Search results

Relevant and appropriate research always aims to answer a new question and contribute to the current body of medical and scientific knowledge. For this reason, there is a certain amount of risk for research participants. Independent ethical review is vital to ensure that participant safety is at the centre of the research.

All investigational medicinal products (IMPs) go through a series of trials before they can be licensed for use.

For this purpose, a prisoner or young offender is defined as any inmate of the prison systems of England and Wales, Scotland or Northern Ireland. It does not include patients detained under the Mental Health Act at special hospitals or other psychiatric secure units, or juvenile offenders detained in local authority secure accommodation or secure training centres.

Depending on what approval you have received you will be asked to complete a progress report to keep us up to date with how your research is progressing.

Amendments are changes made to a research project after approval from a review body has been given. Find out whether you need to notify the review bodies from whom you have received approvals.

This section covers what you will need to consider whilst you are conducting your research including progress reports, as well what to do at the end of your research.

Information Governance, to the HRA, is a framework for handling not only personal and sensitive information but all information in a robust and transparent manner, applying confidentiality and security where appropriate and operating to high ethical and quality standards.

If your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).

The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on the use of confidential patient information – including providing advice to us, the HRA. It also provides advice to the Secretary of State for Health for non-research uses.

The Pharmacy Assurance process coordinates a single technical pharmacy review for eligible studies, which can be used by all participating study sites, rather than all sites conducting their own technical pharmacy review.

The Research Ethics Service (RES) is one of our core functions and is committed to enabling and supporting ethical research in the NHS. It protects the rights, safety, dignity and wellbeing of research participants.

The HRA Board meets on a regular basis, at a range of venues across England, however the majority of meetings do take place in our London office. Members of the public are welcome to attend and observe the meetings. The relevant agenda and papers are published on the website a week before the meeting.

Our business plan set out our business strategy and proposal for the year ahead.

There are a number of key performance indicators and operational indicators that we closely monitor to determine and demonstrate progress across the HRA.

We are one of a number of organisations that work together in the UK to regulate and approve different aspects of health and social care research.