New guidance published on set up of interventional research activity at NHS/HSC organisations
The HRA have published new guidance to support the set up of interventional research projects research activity at NHS/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 (HSC) 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.