Regulating doctors, ensuring good medical practice

Good practice in research: Scope of the guidance

  1. 1.  Research in this guidance refers to an attempt to derive generalisable new knowledge. Research aims to find out what is best practice by addressing clearly defined questions with systematic and rigorous methods. It includes studies that aim to generate hypotheses as well as those that aim to test them.
  2. 2.  This guidance covers research with people, as well as research involving human tissue and records-based research that does not involve people directly.
  3. 3.  It also applies to clinical trials, which cover a broad range of different types of research involving people.4 For example, they can test medicines or vaccines, treatments, surgical procedures, devices, or health prevention or care. A clinical trial of investigational medicinal products is a particular type of trial that is governed by legislation.5 The key elements of the law for conducting a clinical trial of investigational medicinal products in the UK are set out in annex B.
  4. 4.  This guidance does not apply to clinical audit or service evaluation projects, which aim to measure standards of care.6 Nor does it cover innovative treatments designed to benefit individual patients. These activities are covered by the standards and principles set out in Consent: patients and doctors making decisions together and Confidentiality. 

Footnotes:

4The World Health Organization defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes phase I to phase IV trials.

5Under 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 -

  1. (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products,
  2. (b) to identify any adverse reactions to one or more such products, or
  3. (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 -

  1. (a) used or assembled (formulated or packaged) in a way different from the form of the product authorised under the authorization,
  2. (b) used for an indication not included in the summary of product characteristics under the authorization for that product, or
  3. (c) used to gain further information about the form of that product as authorised under the authorization’.

The Medicines and Healthcare products Regulatory Agency (MHRA) (pdf) provide guidance to help work out whether a study is a trial of investigational medicinal products.

6The National Research Ethics Service provides definitions of research, clinical audit, service evaluation and surveillance.

 

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Research definitions

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Click here to read our definitions of 'Clinical Trials' and 'Clinical trials of investigational medicinal products (CTIMP)'

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