New guidance published on set-up of interventional research activity

New guidance has been published to support the set-up of interventional research activity in NHS and Health and Social Care (HSC) organisations.

This UK wide guidance is a collaborative production between the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), NHS Research Scotland, Health and Social Care Northern Ireland and Health and Care Research Wales.

If you sponsor or undertake interventional research, please read the guidance and review your local Standard Operating Procedures (SOPs), to ensure that they align with the new guidance.

The guidance outlines:

• the oversight arrangements that should be in place for an activity associated with an interventional research study
• whether an activity associated with an interventional research study should be overseen by a Principal Investigator (PI)
• whether oversight may only be effective if provided by an individual employed by the organisation delivering the activity, or if effective oversight could be provided by a PI employed by another organisation
• advice on undertaking a risk assessment to support research sponsors in making determinations on oversight arrangements
• expectations for aspects of study set-up that relate to oversight considerations

The guidance is intended to help sponsors design and manage studies around the patient, for example, by ensuring that patients are not routinely required to travel to a distant research site when this is not necessary for the study.

Alastair Nicholson, Head of Coordination and Standardisation at the HRA, said: ‘This new guidance aims to support a wider challenge, to ourselves as regulators, to sponsors and to researchers, to find new approaches to bring research to patients. It does so by setting out principles for effective oversight of high-quality research, empowering those who design research to put the participant, not the site, at the heart of study delivery.’

The guidance provides principles and examples. It is not envisaged that the examples are exhaustive, nor that a sponsor should replace careful risk assessment of the specifics of their study with an ‘off the shelf’ solution. The examples are however intended to illustrate how a risk-based approach might apply the basic principles in specific scenarios.

We will be capturing all feedback to support future guidance. If you have any queries relating to the guidance please email Alastair.Nicholson@hra.nhs.uk

Additional tools to support the guidance are being developed.

Complementary guidance is in preparation to cover the set-up of non-interventional studies in the NHS/HSC.