Glossary

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• Adverse event / incident

  An adverse event or incident is any undesirable occurrence on a particular study.

  In relation to a study participant, it can be described as any unfavourable and unintended sign, symptom or disease temporally associated with participation in the research project.

  The term has also been used to describe unfortunate events that may have serious consequences for the research project, e.g. breaking down of a freezer and loss of tissue samples.

   

• Amendment

  A change made to the terms of the Research Ethics Committee (REC) application, the protocol or any supporting documentation after the study has started. A study is normally considered to start after the commencement of any protocol procedures. Amendments can be 'substantial' or 'non-substantial’.

  Substantial amendments
  

  These require the issue of a favourable opinion from the main REC and NHS R&D departments. If the amendment has implications for study in terms of the scientific peer review, the funding body should also be consulted.

  Non-substantial amendments

  The REC, NHS R&D departments (if appropriate) and sponsor(s) may require notification of non-substantial amendments. NHS RECs do not require notification of non-substantial amendments.

  For more information please see the Protocol amendments station in the Data and Tissues Tool Kit.

   

• Anonymised data / information

  Anonymised data are data prepared from information from which the person to whom is relates cannot be identified. The term is used when referring to robustly pseudonymised / linked data or unlinked anonymised data.

  Pseudonymised data, also referred to as linked anonymised

  This is anonymous to the people who receive and hold it (e.g. a research team), but contains information or codes that would allow others (e.g. those responsible for the individual’s care) to identify an individual from it.

  Unlinked anonymised data, or truly anonymised data

  This contains no information that could reasonably be used, by anyone, to identify the individual or study participant.

   

• Anonymised tissue

  The Human Tissue Authority consider that tissue is anonymised if the researcher is not in possession, and is not likely to come into possession, of information from which the individual can be identified. This does not mean that samples must be permanently unlinked, and coding samples meets these requirements.

   

• Archiving

  The retention of valuable research data which may have secondary use, or may be analysed further to verify results or as part of a meta-study; and the retention of study files which demonstrate the compliance of the investigator and sponsor with GCP and regulatory requirements.

  During archiving it should be ensured that data are properly selected, stored, can be accessed and that logical and physical integrity are maintained over time, including security and authenticity.

  Periods of retention will depend on the nature of the research and sponsor’s and funder’s requirements. Please see the Research Scenarios section of the Data and Tissues Tool Kit for more guidance on this area.

   

• Audit

  A systematic and independent examination of study-related activities and documents, to determine whether the evaluated study-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor's standard operating procedures (SOP’s), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  The Department of Health’s minimum standards for research governance state that at least 10% of projects should be routinely audited. Audit should look at areas such as: protocol amendments, start and stop dates, changes to inclusion/exclusion criteria, changes to the consent procedure, changes to recruitment, funding, research team or the patient information sheet, approvals for amendments, adverse events, health and safety, intellectual property, subject logs, recruitment, consent, and changes to data management.

  A distinction should be made between monitoring and auditing. All research activity should be monitored routinely. In addition, an organisation should conduct formal audit of a selection of research projects/activity.

   

• Authorisation

  The Human Tissue Act 2004 uses the term ‘consent’, whereas the Human Tissue (Scotland) Act 2006 uses the term ‘authorisation’.

   

• Bodily material

  The Human Tissue Authority defines bodily material in the context of DNA analysis as: Material that has come from the human body (living or deceased) and which consists of or includes human cells. This includes hair, nails and gametes, and does not specifically exclude gametes.

  Under the Human Tissue Act 2004, it is an offence to have bodily material with the intent of analysing its DNA without qualifying consent, subject to certain exceptions, which are outlined in the Consent Code of Practice. This applies UK-wide.

   

• Chief Investigator (CI)

  The Investigator with overall responsibility for the research, who is accountable to their employer, and through them to the sponsor. In a multi-site study the CI has responsibility for design, management and reporting of the study, coordinating investigators who take the lead at each site.

  All applications for ethical review should be submitted by the CI.

   

• Child

  There are different and confusing definitions of ‘child’ that affect consent issues in medical research. The situation is best explained in the Children station in the Data and Tissues Tool Kit.

   

• Clinical trial

  With the advent of the Clinical Trial Regulations, the term clinical trial is used to describe a trial that tests the safety or efficacy of an investigational medicinal product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. To avoid confusion we recommend that the term Clinical Trials Of an Investigation Medicinal Product or CTIMP is used for this definition.

  In the academic sector the term clinical trial is commonly used more loosely to describe:

  Any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (e.g. dietary) advice.

   

• Clinical Trial of an Investigational Medicinal Product (CTIMP)

  A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, i.e. a trial that tests the safety or efficacy of an investigational medicinal product. For more information, please see Is the trial within the scope of the UK Regulations? station in the Clinical Trials Tool Kit.

   

• Clinical Trial Regulations

  The Medicines for Human Use (Clinical Trials) Regulations (2004) is the law within the UK that applies to research into the safety and/or efficacy of investigational medicinal products. These Regulations are how the EU Clinical Trials Directive was transposed into UK legislation. Further information can be found in the Clinical Trials Tool Kit.

   

• Coded

  Coded samples or data have a coded identification to protect the confidentiality of the individual during routine use, but it is possible for the code to be broken, and thus identify the individual from whom they were obtained. The key should not be freely accessible but held by senior individuals with a strict duty of confidentiality.

   

• Competence

  The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.

  In relation to research this would be the ability to understand the research project and their proposed role with in that project. And to make a decision as to whether they would like to participate or not, based on this information.

   

• Confidential information

  Any information obtained by a person on the understanding that they will not disclose it to others, or obtained in circumstances where it is expected that they will not disclose it. The law assumes that whenever people give personal information to health professionals caring for them, it is confidential as long as it remains personally identifiable. See also 'Personal data'.

   

• Confidentiality

  The duty of persons to whom personal information has been given not to share the information with any unauthorised person.

   

• Consent

  The voluntary agreement of an adult or competent child to participate in research, based on adequate knowledge and understanding of the relevant information.

  Consent is often recorded by a signature on a consent form, but is simply a record of the dialogue and thought which has taken place. Consent can be verbal, the person seeking consent should record this.

   

• Consent form

  A written record of the study participant’s decision to take part in the research study.

   

• Custodian

  The custodian is responsible for the safekeeping of data or tissue samples and control of their use, and eventual disposal (if required), all in accordance with legislation and the terms of the consent given by the donor.

  Custodianship implies some rights to decide how the data/samples are used and by whom, and also responsibility for safeguarding the interests of the donors.

   

• Data curation

  The actions needed to maintain research data from point of creation to ensure they are fit for contemporary purpose and available for discovery and re-use. Implicit to this are the processes of archiving and preservation. Higher levels of curation will involve maintaining links between datasets, annotation, published materials and other information resources.

   

• Database (resarch database)

  A collection of research data that is organised and allows its contents to be easily accessed, managed and updated. The types of database depends onteh requirements of each study. A common type is the relational database, where data are related to each other in a systematic manner so that they can be reorganised and accessed in a number of different ways.

  A database may house one or many datasets.

   

• Dataset

  An organised collection of data that have a common theme, source or format; usually considered as a discrete entity.

   

• DNA analysis

  The Human Tissue Act 2004 uses the term DNA analysis. This is not defined in the Codes of Practice, it could be interpreted as the investigation of variation in the nuclear or mitochondrial DNA that forms the genome of an individual and may be inherited from parent to child.

  Under the Human Tissue Act 2004, it is an offence to have bodily material with the intent of analysing its DNA without qualifying consent, subject to certain exceptions, which are outlined in the Consent Code of Practice. This applies UK-wide.

   

• Exclusion criteria

  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.

   

• GCP (Good Clinical Practice)

  Good Clinical Practice (GCP) is an ethical and scientific quality standard for designing, conducting and reporting trials that involve the participation of human subjects. The International Conference on Harmonisation (ICH) standardised practice across Europe, Japan and the USA.

  The relevant principles of GCP should be applied to any research that involves human participants, their tissues or data. The principles of GCP are listed in MRC Guidelines for GCP, page 10.

   

• GTAC (Gene Therapy Advisory Committee)

  GTAC is the ethics committee for clinical trials of gene therapies. They define gene therapy as the deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes.

   

• Harm

  That which adversely affects the interests or welfare of an individual. This may be physical harm, discomfort, anxiety, pain, and psychological disturbance or social disadvantage.

   

• Hazard

  Anything that could cause harm.

   

• Health & Safety

  Health and Safety is a discipline, enshrined in primary legislation, concerned with preserving and protecting human and facility resources in the workplace. All employers are subject to the law and can be Inspected.

   

• Healthy volunteers

  Persons recruited to and consenting to participate in research NOT by virtue of the fact they are a NHS patient with a specific condition, but rather as they represent normal, non-diseased physiology.

   

• HFEA (Human Fertilisation and Embryology Authority)

  The HFEA is the UK's independent regulator overseeing safe and appropriate practice in fertility treatment and embryo research. The HFEA license and monitor centres carrying out IVF, donor insemination and human embryo research. They provide a range of detailed information for patients, professionals and Government.

   

• HTA (Human Tissue Authority)

  The Human Tissue Authority (HTA) regulates the removal, storage, use and disposal of human bodies, organs and tissue from the living and deceased.

  Under the Human Tissue Act 2004, the HTA has jurisdiction in England, Wales and Northern Ireland. For human application (under the EU Tissue and Cells Directive), the HTA has a UK-wide role.

   

• HTA licence

  The HTA license premises for storage of relevant material for research purposes in England, Wales and Northern Ireland. There are many exemptions to the need for an HTA licence for research, best described in HTA Licence [insert link] station of the Data and Tissues Tool Kit.

  The HTA also issues licences for human application under the EU Tissues adn Cells Directive, in the whole of the UK.

   

• Human tissue or samples

  Generic term used to encompass human organs, tissues and biological samples. Depending on the context, human tissues or samples may be used in this Tool Kit to describe relevant material, this is likely when used in reference to the Human Tissue Act 2004. Strictly speaking relevant material is a more specific term.

   

• Identifiable information

  See ‘Personal Data’.

   

• Inclusion criteria

  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.

   

• Information Commissioner's Office (ICO)

  The Information Commissioner’s Office is the UK’s independent authority set up to promote access to official information and to protect personal information under the Data Protection Act 1998. Also the authority that deals with Freedom of Information in England, Wales and N. Ireland.

   

• Information sheets

  See 'Participant / Patient information sheets'.

   

• Inspection

  Inspection is a statutory activity, undertaken by government agencies or those acting on their behalf. It is a systematic investigation into systems and processes to measure compliance with legal frameworks.

   

• IRAS

  IRAS is a single system for applying for the permissions and approvals required for health and social care / community care research in the UK.

• MHRA (Medicines and Healthcare products Regulatory Agency)

  The MHRA is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

  They have statutory powers both in the approval of drug / devices for licence and in approving Clinical Trials of Investigational Medicinal Products, and clinical investigations involving devices.

   

• Monitoring

  The process of monitoring a study should ensure that the rights and wellbeing of any participants are protected, the reported data are accurate and complete, and that the conduct of the study is in compliance with the approved protocol/amendments and with applicable regulatory/governance requirements.

  Monitoring should be built into the conduct of the study as a means to minimise risk, and should be ongoing and performed by members of the research team and people independent to it.

   

• NHS R&D Forum

  The NHS R&D Forum is a network for those involved in planning and managing research in health and social care.

   

• NHS Research Governance Framework

  The UK Health Departments’ Research Governance Frameworks (RGF) documents a set of standards and principles for carrying-out health related or social/community care research in the UK. It is mandatory for all research taking place in the NHS and using NHS resources. It aims to improve research and safeguard the public by:

  • Enhancing ethical awareness and scientific quality
    Promoting good practice
    Reducing adverse incidents and ensuring lessons are learned
    Forestalling poor performance and misconduct

   

• NIGB (National Information Governance Board)

  National Information Governance Board for Health and Social Care.  The Health and Social Care Act 2008 formally established the NIGB for England which will replace PIAG as the statutory body with responsibility for Section 251 of the NHS Act 2006.

• NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC)

  The National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN CC), formerly known as UKCRN Coordinating Centre (UKCRN CC), was established to support clinical research and to facilitate the conduct of trials and other well-designed studies within the NHS. As part of the UK Clinical Research Collaboration (UKCRC), it works towards the development of a world class infrastructure to support clinical research in the UK.

• NRES (National Research Ethics Service)

  The National Research Ethics Service (NRES) Head Office is a directorate within the National Patient Safety Agency and provides help and leadership for NHS Research Ethics Committee’s (RECs) by co-ordinating the development of operational and infrastructure arrangements in support of their work. This includes implementing standards to ensure national consistency, providing training for REC members and Co-ordinators, identifying IT solutions for procedural management and establishing regional REC centres to manage RECs.

  Formerly (Central Office for Research Ethics Committees) COREC.

   

• Parent / Guardian

  Describes those with legal responsibility for a child. The term, person with parental responsibility is used by the Human Tissue Authority.

   

• Participant

  A person who takes part in a research study or allows their tissue samples or information to be used in research, following appropriate consent, e.g. a patient or a healthy volunteer.

   

• Participant / Patient information sheet (PIS)

  The participant information sheet, in a form appropriate for the study population, explains what the research involves and how the research study will affect the participant. It is usually accompanied by a consent form.

   

• Peer review

  A system whereby research, or research proposals, are reviewed by independent experts to assure the quality of the research (e.g. can the research design answer the question? Does the research add to existing knowledge?).

   

• Personal data

  In the context of the Data Protection Act 1998 personal data comprise information about living people who can be identified from that data, or from combinations of data and other information which the person in control of the data has, or is likely to have in future.

  This includes written and electronic records, opinions, images, recordings and information obtained from samples, from which the person can be identified.

  The terms: confidential personal/patient data/information; identifiable personal/patient information/data; or identifiable confidential information, are used interchangeably and mean the same as personal data.

   

• PI (Principal Investigator)

  The Research Governance Framework defines the Principal Investigator as the leader responsible for a team of individuals conducting a study at a site. In a single site study the PI and the CI are likely to be the same person. (To avoid confusion the term Principal Applicant is being increasingly used to describe the lead investigator on a funding application.)

   

• PIAG (Patient Information Advisory Group) (see NIGB)

  PIAG was established to provide advice on issues of national significance involving the use of patient information and to oversee arrangements created under Section 60 of the Health and Social Care Act 2001. Its membership is drawn from patient groups, healthcare professionals and regulatory bodies.  This has been replaced by the National Information Governance Board (NIGB).

   

• Proposal

  A proposal details the scientific and ethical reasons for research and should demonstrate conceptual innovation, methodological rigor and substantive content. The term is used to refer to a document produced to apply for funding.

   

• Protocol

  A research protocol is a written document demonstrating the necessity and feasibility of a particular study, as well as giving a detailed plan of how the study will be conducted, analysed and disseminated.

   

• Pseudonymised data / information

  Described under the Data Protection Act 1998 to mean where the normal personal identifiers have been replaced by an artificially-created identifier so as to conceal the identity of the patient. The links between the artificial and normal identifiers are stored separately and securely, and so the data may still qualify under the Data Protection Act as personal data. Also referred to as linked anonymous data or coded data.

   

• R&D office / department

  This term is used generically to describe Research and Development offices or departments within either NHS organisations or universities. Meaning the office or department that has responsibility for research governance in that organisation.

   

• Regulators or Regulatory Authorities / Agencies / Bodies

  A body that has a statutory role to ensure compliance with regulation. Their role is usually described within the relevant primary legislation or associated regulations. They may issues licences (e.g. Human Tissue Authority), approvals (e.g. HFEA) and usually will have an Inspection role.

   

• Related and unexpected serious adverse events

  NRES define this term as:

  A serious adverse event (SAE) occurring to a research participant should be reported to the REC that gave a favourable opinion of the study (the ‘main REC') where in the opinion of the chief investigator the event was:

  • ‘related' - that is, it resulted from administration of any of the research procedures; and
  • ‘unexpected' - that is, the type of event is not listed in the protocol as an expected occurrence.

  A serious adverse event is an untoward and unexpected occurrence that:

  1. results in death;
  2. is life-threatening;
  3. requires hospitalisation or prolongation of existing hospitalisation;
  4. results in persistent or significant disability or incapacity;
  5. consists of a congenital anomaly or birth defect.

   

• Relevant material

  In the Human Tissue Act 2004, "relevant material" is defined 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:

  (a) embryos outside the human body, or

  (b) hair and nail from the body of a living person.

  The HTA has a more detailed definition of relevant material.

  Relevant material is different to Bodily material.

   

• Research ethics committee (REC)

  RECs are independent committees that review the ethical issues within research projects that involve people as participants or their data or tissues. See Ethical approval station in the Data and Tissues Tool Kit for more information on the remit of RECs.

   

• Research Governance

  Research governance is a term that is first used in the UK Health Departments’ Research Governance Frameworks. See ‘NHS Research Governance Framework’.

  It is commonly used in a generic way to encompass the Research Governance Framework standards and principles, including all applicable regulatory requirements.

   

• Research tissue bank

  The HTA define a Tissue Establishment as a tissue bank or unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissue and cells are undertaken. It may also be responsible for procurement or testing or tissue and cells.

  A research tissue bank could be described as organised entities that procure, store and distribute tissues samples for research purposes.

   

• Risk

  The likelihood of harm being caused by a hazard. The characteristics of risk include the probability of its occurrence, as well as the magnitude and duration. Harm may be to a research participant, a researcher or to the research itself.

   

• Sensitive information

  Information that when used incurs a need for extra care, e.g. about mental health, sexuality and other areas where revealing confidential information is especially likely to cause embarrassment or discrimination. According to the Data Protection Act 1998 “sensitive personal data” includes all information about physical as well as mental health or condition, or sexual life.

   

• Serious advise event (SAE)

  The HTA describe a serious adverse event as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolong, hospitalisation or morbidity.

  NRES define a serious adverse event as an untoward and unexpected occurrence that:

  1. results in death;
  2. is life-threatening;
  3. requires hospitalisation or prolongation of existing hospitalisation;
  4. results in persistent or significant disability or incapacity;
  5. consists of a congenital anomaly or birth defect.

   

• Source data verification

  Source data verification (SDV) is a check that the data collected on a research study (e.g. on a case report form or in a database) can be verified by looking at a primary source (e.g. medical record). In essence, checking for consistency and accuracy in transcribing data from one place to another. Auditors will often wish to see SDV documented when the risks involved indicate it should be used.

  Sometimes the research record will be the source data, e.g. for electronic questionnaire-based studies. In these situations mechanisms should be built in to ensure that checks are in place to minimise the chances of error when completing the questionnaire.

   

• Sponsor

  The sponsor is the individual, or organisation (or group of individuals or organisations) that takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trial Regulations.

   

• Tissue bank

  See 'Research tissue bank'.

• Tissue sample

  See 'Human tissue sample'.

• UKCRC

  The UK Clinical Research Collaboration (UKCRC) is a partnership of organisations working to establish the UK as a world leader in clinical research. The UKCRC brings together key organisations in the UK clinical research environment. This includes the main funding bodies, academia, the NHS regulatory bodies, industry and patients.

   

• UKCRN (see NIHR CRN CC)

  The UK Clinical Research Network was established to support clinical research and to facilitate the conduct of trials and other well-designed studies across the UK. As part of the UK Clinical Research Collaboration, it works towards the development of a world class infrastructure to support clinical research in the UK.  This has been renamed as NIHR CRN CC.

   

• Version control

  Version control is the management of multiple revisions to the same document. Version control enables users to tell one version of a document from another. Usually the latest approved version of a document is the one that should be used.