.008170:0.007958:0.005441:0.004542:0.004542:0.004542:0.007075:0.006356:0.004265:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.006356:0.007255:0.007255:0.008170:0.003154:0.004330:0.007761:0.004739:0.007026:0.008170:0.006046:0.008007:0.005229:0.007255:0.003775:0.004542:0.008170:0.007255:0.004706:0.004739:0.006356:0.007941:0.007255:0.007859:0.003922:0.006356:0.004346:0.008170:0.007843:0.004542:0.007255:0.006176:0.003922:0.007255:0.005163:0.007255:0.003856:0.004542:0.007958:0.007255:0.004592:0.006127:0.007925:0.007925:0.004542:0.006977:0.007255:0.004346:0.004085
of an appropriate indemnity agreement. It is good practice for the GP to notify the Health :@0.340752:0.621475:0.920572:0.621475:0.920572:0.609997:0.340752:0.609997:0.008987:0.005964:0.002288:0.007255:0.008431:0.003186:0.007255:0.008170:0.007941:0.005441:0.008170:0.008170:0.005441:0.004542:0.007255:0.004542:0.007255:0.003840:0.004542:0.008170:0.008170:0.006977:0.012712:0.007958:0.004542:0.004363:0.008170:0.004085:0.007255:0.007859:0.005441:0.006977:0.007255:0.012271:0.007255:0.007859:0.004542:0.004085:0.005016:0.005441:0.004771:0.003105:0.004542:0.006078:0.003922:0.008170:0.008007:0.008170:0.008170:0.003105:0.008170:0.005441:0.007255:0.007255:0.004542:0.004542:0.007255:0.007255:0.003595:0.005719:0.008578:0.005719:0.002778:0.004542:0.007958:0.007255:0.004510:0.011275:0.008742:0.003922:0.004330:0.007843:0.004330:0.008170:0.007925:0.004542:0.004363:0.005441:0.007958:0.003513:0.004542:0.008170:0.007255:0.003562:0.011797:0.007565:0.007435:0.004542:0.004542:0.008480:0.004085
Authority of his participation in any clinical study.:@0.340752:0.638773:0.670000:0.638773:0.670000:0.627295:0.340752:0.627295:0.011797:0.007974:0.004542:0.008170:0.008170:0.005441:0.004542:0.004542:0.007974:0.004330:0.008905:0.005964:0.002778:0.007843:0.004542:0.005997:0.004330:0.008170:0.007255:0.005441:0.004788:0.004542:0.007255:0.004788:0.008170:0.007435:0.004542:0.004542:0.008399:0.008170:0.003595:0.004820:0.008497:0.003513:0.006944:0.007925:0.007925:0.004657:0.007255:0.004346:0.004542:0.008170:0.004542:0.007255:0.007255:0.004542:0.004624:0.006127:0.004248:0.007680:0.007680:0.007680:0.004085
13. :@0.295245:0.673939:0.318203:0.673939:0.318203:0.662462:0.295245:0.662462:0.007598:0.007516:0.003758:0.004085
Clinical investigators should ensure that details of any proposed research study are :@0.341160:0.673939:0.884052:0.673939:0.884052:0.662462:0.341160:0.662462:0.010703:0.004542:0.004542:0.007908:0.004542:0.007059:0.007255:0.004542:0.004085:0.004542:0.008170:0.008170:0.007026:0.006356:0.004542:0.004542:0.008170:0.007255:0.004542:0.008170:0.005441:0.006356:0.004673:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.007255:0.007941:0.006356:0.007941:0.005441:0.006977:0.004330:0.004739:0.008333:0.007255:0.004755:0.003922:0.008007:0.007255:0.004346:0.007255:0.004542:0.004297:0.006356:0.004673:0.008905:0.005964:0.002778:0.007026:0.007843:0.007843:0.004739:0.008170:0.005441:0.008170:0.008366:0.008170:0.006356:0.007451:0.008170:0.004412:0.005441:0.007255:0.006356:0.007255:0.007255:0.005441:0.007255:0.008170:0.004085:0.006193:0.004542:0.007794:0.007925:0.007925:0.004739:0.006863:0.005065:0.006863:0.004085
lodged with the appropriate NHS body and should not commence company-sponsored :@0.340752:0.691236:0.909003:0.691236:0.909003:0.679759:0.340752:0.679759:0.004542:0.008170:0.008170:0.008366:0.007255:0.008170:0.004085:0.011618:0.004542:0.004542:0.008170:0.003578:0.004542:0.007958:0.007255:0.004510:0.007255:0.008170:0.007941:0.005441:0.008170:0.008170:0.005441:0.004542:0.007255:0.004542:0.007255:0.004085:0.011601:0.011797:0.009085:0.003791:0.008170:0.008170:0.008333:0.008170:0.004412:0.007435:0.008170:0.008333:0.004330:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004248:0.007925:0.008007:0.004542:0.004281:0.007255:0.007859:0.012500:0.012712:0.007059:0.008170:0.007026:0.007255:0.004673:0.007255:0.008350:0.012712:0.008366:0.007255:0.008170:0.008170:0.005441:0.006356:0.008170:0.008170:0.008170:0.006356:0.008170:0.005441:0.007255:0.008170:0.004085
research unless an indemnity agreement is in place.:@0.340752:0.708785:0.674657:0.708785:0.674657:0.697308:0.340752:0.697308:0.005441:0.007255:0.006356:0.007255:0.007516:0.005441:0.007255:0.008382:0.003186:0.008170:0.008170:0.004542:0.007255:0.006356:0.006356:0.004085:0.007680:0.008497:0.003595:0.004542:0.008170:0.007958:0.007255:0.012435:0.008170:0.004330:0.004542:0.008170:0.004608:0.007255:0.008350:0.005441:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.003905:0.004248:0.005964:0.004657:0.004820:0.008578:0.003105:0.007925:0.004542:0.006814:0.007026:0.007026:0.004085
14. :@0.292974:0.743952:0.315441:0.743952:0.315441:0.732475:0.292974:0.732475:0.007353:0.007353:0.003676:0.004085
Local Research Ethics Committees (LREC5) provide independent advice to :@0.337663:0.743952:0.835866:0.743952:0.835866:0.732475:0.337663:0.732475:0.009984:0.008170:0.007255:0.007255:0.004542:0.004085:0.010899:0.007451:0.006356:0.007451:0.007255:0.005441:0.007484:0.008333:0.003186:0.009984:0.004542:0.008170:0.004542:0.007255:0.006356:0.004984:0.010899:0.008170:0.012467:0.012712:0.004281:0.004542:0.004363:0.007255:0.007255:0.006160:0.004657:0.005441:0.009673:0.010621:0.009804:0.010703:0.008170:0.005229:0.004330:0.008170:0.005441:0.008170:0.008170:0.004363:0.008170:0.007255:0.004755:0.004542:0.008170:0.008170:0.007255:0.008170:0.007255:0.008170:0.008170:0.007255:0.008170:0.004542:0.004085:0.007255:0.007892:0.008170:0.004248:0.007255:0.007255:0.004085:0.004281:0.007516:0.004085
NHS and other bodies and to clinical researchers on the ethics of proposed :@0.340359:0.761186:0.831471:0.761186:0.831471:0.749708:0.340359:0.749708:0.011601:0.011797:0.008791:0.005065:0.007255:0.008170:0.008170:0.003856:0.008170:0.004739:0.008170:0.007255:0.005441:0.003154:0.008170:0.008333:0.008170:0.004739:0.007255:0.006356:0.004771:0.007255:0.008170:0.008170:0.003448:0.004542:0.008170:0.004608:0.007255:0.004346:0.004542:0.007958:0.004542:0.007059:0.007255:0.004542:0.004085:0.005441:0.007255:0.006356:0.007255:0.007255:0.005441:0.007255:0.008170:0.007255:0.005441:0.006356:0.004346:0.008415:0.008415:0.003105:0.004542:0.008170:0.007255:0.004788:0.007255:0.004346:0.008170:0.004542:0.007059:0.006356:0.004085:0.009085:0.005964:0.002369:0.008170:0.005441:0.008170:0.008170:0.008170:0.006356:0.007255:0.008170:0.004085
research projects that involve human subjects [TISG(91)5]. Clinical :@0.340768:0.778799:0.787582:0.778799:0.787582:0.767322:0.340768:0.767322:0.005441:0.007255:0.006356:0.007255:0.007516:0.005441:0.007255:0.008382:0.003186:0.008170:0.005441:0.008170:0.004542:0.007255:0.007255:0.004542:0.006356:0.004314:0.004542:0.008170:0.007255:0.004706:0.003922:0.004542:0.007876:0.008170:0.008007:0.004542:0.007958:0.007255:0.005000:0.008170:0.008170:0.012908:0.007255:0.008170:0.004085:0.006356:0.007876:0.008170:0.004248:0.007255:0.006961:0.004542:0.006356:0.005768:0.005441:0.009510:0.005229:0.008824:0.011356:0.005441:0.007794:0.007925:0.005229:0.007925:0.005441:0.003791:0.005882:0.010539:0.004542:0.004363:0.008007:0.004542:0.006977:0.007255:0.004346:0.004085
investigators should not commence any research project involving patients or :@0.340359:0.796348:0.850294:0.796348:0.850294:0.784871:0.340359:0.784871:0.004542:0.008170:0.008170:0.007255:0.006356:0.004542:0.004542:0.008170:0.007255:0.004542:0.008170:0.005441:0.006356:0.004722:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.007925:0.008007:0.004542:0.004281:0.007255:0.008170:0.012516:0.012712:0.007255:0.007974:0.007255:0.007042:0.004657:0.007255:0.007941:0.008007:0.004248:0.005441:0.007255:0.006356:0.007418:0.007255:0.005441:0.007255:0.008170:0.003497:0.008170:0.005441:0.008366:0.004542:0.007255:0.007255:0.004804:0.003922:0.004542:0.008170:0.008366:0.008170:0.004542:0.008170:0.004542:0.008399:0.008170:0.003268:0.008170:0.007435:0.004542:0.004542:0.007255:0.008170:0.004542:0.006356:0.004085:0.008382:0.005441:0.004085
human volunteers without LREC agreement. Acceptance of the ABPI :@0.340768:0.813645:0.800294:0.813645:0.800294:0.802168:0.340768:0.802168:0.008333:0.008170:0.013072:0.007255:0.008170:0.002876:0.008170:0.008333:0.004542:0.008170:0.008170:0.004542:0.007255:0.007255:0.005441:0.006356:0.004314:0.011797:0.004706:0.004542:0.008170:0.008170:0.008170:0.004542:0.003578:0.009984:0.010899:0.010163:0.010899:0.004379:0.007026:0.008170:0.005147:0.007255:0.006961:0.012418:0.007255:0.007859:0.004542:0.004085:0.005343:0.011797:0.007075:0.007255:0.007255:0.008170:0.004542:0.007255:0.008170:0.007255:0.007255:0.004771:0.008905:0.005964:0.002369:0.004542:0.007958:0.007255:0.004918:0.011356:0.010621:0.008824:0.005441:0.004085
guidelines and the terms of the model indemnity agreement should normally :@0.340768:0.831196:0.842484:0.831196:0.842484:0.819718:0.340768:0.819718:0.008170:0.008170:0.004542:0.008170:0.006977:0.004542:0.004542:0.008170:0.007092:0.006356:0.004673:0.007255:0.008170:0.008170:0.003448:0.004542:0.007958:0.007255:0.004085:0.004542:0.007255:0.005441:0.012712:0.006176:0.004739:0.008905:0.005964:0.002369:0.004542:0.008170:0.007255:0.004788:0.012712:0.007958:0.008170:0.007026:0.004542:0.004281:0.004542:0.008170:0.007958:0.007255:0.012435:0.008170:0.004330:0.004542:0.008170:0.004608:0.007255:0.008350:0.005441:0.007255:0.007255:0.012712:0.007255:0.008170:0.004542:0.004314:0.006356:0.008170:0.008170:0.007941:0.004542:0.007958:0.004330:0.007925:0.008007:0.005441:0.012206:0.007255:0.004346:0.004542:0.007876:0.004085
be a condition of LREC approval of any pharmaceutical company sponsored :@0.340033:0.848808:0.845261:0.848808:0.845261:0.837331:0.340033:0.837331:0.008333:0.007255:0.004755:0.007435:0.003922:0.007255:0.008170:0.008170:0.008350:0.004542:0.004542:0.004542:0.008170:0.008170:0.003611:0.008905:0.005964:0.002369:0.009984:0.010899:0.010163:0.010899:0.004379:0.007255:0.008170:0.008170:0.005441:0.007974:0.008170:0.007255:0.004542:0.004085:0.009036:0.005964:0.002696:0.007255:0.007941:0.008007:0.004085:0.008170:0.008170:0.007255:0.005441:0.012712:0.007255:0.007255:0.007255:0.008170:0.004542:0.004542:0.007255:0.007255:0.004542:0.004265:0.007255:0.008170:0.012353:0.008170:0.007255:0.007941:0.008170:0.005065:0.006356:0.008170:0.008170:0.008170:0.006356:0.007958:0.005441:0.007255:0.007974:0.004085
project.:@0.340359:0.866357:0.388725:0.866357:0.388725:0.854880:0.340359:0.854880:0.007925:0.005441:0.007876:0.004542:0.006977:0.007255:0.004265:0.004085