Obtaining ethics and other regulatory approvals
Depending on the type of research and the procedures involved, you may need to apply for other approvals in addition to R&D Governance approval. The type of approvals required may be either:
- Ethical Approval; or
- Regulatory Approval; or
The National Research Ethics Service works closely with the UK Health Departments to develop and maintain a common UK-wide system for ethical review of health and social care research.
The requirements for ethical review by Research Ethics Committees are set out in section 2.3 of the harmonised UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC), published by the UK Health Departments in May 2011. These include both:
- Requirements for ethical review of research under legislation applying to the UK as a whole or particular countries of the UK
- Requirements for ethical review under the policy of the UK Health Departments, where research relates to the services for which they are responsible
To check whether your project requires REC review, please refer to the HRA decision tool. This provides guidance on whether REC approval is required due under policy or legislation
When you apply for ethical review please refer to the Central Booking System for guidance and infirmation on which REC to apply to.
Full guidance on the following types of ethical approval are provided by National Research Ethics Service on the Health Research Authority website in the links below:
- Requirements for ethical review under the policy of the UK Health Departments
- Research tissue banks (‘biobanks’)
- Gene therapy clinical research
- Stem cell research
- Social care research
- International research involving the UK
Ministry of Defence research
The Ministry of Defence appoints two Research Ethics Committees to undertake ethical review of research funded by or sponsored by the MoD, including research involving the UK Armed Forces:
- Ministry of Defence Research Ethics Committee (General)
- Ministry of Defence Research Ethics Committee (Personnel, Protection and Effectiveness)
These RECs are known jointly as MoDREC, which is recognised by the National Research Ethics Service (NRES) and works to the same standards as NRES. Research projects undertaken in military establishments or involving predominantly military personnel must be reviewed by MODREC and can only proceed if given a favourable opinion by MODREC. If such a study involves the NHS then a separate application to NRES would not be required unless civilian patients are intended to be specifically recruited into it.
Because of the position of QEHB as the main NHS hospital treating military casualties there is the potential for military patients to be suitable for inclusion in civilian based clinical research studies. Where the occasional military patient is found suitable for inclusion in a civilian study that already has a favourable opinion from NRES, then a separate application to MODREC is not required – Dr Amarjit Samra in the office of the Medical Director of the Joint Medical Command should be informed of this. However, if military patients are a significant component of the study or are specifically targeted for recruitment into the study, then an application to MODREC must be made and military patients cannot be recruited until MODREC has issued a favourable opinion.
Depending on the type of research and the procedures involved, you may need to apply for other approvals in addition to (or in some cases instead of) applications for ethical approval.
A summary of approval requirements for health research, other than Trust R&D approval, in the United Kingdom is provided below. For further advice and guidance, please refer to the websites of the review bodies concerned. Where applications to other review bodies are made using the Integrated Research Application System (IRAS), guidance on the approval requirements and procedures will also be available in IRAS.
- Access to confidential patient information
- Administration of radioactive substances
- Clinical investigations of medical devices
- Clinical trials of investigational medicinal products (CTIMPs)
- Offender health research (including research in prisons)
- Research involving human embryos and gametes
- Storage of human tissue for research