Sponsorship and Indemnity

It is a requirement of the Research Governance Framework that every research project has a Sponsor. The sponsor is the individual or institution that takes responsibility for the initiation, management and financing (or arranging the financing) of the study. The Sponsor will need to be agreed at an early stage of your study design as this has implications for indemnity (see below), funding and resources. You cannot assume that your employer will be willing to take on Sponsorship responsibilities for their research and must discuss your proposed research with potential Sponsors at the earliest opportunity to gain agreement to Sponsor. For NHS Norfolk, NHS Suffolk, NHS Great Yarmouth & Waveney and Norfolk Community Health & Care NHS Trust, this must be discussed with the R&D office in the first instance.
 

Further guidance on Sponsorship can be found in the attached paper.
 

Indemnity

It is a requirement of the Research Governance Framework that indemnity arrangements for negligent and non-negligent harm are made clear before a piece of research can commence. It is the responsibility of the Sponsor to ensure that this is in place. In the case of clinical trials on medicinal products which fall under the EU directive, it is a legal requirement of the Sponsor and the lead investigator to ensure that adequate indemnity/insurance arrangements are in place.

The research ethics committee and the host NHS Trust / PCT will review the adequacy of these arrangements when deciding whether the research can go ahead (see Research Approvals for more information).

Negligent Harm

Negligent harm is the legal liability that arises from the NHS Trust or PCTs duty of care towards patients. Where an individual is harmed in the context of R&D, and an individual or group of individuals can be demonstrated to have caused that harm because of their negligence through, for example, not following an agreed procedure according to set policy or protocol, then that would be deemed negligent harm. Therefore if an NHS patient is harmed in the course of research as a result of negligent actions on the part of staff (including those working under Honorary Contracts) then the NHS Trust is liable or vicariously liable.

Independent Contractors

PCT’s vicarious liability, along with NHS indemnity arrangements provided through the CNST do not extend to independent contractors working under a contract for services to a PCT, or their staff.

Where an independent contractor such as a GP, or their practice staff undertake research as part of their routine clinical services, their personal professional indemnity arrangements provide them with adequate cover for their activity for their own practice patients. However Independent contractors should inform their indemnity providers of any research projects they are hosting and in what capacity the research project is being undertaken.

Non-Negligent Harm

Non-negligent harm (commonly known as no-fault) arises where an individual has been harmed in the context of R&D, through no fault of an individual or institution involved in the research and even though all the correct policies and procedures have been followed. Provision of insurance/indemnity for non-negligent harm is not a requirement and its provision needs only to be considered, and then only for research involving clinical interventions.

It is the role of ethics committees to decide whether or not a study can go ahead without a scheme of compensation for harm caused where there is no negligence. It is the responsibility of the sponsor to consider whether or not the research presents sufficient risk to merit indemnity for non-negligent harm.

Where there are no arrangements in place for non-negligent harm, or where such arrangements are limited to consideration of ex-gratia payments, this should be clearly stated in the agreements between the research partners and in patient information leaflets.

Further information regarding indemnity arrangements for primary care can be found in the attached guidance.