Clinical Trials

Department of Health written question – answered on 5th February 2015.

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Photo of Charlotte Leslie Charlotte Leslie Conservative, Bristol North West

To ask the Secretary of State for Health, what requirements to participate in clinical trials without charging there are in contracts issued to private healthcare providers.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

The NHS Standard Contract is used by commissioners to commission healthcare services other than primary care from any provider, whether from the National Health Service or the independent sector. The service conditions set out in the Standard Contract state that:

- The Provider must put arrangements in place to facilitate recruitment of Service Users and Staff as appropriate into Approved Research Studies.

- In respect of any Approved Research Study the Parties must have regard, as applicable, to NHS Treatment Costs Guidance.

An Approved Research Study is defined as ‘a clinical research study:

(i) which is of clear value to the NHS;

(ii) which is subject to high quality peer review (commensurate with the size and complexity of the study);

(iii) which is subject to NHS research ethics committee approval where relevant;

(iv) which meets all the requirements of any relevant Regulatory or Supervisory Body; and

(v) in respect of which research funding is in place compliant with NHS Treatment Costs Guidance.’

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