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The Research Governance Framework for Health & Social Care outlines the responsibilities sponsors have for the quality of conduct and delivery of research. The Concordat to Support Research Integrity seeks to provide a comprehensive national framework for good research conduct and its governance. In spite of the presence of such documents aimed at supporting the integrity of research, concerns are still raised by organisations which host and regulate research around the variability of how sponsors address their responsibilities, and the often evident lack of shared understanding of their role and responsibilities.
In February 2013 the HRA ran a stakeholder event which included a series of workshops to collate feedback on a range of collaborative workstreams, including Sponsorship Standards. Opinions were sought on what were considered to be the key issues and suggestions were welcomed as to what tools could be introduced to help overcome them. Examples were also sought on evidence of good sponsorship and what systems and processes were in place to ensure the required level of quality.
Since the stakeholder event, a further scoping exercise was undertaken seeking opinions and feedback from the wider R&D community. Issues raised from these combined sources include:
- Serious problems have occurred as a result of lack of clarity on sponsor responsibilities particularly escalation and reporting processes, the management of Serious Adverse Events, protocol breaches, allegations of fraud or misconduct, and the injury or death of a research participant.
- Authorisation of IRAS applications by sponsors without adequately scrutinising what was being authorised. In particular, Sponsor Authorisation had been given to applications where the scientific review process was not described and justified, copies of the report were not attached to the application or even not addressed at all in the application
- As a result of the above, further on in the permissions process it was not always possible to tell what sponsors had reviewed or considered, sometimes becoming apparent that some issues had been overlooked. Intervention from R&D offices or RECs to try and resolve the issues subsequently introduced delays to the process and frustrated researchers.
- Irrespective of the time taken to sign off applications, there is often no transparency perceived in a sponsor’s project oversight and some NHS R&D offices report instances when sponsors authorise applications, receive a grant, then undertake no further duties in overseeing the conduct, progress, completion and reporting aspects of a study.
RECs and NHS R&D offices require assurance that sponsoring organisations understand their role and responsibilities and have the necessary systems and processes in place in order to support and promote high quality research. The HRA also believes that transparency in the way in which sponsors describe these systems and processes will enhance public confidence in health research, and publication of these could greatly help overseas sponsors in identifying potential UK partners.
In early 2014 the HRA published its expectations of sponsorship. In conjunction with this we sought views on the use of a declaration by sponsors, to be made publicly available, outlining types of research which are sponsored by an organisation, and recording systems and processes in place for undertaking sponsorship responsibilities.
The closing date for responses was 28 February 2014. Responses were welcomed from across England, particularly from researchers, sponsors of research and the public.