Page 22 - Pharmacy Appeals 1/4/04 to 31/3/05

NHS Indemnity Several health authorities and trusts have independently developed forms of
indemnity agreement. However, difficulties have arisen when different
authorities have required varying terms of indemnity and this has, on
occasion, impeded the progress of clinical research within the NHS.
Particular difficulties may arise in large multi-centre trials involving many NHS
bodies when it is clearly desirable to have standardised terms of indemnity to
provide equal protection to all participants in the study.

9. Responsibility for deciding whether a particular company-sponsored research
proposal should proceed within the NHS rests with the Health Authority or
Trust within which the research would take place, after consideration of
ethical, clinical, managerial, financial, resource, and legal liability issues. The
NHS body is responsible for securing an appropriate indemnity agreement
and should maintain a register of all clinical studies undertaken under its
auspices with an indication whether it is a company-sponsored study and, if
so, with confirmation that an indemnity agreement is in place. If for any
reason it is considered that the model form of indemnity is not appropriate or
that amendments are required, the NHS body involved should seek legal
advice on the form or amendments proposed.

10. Even when the model form of indemnity is agreed, the NHS body should satisfy itself
that the company sponsoring the study is substantial and reputable and has appropriate
arrangements in place (for example insurance cover) to support the indemnity. The NHS
body will carry full liability for any claims in negligence if the indemnity is not honoured
and there is not supporting insurance.

11. Where a clinical study includes patients or subjects within several NHS bodies, for
example in a multi-centre clinical trial, it is necessary for each Authority or Trust to
complete an appropriate indemnity agreement with the sponsoring company.

12. Where independent practitioners, such as general medical practitioners, are engaged in
clinical studies, Health Authorities should seek to ensure that such studies are the subject
of an appropriate indemnity agreement. It is good practice for the GP to notify the Health
Authority of his participation in any clinical study.

13. Clinical investigators should ensure that details of any proposed research study are
lodged with the appropriate NHS body and should not commence company-sponsored
research unless an indemnity agreement is in place.

14. Local Research Ethics Committees (LREC5) provide independent advice to
NHS and other bodies and to clinical researchers on the ethics of proposed
research projects that involve human subjects [TISG(91)5]. Clinical
investigators should not commence any research project involving patients or
human volunteers without LREC agreement. Acceptance of the ABPI
guidelines and the terms of the model indemnity agreement should normally
be a condition of LREC approval of any pharmaceutical company sponsored
project.