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Research

Sponsorship & indemnity

The following provides general guidance on the role of ‘sponsor’ as well as more specific guidance relevant when the MRC takes on a sponsorship role. Please be aware that from 3 April 2018, the MRC can no longer take on sponsorship for new studies. We will update these pages once UKRI has clarified their position on sponsorship.

Sponsorship

Your research may require a ‘sponsor’ if it involves people as participants, their tissues or data.

The role of ‘sponsor’ is defined in both the UK health departments’ research governance framework (ie the UK policy framework for health and social care research) and the UK clinical trials regulations.  It is the role of sponsor(s) to ensure that proper arrangements are in place to initiate, manage and report on a study.  Sponsors must also ensure that appropriate indemnity is in place before research begins.

The following pages detail MRC policy for MRC-funded researchers:

Sponsor’s Responsibilities (PDF, 92KB) outlines the role of the sponsor under the UK policy framework for health and social care research.  For guidance on the role of sponsor under the UK clinical trials regulations please see the Clinical Trials Toolkit.

All studies that receive MRC funding have been robustly peer reviewed, details of the process can be found here.

Co-sponsorship

Due to the collaborative nature of research, it may be appropriate for a research organisation to adopt a co-sponsorship role, where the research organisation 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

One of the sponsor’s responsibilities is to ensure that the appropriate approvals are in place before research begins.

The vast majority of studies involving people as participants, their tissues or data should undergo a research ethics committee (REC) review, and many research studies may require review by an NHS REC.  Please visit the HRA decision tool Do I need NHS REC approval? for more information.

As part of the REC review the committee will consider indemnity arrangements.

IRAS

The Integrated Research Application System (IRAS) should be used when applying for NHS REC approval and for other regulatory approvals.

The MRC / HRA IRAS online guide provides instructions on how to use IRAS and is designed to help those who apply for approvals, as well as those who review and/or authorise projects.

MRC 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.

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 / Institute, 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 / Institutes 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 (eg 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 (eg 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 (eg NHS hospitals or universities) then appropriate arrangements should be put in place ie 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.