Latest research update

Collection of patients ‘consent for contact’ in Epic relating to research studies

Consent for contact is about asking patients if they would like to be contacted about participating in research studies conducted at the Trust, and then documenting their consent to be contacted by research team members outside of their treatment team for studies for which they may be eligible.

From Tuesday 17 October 2023, all outpatient-based clinical staff will be able to record a patient’s consent for contact within their chart in Epic – ‘Research Preference’ section within Overview – following verbal discussion during a clinic consultation.

Patients that have MyChart will also be able to add their consent for contact for research studies within their MyChart account, which will then appear in their Epic record.

Collection of this information will help the research and development team to identify patients who are eligible to participate in certain research studies, and who have already consented to be contacted, to see if they would like to participate.

Research studies that a patient is actively participating in will show in their Epic record and will also be visible to them directly if they have MyChart. Within MyChart, patients will be able to view and amend their research contact preferences and see which research studies they have been contacted about; which ones they have been involved in, which ones they are actively involved in, and studies that they have declined.

Commercial Research update

From Mid-October as part of work to improve the set-up of commercial studies in the UK, local contract negotiation is changing in Stage 2 of the National Contract Value Review (NCVR) which was implemented in response to Lord O’Shaughnessy’s independent review of commercial clinical trials

What is changing?

For all studies submitted from Sunday 1 October 2023:

• Regulatory and costings submissions will be made at the same time
• The budget will be shared with the lead applicant (lead NHS site) for national costing. This finance schedule will be put into a new template contract appendix, to be shared with sites
• There is no local site budget negotiation as the financial appendix is mandated for use, unmodified.
• From 18 October, any contract not already agreed will need to follow NCVR stage 2.
• The aim is to speed up commercial trial setup so sites can concentrate on assessing resource to provide capacity and capability to deliver the trial.
• Further information available here.  

Which studies are affected?

All commercial contract research to take place in the NHS across the UK is planned to be in scope of NCVR. There are some exceptions for stage two: phase I-IIa, advanced therapy medicinal product (ATMP) studies and studies carried out in independent contractor primary care.

Studies excluded from stage two in the NCVR process will be included as soon as possible.