This jargon buster or glossary of words contains the definitions of some of the terms commonly used in public involvement in research. It is not a complete list of all the words you might come across. The original definitions were developed for INVOLVE by TwoCan Associates working in consultation with a panel of researchers and a panel of people who use services, and we add to them continually.
The jargon buster can be searched by clicking on one of the letters below or browsing all terms.
Integrated Academic Training Programme
Informed Consent Form
International Conference on Harmonisation (Europe, USA, Japan): Defined standards for the terminology, design, conduct, monitoring, recording, analysis and reporting of a study. These standards give assurance that the reported results are accurate and credible and that the rights, integrity and confidentiality of all study participants have been protected throughout the study. Section E6 of ICH defines principles of Good Clinical Practice (referred to as ICH-GCP). Research teams on CTIMPs in the UK must follow GCP requirements as detailed in MfHU (CT) Statutory Instruments; all non-CTIMP studies conducted within the NHS adhere to GCP according to Research Governance Framework
Independent Data Monitoring Committee
Investigational Medicinal Product: an unlicensed new drug, or an existing drug tested outside its licence, or existing drugs tested against each other for their efficacy/safety. The MHRA provide an algorithm to establish whether a study is a CTIMP: see Resource 2 or the MHRA website (provided on p67) http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con009394.pdf
Implementation involves putting research findings into practice. This means using research findings to make appropriate decisions and changes to health and social care policy and practice.
An adult unable by virtue of physical or mental incapacity to give informed consent.
Specific criteria which are defined within the study protocol that expressly include specific individuals to participate in a study e.g. individuals within a certain age range, with a specific condition, etc.
Investigational New Drug: sometimes used instead of IMP
Insurance or indemnity includes provision for meeting losses or liabilities—
a) under a scheme established under—
i) section 21 of the National Health Service and Community Care Act 1990 (schemes for meeting losses and liabilities etc. of
certain health service bodies in England and Wales)(d),
ii) section 85B of the National Health Service (Scotland) Act 1978 (schemes for meeting losses and liabilities etc. of certain
health service bodies in Scotland)(e), or
iii) Article 24 of the Health and Personal Social Services (Northern Ireland) Order 1991(schemes for meeting losses and
liabilities etc. of certain health service bodies in Northern Ireland)(f), or
b) in accordance with guidance issued by—
i) the Secretary of State,
ii) the Scottish Ministers,
iii) the National Assembly for Wales, or
iv) the Department for Health, Social Services and Public Safety,
As to the arrangements to be adopted by health service bodies for meeting the costs arising from clinical negligence (known as NHS Indemnity).
Compensation for damage, loss or injury
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
For CTIMPs: A person gives informed consent to take part only if his/her decision:
a) is given freely after that person is informed of the nature, significance, implications and risks of the trial; and
i) is evidenced in writing, dated and signed, or otherwise marked, by that person so as to indicate his consent, or
ii) if the person is unable to sign or to mark a document so as to indicate his consent, is given orally in the presence of at least one witness and recorded in writing.
The act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and / or contract research organisation’s facilities, or at other establishments which the competent authority sees fit to inspect.
In the UK, the MHRA’s Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA.
The generic term used by the Food & Drugs Administration (FDA) in the United States for independent ethics committees that have been formally designated to review and monitor biomedical research involving human subjects.
The online application system used to apply for most permissions and approvals for research in health and social care in the UK.
IP can be described as the novel or previously undescribed tangible output of any intellectual activity. It has an owner and can be bought, sold or licensed and must be adequately protected. It can include inventions, industrial processes, software, data, written works, designs and images.
The situation in which the effect of one independent variable on the outcome is affected by the value of a second independent variable.
Interactive Response Technology (IRT) is software that enables activities such as randomisation into clinical trial and dispensing medications in a blinded trial. Examples include telephone based Interactive Voice Response Systems (IVRS) or internet based, Interactive Web Response Systems (IWRS). These technologies are also used in other trial management activities and the EMA has published a reflection paper with further guidance.
View the Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials (PDF, 127 KB).
A website that encourages people to interact with it, rather than just offering information or selling products. For example it might invite contributions (e.g. stories, photos, films), comments and blogs; hold online events and discussions; and include open or closed discussion forums.
Analysis comparing intervention groups at any time before the formal completion of a trial, usually before recruitment is complete. Often used with stopping rules so that a trial can be stopped if participants are being put at risk unnecessarily. Timing and frequency of interim analyses should be specified in the protocol.