Emily Cadman, Rosie Glazebrook (REC Chair), Christie Ord (REC Approvals Manager)
This article follows on from Emily’s previous article on the Research Ethics Committee
There are some fairly common errors we see in research applications, which cause delays in you receiving approval from the REC and may even lead to your proposal being rejected. So we have compiled a list of Top Tips to speed up and smooth your progress through the journey that is Ethics Approval.
- IRAS = Integrated Research Application System (i.e. your application form)
- REC = Research Ethics Committee
- HRA = Health Research Authority
- PPI = Patient and Public Involvement
While you are writing your IRAS, waiting to hear back from the REC (you will hear their decision within 10 working days for the meeting) or submitting corrections/amendments to them, if you find yourself getting frustrated with the whole process, just remember that the purpose of every REC is to “enabl(e) and support ethical research in the NHS…maximise UK competitiveness for health research and maximise the return from investment in the UK while protecting participants and researchers”. In other words: they are there to help you, help your patients and maintain the reputation of UK research- they are your friend. I promise.
1) There are some exceptions to the rule “all projects need approval” For example, service evaluations do not count as research and so do not require REC approval. If you are planning a project and are not sure if you need REC approval have a look at the HRA website.
2) Before you start to fill in any forms, have a read of all the advice on the HRA website to help you ‘get it right first time’. There is specific advice about trials using radiation, new drug trials and the Confidential Advisory Group for projects that use identifiable data where it is not always practical to obtain consent.
3) You can choose which Committee you submit to; for example some
people feel it is easier to go to their nearest Committee, or if you are under time pressure you might want to submit to the Committee with the next available space. If your proposal comes under certain categories (e.g. CTIMPS, research involving prisoners, research using children and research using people lacking mental capacity) you will need to submit to a committee that is “flagged” to review those projects. This means the Committee has additional experience at considering those particular ethical issues, and there is likely a higher proportion of relevant specialists sitting on the committee. When choosing the Committee to submit to, you can search the directory on the HRA website.
4) Choose the correct ‘filter’ on the IRAS form for your project, as that creates the correct set of questions for you to answer, which will in turn mean that you supply the REC with all the information that they need.
5) Consider PPI, especially when it comes to writing questionnaires, posters, or Participant Information Sheets. PPI is not needed for every research project, but can be very helpful in others. The HRA have templates and guidance for writing information sheets and consent forms.
6) Make sure you submit all relevant documents to avoid any delays. The REC have to see every document you will use publically before giving approval. For example, even if everything else is perfect, if they have not seen the recruitment poster you plan to put up in the waiting room, they will only be able to give “provisional approval” until they have seen and approved your poster. Which will delay you being able to start recruiting. Which is just frustrating for you. (Not to mention extra work for the REC!)
7) If your project is being reviewed by a full REC meeting, please do attend if at all possible (hence why people often try and submit to a local Committee). The details of the meeting will be sent to you once your application has been submitted and checked. There is guidance about attending the meeting available to read on the HRA website.
8) Know your project inside out. When you attend the REC meeting, you may be asked questions about any of; study design, recruitment, PPI, statistics, time burden to participants, safeguarding/whistleblowing and lone worker policies. It is confidence inspiring and reassuring if you know your project and protocols well.
9) If this is an educational project do try to bring your supervisor with you, especially if it is your first submission to a REC.
10) If you have any questions before submitting your application or at any point during the process please do contact the relevant Approvals Officer; they are wonderfully knowledgeable, efficient and a mine of information. You can find their contact details on the confirmation email you receive when your application is booked, or on the REC directory by clicking on the REC that you have booked to.
For help with the IRAS form: http://www.myresearchproject.org.uk/help/hlpusingiras.aspx
For help with the whole approvals process: hra.nhs.uk
For help with relevant legislation and guidance ( Mental Health Capacity Act, research in emergency settings, research in prisons): hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/