This section sets out the responsibilities of the Trust and employees in healthcare research.
If you are a Trust employee, or hold an honorary Trust contract, and are involved in healthcare research it is important you are aware of your obligations under relevant UK regulations, the Research Governance Framework and Good Clinical Practice. By healthcare research, we mean any research which involves humans, their tissue and/or data.
Your specific responsibilities will depend on how exactly you are involved in the research and as an individual you may be involved in a number of different capacities.
To remain liable for the work of employees who are involved in health and social care research, including Chief Investigators and Researchers.
The Trust is responsible for:
Developing and promoting a high quality research culture and holding employees to account for the professional conduct of research.
Ensuring that Principal Investigators and Researchers understand and discharge their obligations to the research and clinical research process as set out in law and relevant guidance.
Complying with all current employment and health and safety legislation.
Demonstrating the existence of clear codes of practice for our staff and mechanisms to monitor and assess compliance.
Discharging our agreed role in the management and monitoring our clinical research, as appropriate.
Operating systems for continuous professional development of all staff involved in research.
Having agreements and systems for the identification, protection and exploitation of intellectual property.
Ensuring anyone harmed as a result of negligence on the part of our staff, students and others for whom we have a liability can be compensated. Also, where it has been agreed for a particular study, compensating participants for non-negligent harm arising from the research.
Operating systems to detect and address fraud, and other scientific or professional misconduct by our staff.
Having systems to address and learn lessons from any errors or complaints brought against our employees.
Permitting and assisting any statutory audits or inspections by relevant authorities arising from errors or complaints associated with our employees.
To be responsible for ensuring appropriate arrangements are in place for the initiation, management and financing of clinical research projects.
The Trust is responsible for ensuring appropriate arrangements are in place for:
Research teams to access sufficient resources to deliver their research as proposed.
The collection of high quality and accurate data.
The management and monitoring of research, to ensure it is carried out in accordance with the approved protocol (or proposal) and regulatory requirements.
Recording and reporting of significant developments as research proceeds, either in relation to the safety of individuals or scientific direction. In particular, ensuring appropriate arrangements for the recording and reporting of serious adverse events/reactions of any kind.
Approving modifications to the design of studies, obtaining any regulatory approvals and implementing them.
The conclusion of a study, including plans for disseminating findings.
The Trust is also responsible for ensuring that:
Research proposals respect the dignity, rights, safety and well-being of participants and for healthcare research the relationship with care professionals.
Only research of high scientific quality and good value for money is undertaken.
For clinical trials of investigational medicinal products, the Chief Investigator obtains a clinical trial authorisation and all trial arrangements comply with the law.
All clinical research being undertaken through or within the Trust, including research undertaken by students as part of their training, is formally registered.
The Chief Investigator and other key researchers have the necessary expertise and experience to conduct research as proposed.
Agreement has been reached about compensation in the event of harm to research participants. For further information about this, please see our section on insurance.
Auditing or inspection by relevant authorities is permitted and assisted.