Facilitating world-class research
The UK policy framework for health and social care research replaces the Research Governance Frameworks (RGF) previously issued in each of the four UK countries. The policy framework sets out principles of good practice in the management and conduct of health and social care research that take account of legal requirements and other standards.
GCP is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting research that involves human participation. Compliance provides public assurance that the rights, safety and wellbeing of participants are respected and protected, and that the data generated are credible and accurate.
Compliance with GCP is a legal obligation in Europe for all trials of investigational medicinal products.
Comprised of 13 core principles, GCP applies to all clinical investigations that can affect the safety and well-being of human participants, particularly clinical trials of investigational medicinal products.
Please refer to ICH Good Clinical Practice Guidelines.
The EU Clinical Trials Directive (EUCTD – 2001/20/EC) sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies.
The Good Clinical Practice (GCP) Directive (2005/28/EC) supplements the EUCTD, strengthening the legal basis for requiring member states to comply with the principles and guidelines of good clinical practice, as set out in the ICH GCP guidelines.
The EUCTD was implemented into UK law in May 2004, as the Medicines for Human Use (Clinical Trials) Regulations 2004, and has since been amended (2006a, 2006b, 2008). For details see the full document.
The regulations provide additional protection for a minor who is being considered for a clinical trial, ie a person under the age of 16. They require, among other provisions, that:
In relation to the minor himself:
The Human Tissue Act 2004 repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they related to England and Wales, and the corresponding orders in Northern Ireland. The Human Tissue Authority regulates the removal, storage, use and disposal of human bodies, organs and tissue.
The Declaration of Helsinki was developed by the World Medical Association as 'a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data' (Para 1, Declaration of Helsinki).
Most clinical research requires the processing and/or storage of personal and sensitive information. The General Data Protection Regulation (GDPR) legislates for the control and protection of personal information relating to living individuals including both facts and opinions about the individual. It is vital that all University research and researchers comply with the act and process/store all personal information in accordance with it.
Please refer to the University's guidance on data protection and research and policy on data protection.
Research studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005. This includes persons with dementia, learning disabilities, mental health problems, stroke or head injuries who may lack capacity to make certain decisions, including consenting to participate in a research study. The act does not apply to studies falling under the Clinical Trials Regulations (CTIMPs).
Any research involving a person lacking capacity that would otherwise have required consent from participants may only be lawfully carried out if an NHS REC in England or Wales has given a favourable opinion. This includes research that would otherwise fall outside the remit of an NHS REC. The REC can only approve the research if it meets the following criteria:
The MCA also includes provisions for the REC to issue an emergency waiver of consent to allow the recruitment of adults lacking capacity into emergency studies where the patient is incapacitated and it would not be feasible or safe to attempt to consult them on their inclusion in the study. In such cases, the adult patient could be incapacitated because they are unconscious, acutely confused or intoxicated or because they are experiencing shock, severe anxiety, terror or severe pain etc. In such cases, consultee advice must be sought or the patient consented to continued study participation as soon as is reasonable practicable after the emergency has passed.
The current regulatory framework in the UK/EU allows for a range of risk-adapted approaches that may simplify the processes for initiating and conducting some clinical trials. These adaptations are largely related to how much is known about the investigational medicinal product (IMP), and are based on the marketing status of the IMP and standard medical care. Using a simple categorisation of three risk types (safety risks, risk related to participant rights and risk to reliability of results), it is possible to highlight, particularly for lower risk trials, where simplification is possible.
The use of genetically modified organisms (GMOs) in clinical research, usually in the form of vaccines or gene therapy agents (and otherwise known as Advanced Therapy Medicinal Products (ATMPs)), requires:
The assessment or licence will address the safety issues for those researchers and clinical staff handling the agent and also the risk posed to the environment.