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NHS patients, service users, data or tissue (e.g. patients or carers)

Further information can be found at:

• Swansea Trials Unit
• Joint Clinical Research Facility

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:

• dental and surgical instruments
• bandages and splints
• treatment chairs and hospital beds

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 IVDRn

Vitro Diagnostic Medical Device Examples:

• • pregnancy tests
• • blood glucose monitors

MHRA guidance 

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.

• The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.
• The Act applies in England and Wales only.
• Researchers and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.
• All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research.

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:

• dementia
• mental illness
• learning disability
• brain damage
• intoxication
• any other condition causing confusion, drowsiness or loss of consciousness (e.g. concussion, stroke, heart attack, epileptic fit, serious accident, delirium).

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

• Ionising Radiation (Medical Exposure) Regulations 2017
• Ionising Radiation (Medical Exposure) (Northern Ireland) Regulations 2018 (referred to as IR(ME)R)

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:

• general radiography, interventional imaging, CT scans, DXA scans, mammography and dental radiography
• radiotherapy (including brachytherapy and therapy using unsealed sources)
• administration of radioactive substances (e.g. nuclear medicine and PET/CT).

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

• Regulatory review
• Medical Physics Expert (MPE),
• Clinical Radiation Expert (‘CRE),
• Information provided to participants
• Generic risk statements
• Radiation Assurance

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, anonymused 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.