Go straight to content.
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
In England, Northern Ireland and Wales – Capacity is absent if, at the time of decision making:
A person is deemed unable to decide whether to take part in research if they cannot:
In Scotland – Adults with incapacity 'Incapable' means unable to:
For further guidance visit the Consent and Participant Information Guidance online tool.
The clinical care team refers to health professionals involved in the diagnosis, treatment or care of a patient. This includes pathology and radiology staff whose activities directly support the care of the patient even though usually they have no contact with the patient.
Conformité Européenne - European mark of approval for medical devices
The investigator with overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites. All applications for ethical review should be submitted by the CI.
For consent to be valid, it must be given voluntarily by an appropriately informed person who has the capacity to consent to the intervention in question. In specific circumstances the law does allow for a proxy to give consent (e.g. adults not able to consent for themselves and minors).
Clinical Trial of an Investigational Medicinal Product (CTIMP)
A Clinical Trial of a Medicinal Investigational Product is an investigation in human subjects which is intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies.
Visit the MHRA algorithm - Is it a clinical trial of a medicinal product?
Visit the MHRA pages on clinical trials for medicines legislation.
Human Fertilisation and Embryology Authority
www.hfea.gov.uk
Health and Social Care in Northern Ireland
www.hscni.net
Human Tissue Authority
www.hta.gov.uk
Under section 30 of the Mental Capacity Act in England and Wales, research is intrusive if it is of a kind that would be unlawful if it was carried out “on or in relation to a person who had capacity to consent to it, but without this consent”. Therefore, intrusive research means research that would legally require consent if it involved people with capacity.
Similarly, Section 132 of the Mental Capacity Act (Northern Ireland) states that research is ‘intrusive’ if it is of a kind that would be unlawful if it were carried out:
Procedures involving ionising radiation include:
Diagnostic X-rays, CT scans or DXA scans. Radiotherapy (including brachytherapy and therapy using unsealed sources). Radionuclide imaging (including diagnostic imaging and in vitro measurements).
Magnetic Resonance Imaging (MRI) or ultrasound investigations do not involve ionising radiation.
A number of activities can only be carried out where the establishment is licensed under the HT Act 2004 by the HTA (i.e. for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions). Organisations whose activities involve the removal, storage or use of relevant material may need to work under a HTA licence. All establishments working under a HTA licence must work to specified standards set by The HTA.
The MHRA operates a system of licensing before the marketing of medicines. Medicines which meet the standards of safety, quality and efficacy are granted a marketing authorisation (previously a product licence), which is normally necessary before they can be prescribed or sold. This authorisation covers all the main activities associated with the marketing of a medicinal product.
Any instrument, apparatus, appliance material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of:
Please refer to the MHRA guidance on approval for medical devices research.
MHRA guidance on software applications is available here.
Medicines and Healthcare products Regulatory Agency
www.mhra.gov.uk
National Health Service (England, Wales and Scotland)
www.nhs.uk
A prisoner or young offender is defined as any inmate of the prison systems of England and Wales, Scotland or Northern Ireland. It does not include patients detained under the Mental Health Act at special hospitals or other psychiatric secure units, or juvenile offenders detained in local authority secure accommodation or secure training centres.
Post Market Surveillance (PMS) studies of CE marked devices may be classified as service evaluation, where all the following criteria are met:
If the study does not meet all of these criteria, it should be regarded as research. In particular, any case series study involving additional research procedures (e.g. scans, questionnaires) or additional clinical monitoring should be regarded as research.
Processing, in relation to information or data, means obtaining, recording or holding the information or data or carrying out any operation or set of operations on the information or data, including:
Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include:
The Medicines for Human Use (Clinical Trials) Regulations define the sponsor of a clinical trial as "the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial".
Note: The Clinical Trials Regulations allow for two or more persons to take responsibility for the functions of the sponsor. Where this applies, they require that one of the sponsors should take responsibility for each of the following functions:
In this context it is any human material i.e. blood, biopsies, urine etc. This definition includes relevant and bodily material.
Xenotransplantation means putting living cells, tissue or organs from animals into people.
Close window and return to tool
