Every clinical research project would need to have a Sponsor in place. This is an organisation that takes overall responsibility for proportionate and efficient agreements being in place for the duration of the project. More information of the specific responsibilities of a Sponsor can be found within the UK Policy Framework for Health and Social Care Research.
You will need to identify an institution that is willing to take on this role. Many of the main funding bodies are willing to provide grants for research, but are not able to take on the responsibilities of Sponsor.
Buckinghamshire Healthcare NHS Trust (BHT) is willing to accept the role of Sponsor of a research study when it is appropriate to do so; usually when a BHT employee has designed the study and is acting as the Chief Investigator. In any situation, BHT must actively consent in writing to acting as Sponsor of a study, which is the signing of the Integrated Research Application System (IRAS form) before submission to regulatory bodies.
If you would like BHT to act as Sponsor for your study, it is important that you approach the R&I Department early in the development of your Study Protocol.
The purpose of the BHT Sponsorship Review is to:
check that the essential documents have been produced and have been checked by the appropriate teams/individuals
with the help of independent peer reviewers assess the quality of the application to anticipate REC/HRA queries
ascertain that essential legislation and guidance is being applied
All clinical trials need to undergo a risk assessment before initiation so that foreseeable risks and inconveniences/burdens can be weighed against the anticipated/likely benefit(s) for participants. A trial must only be started and continued if the anticipated benefits justify the risks.
Any identified risks must be addressed/mitigated before the trial begins or at its earliest opportunity to minimise any harm to the trial subjects.
Data management plan
A data management plan is required to be completed for all clinical research project that wish for BHT to act as Sponsor. This will detail; what data is being collected, identifiable or non-identifiable, when, arrangements for transfer, how it will be stored, how long, plans for archiving and destruction.
Independent scientific peer review
For every clinical research project an independent scientific peer review will be conducted by an independent reviewer arranged by the BHT R&I Department. The review process will look into the scientific and ethical aspects of the project and recommend whether for BHT to Sponsor, Sponsor with adjustments or not Sponsor.
Sponsor authorisation from BHT will be given in the form of electronic authorisation of the IRAS form by an authorised Trust signatory before it is submitted to the Health Research Authority. In some circumstances and upon request a signed letter may also be issued from a Trust signatory.