Research Ethics Committees (RECs) are convened to provide independent advice on the extent to which proposals for research comply with ethical standards. The purpose of a REC in reviewing the proposed study is to protect the dignity, rights, safety and well being of all actual or potential research subjects. Ethical approval from the appropriate NHS Research Ethics Committee is required for any research proposal involving:
 |
patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions |
|
individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above |
|
access to data, organs or other bodily material of past and present NHS patients |
|
foetal material and IVF involving NHS patients |
|
the recently deceased in NHS premises |
|
the use of, or potential access to, NHS premises or facilities |
|
NHS staff recruited as research participants by virtue of their professional role |
National Research Ethics Service (NRES)
NRES was launched from 1 April 2007. It comprises the Head Office function and NHS RECs in England. NRES will continue to work with colleagues in Scotland, Wales and Northern Ireland to maintain the established UK-wide framework for ethical review of research.
The change in name symbolises the change to a more responsive and robust research ethics review process and makes a shift away from the concept of a system composed of only RECs to one of a service that will provide robust ethical review as well as ensuring, through the delivery of a professional service, that it is also able to promote and facilitate ethical research within the NHS. The NHS REC application form is now integrated within the IRAS form.
All Clinical Trials of Medicines falling under the remit of the European Clinical Trials Directive must go through the NRES central allocation system, as must multi-site research being carried out in more than one domain (Health Board area). Single site studies and multi-site studies being carried out at multiple sites within the same domain can go directly to the REC. Further information on applying for ethical review can be found on the NRES website (http://www.nres.nhs.uk/).
If the research project falls under the Adults with Incapacity (Scotland) Act, the application must be approved by the Scotland A REC (contact details). Members of the Scotland A REC are appointed by the Scottish Ministers.
If you are interested in becoming a member of the Scotland AREC, the application form can be downloaded. Vacancies arise from time to time and it is useful to have names of individuals who are interested in serving on the committee.
Information on the following is also available:
|
Governance arrangements for research ethics committees are available to download in PDF format (revised version effective from 1 September 2011) |
Sponsorship of clinical trials - The European regulatory framework for clinical trials of investigational medicinal products enables reliance on sponsors who are established or legally represented outside the UK but elsewhere in the European Economic Area. Research other than CTIMPs is not subject to EEA-wide arrangements that support the same confidence in assurances from outside the jurisdiction of the UK.
This issue is addressed in paragraph 3.8.1 and footnote 21 of the Research Governance Framework (paragraph 3.19 and footnote 19 in Scotland; paragraph 3.20 and footnote 16 in Northern Ireland). It has come to the UK Health Departments’ attention that some NHS R&D offices are misinterpreting the sponsorship requirements set out in the Research Governance Framework.
The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, require a sponsor to be established, or have a legal representative, in an EEA state. That can be an EEA state other than the UK. Neither the sponsor of a CTIMP nor its legal representative, if it has one, need be established in the UK.
If a sponsor of any other research that is subject to the RGF is outside the UK, it must have a legal representative in the UK.(29/07/09)
Tripartite clinical investigation agreement for medical technology industry sponsored research in Scottish health boards - The bipartite mCIA for use by NHS Health Boards and the medical technology industry has now been adapted for use in a tripartite format by NHS bodies, sponsors and Contract Research organisations (CRO). The changes made to the mCIA are based on the changes made to the mCTA in developing the CRO mCTA. The tripartite agreement can now be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. The tripartite agreement has been reviewed by representative bodies as before (NHS hospitals, the NHS Confederation, the NHS R&D Forum, the Medical Schools Council, medical technology companies, CROs, the ABHI and the CCRA). All the bodies have either endorsed the CRO mCIA or do not object to its use as a standard agreement template for investigations of medical technology devices. Versions of the CRO mCIA for use in England, Scotland, Wales and Northern Ireland have been developed and can be downloaded from the UKCRC website.
Ethics Applications - From 1 April 2009 all ethics applications should be made on the IRAS form which can be found at www.myresearchproject.org.uk.
Integrated Research Application System - A single, integrated application system developed to simplify applying for approval or permission to conduct a piece of research in the NHS is now available for use. The system will allow researchers to enter information about their study in one place. More information is available.