Annex A: Legal and governance framework
This annex is a brief guide to the legal and governance framework relevant to research in the UK. It is not intended to be a comprehensive statement of the law or a list of all relevant legislation, nor is it a substitute for independent, up-to-date legal advice.
The laws and governance arrangements that apply to research vary depending on the type of research, the participants involved, how it is funded, and where in the UK it is undertaken. If you are unsure about how the law applies in a particular situation, you should consult your defence body or professional association, or seek independent legal advice.
The UK health departments publish good practice frameworks for the governance of research in health and social care.1 You must follow the relevant framework if it applies to the research you are undertaking.
The International Conference on Harmonisation Guideline for Good Clinical Practice2 sets out the international standards for conducting clinical trials of investigational medicinal products.
Certain types of research must be approved or licensed by a relevant authority in the UK. These authorities include, for example, the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority, the Human Fertilisation and Embryology Authority, and the Gene Therapy Advisory Committee.
Clinical trials of investigational medicinal products
Clinical trials of investigational medicinal products3 are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, which apply in all four UK countries.4 The regulations implement the provisions of the European Clinical Trials Directive (EC2001/20) into UK law. The regulations set out good clinical practice in the conduct of clinical trials of investigational medicinal products, including trials involving children or young people, and adults who lack capacity.
Other types of research involving people
The common law principles in relation to confidentiality and consent apply to research in which an adult has the capacity to consent to take part, and the research is not a clinical trial of investigational medicinal products.
Adults without capacity
Other than clinical trials of investigational medicinal products, research involving people over 16 who lack capacity is governed in England and Wales by the Mental Capacity Act 2005 and in Scotland by the Adults with Incapacity (Scotland) Act 2000.5 In Northern Ireland, there is currently no relevant primary legislation setting out the circumstances in which research (except for clinical trials of investigational medicinal products) involving adults who lack capacity to consent may be undertaken. At the time of publication, a legislative framework for new mental capacity legislation and revised mental health legislation is being developed. See Consent to research for further guidance on seeking consent to involve people who lack capacity in research.
Regulation of human tissue research
The Human Tissue Act 20046 provides the framework for the regulation of human tissue research in England, Wales and Northern Ireland. Scotland has its own Human Tissue (Scotland) Act 2006.7 The Medicines for Human Use (Clinical Trials) Regulations 2004 apply to the use of human tissue in clinical trials of investigational medicinal products.
The Human Fertilisation and Embryology Act 1990 (as amended)8 regulates research in the UK that involves the creation, use and storage of human embryos and human admixed embryos (embryos combining both human and animal material). It also defines access by researchers to data collected by the Human Fertilisation and Embryology Authority.
Confidentiality9 provides guidance to doctors undertaking records-based research that does not involve participants directly. It gives guidance on disclosing identifiable information for research or other secondary uses if the disclosure is required by law.
2 International Conference on Harmonisation Topic E 6 Note for Guidance on Good Clinical Practice (2002)
3 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’.
4 Medicines for Human Use (Clinical Trials) Regulations 2004
Amendments to the Medicines for Human Use (Clinical Trials) Regulations 2004:
7 Human Tissue (Scotland) Act 2006
The Human Tissue Authority was set up under the Human Tissue Act 2004 but performs certain tasks on behalf of the Scottish Executive (approval of living donation and licensing of establishments storing tissue for human application).
8 Human Fertilisation and Embryology Act 1990 (as amended) and the Human Fertilisation and Embryology Act 2008