Guidance and Resource Directory

• The Research Governance Framework was published by the Department of Health in March 2001. It defines the standards under which all research undertaken in the NHS should be undertaken. Importantly it also defines the responsibilities of all those involved in research.
  The DOH Research Governance web pages can be seen at: www.doh.gov.uk
  Also see the GMC's new guidance: Research: The role and responsibilities of doctors
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• Information Management Policy: Research and Clinical Audit - Corporate Policy 13 The Hull & East Yorkshire Hospital’s policy regarding the use of patient information for research and audit purposes specifies the necessary procedures for obtaining clinical information and how data should be stored.
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• World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
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• Federal Wide Assurance - Any trial that is funded by, or in collaboration with, any American funding body, needs to have FWA. Hull & East Yorkshire Hospitals has obtained this Assurance. It is valid for 3 years and will cover any other studies that require it. Contact your R&D department for the Assurance number if needed.
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• The Clinical Trial Regulations
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• Informed Consent - This information note summarises the statutory requirements for informed consent of participants in clinical trials of investigational medicinal products (CTIMPs). The requirements are set out in Schedule 1 to the Clinical Trials Regulations. The Regulations transpose the provisions of the European Clinical Trials Directive (EC2001/20) into UK law.
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• Investigators Guide to the EU Directive
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• MHRA Definitions: What is a medicinal product or Investigational Medicinal product (IMP)? To help you decide if your trial needs a Clinical Trial Authorisation the MHRA have produced an algorithm.
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• The National Research Register (NRR) is a database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS).
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• NHS Research and Development Forum. A website for all those involved in research and development in the NHS. Providing updates on the implementation of the EU Directive on Good Clinical Practise 2001/20/EC, jobs and courses, discussion groups, and much more.