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- HRA project hopes to help student researchers get it right first time
- Blog: GDPR guidance updated as new law approaches
- GDPR technical guidance: transparency
- Template email for sponsors sharing a GDPR amendment
- The NHS R&D Forum 2018The Annual NHS R&D Forum is taking place on 13, 14 and 15 May at Celtic Manor, Newport, Wales.
- New framework for UK health and social care research launchedTransparency, public involvement, safety and proportionality must be at the centre of UK health research, a new position statement published today has demanded.
- Examples of substantial and non-substantial amendmentsFind examples of substantial and non-substantial amendments.
- Publication and dissemination of research findingsWe publish details of all research reviewed by the Research Ethics Committees (RECs) in the UK as a research summary record. This record consists of some basic information about the research (e.g. title, available registry reference numbers), summary of the research as submitted to the REC and the REC’s opinion.
- HRA Approval in action: First patient and first site recruited in a global studyBiotechnology 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.
- New National Research and Ethics Advisors’ Panel starts workThe 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.
- Research in emergency settingsEmergency research poses its own set of challenges in terms of providing information about the research and obtaining consent.
- Regenerative medicineFor the purposes of the content provided within this area we have adopted the definition of the term “regenerative medicine” that was used in the House of Lords Regenerative Medicine Report. "Regenerative medicine is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices."
- Gene therapyIf your application is for ethical approval of a gene therapy clinical trial you must apply to the Gene Therapy Advisory Committee (GTAC).
- Planning and working with sitesIt is vital to the success of your project that you consider at an early stage how and where participants will be identified, recruited and participate in your project.
- Equality, diversity and inclusion (EDI)We are committed to providing a service that promotes human rights, equality and diversity and does not discriminate against any staff, potential staff, members, partners, service users or anyone that deals with us in any way.
- Publication schemeThe FOI Act requires that each public authority adopts and maintains a publication scheme that describes the classes of information that the Authority publishes or intends to publish. We will regularly review this publication scheme and update it where necessary, subject to approval from the Information Commissioner.
- ConsultationsThis area covers all live consultations and calls for good practice or evidence.
- The Over-Volunteering Prevention SystemThe Over-Volunteering Prevention System (TOPS) is a database, free to all UK organisations undertaking Phase I trials in healthy volunteers, that aims to prevent participants from taking part too frequently in trials of new medicines.
- National Research and Ethics Advisors' PanelThe National Research and Ethics Advisors' Panel (NREAP) is an independent, multidisciplinary expert panel which provides advice to the Health Research Authority (HRA) on an ad-hoc basis. The panel encompasses expertise in a wide range of disciplines related to health research including bioethics, medical research, patient and public involvement and Research Ethics Committees (RECs).
- CAG group meetings and minutesThis section outlines both meeting dates and minutes for CAG meetings. Valid applications received by the relevant submission dates can expect to receive an approval decision from the Secretary of State for Health (non-research) or Health Research Authority (research) within a maximum of 60 working days.