The protocol is a combination of planned actions related to routine clinical management of patients, audit, service development, education and clinical research. As such, there is a range of ethical considerations, which overlap these various activities.
Some aspects of the protocol are outside the jurisdiction of GafREC, but are included in the formal ethics application for completeness.
The protocol (and sub-protocols and linked studies) will be conducted in accordance with the principles of the Declaration of Helsinki 1996 (Recommendations guiding Biomedical Research Involving Human Subjects).
This protocol will be conducted in accordance with the requirements of the Data Protection Act 2018. Data will only be collected and utilised for projects which have ethical, scientific and information governance endorsement. All data will be protected within the requirements of the Barts Health NHS Trust and Connecting for Health.
The protocol will be conducted in accordance with the regulations relating to the Human Tissue Act 2004 and relevant Institutional standards of conduct relating to Human Tissue.
The residual clinical biological samples to be retained are a by-product of the planned clinical procedures and would otherwise be discarded and incinerated. The prospective collections that may include up to 50ml of venous blood, saliva, swabs, urine, faeces and human soft/solid tissue, such as atrial appendage or pulmonary vein tissue, have minimal ethical concerns or issues.
Follow up and contract tracing are routine activities for clinical care within the NHS. However, access to routine medical and other health-related records will be confined to specific members of the research group/clinical care team, but all future patient contact related to potential participation in clinical research will be related to projects which have a specific and project specific Research Ethics approval. Such a system will undoubtedly reduce the incidence of contact with families of deceased patients which is an on-going problem within the NHS and which causes considerable distress.
All patients will be clearly informed that their consent will be optional.
Specific ethical considerations:
The best interests (clinical, physical, mental and personal) of the patient will always take precedence over the conduct and continuance of this and linked protocols.
A communication plan will be established to inform the whole Trust community (service users, carers, clinicians and other Trust staff) about the existence, potential benefits and proposed uses of the Barts BioResource.
The Stakeholder participation will facilitate regular consultation on the ethical, societal and practical issues of the project.