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The Department of Health (DH) and the Health Research Authority (HRA) have been working together to review the standard DH contract for NIHR funded research. From today research funded by an NIHR research programme will be able to receive payments for start-up in advance of ethical approval. This enables more rapid, efficient and streamlined set-up of research and quicker translation of research into patient benefit.

The Medical Research Council (MRC) working with the Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Research Authority (HRA) has submitted a joint response to the Innovative Medicines Initiative (IMI) consultation on Advanced Therapies Concept Paper.

The EU Commission’s Directorate General for Health and Food Safety (DG SANTE) Clinical Trials Regulation has recently consulted on four documents developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.

This consultation follows the independent review of data security, consent and opt-outs by National Data Guardian Dame Fiona Caldicott.

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), has recently consulted on a concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products’.

In response to requests, the Health Research Authority (HRA) has published a new brief leaflet setting out high level information about the HRA Approval process. It provides an overview, highlighting our aim to simplify and streamline the approval process.

Three research ethicists with close links to the Health Research Authority have been recognised in the Queen’s New Year’s Honours for a combined total of nearly 45 years’ service to Research Ethics Committees.

We’re about to begin work to improve the HRA website – we want to make it easier to access the information you need. We’d love to hear your thoughts on what you like and don’t like about our current site, and what new features would make your life easier.

The HRA is encouraging researchers to take a more proportionate approach to the process of seeking consent for participation in research.

Registration for this event has now closed due to a large number of expressions of interest. Those who obtained a place will be contacted on Monday 13th February 2017.

It is with great sadness that we hear of the news of the death of a close friend of the Health Research Authority, Dr Richard Tiner. A former general practitioner in the South West of England for many years, Richard was medical director of the Association of British Pharmaceutical Industry from 1996 – 2009.

What are the circumstances under which it is acceptable to use confidential patient and service user information without consent for purposes beyond direct patient care?

The range of independent advice and expertise available to the Health Research Authority has been broadened with the expansion in March of the HRA’s national panel of experts.

If you are a researcher who needs to explain the risks of ionising radiation to your study participants, then we have produced some generic statements to help you.

The Annual NHS R&D Forum is taking place in Manchester on 15 - 16 May 2017 – the must-attend meeting of the year for those working in health and care research management, support and leadership.

Biotechnology company Amgen was keen to get HRA Approval for an international research study into the effectiveness of a new treatment for patients with aggressive B-cell Non-Hodgkin’s lymphoma.

The first study to ever go through HRA Approval has now been completed. The study, led by NHS South Norfolk Clinical Commissioning Group (CCG), looked into interagency working across local health agencies, local authorities and the police in safeguarding adults, and involved interviews with members of the local safeguarding adults board. The application was made in May 2015, during HRA Approval’s phased roll-out.

Health and social care researchers used to be faced with a very complex regulatory system – everyone agreed we needed a new approach. So we consulted with a wide range of stakeholders to develop HRA Approval, which brings together the assessment of legal compliance and the ethics review into one streamlined system.

Researchers working across the four United Kingdom countries should find it easier to set up and carry out health research across the NHS and Health and Social Care in Northern Ireland (HSC). This is thanks to the UK research approval bodies carrying out a new programme of work to implement.

We’ve worked with the NHS R&D Forum to create a short animation to explain HRA Approval and to illustrate the experience of researchers applying for approvals before and after its development.