Swansea University Sponsorship
Research sponsorship is required under the UK Policy Framework for Health and Social Care in Research under legal requirements for all studies that involve:
Research sponsorship is required under the UK Policy Framework for Health and Social Care in Research under legal requirements for all studies that involve:
NHS patients, service users, data or tissue (e.g. patients or carers)
Further information can be found at:
Definition
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.
A full definition can be found in Article 2(1) of the MDR.
Medical Device Examples:
Definition
‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
A full definition can be found in Article 2(2) of the IVDR
Vitro Diagnostic Medical Device Examples:
Flowchart MHRA devices flowchart
Training
The HRA provides an e-learning module on medical devices, explaining the regulations and considerations for clinical investigations or other research studies of medical devices across the UK. The module can be accessed here.
Further information on the Human Tissue Act, including training, quality management system and related forms can be found here.
The Mental Capacity Act 2005 (MCA) is the legal framework that covers research involving adults (aged 16 years and over) who lack capacity ie are unable to make decisions for themselves.
All research that includes people who lack capacity to consent is required by law to be carefully reviewed by a NHS Research Ethics Committee (REC).
What is capacity?
Capacity refers to the everyday ability that individuals possess to make decisions or to take actions that affect them, from simple decisions to far-reaching decisions.
A person lacks capacity if he or she is unable to make or communicate a decision about a particular matter because of an impairment of, or a disturbance in, the mind or the brain. This may be the result of a variety of conditions, including:
Clinical Trials
Clinical trials of investigational medicinal drug products (CTMIP) are regulated separately by the Medicines for Human Use (Clinical Trials) Regulations 2004.
The HRA provides a free eLearning module on research involving the Mental Capacity act.
www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/
NHS Research Ethics Committee (REC) approval is required where participants are to be exposed to ionising radiation as part of their involvement in medical or biomedical, diagnostic or therapeutic, research. This includes both patients and healthy volunteers.
The legal framework are
Research studies involving the administration of radioactive substances must also be approved by the Administration of Radioactive Substances Advisory Committee (ARSAC).
Scope of IR(ME)R
Procedures involving ionising radiation include, but are not limited to:
Procedures such as Magnetic Resonance Imaging (MRI) or ultrasound investigations do not involve ionising radiation and therefore IR(ME)R is not applicable to those procedures.
More information on
The HRA provides a free eLearning module on research involving exposure to ionising radiation.
www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/ionising-radiation/
The SAIL databank is a research database providing access to linkable, anonymised datasets.
Further information regarding research using human embryos can be found on the Human Fertilisation and Embryology Authority website.
Certain Research Ethics Committees (RECs) are flagged for health research involving prisons and/or prisoners. Further information can be found on the HRA website.
The Ministry of Defence Research Ethics Committee (MODREC) ensures that all research involving human participants undertaken, funded or sponsored by the Ministry of Defence meets nationally and internationally accepted ethical standards.
Research within the remit of MODREC should be submitted to MODREC for ethical review rather than to a REC within the UK Health Departments’ Research Ethics Service.
Further information can be found on the MODREC webpages.
Confidentiality Advisory Group (CAG) - If you intend to access confidential patient information without consent in England and Wales you should apply to the Confidentiality Advisory Group (CAG). You will need to apply whether your project is managed as research or non-research.
Artificial Intelligence (AI) - Artificial Intelligence offers huge opportunities for healthcare. There is some introductory information here. In addition, please see the NIHR e-learning course on AI, aimed at clinical researchers, which would be of benefit to Swansea University staff and students planning a study in this area.