This document clarifies what primary care trusts need to consider before granting permission for research that involves NHS patients.
For research under the Clinical Trials Regulations, the NHS decision to give permission should normally be a formality, provided sponsors:
- confirm who is authorised to act on their behalf
- supply evidence that the project has received the favourable opinion of a research ethics committee, authorisation by the MHRA and independent expert review
- give details of provisions to cover any liabilities
PCT permission form for industry trials
The Pharmaceutical Industry Competitiveness Task Force (PICTF) Clinical Research Working Group, in association with the NHS Research and Development Forum Primary Care Working Group, has developed a standard form, published in April 2007, to make explicit what is expected of industry sponsors and companies under the DH guidance, and allow them to make a declaration about their undertakings in a format that satisfies PCTs’ need for assurances.
The permission form is intended for use with any clinical trial in NHS general practice. It is endorsed by the NIHR, the ABPI, the BIA and the UKCRN.