Trust & University of Leeds as Sponsor

Both the LTHT and the University of Leeds will act as sponsor for studies. In order to accept this responsibility, the organisations need to be assured that there are adequate arrangements in place for the management of the study.

Clinical Trials Involving Investigational Medicinal Products

Clinical Trials involving Investigational Medicinal Products are governed by the Medicines for Human Use (Clinical Trials)Regulations 2004. The Regulations will help to ensure that the rights, safety and well-being of clinical trial subjects are protected by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognised principles of good clinical practice.

Peer Review

All research projects involving patients, their organs, tissue or data must undergo appropriate independent expert review. Peer review should occur before full R&D Approval and Research Ethics Committee approval is sought.

Honorary Contracts

The Trust must ensure that all individuals undertaking research in the Trust have a contract of employment with the Trust (either full or honorary). By issuing non-LTHT research staff with honorary contracts the Trust can extend NHS Indemnity to these individuals and ensure that all researchers working on Trust premises or with its staff, patients, their organs, tissue or data, are contractually bound to take proper account of the NHS duty of care. H onorary contracts therefore afford protection to both parties.

Non-LTHT researchers require an honorary contract if they:

• Have direct contact with patients or staff (including interviews and observation); or
• Visit Trust premises for the purposes of collecting or extracting patient-identifiable information or samples or using trust equipment; or
• Are chief investigators (CI) of projects which involve access to patient-identifiable information or samples (if the CI of a multi-centre project is external to Leeds then the co-investigator based in Leeds should be designated the “Principal Investigator” and should obtain an honorary contract.

Data Protection

Informed consent is at the heart of ethical research. All studies must have appropriate arrangements for obtaining consent, and the ethical review process pays particular attention to those arrangements.

Health & Safety

Research may involve the use of potentially dangerous or harmful equipment, substances or organisms. The safety of participants, and of research and other staff must be given priority at all times, and health and safety regulations must be observed.

NHS Indemnity

The Research Governance Framework requires that insurance or indemnity arrangements for negligent and non-negligent harm are made clear before a piece of research can commence. The Clinical Trials Regulations that govern trials of medicinal products makes it a legal requirement for the sponsor and the lead investigator to ensure that adequate arrangements are in place to address insurance/indemnity for the trial.

The Trust NHS participates in the Clinical Negligence Scheme for Trusts (CNST), run by the NHS Litigation Authority, which pools the risk of clinical negligence claims. The Trust will only extend NHS indemnity cover (for negligent harm) to its employees, both substantive and honorary, taking part in projects that have been approved by the R&D Department. The Trust can't accept liability for any activity that has not been properly registered and managerially approved.

A useful summary can be found on the DH website. 'Research in the NHS: indemnity arrangements'
This note summarises the current position on NHS indemnity for NHS bodies involved in research. It is a guide to managing the risks associated with research that involves NHS staff and/or NHS patients, including their organs, tissues or data. These notes represent existing guidance as in 'HSG(96)48: NHS Indemnity - Arrangements for handling clinical negligence claims against NHS staff' and the associated good practice document.

Further details can be found on our R&D Approvals - Indemnity advice page.

Patient & Public Involvement

Involving patients and public in research is an increasingly important part of NHS R&D and is indeed a key requirement of research governance. Department of Health policy over recent years has increasingly emphasised the importance of involving patients and the public in all aspects of their health care, including research.

Involvement means that people who use services are active partners in the research process rather than the subjects of research. Many people describe public involvement in research as doing research with or by the public rather than to, about, or for the public. Involvement can occur during any or all of the processes involved in R&D including, setting the research agenda, commissioning research, undertaking research, interpreting research, disseminating the results of research and getting findings put into practice.

Good Clinical Practice

Good Clinical Practice sets out how trials should be carried out, from initiation through to completion, dissemination and archiving of data.

Safety Reporting

Researcher's bear the day-to-day responsibility for the conduct of the research. One of the researcher's responsibilities under Research Governance is safety reporting, Researchers are responsible for reporting any failures in respect, any adverse drug reactions and other events or suspected misconduct through the appropriate systems.

There are separate safety reporting procedures for use in Clinical Trials of Investigational Medicinal Products and all other research. Information can by found be following the link below.

Audit & Monitoring

To comply with the Research Governance Framework, NHS Trusts are required to ensure all research involving their staff or patients is adequately monitored. The Trust has an audit mechanism to ensure that informed consent and other procedures in the research protocol approved by the research ethics committee are being adhered to. All data and documentation associated with the study must be available for audit at the request of the appropriate auditing authority. Currently 10% of REC approved projects are randomly selected for audit inspection by the R&D Department each year. You will be informed by letter if your study is selected.

Dissemination

Health and social care research is conducted for the benefit of patients, users, care professionals, and the public in general. Therefore, all those pursuing health and social care research must open their work to critical review through the accepted scientific and professional channels.