National Research Ethics Service

Glossary

A | B | C | D | E | G | H | I | L | M | N | O | P | R | S | T | U | V

A

AAPEC: Appointing Authority of Phase 1 Ethics Committees
ABHI: Association of British Healthcare Industries
ABPI: Association of the British Pharmaceutical Industry
Adverse reaction: In a CTIMP, any untoward and unintended response in a subject to an IMP which is related to any dose administered to that subject. See also SSAR and SUSAR.
ALC: Adults lacking capacity (see the Mental Capacity Act 2005).
Amendment: A change made to the terms of the REC application, the protocol or any other supporting documentation after the study has started. A study is normally considered to start with the commencement of any protocol procedures.
Appeal: Following the issue of an unfavourable opinion, the submission of the application without revision to another REC for a second ethical opinion.
Appointing authority: The body responsible for the establishment and support of RECs.

Approval conditions: Conditions to be met by the applicant prior to the start of the research. Approval conditions are issued by the REC with the final letter confirming a favourable ethical opinion. (Note: Approval conditions are distinct from the further information or clarification requested from the applicant when issuing a provisional opinion.)
ARSAC: Administration of Radioactive Substances Advisory Committee
Authorised REC: A REC established under GAfREC but not recognised by UKECA. An authorised REC may review all applications except those relating to CTIMPs.

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B

Booking: The booking of a new application or an appeal for review by a REC, and reservation of an agenda slot. Bookings may be made through CAS or direct to the office of a local REC, depending on the type of application.; [top]

C

Care organisation: The organisation(s) responsible for providing care to patients and/or users and carers participating in the study. Care organisations remain liable for the quality of care, and for their duty towards anyone who might be harmed by a study.
CAS: Central Allocation System, the booking system administered by NRES Head Office for certain types of application.
Chair: The member of a REC appointed to be chair by the appointing authority. Where the chair is unavailable for any reason, his/her duties may be performed by the vice-chair or alternate vice-chair.
Chief investigator (CI): The investigator with overall responsibility for the research. In a multi-site study, the CI has co-ordinating responsibility for research at all sites. All applications for ethical review should be submitted by the CI.
CHM: Commission on Human Medicines (based in MHRA)
CHMP: Committee for Medicinal Products for Human Use (based in European Medicines Agency)
CIOMS: Council for International Organisations of Medical Sciences
Clinical Trials Regulations: The Medicines for Human Use (Clinical Trials) Regulations 2004
Clock: The period allowed for the ethical review of a new application or substantial amendment. The clock starts on receipt of a valid application. See 60 day clock and 35 day clock.
COREC: Central Office for Research Ethics Committees; the predecessor of NRES.
CSP: National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission
CTA: Clinical Trial Authorisation, the authorisation from the MHRA to conduct a CTIMP. No CTIMP can commence in the UK without both a CTA and a favourable ethical opinion. Applications to the MHRA and the REC may be made in parallel.
CTIMP: Clinical trial of an investigational medicinal product. (Any other type of research is known as a non-CTIMP).; [top]

D

DH: Department of Health
DMC: Data Monitoring Committee
Domain: The area covered by a Strategic Health Authority (SHA) (in England), a Health Board (in Scotland), a regional office of the NHS Wales Department or the whole of Northern Ireland.; [top]

E

EAG: Expert Advisory Group (based in MHRA)
ECC: Ethics and Confidentiality Committee (previously known as the Patient Information Advisory Group)
EFGCP: European Forum for Good Clinical Practice
Electronic signature: A digitally encrypted signature capable of verification by an independent service provider, in accordance with the Electronic Signatures Regulations 2002.
Employing organisation: An organisation employing the chief investigator, other investigators or research collaborators. Employers remain liable for the work of their employees.
EU Directive: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

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G

GAfREC: Governance Arrangements for NHS Research Ethics Committees
GCP: Good Clinical Practice
GTAC: Gene Therapy Advisory Committee; [top]

H

HFEA: Human Fertilisation and Embryology Authority
HTA: Human Tissue Authority; [top]

I

IMP: Investigational medicinal product
Investigator’s brochure: A document containing a summary of the clinical and non-clinical data relating to an IMP which are relevant to the study of the product in human subjects.
IPEM: Institute of Physics and Engineering in Medicine (previously known as the Institute of Physics and Dental Medicine)
IRAS: Integrated Research Application System, the online application system used to apply for most permissions and approvals for research in health and social care in the UK.; [top]

L

Lead site: In the case of a multi-site study, the site for which the chief investigator is also the principal investigator.
Local collaborator: A person undertaking certain types of straightforward research procedure, not requiring the appointment of a principal investigator. Local collaborators at NHS sites must seek a Site Specific Assessment (SSA) from the R&D office.; [top]

M

Main REC: In the case of multi-site studies, the REC undertaking the ethical review of the application.
Medical devices: See Annex G of the SOPs.
MHRA: Medicines and Healthcare products Regulatory Agency. MHRA (Medicines) is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations 2002.
Minor amendment: An amendment which is not a substantial amendment, not requiring review by a REC. For examples, see the Amendments page.
Modified amendment: Following the issue of an unfavourable opinion on a substantial amendment, the re-submission of the amendment in modified form.
MODREC: Ministry of Defence Research Ethics Committee: the two RECs established by the Ministry of Defence to review research involving the British Armed Forces. MODREC has recognition from UKECA to review Phase 1 clinical trials in healthy volunteers.
MoU: Memorandum of Understanding; [top]

N

NIGB: National Information Governance Board for Health and Social Care; incorporates the functions of the former Patient Information Advisory Group.
NOMS: National Offender Management Service; the Ministry of Justice high-level policy arm for prison and probation services in England and Wales.
Non-CTIMP: Any research study that is not a clinical trial of an investigational medicinal product.
NPSA: National Patient Safety Agency
NRES: National Research Ethics Service
NRES Head Office: The part of NRES employed by NPSA, responsible for the operational management of NRES.
NRES Director: The senior manager with overall responsibility for management of NRES.; [top]

O

OHRN: Offender Health Research Network (formerly known as Prison Health Research); [top]

P

Participant: Patient, service user, carer, relative of the deceased, professional carer, other employee, or member of the public, who consents to take part in a study. (Under the Clinical Trials Regulations, participants in CTIMPs are referred to as “subjects”.)
Phase 1 trial: A clinical trial to study the pharmacology of an IMP when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial.
PIAG: Patient Information Advisory Group (now the ECC)
Principal investigator (PI): The investigator responsible for the research site where the study involves specified procedures requiring SSA. There should be one PI for each research site. In the case of a single-site study, the chief investigator and the PI will normally be the same person.
Protocol: A document that describes the objectives, design, methodology, statistical considerations (or other methods of data analysis) and organisation of a research study.
Provisional opinion: A decision reached by a REC on an application, subject to the receipt of further information or clarification from the applicant. The 60 day clock is suspended until the information is received.; [top]

R

REC: A Research Ethics Committee established in any part of the UK in accordance with GAfREC and/or recognised by the UKECA under the Clinical Trials Regulations.
REC reference number: Reference number assigned by the REC accepting the application for review. This includes a REC local identifier, specific project number and year.
REC operational manager: A generic term for the manager with first line responsibility for professional oversight and support of the REC concerned. The title of the postholder will vary, according to the type of REC and area of the UK. For NHS RECs in England this will be the NRES Senior Research Ethics Service (SRES) Manager for the relevant area except where a more senior manager is indicated in the text. For NHS RECs in Northern Ireland, Scotland or Wales this will be the Office for Research Ethics Committee Manager for the country concerned. For Phase 1 ethics committees outside the NHS, this will be the Business and Operations Manager for AAPEC.
Receiving REC: The REC that first receives an application, whether or not it is then transferred to another REC for review.
Recognised REC: A REC legally recognised by UKECA to give an ethical opinion on a CTIMP to be undertaken anywhere in the UK.
RED: The Research Ethics Database used by the REC system.
Referee: A person or body who gives expert advice to a REC on an application or any related matter.
Research site: The organisation or unit responsible for conducting any of the research procedures in a study at a particular locality.
Revision of application: Any changes made to the terms of an application at the request of the REC following the meeting or, following issue of an opinion, before the research has started. Revision is not permitted prior to the REC meeting once the application has been validated.; [top]

S

SAE: Serious Adverse Event. An untoward occurrence that: (a) results in death; (b) is life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation; (d) results in persistent or significant disability or incapacity; (e) consists of a congenital anomaly or birth defect.
SCREC: Social Care REC, the national REC for research in social care to be established during 2009 under GAfREC. The appointing authority for SCREC is the Social Care Institute for Excellence (SCIE).
SDBD: Scientific Development Bioethics Division (of DH)
Second REC: The REC that reviews an application on appeal following the issue of an unfavourable opinion by the “first REC”.
Single ethical opinion: The ethical opinion given by a REC on a research study, with application to the whole of the UK. An ethical opinion may be either favourable or unfavourable.
Site-specific assessor: The body responsible for undertaking a site-specific assessment, either the R&D office for a NHS site or an appropriate local REC for a non-NHS site.
60 day clock: The period of 60 calendar days allowed for the issue of an ethical opinion on a new application. The clock may stop once while awaiting a complete response from the applicant to one written request from the REC for further information or clarification.
SOPs: The Standard Operating Procedures issued by the NRES Head Office.
Sponsor: The person who takes on ultimate responsibility for the initiation, management and financing (or arranging the financing) of a clinical trial. Note: The Clinical Trials Regulations allow for two or more persons to take responsibility for the functions of the sponsor. Where this applies, they require that one of the sponsors should take responsibility for each of the following group of functions: (a) communications relating to substantial amendments, modified amendments and the conclusion of the trial; (b) communications relating to urgent safety measures; (c) pharmacovigilance reporting.
SSA: Site-specific assessment, an assessment of the suitability of the investigator, site and facilities for each research site. SSA is undertaken for certain types of study only. More information is available in section 4 of the SOPs.
SSAR: Suspected Serious Adverse Reaction. An 'adverse reaction' is any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that subject. An adverse reaction is “serious” if it: (a) results in death
(b) is life-threatening; (c) requires hospitalisation or prolongation of existing hospitalisation; (d) results in persistent or significant disability or incapacity; (e) consists of a congenital anomaly or birth defect. A 'suspected serious adverse reaction', therefore, is any event which is suspected of meeting the above criteria.
SSI Form: Site-Specific Information Form
Substantial amendment: Under the Directive and the Clinical Trials Regulations, an amendment to a CTIMP that must be notified to both the ethics committee and the competent authority; it requires a favourable opinion from the main REC and/or a notice of no objection from the MHRA before it can be implemented. In the case of non-CTIMPs, a substantial amendment requires the issue of a favourable opinion from the main REC except where it only involves adding a new site or principal investigator at a NHS site.; For examples, see the Amendments page.
SUSAR: Suspected Unexpected Serious Adverse Reaction. This is a SSAR which is also “unexpected”, meaning that its nature and severity are not consistent with the information about the medicinal product in question set out: (a) in the case of a product with a marketing authorisation, in the summary of product characteristics for that product; (b) in the case of any other investigational medicinal product, in the investigator’s brochure relating to the trial in question.; [top]

T

35 day clock: The period of 35 days allowed for the issue of an ethical opinion on a substantial amendment. The clock does not stop while awaiting any further information.
Transfer: The transfer of an application by the receiving REC to another REC for review.; [top]

U

UKCRC: UK Clinical Research Collaboration
UKCRN: UK Clinical Research Network
UKECA: United Kingdom Ethics Committee Authority; [top]

V

Validation: An administrative check carried out by a REC co-ordinator to verify that an application is complete and may be accepted for review. Decisions on validation should be made within five working days of receipt.
Validation date: The date on which a valid application is received by a REC. It is the working day on which the complete application, including all relevant signatures and all supporting documents, is delivered to the address of the REC, either in electronic or paper format. This applies whether or not the co-ordinator or another member of the REC office staff is present to receive the application. Where packages are not date stamped on receipt, the date of receipt should be presumed to be the working day after the day of posting (1st class post) or the third working day after posting (2nd class post).; [top]