Indemnity
It is important that the appropriate indemnity is in place for research that involves human participants, their tissues or data.
MRC Policy outlining MRC Indemnity when acting as Sponsor or Funder; and circumstances when MRC will not provide indemnity:
All studies that involve human participants, their tissues or data should undergo an ethical review. Many research studies require specifically an NRES (National Research Ethics Service) ethical opinion. These include:
• All studies involving NHS patients or NHS resources,
• All clinical trials of investigational products (see Clinical Trials Tool Kit), and
• Some studies involving human tissue samples (see Data and Tissues Tool Kit)
The Integrated Research Application System (IRAS) should be used when applying for NRES ethical approval and for other regulatory approvals.
As part of the ethical review of each study the Ethics committee will consider the arrangements for indemnity.
All research activities run through an MRC unit
We suggest that, where the MRC is sole Sponsor of all the study activities, and all the research activity is run through the Unit, MRC indemnity should cover all parts of questions A76 and A77 on the IRAS form. You should write the following for both questions:
MRC will provide indemnity in the case of negligent harm for research conducted through its Units when it is Sponsor and for employees or others acting on behalf of the Council.. (insert 1* and/or 2** as appropriate). The MRC when acting as Sponsor, in some circumstances, may be prepared to offer, on a voluntary basis, an ex-gratia payment in the event of non-negligent harm.
1* When research is conducted within a care organisation (e.g. an NHS organisation) add:
Care organisations continue to be responsible for any breaches of the duty of care they owe with respect to participants of this research.
2** For trials of investigational products add:
Responsibility for the quality of investigational products (e.g. investigational medicinal products, investigational devices) lies with the manufacturer of the product.
Multi-Centre Research
This is more complicated as, even when the MRC is Sponsor, MRC indemnity should not cover responsibilities of other organisations. If MRC is Sponsor but research takes place at other sites (e.g. NHS hospitals or Universities) then appropriate arrangements should be put in place i.e. the employers of the researchers at each site accept insurance or indemnity liability for their employees.
In this situation indemnity responsibilities are likely to be split and these will need to be agreed on a study-by-study basis. Please contact the Regulatory Support Centre if help is needed.
It is the responsibility of the Sponsor to ensure that appropriate indemnity arrangements are in place, and that there are agreements to ensure all parties are aware of their responsibilities.
