IMPORTANT CHANGES TO THE REGULATIONS GOVERNING NHS ETHICAL REVIEW
As from 1st September 2011, there have been some changes to the regulations regarding whether research studies require ethical approval.
Here is a brief overview of the main messages from these changes.
Full details can be obtained from the following documents and on the National Research Ethics Service (NRES) web site. Please contact the Research & Innovation Department for advice and support on these changes.
The following studies would NOT now require ethical approval and only organisational (R&D) approval
Research involving staff as participants (Note, if a study raises any particularly sensitive / ethical issue then it may require ethical approval)
Health care market research, as long as it is within legal and ethical guidelines
Research involving previously collected NON-IDENTIFIABLE DATA. Secondary use of this data collected in the course of normal care is therefore now permitted without approval provided service users are not identifiable to the research team. Care teams can also progress with this as long as data is anonymised or pseudonymised
Research involving previously collected, non identifiable tissue data. Some exceptions (see documents) BUT research on these tissues must have been included in the original terms of the consent
Research involving acellular material
Ethical review will still be required when there is either a requirement under legislation or under policy of the UK health departments
Legislative requirements – ethical approval required for studies involving:
1. Investigational medical products / devices
2. Radiation
3. Storage of tissues and other bits
4. People lacking mental capacity
5. Confidential personal information
6. Persons cared for in the independent sector
7. Studies involving practicing midwives
Policy requirements – ethical approval required for studies involving:
8. Research involving people accessing services for which the UK health departments are responsible
9. Relatives and carers of the above
10. Collection of tissues or information from the above
11. Research involving prisoners
12. Research involving xenotransplanatation (don’t ask)
13. Social care research funded by the DoH
Due to these and other national changes our own Research Management & Governance Procedure requires review and updating. A copy of the procedure is below. Although it has rapidly become out-dated we have kept a copy of it below because it can still be a useful source of help for those new to research. Please do not hesitate to contact the R&I office for further help and advice.
