Glossary

Association of the British Pharmaceutical Industry: a trade association for UK pharmaceutical companies.

A brief summary of the study and its results. It should tell you what the study tried to show, how the researchers went about it, and what they found.

‘Attributing the costs of health and social care Research and Development’. A DHSC framework to identify, attribute and recover the various costs associated with research in the NHS. For more information see: AcoRD guidance.

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.

An unwanted or harmful reaction which occurs after administration of a drug or drugs and is suspected or known to be due to the drug(s).

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.

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 (AHPs) are people who work in health care professions distinct from dentistry, nursing, medicine, and pharmacy. They provide a range of diagnostic, technical, therapeutic, and support services in connection with health care, for example, occupational therapists, dietitians and podiatrists.

Association of Medical Research Charities: a membership organisation of the leading medical and health research charities in the UK.

Academy of Medical Sciences: the independent body in the UK representing the whole spectrum of medical science.

NIHR Applied Research Collaborations (ARCs) support high quality, generalisable, applied health and care research that responds to, and meets, the needs of local populations and local health and care systems. The collaborations also support, facilitate and increase the rate at which research findings are implemented into practice.

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.

(APC) A publishing fee paid to journals to publish a research article open access.

The loss of participants during the course of a study. Also called 'loss to follow up'.

An audit of health or social care involves carrying out a systematic assessment of how well that care is being delivered. Current policy and practice is compared with an agreed standard, so that any problem areas can be identified and improved. Later, the audit can be carried out again to check that the changes made have actually made a difference

(AAM) The author’s version of a research article that has been peer-reviewed and is accepted for publication, prior to typesetting by the publisher. It may otherwise be known as the ‘author manuscript’ or ‘final author version’ or ‘post-print’.

Basic research aims to improve knowledge and understanding, rather than finding a solution to a specific practical problem. It usually involves work in a laboratory – for example to find a gene linked to a disease or to understand how cancer cells grow. This kind of research can sometimes provide clues as to which avenues to explore to develop new treatments.

A systematic error or deviation in results or inferences from the truth. In studies of the effects of health care, the main types of bias arise from systematic differences in the groups that are compared (selection bias), the care that is provided, exposure to other factors apart from the intervention of interest (performance bias), withdrawals or exclusions of people entered into a study (attrition bias) or how outcomes are assessed (detection bias). Reviews of studies may also be affected by reporting bias, where a biased subset of all the relevant data is available.

NIHR’s 20 Biomedical Research Centres (BRCs) are collaborations between world-leading universities and NHS organisations that bring together academics and clinicians to translate lab-based scientific breakthroughs into potential new treatments, diagnostics and medical technologies.

The process of preventing those involved in a trial from knowing which comparison group a participant belongs to. The risk of bias is minimised when fewer people know who is receiving the experimental intervention or the control intervention. Participants, caregivers, outcome assessors, and analysts are all candidates for being blinded. Blinding of certain groups is not always possible, for example, surgeons in surgical trials.

Blood and Transplant Research Units (BTRUs) are four research partnerships between universities and NHS Blood & Transplant (NHSBT) that undertake research to improve the supply of blood, blood products, stem cells and tissues, and organs for transplantation.

Blood and Transplant Research Units (BTRUs) are four research partnerships between universities and NHS Blood & Transplant (NHSBT) that undertake research to improve the supply of blood, blood products, stem cells and tissues, and organs for transplantation.

A carer is a relative, friend or partner who provides, intends to provide, or used to provide a substantial amount of care to another person on a regular basis, but not necessarily through living with them.

The chief investigator (CI) is the person who takes overall responsibility for the design, conduct and reporting of a study.

The CLAHRCs (Collaborations for Leadership in Applied Health Research and Care) were superseded by the 15 NIHR Applied Research Collaborations (ARCs) in 2019.

A systematically developed statement for practitioners and participants about appropriate health care for specific clinical circumstances.

Clinical research aims to find out the causes of human illness and how it can be treated or prevented. This type of research is based on examining and observing people with different conditions and sometimes comparing them with healthy people. It can also involve research on samples of blood or other tissues, or tests such as scans or X-rays. Clinical researchers will also sometimes analyse the information in patient records, or the data from health and lifestyle surveys.

NIHR’s 23 Clinical Research Facilities (CRFs) are purpose built facilities in NHS hospitals where researchers can deliver early-phase and complex studies.

An experiment to compare the effects of two or more healthcare interventions. ‘Clinical trial’ is an umbrella term for a variety of healthcare trial designs.

Authorisation by a competent authority (Medicines and Healthcare products Regulatory Agency in the UK) to conduct a clinical trial.

Specialist units with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. The NIHR provides support funding for a number of UKCRC registered units.

An online archive of scholarly materials.

A trial where clusters of individuals (e.g. clinics, families, geographical areas), rather than individuals themselves, are randomised to different arms.

An approach in which researchers, practitioners and the public work together, sharing power and responsibility from the start to the end of the project, including the generation of knowledge. The assumption is that those affected by research are best placed to design and deliver it and have skills and knowledge of equal importance.

Where two or more organisations share a significant interest in a study, they may elect to act as co-sponsors.

The Cochrane Collaboration is an international, non-profit, independent organisation. It ensures that up-to-date and accurate information about the effects of healthcare interventions is readily available worldwide. It produces and disseminates systematic reviews of healthcare interventions, and promotes the search for evidence in the form of clinical trials and other studies on the effects of interventions.

An observational study in which a defined group of people (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, to examine people who were exposed or not exposed (or exposed at different levels) to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective (or historical) cohort study identifies subjects from past records and follows them from the time of those records to the present.

Collaboration involves active, on-going partnership with members of the public in the research process. For example, members of the public might take part in an advisory group for a research project, or collaborate with researchers to design, undertake and/or disseminate the results of a research project.

Calls for proposals based on pre-defined research questions developed to respond to the information needs of decision-makers (typically, but not exclusively, within the NHS).

Commissioned workstreams start with the information needs of decision makers typically, but not exclusively, within the NHS. These are refined and prioritised by experts in the field, and commissioning briefs are then advertised. Applications are assessed for compliance with the commissioning brief, scientific quality, feasibility and value for money.

A commissioner is the person (or organisation) who asks for a piece of research to be carried out.

A group of experts who consider the scientific merits of grant applications and make recommendations.

A detailed description of a question to be answered by new research. In responding to a commissioning brief, researchers outline what studies they would undertake to obtain the information required.

An investigational or marketed product (i.e. active control) or placebo, used as a reference in a clinical trial.

A measure of the uncertainty around the main finding of a statistical analysis. Wider intervals indicate lower precision and narrow intervals indicate greater precision.

During a research project, the researchers must put data protection measures into place, to ensure that all of the information collected about the participants is kept confidential. This means that the researchers must get the participants’ written permission to look at their medical or social care records. It also means that any information that might identify the participants cannot be used or passed on to others, without first getting the participants’ consent. For example, when researchers publish the results of a project, they are not allowed to include people’s names. This confidentiality will only be broken in extreme circumstances: where it is essential for the person’s care, treatment or safety, where it is required by a court order, for example in a criminal investigation, or where it is necessary to protect the public.

A factor that is associated with both an intervention and the outcome of interest. For example, if people in the experimental group of a controlled trial are younger than those in the control group, it will be difficult to decide whether a lower risk of death in one group is due to the intervention or the difference in age. Age is then said to be a confounder, or a confounding variable. Randomisation is used to minimise imbalances in confounding variables between experimental and control groups. Confounding is a major concern in non-randomised trials.

Consultation involves asking members of the public for their views about research, and then using those views to inform decision-making. This consultation can be about any aspect of the research process – from identifying topics for research, through to thinking about the implications of the research findings. Having a better understanding of people’s views should lead to better decisions.

In health and social care research, the term consumer is used to refer collectively to people who use services, carers, organisations representing consumers’ interests, members of the public who are the potential recipients of services, and groups asking for research to promote good health or because they believe they have been exposed to potentially harmful circumstances, products or services.

The unintended application of the intervention being evaluated to people in the control group; or unintended failure to apply the intervention to people assigned to the intervention group.

A Contract Research Organisation (CRO) is a company that is contracted by life sciences industry (pharmaceutical, biotechnology, and medical device industries) to support the clinical development process once a new molecule or treatment has been discovered. For example, the CRO may lead and manage the planning, set-up and delivery of clinical trials.

A participant in the arm that acts as a comparator for one or more experimental interventions. Controls may receive placebo, no treatment, standard treatment, or an active intervention, such as a standard drug.

The comparison group in the randomised trial. Those who are in the control group (or arm) will not receive the new medication, device or treatment that is under study, but will provide a comparison to see how the innovation compares against no treatment or a known treatment.

A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a “historical control”).

The bundle of rights which relates to a work which determines who may publish, copy and distribute it

A measure addressing the cost implications of achieving health benefits. To facilitate comparisons, health benefits can be quantified in terms of ‘QALYs’ (Quality-Adjusted Life Years), which incorporate both extra life achieved and improvements in quality of life. Knowing the cost associated with each QALY gained can help decision-makers assess whether the introduction of a treatment or service should be recommended.

An economic analysis that views effects in terms of overall health specific to the problem, and describes the costs for some additional health gain (e.g. cost per additional stroke prevented).

A licence which allows anyone to read, share, and adapt the original material for free, but the user must give appropriate credit and indicate if changes were made.

A licence which allows anyone to read and share the original material for free, with appropriate credit (like the CC BY licence), but with the additional restriction that if the reader adapts the original material, they may not distribute the adapted material.

This is a Creative Commons ‘No rights reserved’ licence, which places materials as completely as possible in the public domain, so that others may freely build upon, enhance and reuse the works for any purposes without restriction under copyright or database law.

NIHR’s 23 Clinical Research Facilities (CRFs) are purpose built facilities in NHS hospitals where researchers can deliver early-phase and complex studies.

The CRN makes it possible for patients and health professionals across England to participate in clinical research studies, in both the NHS and in the wider health and social care environment. The CRN provides the infrastructure that allows high-quality clinical research and meets the costs of using NHS staff that support research and provides specialist training so that patients can be confident that research is being delivered by trained, experienced NHS staff. The CRN also meet the costs of using NHS facilities, such as scanners and x-rays that are needed in the course of a study, so that research is not subsidised with funding that has been provided for patient care.

A metadata standard set by Crossref.

Data is the information collected through research. It can include written information, numbers, sounds and pictures.

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.

All personal information is protected in the UK by the Data Protection Act 2018. This means that researchers have to put in all the necessary safeguards to protect the confidentiality of the information they collect about research participants. They should explain in the patient information sheet: how the participants’ data will be collected, how it will be stored securely, what it will be used for, who will have access to the data that identifies participants, how long it will be kept and how it will be disposed of securely.

The Department of Health and Social Care (DHSC) is the government department supporting ministers in leading the nation’s health and social care to help people live more independent, healthier lives for longer.

A diagnostic test is an indicator or predictor of an illness state. As such, the term needs to be interpreted broadly as it includes diagnostic tests, screening, tests to stage disease, treatment monitoring, and estimate prognosis estimation.

Discoverable publications mean that they can be found by readers and search engines, usually facilitated through a bibliographic or metadata record associated with the full text.

Dissemination involves communicating the findings of a research project to a wide range of people who might find it useful. This can be done through producing reports, publishing articles in journals or newsletters, issuing press releases or giving talks at conferences.

A Data Monitoring Committee (DMC) is a committee that may be established by the sponsor to assess at intervals, the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Digital Object Identifiers, a persistent identifier system

A trial where the investigators and the subjects included in the trial (healthy volunteers or patients) do not know which interventions / treatments have been assigned.

Experimental Cancer Medicine Centres (ECMCs) act as an efficient and effective UK-wide network for delivering pioneering, early-phase cancer trials, bringing together world-leading laboratory and clinical researchers to test new treatments for adults and children with cancer.

Comparison of the relationship between costs and outcomes of alternative healthcare interventions.

A collection of scholarly or scientific chapters written by different authors. The chapters in an edited volume are original works (not republished works).

A generic term for the estimate of treatment effect for a study.

The extent to which an intervention produces a beneficial result under ideal conditions. Clinical trials that assess efficacy are sometimes called explanatory trials.

The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.

The European Medicines Agency: a body of the European Union which has responsibility for the protection and promotion of public health through the evaluation and supervision of medicines for human use.

With emancipatory research, people who use services, rather than professional researchers, have control of the whole research process. They plan and undertake the research, and interpret the findings. The main aim is always to empower people and improve people’s lives. ‘Professional’ researchers may be brought in as advisers or have specified roles within the project.

A period during which access to scholarly work is restricted to those who have paid for access.

Efficacy and Mechanism Evaluation, one of the NIHR programmes. The EME Programme funds research which aims to establish definitive proof of clinical efficacy. Studies may also include embedded mechanistic studies which will add to our understanding of biological or behavioural mechanisms.

This is the process by which people who use services equip themselves with the knowledge, skills and resources they need to be able to take control over decisions and resources. It often involves people building confidence in their own strengths and abilities. It does not always mean people take control over all decisions or all resources.

Ways in which research can be shared with the public in a two-way process. Engagement encourages researchers to listen and interact with the general public, for example, via science festivals, open days, media coverage.

The act of admitting a participant into a trial. Participants should be enrolled only after study personnel have confirmed that all the eligibility criteria have been met. Formal enrolment must occur before randomised assignment.

The study of population and community health, not just individuals.

A state of uncertainty where a person believes it is equally likely that either of two treatment options is better.

Ethics are a set of principles that guide researchers who are carrying out research with people. Ethical principles are designed to protect the safety, dignity, rights and well-being of the people taking part. They include the requirement to ask each individual to give their informed consent to take part in a research project.

The job of an ethics committee is to make sure that research carried out respects the dignity, rights, safety and well-being of the people who take part. Increasingly ethics committee approval is needed for health and social care research. Ethics committee members include researchers and health care professionals as well as members of the public.

A permanent, free-to-access online digital repository which contains full-text preprints and peer-reviewed life sciences publications.It is hosted by European Molecular Biology Laboratory's European Bioinformatics Institute, and is partnered with PubMed Central.

This involves assessing whether an intervention (for example a treatment, service, project, or programme) is achieving its aims. A project can be evaluated as it goes along or right at the end. An evaluation can measure how well the project is being carried out as well as its impact. The results of evaluations can help with decision-making and planning.

Evaluative research seeks to assess or judge in some way, providing useful information about something which cannot be gleaned by mere observation or investigation of relationships.

An evidence base is a collection of all the research currently available about a health or social care topic, such as how well a treatment or a service works. This evidence is used by health and social care professionals to make decisions about the services that they provide and what care or treatment to offer people who use services.

Evidence synthesis involves the development of techniques to combine multiple sources of quantitative and qualitative data to derive best evidence for use in healthcare.

Specific criteria which are defined within the study protocol that expressly exclude specific individuals from participating in a study. The reasons for considering exclusion can range from safety issues, potential difficulties in management of particular participants or the need to control variables within the study. Exclusion criteria must always be defended ethically to guard against discrimination.

This type of research allows researchers to explore cause and effect. For example, experimental research would be used to see whether a new drug is effective in reducing blood pressure. The research design (in this example a randomised controlled trial) will tell the researcher whether any reduction in blood pressure is definitely due to the drug.

The term ‘experts by experience’ refers to service users and carers, who are experts through their experience of illness or disability and services.

A trial design used to assess the individual contribution of treatments given in combination, as well as any interactive effect they may have. In a trial using a 2x2 factorial design, participants are allocated to one of four possible combinations. This type of study is usually carried out in circumstances where no interaction is likely.

Food and Drug Administration: the Competent Authority in the United States, giving authorisation to conduct clinical trials and issuing marketing licences.

Feasibility Studies are pieces of research done before a main study in order to answer the question "Can this study be done?". They are used to estimate important parameters that are needed to design the main study.

A focus group is a small group of people brought together to talk. The purpose is to listen and gather information. It is a good way to find out how people feel or think about an issue, or to come up with possible solutions to problems.

The observation over a period of time of study/trial participants to measure outcomes under investigation.

Full and appropriate funding is provided because no upper limit is placed on the amount of funding granted for a project. Subject to availability of funds, if the question is important enough and the science requires it, we will fund it. For University based projects, we will fund up to 80 per cent of the Full Economic Cost (FEC) of the research, and 100 per cent of the direct costs for NHS Trust based projects. Other organisations are welcome to apply to our programmes and should discuss costing with us.

An organisation providing funding for a study (through agreements, grants or donations to an authorised member of the employing and/ or care organisation). The main funder typically has a key role in scientific quality assurance. In any case, it remains responsible for securing value for money.

A group of experts who consider grant applications and reviewer reports to decide whether to recommend funding.

The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical settings.

The method, procedure, or measurement that is widely accepted as being the best available, against which new developments should be compared.

Good clinical practice (GCP) is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.

Good manufacturing practice (GMP) is that part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorisation or product specification.

Grey literature is material that is less formal than an article in a peer review journal or a chapter in a book – so it’s not easily tracked down. It includes internal reports, committee minutes, conference papers, factsheets, newsletters and campaigning material.

A persistent identifier system.

For the purposes of NIHR and other clinical academic funding, the definition of regulated healthcare professionals (HCPs) are those regulated and registered healthcare professionals, excluding doctors and dentists, who are currently registered with one of the national regulatory bodies, including the:

• Nursing and Midwifery Council
• Health and Care Professions Council
• General Dental Council
• General Medical Council
• General Optical Council
• General Osteopathic Council
• General Chiropractic Council
• General Pharmaceutical Council
• Pharmaceutical Society of Northern Ireland

This definition has been the result of a wide consultation process. It is to provide collective terminology for the largest workforce in the NHS, which includes nurses, midwives, allied health professionals, regulated clinical and practitioner psychologists, pharmacists, and healthcare scientists. Labels such as non-medics and professions allied to medicine, which categorise groups according to their relationship to medicine, has been controversial; and NMAHPs (nurses, midwives, and allied health professionals) is exclusionary for other regulated healthcare professionals, such as pharmacists and healthcare scientists. 

While acknowledging that doctors and dentists also technically are healthcare professions, they are more publicly known as doctors and dentists. 

This definition has been endorsed by the Clinical Academic Training Forum.

The Health Research Authority (HRA) is an NHS organisation established to protect and promote the interests of patients and the public in health research.

Health Technology is an internationally recognised term that covers any method used by those working in health services to promote health, prevent and treat disease and improve rehabilitation and long-term care. "Technologies" in this context are not confined to new drugs or pieces of sophisticated equipment.

Health Education England: an executive non-departmental public body of the Department of Health. Its function is to provide national leadership and coordination for the education and training of the health and public health workforce within England.

Higher Education Institution: a term used to talk about organisations that provide higher, post-secondary, tertiary, and/or third-level education.

The NIHR Health Informatics Collaborative (HIC) has been set up to deliver high quality data in five key therapeutic areas across five of the largest university hospital trusts, each of which hosts a BRC.

Honorary contracts are required by anyone who wants to carry out research or observe people in an NHS setting, but who does not already have an employment contract or a volunteer contract with the relevant NHS Trust. The contract ensures that they are covered by NHS liability insurance, and that they are contractually bound to take proper account of the NHS duty of care.

Health Protection Research Units (HPRUs) are 13 research partnerships between universities and Public Health England (PHE) and act as centres of excellence in multidisciplinary health protection research in England.

Health and Social Care Delivery Research, one of the NIHR programmes. The HSDR Programme funds research into the quality, access and organisation of health services, including costs and outcomes.

Health Technology Assessment, the HTA Programme produces independent research information about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS.

A proposed explanation made on the basis of limited evidence as a starting point for further investigation.In a trial, this would be a statement relating to the possible different effect of the interventions on an outcome.

The NIHR Invention for Innovation (i4i) Programme supports the preclinical and clinical development of medical devices in areas of existing or emerging patient need.

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 that 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.

A process by which a participant 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 decision to participate.

(I4OC) An initiative to promote the availability of data on citations that are structured, separable, and open.

The situation in which the effect of one independent variable on the outcome is affected by the value of a second independent variable.

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.

The process of intervening on people, groups, entities or objects in an experimental study. In controlled trials, the word is sometimes used to describe the regimens in all comparison groups, including placebo and no-treatment arms.

A group of participants in a study receiving a particular health care intervention. Parallel group trials include at least two intervention groups.

A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

In research, an interview is a conversation between two or more people, where a researcher asks questions to obtain information from the person (or people) being interviewed. Interviews can be carried out in person (face-to-face) or over the phone.

A person who is conducting a (clinical) study . Those researchers leading the team are referred to as chief investigator or principal investigator.

James Lind Alliance: an initiative that brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise the top 10 unanswered questions or evidence uncertainties that they agree are the most important in a specific condition, area or topic.

A journal is a publication in which researchers formally report the results of their research to people who share a similar interest or experience. Each journal usually specialises in one particular topic area.

Getting the right information to the right people in the right format at the right time, so as to influence decision-making. Knowledge Mobilisation includes dissemination, knowledge transfer and knowledge translation.

The term ‘lay’ means non-professional. In research, it refers to the people who are neither academic researchers nor health or social care professionals.

A lay summary is a brief summary of a research project or a research proposal that has been written for members of the public, rather than researchers or professionals. It should be written in plain English, avoid the use of jargon and explain any technical terms that have to be included.

The licence outlines what a person may do with a third party copyright work (e.g., a Creative Commons (CC) licence or Open Government licence).

(LMICs) Countries defined from time to time by the Organisation for Economic Cooperation and Development’s (OECD) and listed on the Development Assistance Committee (DAC) list.

Data (e.g. content of a document) that can be readily processed by computers.

Any instrument, apparatus, implement, machine, appliance, implant, software, material, or similar that can be used for: diagnosis, prevention, monitoring, treatment or alleviation of disease; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices: that doesn’t achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means.

MedTech and In Vitro Diagnostic Co-operatives (MICs) build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic (IVD) tests. The MICs replace the NIHR Healthcare Technology Co-operatives (HTCs) and NIHR Diagnostic Evidence Co-operatives (DECs), incorporating and retaining the remits of both.

When using the term ‘public’ we include patients, potential patients, carers and people who use health and social care services as well as people from organisations that represent people who use services. We also include those members of the public who are potential recipients of health promotion programmes, public health programmes, and social service interventions. Other organisations may have different definitions of this term.

A mentor is a person willing to share their experience, knowledge and wisdom to help, guide and support someone who is less experienced. Mentors act as friends, teachers and advisers. A person who is newly involved in research can ask for a mentor to help them adjust to their new role.

Combining data from multiple independent studies. May be undertaken in evidence syntheses.

Summarises basic information about data (for example, author, date created, date modified, file size).

The term methodology describes how research is done – so it will cover how information is collected and analysed as well as why a particular method has been chosen.

Medicines and Healthcare Products Regulatory Agency: the competent authority for the UK, it is responsible for ensuring that medicines and medical devices work and are acceptably safe.

MedTech and In Vitro Diagnostic Co-operatives (MICs) build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially-supplied in vitro diagnostic (IVD) tests. The MICs replace the NIHR Healthcare Technology Co-operatives (HTCs) and NIHR Diagnostic Evidence Co-operatives (DECs), incorporating and retaining the remits of both.

Maintaining contact with funded projects to ensure they progress satisfactorily and deliver meaningful results.

Monitoring research involves keeping up to date with the progress of a research project. This will include ensuring that the researchers are carrying out their research according to their research proposal or protocol, that the research is keeping to time and budget and that the research is being conducted ethically.

A long article or short book on a particular subject.

Illness or harm.

Death.

Medical Research Council, the main UK Government source of funds for biomedical and early stage clinical research. The MRC funds the researcher-led workstream of the EME Programme.

A trial conducted at several geographical sites. Trials are sometimes conducted among several collaborating institutions, rather than at a single institution - particularly when large numbers of participants are needed.

The UK national body that advises on screening programmes within the NHS.

We are needs-led because we assess the important questions and the priority they should be answered in. We actively ensure that our programmes meet the needs of decision makers. We ensure that we are needs-led throughout the funding pipeline, by actively assessing need and priority for all funding streams.

National Health Service: government-funded medical and health care services that everyone living in the UK can use without being asked to pay the full cost of the service.

NHS research is research carried out in the NHS or funded by the NHS. This includes research that takes place in local hospitals or GP surgeries, and larger studies commissioned by the NHS at a national level. For example a study based in a GP surgery looking at people’s experience of long-term chronic pain or a randomised controlled trial to look at the best treatment for people with bowel cancer.

The National Institute for Health and Clinical Excellence recommends which treatments should be provided by the NHS. NICE makes extensive use of evidence generated by the NIHR programmes.

The NIHR Academy is responsible for development and coordination of NIHR academic training, career development and research capacity development.

The NIHR BioResource for Translational Research in Common and Rare Diseases (NIHR BioResource) is a national resource of patients and members of the general population who have volunteered to be called up for research based on their genotype and phenotype.

The NIHR Health Informatics Collaborative (HIC) has been set up to deliver high quality data in five key therapeutic areas across five of the largest university hospital trusts, each of which hosts a BRC.

The NIHR National Biosample Centre provides high throughput and high quality biosample processing, storage and retrieval services to for NIHR-supported research, and research funded by partners of the Department of Health, such as the MRC, charities and industry.

A trial designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a pre-specified amount.

A study in which the investigators do not seek to intervene, but simply observe the course of events. There is a greater risk of selection bias than in experimental studies.

The earliest date that the final version-of-record is made available on the publisher's website.

The online permanent availability of scholarly work via the internet, free of charge to individuals who wish to access, read and re-use.

(OGL) Work created by officers or servants of the Crown in the course of their duties is Crown copyright and cannot usually be assigned away from the Crown. Collaborations between Crown officers or servants and others will also be Crown copyright in respect of the Crown contributions. The default licence which must be used for most Crown copyright information is the Open Government Licence.

Describes a clinical trial in which masking is not used. That means that all parties involved with the trial know which participants have been assigned which interventions.

Metadata specifications set by OpenAIRE.

Directory of Open Access Repositories - An online OA repository which lists information such as metadata policy and location.

ORCID provides a persistent digital identifier (an ORCID iD) to researchers that distinguishes them from every other researcher.

A component of a participant's clinical and functional status after an intervention has been applied, that is used to assess the effectiveness of an intervention.

Outcome measures are measurements of the effects of a treatment or service. They might include physical measurements – for example, measuring blood pressure – or psychological measurements – for example, measuring people’s sense of well-being. So if someone takes part in research, they may be asked questions, or they may be asked to have extra tests to assess how well the treatment or service has worked.

Published results from a research project. NIHR projects often generate papers that are published in the scientific literature. Full details of NIHR projects and their results are published in special reports or journals. Some projects generate briefing papers or other outputs for particular audiences.

An individual who is studied in a trial, often, but not necessarily, a patient.

The act of taking part in a research study, for example people being recruited to take part in a clinical trial or another kind of research study, joining in a focus group or completing a questionnaire.

This is a type of research where researchers and people who use services or carers are partners in a research project. The research addresses an issue of importance to service users or carers, who are involved in the design and conduct of the research, and the way the findings are made available. The aim of the research is to improve people’s lives. This isn’t a research method – it’s an approach to research, a philosophy.

Also known as PPI, involvement or public involvement. An active partnership between patients and the public and researchers in the research process, rather than the use of people as ‘subjects’ of research. Patient and public involvement in research is often defined as doing research ‘with’ or ‘by’ people who use services rather than ‘to’, ‘about’ or ‘for’ them. This includes, for example, working with research funders to prioritise research, offering advice as members of a project steering group, commenting on and developing research materials, and undertaking interviews with research participants. When using the term ‘public’ we include patients, potential patients, carers and people who use health and social care services as well as people from organisations that represent people who use services.

Researchers must provide a patient information leaflet to everyone they invite to take part in a research study, to ensure people can make an informed decision about this. The leaflet explains what taking part will involve and should include details about: why the research is being done, how long it will last, and what methods will be used; the possible; contact details; how the results will be shared with others.

Patient Safety Translational Research Centres (PSTRCs) conduct and support research to investigate ways to improve the safety, quality and effectiveness of the services that the NHS provides to its patients.

A method of restricting access to content, (e.g., research articles, news), via a purchase or a paid-for subscription.

NIHR Programme Development Grants (PDG) support researchers to carry out targeted preparatory work to strengthen an application for future full Programme Grants for Applied Research (PGfAR) funding award.

Peer interviewing is where people are interviewed by others who have a similar experience to them – their peers. For example, in a project to find out about children’s experiences of after school care, children with experience of using after school care may act as peer interviewers, asking other children about their experience. Some researchers believe that this kind of interviewing enables people to talk more freely about their experience.

A reviewing process for checking the quality and importance of reports of research. An article submitted for publication in a peer-reviewed journal is reviewed by other experts in the area.

(PID) A long-lasting reference to a resource.

A user perspective is often what people with experience of using health or social services are asked to bring when they get involved in research. They are asked to provide ideas, comments and suggestions based on the unique insight they have from their knowledge and experience of life with a health condition. They cannot be representative of everyone who uses a particular service, but they can offer their own perspective, and often that of other people.

NIHR Programme Grants for Applied Research (PGfAR) funds collaborative, multidisciplinary programmes of applied research to solve health and social care challenges.

Public Health Intervention Responsive Studies Teams

The PHR Programme evaluates interventions taking place outside of the NHS that aim to improve public health.

Pilot studies are a smaller version of the main study used to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure that recruitment, randomisation, treatment, and follow-up assessments all run smoothly.

An inactive substance or procedure administered to a participant, usually to compare its effects with those of a real drug or other intervention, but sometimes for the psychological benefit of the belief of receiving treatment. Placebos are used in clinical trials to blind people to their treatment allocation. Placebos should be indistinguishable from the active intervention to ensure adequate blinding.

An online archive of scholarly materials.

The probability of rejecting the null hypothesis when a specific alternative hypothesis is true. In clinical trials, power is the probability that a trial will detect, as statistically significant, an intervention effect of a specified size. Ideally, we want a test to have high power.

Patient and Public Involvement. In research, PPI takes various forms, from involvement of public contributors in priority setting, representation on committees, and as reviewers. NIHR appoint public board and panel members via open competition.

A trial that aims to test a treatment policy in a 'real life' situation, when many people may not receive all of the treatment, and may use other treatments as well.

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

A complete scientific manuscript (often one also being submitted to a peer-reviewed journal) that is uploaded by the authors to a preprint repository or service, typically without formal peer review of that version, such as would be undertaken by a publisher for a scholarly journal.

The outcome of greatest importance.

Experimental studies generating new data (cf. secondary research, which analyses existing data).

The principal investigator (PI) may be the chief investigator, or where the research is taking place across than one site, the principal investigator is the person at each site who is responsible for the day to day running of the research project.

Rigorously examining potential topics for research to identify their importance and where the need for new evidence is greatest.

The chance or risk of something happening.

The plan or set of steps to be followed in a study.

The NIHR Policy Research Programme (PRP) enables evidence informed policy making in health and social care.

NIHR Policy Research Units (PRUs) undertake research to inform government and arms-length bodies making policy decisions about health and social care. The units create a critical mass of experts for research in priority areas for health and social care policy.

Patient Safety Translational Research Centres (PSTRCs) conduct and support research to investigate ways to improve the safety, quality and effectiveness of the services that the NHS provides to its patients.

Public contributor is an umbrella term used to describe members of the public who take part in patient and public involvement activities. We use the definition of 'public' to include patients, potential patients, carers and people who use health and social care services as well as people from organisations that represent people who use services.

Public health is concerned with promoting good health, preventing disease and protecting people from hazards, rather than treating illnesses. It covers topics like the control of infectious diseases, vaccinations, and helping people to adopt healthy lifestyles. Public health research involves finding out new knowledge (or testing out existing ideas) to do with public health – so it might address questions about the best ways to help people stop smoking or how flu spreads.

A term to collectively describe ways in which patients, service users, carers and members of the public work with researchers, and health and care professionals, in the creation and use of health and care research. Public partnerships encompasses participation, involvement and engagement; they are all important in the process of creating and making use of high quality research. Each can take place in isolation, or in parallel. Experience, as well as research, has shown that they are mutually supportive in making research as relevant and impactful as possible. Use of the term Public Partnerships is not intended to replace, or make redundant, any existing terms or preferred ways of describing things.

The publishing platform for the original publication of research articles. Platforms that merely serve to aggregate or re-publish content that has already been published elsewhere are not considered as such.

A permanent, free-to-access online digital repository operated by the United States National Library of Medicine, which contains full-text preprints and peer-reviewed life sciences publications.

Detailed subjective evaluation, used to capture views of individuals’ and groups.

The evaluation of data from qualitative research, for example, text data from interview transcripts.

Qualitative research is used to explore and understand people’s beliefs, experiences, attitudes or behaviours. It asks questions about how and why. Qualitative research might ask questions about why people want to stop smoking. It won’t ask how many people have tried to stop smoking. Qualitative researchers use methods like focus groups and interviews (telephone and face-to-face interviews). This research does not collect data in the form of numbers but might collect data in the form of interview transcripts, or notes from focus groups.

Numerical evaluation of an intervention.

Numerical evaluation of data.

In quantitative research, researchers collect data in the form of numbers. So they measure things or count things. Quantitative research might ask a question like how many people visit their GP each year, or what proportion of children have had an MMR vaccine, or whether a new drug lowers blood pressure more than the drugs that are usually used. Quantitative researchers use methods like clinical trials.

A questionnaire is a prepared set of written questions used to obtain information from research participants. Questionnaires can be completed on paper, using a computer or with an interviewer.

There are two components to randomisation: the generation of a random sequence, and its implementation, ideally in a way so that those entering participants into a study are not aware of the sequence (concealment of allocation).

An experiment in which two or more interventions, possibly including a control intervention or no intervention, are compared by being randomly allocated to participants. In most trials one intervention is assigned to each individual but sometimes assignment is to defined groups of individuals (for example, in a household) or interventions are assigned within individuals (for example, in different orders or to different parts of the body).

The area of authority or responsibility of an individual, group, or organisation.

A bias caused by only a subset of all the relevant data being available.

An online archive of scholarly outputs (e.g., Europe PMC). The collection can include publications in peer-reviewed journals, books and book-sections, technical reports, working papers, monographs, conference presentations, research data, audio and visual materials or any other research content that has some scholarly value.

A representative is expected to speak on behalf of a larger group of people. If you’ve been asked to get involved in research as a representative of a particular group, you may want to think about how you can be confident that you are representing a wider range of people’s views, rather than just offering your own perspective.

The term research means different things to different people, but is essentially about finding out new knowledge that could lead to changes to treatments, policies or care. The definition used by the Department of Health is: “The attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.”

A research brief is often written by a commissioner to describe why they want to commission a piece of research, what questions the research should address and sometimes how the research should be carried out. It might include information about when the research needs to be completed and how much money is available.

Research governance is a process aimed at ensuring that research is high quality, safe and ethical. For more information, you can read the UK Policy Framework for Health and Social Care Research.

Research grants are specific amounts of money given to researchers to carry out a particular piece of research. They might amount to millions of pounds for a major study about genetics for example, or a few hundred pounds for a local study about people’s experience of using a particular service. Usually, in order to get research grants, researchers have to write a research proposal and receive a positive peer review.

Research methods are the ways researchers collect and analyse information. So research methods include interviews, questionnaires, diaries, clinical trials, experiments, analysing documents or statistics, and watching people’s behaviour.

Research networks aim to bring together people who have an interest in research about a particular condition or group of people. Networks might be national or local, within the NHS or run by charities or other organisations.

The term research partner is used to describe people who get actively involved in research, to the extent that they are seen by their ‘professional’ colleagues as a partner, rather than someone who might be consulted occasionally. Partnership suggests that researchers and service users/carers have a relationship that involves mutual respect and equality.

This is usually an application form or set of papers that researchers have to complete to say what research they want to do and how they want to do it. The proposal might be addressing a specific research brief and it will also cover the aim of the research, what the research questions are, who will be involved (both as participants and in carrying out the research), the time-scale and the cost.

Researchers are the people who do the research. They may do research for a living, and be based in a university, hospital or other institution, and/or they may be a service user or carer.

Open calls for researchers to apply for funding for their own topics and questions. These applications are prioritised in terms of NHS or other information need in a process similar to that of the commissioned workstreams. Applications are assessed for scientific quality, feasibility and value for money.

A study in which the outcomes have occurred before the study commenced. Case-control studies and cohort studies can be retrospective, but randomised controlled trials never are.

An individual with specific knowledge, experience and skills in a field of practice who undertakes an independent review of a grant application, commissioning brief or document for publication. The comments made by this independent ‘external reviewer’ are used to inform the funding decision or the preparation of a written document.

The NIHR Research for Patient Benefit (RfPB) programme funds health, public health and social care research to improve the lives of people with health and care needs.

NIHR Research and Innovation for Global Health Transformation (RIGHT) funds cutting-edge interdisciplinary applied global health research in key areas in low and middle-income countries where a strategic and targeted investment can result in a transformative impact.

The number of participants included in a clinical trial. The sample size should be adequate to provide a high probability of detecting as significant an effect size of a given magnitude if such an effect actually exists. The achieved sample size is the number of participants enrolled, treated or analysed in the study.

An outcome used to evaluate additional effects of an intervention deemed as being less important than the primary outcomes.

A review of individual studies (each of which is called a primary study). A systematic review is a secondary study.

The process of archiving research articles to a repository along with bibliographic metadata (data that describes other data. For items in open access repositories, this usually consists of a full bibliographic reference, abstract, keywords and similar information).

A service user is someone who uses or has used health and/or social care services because of illness or disability. Some people do not like this term because they feel it has negative connotations.

The research setting is the environment in which research is carried out. This could be a laboratory or a 'real' setting, such as the subject's working environment if you are conducting research into people's working lives.

A tool that provides a database of journal and publisher policies on copyright and self-archiving.

A review of evidence on one specific treatment, usually carried out for policy customers such as NICE.

Social care refers to a range of services provided across different settings, usually in the community. These include: home care, day care and residential care for older people; residential care and fostering for children; support for parents of disabled children; supporting mental health service users, physically disabled people and people with learning difficulties; and support for carers.

Social care research involves finding out new knowledge (or testing out existing ideas) to do with social care. For example, social care research might address questions about people’s experience of using different home care services or the best ways to train new foster parents.

School for Primary Care Research (SPCR) is a partnership between nine leading academic centres for primary care research in England. The School aims to increase the evidence base for primary care practice through high quality research and strategic leadership, and to build capacity in primary care research.

In screening / diagnostic tests this is a measure of a test’s ability to correctly identify people who do not have the disease.

School for Public Health Research (SPHR) is a partnership between eight leading academic centres of public health research in England. The School aims to build the evidence base for effective public health practice by bringing together England’s leading public health research expertise in one virtual organisation.

Surgical Reconstruction and Microbiology Research Centre (SRMRC) brings both military and civilian trauma surgeons and scientists together in a partnership with the Ministry of Defence, University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham.

School for Social Care Research (SSCR) is a partnership between five leading academic centres for social care research in England. The School aims to develop the evidence base to inform and improve adult social care practice by commissioning and conducting world-class research.

Statistical analysis uses a set of mathematical rules to analyse quantitative data. It can help researchers decide what data means. For example, statistical analysis can assess whether any difference seen between two groups of people (for example between the groups of people in a clinical trial) is likely to be a reliable finding or simply due to chance.

A result that is unlikely to have happened by chance.

Statistics are a set of numbers (quantitative data) obtained through research. For example, the average age of a group of people, or the number of people using a service.

An analysis in which the intervention effect is evaluated in a defined subset of the participants in a trial, or in complementary subsets, such as sex or age.

Surgical Reconstruction and Microbiology Research Centre (SRMRC) brings both military and civilian trauma surgeons and scientists together in a partnership with the Ministry of Defence, University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham.

Survivor is a term some people who have used health or social care services use to describe themselves – they see this as a more empowering term than ‘patient’ or ‘sufferer’. For example, some people who have used mental health services or who have experienced mental or emotional distress call themselves survivors of the psychiatric system. Some people who have recovered from cancer call themselves cancer survivors. If someone describes themselves as a survivor researcher, they are making a statement about the fact that they have used health or social care services as well as being a researcher.

A review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyse data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyse and summarise the results of the included studies.

A systematic assessment of an intervention (or group of interventions), usually undertaken for policy customers such as NICE.

The Medical Research Council (MRC)/NIHR National Phenome Centre enables scientists to better understand and tackle diseases that are triggered by environmental as well as genetic causes, and to develop strategies for their prevention and treatment. It uses nuclear magnetic resonance and mass spectrometry technology to give the most accurate readings to date of the exact chemical make-up of people’s blood and urine.

A call for proposals in a particular area of medicine or health (e.g. obesity, dementia).

Activities carried out to identify suitable topics for research. These activities provide a way for individuals and groups to propose areas where good evidence is lacking or unanswered questions exist.

The degree to which a medicine is poisonous. How much of a medicine can be taken before it has a toxic effect.

Arrangements such as ‘transitional agreements’, which are contracts which gradually shift the basis of payments from an institution to a publisher from subscription-based reading to OA publishing services in a controlled manner.

Translational Research Collaborations (TRCs) bring together world-class health researchers within designated BRCs to effectively pull discoveries from the country’s world-leading basic and translational research into real benefits for patients, share their considerable resources and world-leading expertise to improve treatment and care, and to maximise the impact of NIHR investment. The collaborations also play an important role in collaborating with the life sciences industry.

The process of intervening with the aim of enhancing health or life expectancy. Sometimes, and particularly in statistical texts, the word is used to cover all comparison groups, including placebo and no treatment arms of a controlled trial and even interventions designed to prevent bad outcomes in healthy people, rather than cure ill people.

Used to refer to a person conducting or publishing a controlled trial.

The role of the Trial Steering Committee (TSC) is to provide the overall supervision of the trial. Ideally, the TSC should include members who are independent of the investigators, their employing organisations, funders and sponsors. The TSC should monitor trial progress and conduct and advise on scientific credibility. The TSC will consider and act, as appropriate, upon the recommendations of the Data Monitoring Committee (DMC) or equivalent and ultimately carries the responsibility for deciding whether a trial needs to be stopped on grounds of safety or efficacy.

The UK Clinical Research Collaboration (UKCRC) Tissue Directory is a free online resource that catalogues the different types of human sample resources across the UK (biobank, cohort, biorepository, clinical trial etc). The directory has characterized over 180 sample resources, hosting over 400 sample collections, covering 136 diseases and counting.

(URN) A Uniform Resource Identifier (URI) that is assigned under the "urn" URI scheme and a particular URN namespace, with the intent that the URN will be a persistent, location-independent resource identifier.

User controlled research is research that is actively controlled, directed and managed by service users and their service user organisations. Service users decide on the issues and questions to be looked at, as well as the way the research is designed, planned and written up. The service users will run the research advisory or steering group and may also decide to carry out the research. Some service users make no distinction between the term user controlled and user led research, others feel that user led research has a different, vaguer meaning. They see user led research as research which is meant to be led and shaped by service users but is not necessarily controlled by them. Control in user led research in this case will rest with some other group of non-service users who also have an interest in the research, such as the commissioners of the research, the researchers or people who provide services.

A user researcher is someone who uses or has used health and/or social care services because of illness or disability, who is also a researcher. Not all researchers who use health or social care services call themselves user researchers. Calling yourself a user researcher is making a statement about your identity as a service user as well as a researcher.

The final published version of the article containing the publisher's copy edits and layout.