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.
Association of the British Pharmaceutical Industry: A trade association for UK pharmaceutical companies
This is a brief summary of a research study and its results. It should tell you why the study was done, how the researchers went about it and what they found.
Academic Clinical Fellowships
Action research is used to bring about improvement or practical change. A group of people who know about a problem work together to develop an idea about how it might be resolved. They then go and test this idea. The people who take part in the testing provide feedback on their experiences. They may also identify further actions that need to be researched and tested. This cycle of developing solutions and testing them is repeated until the problem has been solved.
The committee that advises the Health Departments on written applications from practitioners for certificates which will enable them to use specific radioactive medicinal products in diagnosis, therapy or research.
An ARSAC research certificate is obtained for all trials which result in radiation exposure to subjects additional to that involved in their routine diagnostic or therapeutic management.
Adverse Drug Reaction (also known as AR)
Means an ATMP as defined in Article 2(1) of Regulation 1394/2007 which is tested or used in a clinical trial (in accordance with Article 2(d) of Directive 2001/20/EC).
Means any of the following medicinal products for human use:
As defined in Article 2(1) of Regulation 1394/2007.
An unfavourable outcome that occurs during or after the use of a drug or other intervention, but is not necessarily caused by it.
Any untoward and unintended response to an investigational medicinal product related to any dose administered.
Comment: All adverse events judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product would qualify as adverse reactions. The expression ‘reasonable causal relationship’ means to convey, in general, that there is evidence or argument to suggest a causal relationship.
Many research projects have an advisory group (or steering group). The group helps to develop, support, advise and monitor the project. The group often includes people who use services, carers, researchers and other health and social care professionals, who can provide relevant advice.
Allied Health Professionals
A technique used to prevent selection bias by concealing the allocation sequence from those assigning participants to intervention groups, until the moment of assignment. Allocation concealment prevents researchers from (unconsciously or otherwise) influencing which participants are assigned to a given intervention group.
A written description of a change or formal clarification. Substantial amendments (See below under ‘Substantial Amendment’) to protocol, participant information/consent require REC, R&D, MHRA approval, Non-substantial amendments should be ‘notified’ to REC, R&D, MHRA
Association of Medical Research Charities
Academy of Medical Sciences
Data analysis involves examining and processing research data, in order to answer the questions that the project is trying to address. It involves identifying patterns and drawing out the main themes, and is often done with specialist computer software.
Refers to a group of participants allocated to a particular treatment. In a randomised controlled trial, allocation to different arms is determined by the randomisation procedure. Many controlled trials have two arms, a group of participants assigned to an experimental intervention (sometimes called the treatment arm) and a group of participants assigned to a control (the control arm). Trials may have more than two arms.
Administration of Radioactive Substances Advisory Committee: Research studies wishing to administer radioactive medicinal products to human subjects need to obtain ARSAC approval before NHS R&D approval
Annual Safety Report: For studies involving the use of an Investigational Medicinal Product, this is the annual report which must be submitted to the MHRA detailing all SUSARs and SARs that have occurred in subjects on that study in the past year
Copyright: © 2018 INVOLVE
22 July, 2018