Research definitions

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.

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’.

A sponsor is the person, individual or group that takes responsibility for the initiation, management and financing (or arranging the financing) of the research. All research undertaken in the NHS must have a sponsor.

You should refer to the Medicines for Human Use (Clinical Trials) Regulations 2004 for a full definition of a sponsor and its responsibilities in clinical trials of investigational medicinal products.

A legal representative under the Medicines and Human Use (Clinical Trials) Regulations 2004 means a person who is suitable to act as a legal representative for a minor (under 16) or an adult who lacks capacity for the purpose of the trial and is available and willing to do so.

They must not be involved in the conduct of the trial. For trials involving adults who lack capacity in Scotland, a legal representative means any guardian or welfare attorney who has power to consent, or the adult’s nearest relative. In all cases, if there is no such person, a doctor not connected with the conduct of the trial but who is responsible for the medical treatment of the minor or adult, or a person nominated by the relevant healthcare provider can be approached. You should refer to the regulations for a full description.

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

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.