National Information Governance Board for Health and Social Care (NIGB)
An independent statutory body that was responsible for Section 251 of the NHS Act 2006 in England and Wales; and reviewed applications for use of identifiable data where consent was not practicable. From April 2013 this function will transfer to the Health Research Authority (HRA) who will convene a Confidentiality Advisory Group (CAG) to perform this function.
National Research Ethics Service (NRES)
The National Research Ethics Service (NRES) is the core function of the Health Research Authority (HRA) and provides help and leadership for NHS Research Ethics Committees (RECs) by co-ordinating the development of operational and infrastructure arrangements in support of their work.
NHS Permission for research (formerly known as R&D Approval) confirms that appropriate checks have been made and that clinical negligence will be covered by NHS indemnity schemes or by independent contractors' professional indemnity insurance during the course of the research. In addition, where the staff of an NHS organisation were responsible for designing the study, NHS permission confirms that indemnity is provided for harm arising from the design of the study.
NHS permission for research ensures that:
- The organisation is aware of the potential impact of the research in terms of risks and resources.
- The organisation has made the necessary arrangements to support the activity.
- All the activities for which the organisation is responsible are compliant with the law.
- The organisation accepts vicarious liability for the activities of staff for which it is responsible.
NHS Permission Letter
Letter confirming that NHS Permission has been given and the study can commence. Similar terms are used for the permission letter issued in other UK countries.
NHS R&D Office
The responsible person / team acting on behalf of the organisation in matters relating to R&D management. The NHS R&D Office may delegate some of its functions to other parties.
NB. Where a trial is run without NHS involvement, the term NHS R&D office may often be replaced with the term ‘sponsor’s office’.
Non Interventional Trial
A study of one or more medicinal products which have a marketing authorisation, where the following conditions are met:
- The products are prescribed in the usual manner in accordance with the terms of that authorisation
- The assignment of any patient involved in the study to a particular therapeutic strategy is not decided in advance by a protocol but falls within current practice
- The decision to prescribe a particular medicinal product is clearly separated from the decision to include the patient in the study
- No diagnostic or monitoring procedures are applied to the patients included in the study, other than those which are ordinarily applied in the course of the particular therapeutic strategy in question, and
- Epidemiological methods are to be used for the analysis of the data arising from the study.
Non Investigational Medicinal Product (NIMP)
A Non Investigational Medicinal Product (NIMP) is a medicinal product which is not classed as an IMP in a trial, but may be taken by subjects during the trial. Examples include concomitant or rescue/escape medication used for preventive, diagnostic or therapeutic reasons and/or medication given to ensure that adequate medical care is provided for the subject during a trial. See EU Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Products (NIMPs).
Trials that do not involve an Investigational Medicinal Product (IMP) as defined by the MHRA, and therefore do not fall within the scope of the Medicines for Human Use (Clinical Trials) Regulations 2004.