3.3 Research governance approvals and sponsor requirements for health research

Guidance on clinical research, other research which requires NRES review and research which requires sponsorship by the University.
  1. Research where NRES review is required by law ((e.g. within the remit of the Human Tissue Act 2004, the Mental Capacity Act 2005, or the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended in August 2006, December 2006 and May 2008), or research under the remit of the Department of Health’s Research governance framework for health and social care, or the Clinical Trials Regulations, must not commence until an appropriate sponsor has been nominated and approved (the sponsor is different from the funder). Generally, a sponsor is required where research is carried out in the NHS involving NHS patients, their tissue, or data, or involves NHS staff or is carried out on NHS premises, or using NHS facilities or equipment (including GPs providing NHS services).
  2. Researchers who wish to approach the University to act as sponsor must contact the Research Governance Manager to apply for sponsorship review. The University and the University Hospitals of Leicester NHS Trust operate a joint Research Support Office and have a memorandum of understanding on research governance for joint projects.
  3. Clinical and health research which is sponsored by the University must comply with the Standard Operational Procedures issued by Research Sponsorship Management and Operations Group of the College of Medicine, Biological Sciences and Psychology. The Research Governance Manager can be contacted for advice.
  4. Where clinical research is to be undertaken, researchers must familiarise themselves with and adhere to the specific roles and responsibilities assigned to them under the relevant legislation or by other bodies involved with the clinical research, (including of the defined roles of Chief Investigator or Principal Investigator of a Clinical Study).
  5. Where the requirements of an approving body conflict with the provisions of this Code, or where the requirements of multiple approving bodies conflict, researchers must seek guidance from the Research Governance Manager.
  6. Research must be conducted in compliance with any conditions specified by NRES or other relevant approving body, including the University as sponsor.

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Research Support Services Contact details

Tel - (0116) 252 2437 or (0116) 229 7763

Fax - (0116) 252 2028

E mail - RED@le.ac.uk