Sponsorship, Peer Review & Indeminty

What is a sponsor?

A sponsor is an organisation (or group of organisations) that accepts responsibility for ensuring that there are proper arrangements to initiate, manage, monitor and finance a project. The UK Policy Framework for Health & Social Care Research requires that all research taking place in an NHS or social care context must have sponsor. It is a criminal offence to undertake a clinical trial of an investigational medicinal product (ctIMP) without a sponsor.

An electronic signature is required in IRAS from a sponsor representative before submission. Evidence of sponsorship will be required by the R&I office before approval can be given.

A request for NBT to act as sponsor can be made by emailing a copy of the research protocol and any other available information to:

researchsponsor@nbt.nhs.uk – including ‘Sponsorship Request’ in the subject line.

Peer review

Peer review is when a research proposal or protocol is scrutinised by independent experts to promote quality research and prevent poorly designed research from taking place. While the UK Policy Framework places responsibility for assuring the quality of research through peer review to the funder, this will sometimes be undertaken by the sponsor (if they are not the same organisation).

The R&I Office may require confirmation of peer review and in certain circumstances an independent peer review will be carried out.

Indemnity

A key responsibility of the sponsor is to put in place arrangements for compensating participants if they suffer any harm as a result of their involvement in a project.

For research sponsored by NBT, the NHS Clinical Negligence Scheme applies and provides unlimited cover for NHS staff, medical academic staff with honorary contracts and those conducting research against negligent harm. Non‐negligent harm (i.e. harm that has been caused through no fault of those conducting research) is not covered by this scheme, however ex gratia payments may be considered by the Trust in limited circumstances.

For research sponsored by commercial companies, the arrangements for indemnity are covered in the agreement that the R&I Office negotiates with the company.