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Research Introduction Research Links High quality clinical and non-clinical research is essential to providing sound, evidenced based health and social care. Clinical research is any research involving human subjects or tissues, including healthy volunteers. The public has a right to expect:
Read more information on public involvement. All clinical research must adhere to the Department of Health (DOH) Research Governance Framework (2005). Clinical trials, a subset of clinical research, must also adhere to the Medicines for Human Use (Clinical Trials) Regulations, 2004, 2006, and 2008. A number of other Acts of Parliament also have implications for research conduct, for example: the Data Protection Act (1998), the Health and Social Care Act (2001), the Human Tissue Act (2004) and the Mental Capacity Act (2005). The R&D department can provide assistance with project planning to ensure that appropriate regulatory requirements have been considered and implemented. With very few exceptions all clinical research requires approval from a research ethics committee (REC). In addition you will need NHS permission (R&D Approval/Trust Management Approval) if your study involves NHS patients, staff, resources or facilities. Site specific assessment (SSA) for NHS sites is undertaken by R&D as part of the Trust Management Approval process. If you are including non-NHS sites SSA is done by the REC committee. Classifying Your StudyThe Medicines and Healthcare products Regulatory Agency (MHRA) have produced an algorithm to help you decide whether or not your study is a clinical trial – see the MHRA Clinical Trials Authorisations page. Occasionally further clarification is needed. If so you should contact the MHRA Clinical Trials Unit directly for advice: ClinTrialHelpline@mhra.gsi.gov.uk SponsorshipAll clinical research must have a Sponsor. The Sponsor is an institution or organisation that takes on legal responsibility for the study and is a requirement of the Research Governance Framework (2005). Further information can be found on the Clinical Research and Clinical Trials Initial Concept to Submission pages. Costing Your ResearchIt is essential that all clinical research is properly costed and resourced. Sponsors are required by the Research Governance Framework (2005) to ensure that adequate funding is in place to conduct the study. If you are asking the ORH NHS Trust to sponsor your study and you have no formal external study grant in place you should contact the R&D Finance team for advice about costing at the earliest opportunity - please see the contacts page. Further information about costing commercial clinical trials is available on the Commercial Studies page and from the R&D finance team - see the contacts page. Insurance and IndemnityThis is required for all clinical research and is provided by the sponsor. See the Clinical Research and Clinical Trials Initial Concept to Submission pages. ConfidentialityThe confidentiality of records that could identify subjects should be protected in accordance with the Data Protection Act (1998). The Act legislates for the control and protection of personal information. Personal Information covers both facts and opinions about the individual. Most Clinical Research Studies require the processing and/or storage of personal and sensitive information relating to living individual (e.g. patients) and is therefore governed by the Data Protection Act 1998. It is important that you comply with the Act and process/store all personal information in accordance with it. Please also see the Department of Health (DOH) Caldecott Guardian page. This is just an introduction; more detailed guidance is available on the Clinical Trials and Clinical Research pages. If you are unsure of any aspect of setting up a clinical trial or other clinical research study please contact the R&D Department for advice at an early stage. It will save you time and make the task less onerous. Contact the R&D Department on 01865 (5)72238 / 01865 (5)72240 / 01865 (5)72725. |
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