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R&D Approval
How to Manage Commercial Research
- Clinical Trial Agreements
- Financial Probity
- R&D Approval, Indemnity & Sponsor Arrangements
- VAT in relation to research within the NHS. When and when not to charge VAT.
Trust Policy on Industry Funded Research
The Trust has responsibility to ensure that there are appropriate governance arrangements in place for all industry sponsored research that takes place in the organisation. This includes ensuring that all trials are fully costed and costs are recovered; maximum benefit from the research is provided to the investigator and the Trust; and the interests and safety of patients enrolled in trials are protected in all eventualities.
A study is defined as industry initiated and funded if a commercial company has developed the study protocol and is fully funding the additional costs of hosting the trial within the NHS. In these cases any intellectual property arising from the study will usually be fully owned by the commercial company. These trials must be supported by a Clinical Trials Agreement and appropriate indemnification.
Trust
Policy on Industry Funded Research 
National
Guidance to Facilitate the Conduct of Commercially Funded Research in the
NHS
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Clinical Trial Agreements
The Trust supports the use of the DH Model Clinical Trials Agreement. This was developed by the DH and the Association of the British Pharmaceutical Industry and is a standard contractual framework for commercial trials involving NHS patients.
The model covers the legal and financial issues raised by NHS participation in contract research sponsored by pharmaceutical companies. Please find further information in the R&D Approval Industry Initiated & Funded Flow Chart
The R&D Department is responsible for reviewing all commercial research and ensuring that the appropriate indemnity and contractual arrangements are in place. In line with national guidance, the Trust is obliged to recover the additional costs of hosting commercial research, including R&D costs. The Department therefore charges an R&D contract administration fee that recompenses the department for the time taken to scrutinise, negotiate and agree contracts and indemnity arrangements for commercially sponsored studies.
An up-front, R&D contract administration fee is payable on each commercial research project. The company will be invoiced directly by the R&D Department. For further guidance please see the R&D Approval Flow Chart for Industry Initiated and Funded Project.
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Financial Probity
It
is a Research Governance requirement and condition of R&D Approval that
all research is financially managed in an appropriate way. Financial probity
and compliance with the law and with the rules set out by H M. Treasury
for the use of public funds are as important in research as in any other
area.
Researchers,
supported by finance managers, should ensure that any commercial partner
is financially stable and thus in a position to fulfill financial obligations.
In practice, this is only likely to be an issue with small or very new companies
and Trust/University finance mangers may then undertake due diligence checks.
HM Revenue & Customs has issued guidance about medical services and exemption from VAT. This includes information about exemption from VAT in relation to clinical research. Clinical research undertaken by health professionals is exempt from VAT only if it involves patient care, e.g. to monitor a patient involved in the trial for adverse reactions which may be detrimental to their health. If involvement with the patient is restricted to monitoring side-effects for analytical purposes, or to provide analytical testing services with no patient contact, this service is standard-rated. See the HMRC website for detials.
Funding from commercial companies must be managed in accordance with the following Trust policies and procedures:
Standing
Orders, together with Standing Financial Instructions, provide a regulatory
framework for the business conduct of the Trust. They fulfil the dual role
of protecting the Trust's interests and protecting staff from any possible
accusation that they have acted less than properly.
Please see the University of Leeds Research Support Unit's website for further information. University administered grants must be managed in accordance with relevant policy. Details of the regulations relating to grant management can be accessed by clicking here.
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R&D Approval, Indemnity & Sponsor Arrangements
For information on obtaining R&D Approval, Sponsor and indemnity arrangements for Industry sponsored research please see the R&D Approval Flow Chart Industry Initiated & Funded Project
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Research Involving Ionising Radiation
Researchers should be aware of the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER). The regulations control the exposure of people to radiation for medical purposes, including diagnosis, therapy and research. The Department of Medical Physics website contains further guidance and information.
Detailed guidance has been produced by NRES and the NHS R&D Forum. Click here for the guidance and associated flow-chart.
Research projects involving radiation exposures require the approval of the Medical Exposures Committee in addition to that of R&D and the Research Ethics Committee. For information on getting projects approved please see the relevant section of the Medical Physics website by clicking here
For further information, please contact:
| Chris Taylor |
| Head of Radiological Physics |
| Department of Medical Physics |
| Wellcome Wing |
| Leeds General Infirmary |
| Tel: 0113 39 25182 |
| Email: c.taylor@leeds.ac.uk |
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