Planning
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:
- sound scientific, ethical and financial standards from research
- research conduct and governance that adheres to national and local regulatory frameworks
- transparent decision making processes
- read more information on public involvement.
Please see Approvals processes for more information.
Approvals processes
Classifying your study
The Medicines and Healthcare products Regulatory Agency (MHRA) have produced an algorithm to help you decide whether or not your study is a clinical trial - please see Clinical trial planning.
Clinical trial planning
Occasionally, further clarification is needed. If so, you should contact the MHRA Clinical Trials Unit directly for advice:
Email: ClinTrialHelpline@mhra.gsi.gov.uk
More information on classifying your research can be found at the link below.
Is my project research?
Sponsorship
ll 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).
Sponsorship
Costing your research
It 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 OUH 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.
OUH R&D Department - Contact us
Insurance and indemnity
This is required for all clinical research and is provided by the sponsor.
Insurance and indemnity
Confidentiality
The 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 individuals (e.g. patients), and are 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.
More information on confidentiality can be found at the link below.
Information Governance
Other sources of advice
The NIHR Research Design Service - South Central can give advice on a wide range of design and methodology issues for researchers preparing submissions to national peer-reviewed funding competitions. Priority will be given to proposals submitted to a NIHR scheme, with particular emphasis on Research for Patient Benefit.
Clinical Outreach Librarians
Specialist information support for research, consultancy services, mediated literature searches, search skills training.
Medical statistics
Medical Statistics Online Help (pdf, 30 KB)
Research classification and procedures