Approvals and Legislation for Research

New  UK Policy Framework for Health and Social Care Research  replaces former Research Governance Framework  and sets out principles of good practice in the management and conduct of health and social care research in UK. These principles protect and promote the interest of patients, service users and the public in health social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public. It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers.

We have produced short Summary Information Sheets for GPs and Healthcare Organisations, which can be downloaded at the bottom of this page.

Depending on the type of research, and the activities within a study, various laws may apply and approvals may need to be sought from different bodies.

HRA Approval                                                                                                                                                                                                              From 31st March 2016, the Health Research Authority (HRA) Approval is required for all research conducted in the NHS in England. HRA Approval combines NHS Research Ethics Committee review with the legal and governance checks that individual NHS R&D offices previously carried out. For studies led from Scotland, Wales and Northern Ireland with English sites, the lead nation coordinating functions will share the study with the HRA. Further information is available on HRA Approval web page.

Research Ethics Committee (REC) Favourable Opinion                                                                                                                                      Most types of studies which involve patients and/or their data will require a favourable opinion from an NHS REC. The HRA have an algorithm to determine if REC review is needed, as well as information on how to apply for REC review. Please note for studies submitted for HRA approval, REC approval will form part of the HRA Approvals Process.                                                                                                                                                                         

Clinical trials of investigational medicinal products (CTIMPs)
These studies also require Clinical Trial Authorisation (CTA) from the Medicines & Healthcare Products Regulatory Agency (MHRA) as well as HRA Approval and REC favourable opinion. More details on how to apply for a CTA can be found on both the MHRA and HRA websites.

Medical Device Studies                                                                                                                                                                                        Studies which use a medical device will require REC favourable opinion and HRA Approval and no objection from the MHRA. More details on how to apply for no objection from the MHRA can be found on the MHRA and HRA websites.

Section 251 Approval                                                                                                                                                                                           Studies that require the use of identifiable participant information but where it is not possible/practical to obtain consent will need to apply for Section 251, which is managed by the HRA. More information can be found on the HRA website. Prior to applying, researchers are strongly advised to review the precedent set criteria and discuss their application with the Confidentiality Advice Team

Human Tissue Act 2004
The HRA website gives more details about this Act. Individual projects involving the use of human tissue that are ethically approved do not require a licence from the Human Tissue Authority, but an HTA licence may be required if you are planning to set up a tissue bank.
Mental Capacity Act 2005                                                                                                             This act details the procedures required to include participants who lack the capacity to consent. It requires the research team to identify a personal consultee to advise the researcher if the patient should be included in the study. If a personal consultee cannot be found then processes should be in place for identifying a nominated consultee. The Mental Capacity Act only applies to England and Wales and different laws apply for Northern Ireland and Scotland.The HRA website has a Q&A section about this Act

Data Protection Act 1998

All studies should ensure that they comply with the principles of the Data Protection Act.

Understanding Patient Data website will provide you with useful information on how patients data is used and why, how it is safeguarded and how the decisions are made.

There are other legislations/approvals which may be needed for research, but are not frequently encountered by the research office for primary and community care. These include:

Gosia Majsak-Newman,
4 Jan 2018, 02:35
Gosia Majsak-Newman,
4 Jan 2018, 02:35