Proportionate governance processes for R&D studies in the National Health Service (NHS)

Health R&D is highly regulated – and it is important that providers adopt a proportionate approach to governance based on appropriate risks – otherwise set-up and delivery of R&D studies and clinical trials can be inhibited and valuable research lost from the NHS and the UK. Our client wanted to achieve a step change in collaboration, efficiency and effectiveness around the start-up of studies.

The client has published the Research Support Services toolkit of standard operating procedures and risk management tools on its website for use across all providers in the NHS. The toolkit supports a reduction in the time taken to proportionately assess and approve appropriate studies within NHS providers - enabling studies to start earlier, manage patient recruitment requirements and manage quality outcomes.

This enhances the reputation of the NHS to deliver studies and encourages more commercial and non-commercial R&D across the NHS.

• Good understanding of healthcare and stakeholders in the NHS – and an open mind as to the problem, approach and solution.
• An approach which identified key issues and outline solution early – allowing time to elaborate the solution and implementation.
• A collaborative and supportive approach across a large stakeholder group. A long term committed client and BearingPoint project team willing to share and challenge ideas. Clear leadership and focus from the client and BearingPoint.

• BearingPoint worked with the client to develop a consistent understanding of Health R&D governance processes and relationships across a large stakeholder group including NHS providers (clinicians, R&D staff and senior leadership), regulatory bodies, pharmaceutical and medical devices organisations, academic institutions, and others.
• BearingPoint designed and delivered a set of 30+ standard operating procedures and templates that covered the governance processes of R&D studies. These needed to accommodate local variations across the NHS – both in terms of organisation types and study types. This included a twelve point study governance risk assessment which shaped the processes for specific studies. This enables straightforward studies to be fast-tracked – whilst more complex studies can be given more consideration. The toolkit also provided a R&D staff competency framework based on skills, experience and knowledge to utilise the toolkit effectively.
• BearingPoint supported the initial embedding of these changes across the NHS – with a group of NHS ‘champions’ – and communications with other stakeholders such as regulatory authorities and pharmaceutical companies.
• A set of key outcome measures was developed to demonstrate what could be measured and managed across this complex multi-stakeholder R&D landscape.