• 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 will usually have an Inspection role.


  • 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.

    See the HTA's Definition of relevant material for a more detailed explanation.

    Relevant material is different to Bodily material.


  • Research Database

    The NRES definition of a Research Database is "a collection of data, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending".


  • Research ethics committee (REC)

    Research Ethics Committees (RECs) are independent committees that review the ethical issues within research projects involving people as participants or their data or tissues. See the Ethical approval station for more information on the remit of RECs.


  • Research Governance

    Research governance is a term that was first used in the UK Health Departments' Research Governance Frameworks (see below).

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


  • Research Governance Frameworks

    The UK Health Departments' Research Governance Frameworks (RGFs) set 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 / HSC and using NHS / HSC 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

    There are currently 4 separate documents for England, Scotland Wales and Northern Ireland.  However the Health Research Authority has been tasked with developing a replacement.  For further details please see the HRA website.


  • 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.