6. Obtain Ethical and Trust approval?
All projects need to be reviewed by a research ethics committee and you must get permission from all NHS organisations where you will be conducting your research.
Do you know where to start and what to consider in relation to ethics in your research project? The National Research Ethics Service (NRES) has a section on Do you need ethical approval? included with other frequently asked questions.
Applying to a Research Ethics Committee
Research Ethics Committees (RECs) have been working to standard operating procedures since 1st March 2004. NRES gives people access to comprehensive and up-to-date information on the REC system in the UK including Guidance for applicants.
The new Integrated Research Application System (IRAS) is now in use.
Applying to NHS Organisations for R&D Approval
The NHS R&D Forum provides guidance to applying for R&D approval from the NHS.
The SSI form needs to be completed for all studies taking place in the NHS. This form is incorporated into the IRAS.
Your R&D Department and RDDirect may be able to help you with the application process.
Prepare your information sheet and consent form
This is one area where as a researcher you will get extra benefits from including patients/carers in your research project. By including patients in the project from the early stages the project team will be in a position to develop forms specifically for the project that also have appropriate language and have been looked at from the perspective of a potential participant. Often the difficulty comes from producing forms that use lay language but still provide the right information for the project.
How do you fill out ethical consent forms?
Ensure your participant information meets the needs of those using it:
- RNIB clear print guidelines
- Medicines for Children Research Network - See Patients & Families section
- UK Connect – general advice about literature for people with aphasia
Research Governance
What is research governance? How does it affect me?
- Research Governance including the Research Governance Framework
- The UK Medical Research Council and Department of Health have developed a Clinical Trials Toolkit for use in all publicly funded academic trials. This includes guidance on Good Clinical Practice.
- The UKCRC Regulatory and Governance Advice Service publishes information on regulatory and governance events and news, as well as a series of Questions and Answers
