The ultimate aim of clinical research is to create an environment that will benefit patients and the public by improving national health, increasing national wealth, and enriching world knowledge. Clinical trials are essential to the development of this research rich environment to deliver beneficial treatments for patients as the consumers of medicine and healthcare. Clinical trials supported by the pharmaceutical industry play an important role in informing the health care community of the best treatments available and ensuring the NHS remains at the forefront of modern treatments. Commercial research activity offers clinicians and patients early access to the latest technologies for the diagnosis and treatment of disease. NHS engagement in commercial research is vital if the UK is to remain a succesful competitor in the field of medical science.
Plymouth Hospitals NHS Trust in partnerships with the Plymouth University Pensinsula School of Medicine and Dentistry actively supports the conduct of high-quality commercially funded research, which is carried out to recognised international quality standards, by NHS staff on NHS premises. PHNT leads the Peninsula in the recruitment and conduct of interventional studies.
The definition of Commercial Research is a study protocol that has been developed and funded by industry. The intellectual property arising from such a project will in general be owned by the commercial company. The commercial company will be the sponsor and contract with the NHS organisation through a Clinical Trial Agreement and appropriate indemnification. The contract of choice is the Association of the British Pharmaceutical Industry (APBI) model agreements developed in partnership between the ABPI and DoH. These agreements address the legal and financial issues of NHS participation in industry sponsored research.
The R&D Department is responsible for reviewing all research conducted on its premises and this includes commercial research. They will ensure that the appropriate indemnity and contractual arrangements are in place. The Trust will ensure that any additional cost in conducting commercial research is fully recovered In line with national guidance. The PHNT R&D finance team will work with the study sponsors to agree finances in a timely manner. To deliver additional efficiency where more than one Trust in the Peninsula is involved in the same research project a one cost model is adopted to deliver replicated contracts across all sites. A standard one off set up fee will be levied for each department involved in a research project to cover the cost of protocol review and set up. This fee will be invoiced directly to the company on execution of the contract and the issuing of R&D approval.
NHS organisations in line with Research Governance and as a condition of R&D approval must ensure financial probity and ensure compliance with the appropriate law and standing financial instructions as set out by H.M. Treasury for the use of public funds. R&D departments should satisfy themselves of the financial and ethical stability of any commercial company that they enter into partnership with.
Clinical research undertaken by health professionals involving patient care will be VAT exempt however, if involvement with the patient is restricted to monitoring side-effects for analytical purposes, or to provide analytical testing services with no patient contact, such a registry, post marketing and observational studies these fees will attract standard-rated VAT which currently stands at 20%. See the HMRC website for details.
R&D Approval, Indemnity & Sponsor Arrangements
Where ethical approval is in place PHNT aims to give R&D approval within six weeks from confirmation of site selection. To facilitate these timelines the following information, where appropriate, is required at the earliest opportunity:
- MHRA approval
- MREC submission
- MREC approval
- R&D form
- Insurance certificate
- Study documents requiring localisation.
We would ask that a planned date for the Site Initiation Visit (SIV) is penciled in to diaries as soon as possible.
Where R&D approval is not in place it would be helpful if you can provide us with the expected date of REC submission/approval. For further information, please contact the Clinical Trials Manager Corinna Mossop.
Guidance to facilitate the conduct of commercially funded research in the National Health Service (Secondary Care)
This guidance document, produced jointly by the NHS R&D Forum, the Institute of Clinical Research and the Association of the British Pharmaceutical Industry was launched in February 2007.