Consent to research (summary)

Research definitions

This page lists the following research definitions:

  • Parent
  • Clinical trials of investigational medicinal products
  • Sponsor
  • Legal representative
  • Research protocol
  • Research Ethics Committees

Parent (definition)

References to parent or parents in this guidance mean those with parental responsibility for the child. See Appendix 2 of 0-18 years: guidance for all doctors for an explanation of this term.

Clinical trials of investigational medicinal products (definition)

Under the Medicines for Human Use (Clinical Trials) Regulations 2004 a clinical trial means ‘any investigation in human subjects, other than a non-interventional trial, intended –

a. to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,

b. to identify any adverse reactions to one or more such products, or

c. to study absorption, distribution, metabolism and excretion of one or more such products,

with the object of ascertaining the safety or efficacy of those products’.

An investigational medicinal product ‘means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial –

a. used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,

b. used for an indication not included in the summary of product characteristics under the authorization for that product, or

c. used to gain further information about the form of that product as authorised under the authorization’.

Research protocol (definition)

A research protocol is a detailed plan for the research project.

Research Ethics Committees (definition)

Research Ethics Committees (RECs) have a responsibility to safeguard the rights, safety, dignity and wellbeing of people participating in research.

They review applications for research and give opinions about the proposed participant involvement and whether the research is ethical. Guidance on whether research requires ethical review under either the law or the policy of the UK health departments can be found on the National Research Ethics Service website.