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General issues
There are loads of documents! In what order should I submit them?
The ordering of research governance documentation is as follows:
- UCL data protection
- Sponsorship agreement (only needed for NHS research), either via Trust R&D Departments or via UCL Biomedicine R&D
- Ethics application (via NRES or UCL)
- R&D registration (only for NHS research, including honorary contracts if necessary for NHS Trusts)
- Departmental health and safety form
Ethics: general
Do I need ethics approval for my service-related research project?
If research involves only procedures that would normally be carried out in the routine delivery and evaluation of services, and if it is for local consumption, rather than publication, it is defined as audit or service evaluation and therefore does not need to go through an ethics committee (there is a helpful NRES leaflet on this distinction). However, if in doubt, check with your clinical supervisor and/or the administrator of the ethics committee in question.
Is there any case when I don't have to make an ethics committee application for my major research project?
There are a few instances where you do not need to apply for ethics approval.
The main case when you would not have to submit your own ethics application is if your supervisor has already gained ethical approval for the project or if your project forms part of a larger-scale study for which ethical approval has already been obtained. In this case you must establish with your supervisor that appropriate approval has been given for your specific project. You must include a copy of the approval letter as an appendix to your thesis.
For research with NHS staff, IRAS approval is not needed. However, for the purposes of the DClinPsy, approval should be obtained from the UCL Psychology and Language Sciences committee.
In rare cases, research with NHS patients may be classified as audit or service evaluation by the Trust R&D department. If so, an ethics application is not needed, but you must have written confirmation from the Trust that this is the case.
Ethics for NHS research (IRAS form)
Who is the chief investigator for NHS research projects?
Ideally, it is better for you as the trainee to be the chief investigator (since it is your project, and you are ultimately responsible for it). However, there are some major exceptions to this. A common one is if your project is part of your supervisor's larger research programme. In this case, the supervisor would be the chief investigator (and may well have obtained prior ethics approval for the work). Another common exception is that some sponsors (notably UCL) insist that the UCL supervisor be the chief investigator as a condition of sponsorship.
If my research takes place over multiple sites, what do I need to do?
If your research covers more than one site, you will need to obtain approval from the R&D department of each one. You will need to complete a "Site Specific Information Form" for each site, as part of your ethics application.
What are the indemnity arrangements?
By virtue of your employment with Camden and Islington, you are covered by an arrangement called the Clinical Negligence Scheme for Trusts, which extends throughout the NHS. On the relevant question on the IRAS form (currently q.A76) you can tick the box that "NHS indemnity scheme will apply".
Is it OK to reimburse NHS patients for participating in research?
It is acceptable to offer patients a moderate payment (or the equivalent in vouchers) for participating in research. However, it would be unethical to offer a large amount, which would induce reluctant but needy patients to participate.
How do I get a referee's report?
The review of your proposal counts as the referee's report (so it is important to keep a clean copy to submit with your application).
Do I need a statistician's opinion?
Whether formal statistical approval is required is a matter for individual ethics committees. Camden and Islington have said that for trainee projects it will usually be sufficient to have the UCL supervisor's approval if there is an explicit power calculation or other indication of the rationale for the sample size.
Where can I see a sample information sheet and consent form?
The NRES site gives guidance on composing the participant information sheet and consent form. If you are working with a specialist clinical population which poses problems in obtaining consent, it is also good idea to look at past theses in the topic area for examples of wording information sheets and consent forms tailored to that population (but be aware that the requirements for information sheets have changed over the years).
How much lead-in time do I need?
Once the ethics form is drafted out, it can take several weeks to arrange sponsorship and have your application approved by the UCL/UCLH Joint Research Office. After this, you will also need to contact the London Local Allocation System (LLAS) Coordinator on 020 8846 7289020 8846 7289, who will book a slot for the next convenient committee meeting (these sometimes get booked up in advance). All of this means that you need to complete the form and line up any signatures well in advance of submission.Back to Top
Ethics for healthy volunteer research (UCL Research Ethics Committee)
What are the indemnity arrangements for healthy volunteer research?
Healthy volunteer research that has been approved by the UCL research ethics committee is covered by UCL's public liability policy.
Where can I see a sample information sheet and consent form for healthy volunteers?
The UCL committee gives useful advice on formulating the information sheet.
Who signs the ethics form as the Chair of the Departmental Ethics Committee or Head of Department?
The UCL ethics form can be signed by John King in his role as Chair of the Departmental Ethics Committee. Alternatively, it can be signed by Professor Peter Fonagy in his capacity as Head of the Research Department of Clinical, Educational and Health Psychology. To arrange for Prof Fonagy's signature, give the form to his PA in room 543b, well in advance of the submission date.