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Indemnity & Compensation

It is the sponsor's responsibility to ensure that arrangements are in place before a study starts to cover the potential legal liabilities of the various parties arising from the research. Chief Investigators must be clear about all the arrangements for indemnity1, insurance2 and no fault compensation3 before making an application to the Research Ethics Committee (REC) / HRA through IRAS. Noclor will assess the level of indemnity/insurance cover required for a sponsored research study as part of the sponsorship request process prior to declaring sponsorship.

Liability arising from the design of the research

The design of the research is the responsibility of the author and any co-authors of the protocol; the main author will usually be the Chief Investigator.  Employers are responsible for the actions of their staff who design research studies as part of their employment.

If the Chief Investigator’s substantive employer is an NHS organisation, indemnity is provided for harm arising from the design of the study through NHS schemes (no proof of indemnity needs to be provided to Noclor).

If the Chief Investigator’s substantive employer is a university, the employer will hold insurance or provide indemnity to cover their liabilities for the design of the research (the university is likely to hold insurance that is additional to normal employer's liability insurance, to cover CTIMPs or other interventional trials). This situation applies to researchers whose substantive employer is a university, regardless of whether or not a Noclor partner (NHS organisation) agrees to act as sponsor for the trial.  A copy of the relevant policy must be provided to Noclor (prior to sponsorship being agreed).

Liability arising from the management or conduct of the research

For research sponsored or hosted by NHS Trusts arrangements to compensate participants in the event of harm due to fault in the management or conduct of the research will be in place through NHS indemnity schemes. In certain circumstances, e.g. high-risk research activities or vulnerable participants, additional arrangements may need to be made. 

Where non-NHS sites are to be included in the research (and where a Noclor partner is being approached to act as sponsor) the details of insurance/ indemnity arrangements to cover these non-NHS sites will be requested.  

For trials where a commercial company has made a donation of drugs or other financial support to the study (i.e Investigator Initiated Research IIR) the company may, in some circumstances, provide non-negligent indemnity. It is essential that the sponsor determines whether or not this is the case and ensures that the commercial company provides the appropriate documentation. If the company declines to provide non-negligent indemnity, usual NHS arrangements will apply.

Public funded bodies such as the MRC are unable to take out research insurance however the MRC offers assurance that it will consider claims for non-negligent harm arising from MRC funded trials.

Arrangements for no fault compensation cannot be made in advance by the NHS. The REC will inform the Chief Investigator if they consider that provision for no fault compensation is needed.

[1] Indemnity is a contractual arrangement whereby parties agree to provide compensation for any losses suffered by another party. Indemnity specifies that the insured should not collect more than the actual cash value of a loss but should be restored to approximately the same financial position as existed before the loss.

[2] Insurance is a promise of reimbursement in the case of loss; paid to people or companies so concerned about hazards that they have made prepayments to an insurance company. In order to indemnify another against a specified loss, the party providing the form of indemnity may arrange an insurance policy to cover potential losses.

[3] No fault compensation is an arrangement to pay compensation for harm where no legal liability arises or is admitted for any person (e.g. a participant has suffered harm as a result of taking part in the research but there has been no negligence in its management, design or conduct and no other liability arises such as product liability).