R

• 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.