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See more of the latest news and updates from across the HRA

Implementation of HRA Approval continues, with the third cohort of studies incorporating all study types which exclude the first four categories of IRAS from 30 November 2015. This extends HRA Approval to a broad range of studies other than clinical trials or clinical investigations taking place in secondary care in the NHS. Early studies for this cohort have included cross-border studies with the devolved administrations, managed through compatible arrangements between the nations.

The European Medicines Agency’s (EMA) recently consulted on the addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP).

The Confidentiality Advisory Group (CAG) is looking to appoint new members to help it deliver its existing and future functions. The CAG provides the Health Research Authority (HRA) and the Secretary of State for Health (SofS) with independent expert advice about applications for access to confidential patient information. The work of the Group is challenging, but it is also immensely rewarding. Interviews will take place on Tuesday 15, Friday 18 and Monday 21 March 2016.

A discussion paper entitled ‘When should placebo surgery as a control in clinical trials be carried out?’ has been published by contributors to a workshop held jointly by the Health Research Authority and the Nuffield Council on Bioethics in May 2015. The workshop brought together surgeons, patient representatives, regulators and research ethics committees to discuss issues surrounding the use of placebo surgery.

The Health Research Authority (HRA) is working with the NHS R&D Forum to develop an integrated programme of HRA updates, presentations and interactive sessions as part of this year’s annual conference.

HRA responds to the CIOMS Working Group Revision of the CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects.

From 31 March 2016 HRA Approval will be the process for applying for approvals for all project-based research in the NHS led from England. For any new studies that are led from outside England but have English sites, the NHS permissions coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.

Individuals and organisations have one week left to respond to the public consultation on the new UK Policy Framework for Health and Social Care research. The policy framework sets out principles of good practice in the management and conduct of health and social care research. When finalised, it will replace the Research Governance Frameworks currently issued by the four UK health departments. The deadline for responses is Thursday 24 March 2016.

The HRA and INVOLVE today issued an evidence briefing and guidance on involving the public in health and social care research and the relevance of public involvement to the role of Research Ethics Committees.