Sponsorship & indemnity
The Research Governance Frameworks (RGFs) set out guiding principles and standards for conducting research in a healthcare or social/community setting. The frameworks are of direct relevance to those who host, conduct, participate in, fund and manage health and social/community care research, and should be adopted by all conducting research with human participants, their tissues or data.
The Health Research Authority (HRA) is replacing the Research Governance Framework. Links to the current RGFs and details on HRA developments are available from the HRA website.
A research sponsor must be identified for studies that involve human participants, their tissues or data.
A ‘sponsor’ is defined as – an individual or organisation that takes on responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance a study. Sponsors must also ensure that appropriate indemnity is in place before research begins.
The MRC policy on The Health Departments’ Research Governance Frameworks details when it is appropriate for the MRC to take on a sponsorship role.
In these circumstances, the MRC corporately should be named as sponsor. The Directors of MRC units are authorised to accept sponsorship responsibilities on the MRC’s behalf.
Sponsor’s Responsibilities under the Research Governance Framework (PDF, 92KB) outlines the role of the sponsor.
All studies that receive MRC funding have been robustly peer reviewed, details of the process can be found here.
Due to the collaborative nature of research, it may be appropriate for a unit to adopt a co-sponsorship role, where the unit assumes some sponsorship responsibilities in partnership with another, or a small number of other, organisation(s). In these situations it is important to clearly document the roles and responsibilities of each party.
Research Ethics Committee review
The vast majority of studies that involve human participants, their tissues or data should undergo a research ethics committee (REC) review and many research studies may require an NHS REC opinion. Please visit the HRA decision tool Do I need NHS REC approval? for more information.
As part of the REC review of each study the committee will consider the arrangements for indemnity.
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.
The MRC Indemnity Statement (PDF, 26KB) outlines the indemnity arrangements when the MRC acts as sponsor or funder, and the circumstances when the MRC will not provide indemnity.
The Integrated Research Application System (IRAS) should be used when applying for NHS REC approval and for other regulatory approvals.
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.
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 for advice.