Ethical approval from the appropriate NHS REC is required for any research proposal involving:
patients or 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.
fetal material and IVF involving NHS patients.
the recently dead 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.
healthy volunteers where a drug or device is being tested. For healthy volunteer studies where personal or health data is being collected, it is strongly recommended that you receive ethics approval.
the use of any relevant material as defined by the Human Tissue Act (ie. any human tissue samples except serum, hair and DNA/RNA) where consent has been obtained for its use in research projects.
If you have any doubts whether your project needs approval, you are advised to submit your protocol to the research ethics committee administrator for a decision. This will enable you to show that you went through the proper process in the event that your research is audited, or if you wish to publish.
When is something audit and when is it research?
Audit projects do not require a submission to ethics, although they do need to be registered with the Clinical Effectiveness Unit - projects should be registered with this unit and the application form can be found on the website http://bltintranet/A-Z/Information/Clinicaleffecitivenessunit.aspx
Research projects on the other hand must be submitted to ethics for approval. If you are not sure whether your project requires an ethics submission, you should contact the ethics committee and check, then you have covered yourself. If you do not, you run the risk of not being able to publish your research.
It is important that as a researcher you understand the difference between an audit and a research project. The documents below provide some guidance on determining whether your project is audit or research. If you are still in doubt, contact the Joint Research Office, the Clinical Effectiveness Unit or the ethics committee.
If you are in any doubt, as to whether your project is an audit or service evaluation, a copy of the protocol should be forwarded to queries@nationalres.org.uk
Research involving micro organisms
We often receive queries asking if it is necessary to seek ethics approval before commencing research using collections of micro organisms, where the organisms were derived from human samples. Terry Stacey, Director of NRES has advised that there is no need to seek approval from an NHS Research Ethics Committee for such projects. If you are at all in doubt about your study however, it is best to check before going ahead with your project to confirm that no ethics approval is needed. Guidance from the Department of Health’s Inspector of Microbiology confirmed this, and in addition stated that “any bacterial sub-cultures and viruses isolates made from clinical specimens are not part of the specimen themselves, they do not belong to the patient from whom they were obtained, and they do not fall under the provisions of the forthcoming Human Tissues Bill because they are not material taken directly from patients and containing human tissue or DNA”.
The ethics application process
On the 1st March 2004 new procedures for making applications to Research Ethics Committees for approval were put in place. From now on any applications made to any REC must be on the IRAS NHS Ethics application form which you should fill in online at www.myresearchproject.org.uk.
There are now two different ethics application processes in place, depending on whether your trial is an EU Directive Trial (EUD) or not. EUD trials are defined as any trials investigating new or novel usage of medications in healthcare research, ie clinical trials.
The two processes provide an option of either going through a Central Allocation System (CAS) (by phoning 0845 270 4400) where a main REC is allocated to you, or applying direct to a relevant local REC depending on the type of trial.
New definitions of both a research site and a multi-centre research project were also introduced on 1st March 2004. These definitions are:
Research Site: An individual Trust or Institution
Multi-Centre Research Project: Any project taking place within the boundaries of two or more research sites
Strategic Health Authorities are now known as Domains to comply with the wording of the EU Directive on Good Clinical Practice, which came into force on 1st May 2004.
Applications can be made direct to the relevant local REC for single-site research projects and for multi-site research projects where all the sites are located within the same Strategic Health Authority (Domain), so long as they are non-EU Directive (EUD) trials. EUD trials must go through Central Allocation System (CAS) even if the sites are in the same domain. If you apply through the CAS system for non-EUD trials, this gives you the added option of later expanding the study to sites outside of the domain should you wish.
All multi-centre studies (on two sites or more), except those where all sites are within the same domain (see above), must go through the Central Allocation System (CAS).
When you are applying to a local REC for site-specific assessment only, the REC only require the following documents:
SSI of the IRAS form, signed by the Principal Investigator for the site
A short CV for the Principal Investigator
However, you still need to submit your project to the Joint Research Office before you submit to ethics to obtain your letter of provisional R&D approval. More information>>
Sites- The definition of a site as adapted from NRES SOPs is:
Research sites are where participant-related research procedures specified in the protocol - including recruitment and informed consent - are carried out.
Referral of a patient (possibly from another domain) for assessment and possible recuitment is not part of the conduct of the trial. The following are not considered to be research sites:
Clinicians or clinical units making referrals to the research team.
Research units undertaking support functions. eg. project management, site monitoring, data analysis or report writing
Valid Applications
Now this national form is in place, there are also new guidelines on what is considered to be a valid application by the ethics committees. If any of the documents listed in the valid application criteria (see below) are missing, your application will automatically be rejected by the ethics committee without consideration, therefore it is in your best interests to comply with this. The committee should then reach and communicate a decision on the ethics of your research within 60 calendar days of receiving a valid application. Now that the EU Directive on Clinical Trials has been enforced, this 60-day response is a legal requirement of ethics committees. If you find this is not happening, then you are fully within your rights to complain to the NRES.
Getting help with your application
If you need help with putting together your ethics application, or advice on the ethical issues involved in your research, you can contact the R&D Ethics Interface Facilitator on tel 020 7882 7272. The Ethics Interface Facilitator is able to support researchers through their applications to the ethics committee, guide them through the process, screen applications and ensure they are valid before they reach the committee.
Contact details and meeting dates for the Local Research Ethics Committee
Each of the three research ethics committees in the East London & the City Research Ethics Committee now has a dedicated administrator. If you have queries about the deadlines for submission, the progress of your application or comments made by the committee please contact the following people.
Committee 1 and 2
Co-ordinator and chair details are:
Committee 1 - Dr Arthur Tucker (Chair), Miss Sandra Burke (Co-ordinator) e-mail sandra.burke@thpct.nhs.uk
Committee 2 - Dr Cliff Chaplin (Chair), Miss Sandra Grote (Co-ordinator) e-mail sandra.grote@thpct.nhs.uk
At present it is not possible to accept hand delivered applications, therefore send the application, by post, to:
Room 24
2nd Floor Burdett House
Mile End Hospital
Bancroft Road
London E1 4DG
Tel: 020 7725 2558
For general enquiries it is recommended these should be e-mailed to the dedicated NRES queries address queries@nationalres.org.uk
Membership of the Ethics Committee
Committees are particularly keen to recruit:
Medical members (both hospital and GP): Any consultant joining the committee will have their commitment formally recognised in their job plan and will therefore have time out for committee work. Involvement in an REC will also be recognised through the appraisal process.
Nurses, midwives or allied health professionals experienced in research
Lay people who must have no links to NHS or academic health research. These must make up 50% of each committee.
In addition some specialities which are very research active have no representation on the East London & City Research Ethics Committee. Cancer is a particular case in point.
The REC is interested to hear from any clinical member of staff interested in joining or clinicians who may know of suitable lay representatives. For more information about working on the committee please contact the REC.
Funding
Current guidance from NRES insists that research projects must have secured funding before they can be considered by ethics committees. If funding has not been secured, the application will be considered invalid and will automatically be rejected by the ethics committee. This of course does not apply to projects with no funding attached - in this situation you must clearly indicate on the form that there is no intention of seeking any funding once the application has ethics approval.
The Wellcome Trust are now also accepting grant applications before ethics approval has been received. They will however still expect the ethics part of the grant application to be completed. You must remember to take into account when completing start dates for the grant application that you still need to go through the ethics approval process before commencing your research.
If you find that the funding body you are applying to refuses to accept an application without ethics approval in place, then you must include a covering letter with your ethics application explaining this.
R&D Office submission
Ethical approval