Guest Blog : Reflections on an application for NHS ethical approval

Guest Blog post by Jennifer Watson

PhD Student Manchester Metropolitan University

The IRAS system:  The Integrated Research Application System (IRAS) is an ingenious device whereby a potential researcher can complete several application forms, all required in order to carry out research within the NHS, at one time.  “That’s wonderful, why did no one tell me this before” you may cry.  The reason nobody speaks about it is that the pathway through it is strewn with the hopes and aspirations of hapless researchers rather like Hansel and Gretel’s breadcrumbs.

 

Of course, the concept is a good one and, having never been unfortunate enough to apply for ethical approval in the pre-IRAS days, I can only assume that this is an improvement.  The problem is, that the more you delve into the process, the more complicated it becomes. The first challenge is to register with IRAS and to complete the on-line training.  Looking back, this could be where I went wrong in that I didn’t (complete the online training course, that is) but I took the “I’ll look back at it when I encounter a problem” attitude before throwing myself headlong into my application.

Completion of the forms: Firstly, there is the screening process, whereby you fill in 

some answers and IRAS tells you which forms you need to complete.  In my case I needed to satisfy the NHS Research Ethics Committee (REC) and the Research and Development  (R&D)group covering the area in which I wanted to carry out the research.  So far so good.  IRAS then supplies you with the questions you need to cover both forms to avoid duplication and henceforth all should be plain sailing: answer the questions, click the submit button and everyone will receive the necessary information.  This is where I realised I should have completed the online tutorial.  “Submission” in IRAS-speak does not pass your well-considered replies to anyone, it merely saves them in a form which can then be sent to…… who?  We will return to this conundrum later.

Just in case you were planning to complete the IRAS forms on a quiet afternoon as a break from the literature review, I feel I should prepare you – there are a lot of questions.  Not only are there a lot, there are a lot of “But surely I have just answered that” type of questions.  This need not be viewed entirely negatively though as it does give plenty of opportunity to practice your cutting and pasting technique.  Another word of warning here, it may well be that your DOS/supervisor(s) wish to “look over” your answers before submission to the relevant bodies.  Prepare for several weeks of reminder emails followed by resulting amendments and more weeks of “looking over” the amendments.  Obviously, the more over-lookers you have, the greater the delay, but this must be regarded as part of the process and, if it can’t be enjoyed, at least you may learn something from it.  Which, can’t be all bad.

Submission:  I feel at this stage that I must confess to receiving insider information from a former colleague who worked on an ethics committee. I was therefore aware at least of the existence of Local RECs, i.e. the bodies who will review our applications and grant ethical approval to carry out research within the NHS.  That’s fine, the REC form is submitted to the local REC and I can sit back and wait for their approval.  However, pondering over the submission instructions on the IRAS form, I discover that I need to book an appointment to attend the REC in person for the review.  In addition the earliest appointment is six weeks ahead and 30 miles away. There is also the matter of the REC checklist of accompanying documents to be forwarded, which must be submitted within four days of the booking.  This begins with a straightforward request for relevant documents such as consent form, protocol, patient information sheet and so forth but gradually becomes more challenging:  CV (got that saved somewhere), CV of supervisor (ah, fire off an email), letter from sponsor (who?), evidence of sponsor’s insurance (whose what?).  None of these documents are unobtainable however and eventually can be tracked down with a little investigation.  Even the process of obtaining electronic authorisation instead of signatures can be strangely satisfying.

In the early stages of this process, I naively believed that REC approval would give me the green light to happily stroll into GP practices and recruit patients for my study.  That was before I discovered local R&D approval.  In other words, I need separate approval to work in a specific NHS area – hence the R&D form completed through IRAS.  We now return to the “submit to whom/where” dilemma.  Easy, a bit of Googling provides me of the name of the lead for R&D in the area in which I want to work.  This is fine, except the helpful reply to my email tells me that I need to get in touch with the Greater Manchester Comprehensive Local Research Network (GMCLRN) who will be able to approve my application for the area in which I plan to do my study.  Oh, and, by the way, I will need an NHS Research Passport form to enable me to work on NHS premises (in that case, what is everything else about?), copies of which, when completed and approved, need to be sent to the R&D person in every NHS area I may wish to use.  That brings me to another point, the very helpful person at the GMCLRN reminds me that I will need a Site –specific form (SSI) for any area I may wish to enter and that I will probably need to cover three areas just in case I cannot recruit sufficient participants from my first choice.  At least the SSIs can be completed as an add-on to the IRAS and can be submitted to the GMCLRN, with more additional documents, all in a nicely zipped folder attached to an email.

Nearly there now (six months on!).  There is, of course, the matter of the MMU ethics application form but, having weaved through the IRAS maze, the MMU ethics form is almost disappointingly challenge free.

Just the Research Passport application to deal with now and we’re off! Once I have my Criminal Records Bureau (CRB) check and Occupational Health Clearance my passport will be granted and recruitment can commence!

Just the small matter of an ethics review and amendments to consider, but I will leave those for another day………….

Quantitative purgatory

According to the Catholic Church, Purgatory is a place or condition of punishment for those who although possessed of grace are not entirely free from sin. As an atheist I never really thought that purgatory was something I would need to concern myself about until I became a quantitative researcher. As a someone whose PhD was once described as 385 pages of statistical tables and some text, I flatter myself that although not a statistician I can make SPSS do what I want it to do and I can understand the results it gives me. I can look at a mess of data,  know what questions to ask it and comprehend the answer I come up with. I know when to use non-parametric tests and I can identify scenarios when only a parametric test will do. In other words like Michael Faraday, Gregor Mendel and Thomas Edison I am an amateur. However, being a keen amateur does not mean my quantitative activities are less accurate or appropriate than those of Charles Spearrman (a well known statistician although really a psychologist) or Jacob Cohen (another well known statistician who started life a psychologist). I'm not asking you to believe that the Haigh Test for statistical complexity is imminent, what I am asking is - why, when the stats tests I'm using are really, really simple am I constantly told I need to have a statistician on my research team!?!

It's annoying for me as someone who can do simple stats such as cross tabs and ANOVAs (even, dare I say it, some multivariate regression) and it must be bloody annoying for statisticians who have studied for 3 years or more to be constantly asked to advise on what, for them, is the statistical equivalent of learning to use a spoon.

So, here I sit, in statistical purgatory - in a state of grace because I understand what 'p' values are for but full of sin because I don't have a stats degree. The only good thing is...there are loads of us here.

What your supervisor will expect from you

Whilst, in previous blogs, I have outlined the things a doctoral student can expect from their supervisor it is important to remember that your supervisor has the right to expect certain things in return. For example;

• If you want your supervisor to review and comment on written work they will probably expect you to send it to them at least three weeks before your supervision session. It is pointless sending your supervisor the first 20,000 of your methods chapter the day before you are due to met and expecting them to have read it...or be happy about it.

• If you have an appointment with your supervisor - turn up! (pretty obvious I know but you would be surprised how often it happens)

• They will expect you to be prepared to present to peers, within and external to the university.

• If you are going to publish something with their name on it, make sure they see it before you submit. Academics are only as good as their last paper so it's important they have the opportunity to provide input.

• Some supervisors will expect you to be the one to keep in touch, so if you drift or drop off of the radar they won't chase you up. It is a good idea to find out at the beginning of the relationship if they are expecting you to instigate contact.
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Of course the easiest thing to find out what your supervisor expects from you is to simply ask them. Your relationship will, ideally be mutually supportive and most supervisors will be pleased and touched if you show them this level of consideration - it will probably be the first time any one has!

Pick a side!

When did it become desirable, fashionable  or acceptable to shoehorn chunks of quantitative data collection into what is obviously designed to be a qualitative study? I'm not talking about genuine mixed-methods studies but doctoral theses, and it usually IS doctoral theses I'm afraid, that undermine perfectly acceptable and robust qualitative studies with a few badly presented descriptive statistics. If a student is focussed upon qualitative work then, generally,the inclusion of poorly analysed and weak quantitative data does not enhance their work - it weakens it. Examiners who know about statistical analysis will be irritated by things like appallingly bad response rates, inappropriate statistical tests (usually treating non-parametric data as parametric) and meaningless extrapolation of non-significant findings to the general population. Examiners who are knowledgeable about qualitative methods will struggle to find meaning in the inclusion of such data and be annoyed because it detracts form the richness of the qualitative elements. I think it may be time for researchers, students and supervisors to pick a side and stop sitting on the methodological fence. Neither approach is better than the other - they are too different. They explore different things, ask different questions and give different answers - not better, just different. So, be whole hearted qualitative or be proudly quantitative. PICK A SIDE!!!! 

Looking above the heads of the crowd

I was having a research-y conversation with a colleague when he said something very profound. "The problem with me" (he said) "is that I'm interested in too many things". My first thought was 'yeah, me too'. If you ask my mentor 'what is the problem with Carol Haigh?' somewhere in the 15 volumes of documentation he would hand you in return would be the phrase "She has no focus". But my second thought was "why is that a bad thing? 


Without doubt we need people who are happy to spend their entire career concerned about the healing rate of diabetic ulcers in women whose birth sign is Libra or are exercised about the life cycle of the Tibetan water snail but we also need individuals who can't settle on one topic or idea, people who consistently poke their heads above the crowd to see what's coming next. These are the people who can adapt their research interest to changes in policy or technology. They are the people for whom cross-disciplinary collaboration holds no fear because they aren't afraid to knock on the door of other previously unrelated disciplines and say, ' I can help with this'.


My fear for the next generation of researchers is that they won't be encouraged to celebrate their generalist tendencies and will be expected to slot themselves into the narrow confines of a specialist subject. Research has changed dramatically over the past decade - the age of the solitary researcher is coming to an end and multi-site, multi-institutional  collaboration is now the norm, interdisciplinary collaboration is already being seen as advantageous when bidding for large research grants and cross disciplinary research, such as  between health, technology and industry for example, is the next logical step.


For this to work we need to encourage the generalists, we need people who are willing to change focus and direction and use a macro gaze in order to move the whole of their discipline forward into the second decade of the 21st century as much as we need the  micro gaze of the specialists 

How to manage your supervisor 3 - Great Expectations

So far in this short blog series we have looked at how to select a supervisor and how to manage the first supervisory meeting but there are things that you should expect from your supervisor.  Most universities and research supervisors take student demands very seriously and will try to support them in any reasonable requests. Unfortunately though they rarely tell students what is on offer and so students don't know what is available and what they can ask for. The following are just a few of the things you can expect your supervisor to help you with.


Provide guidance in planning the research project - A PhD is a research training program, no-one expects a new doctoral student to have their research project completely planned from day one. You can expect your supervisor to be able to discuss different approaches to answering your  research question. You should also be able to look to them to provide suggestions and guidance with regards to suitable places to start literature searching as well. In addition, if you have identified and area in which you feel you need further training or education, your supervisor should be able to help you find internal or external resources that will help or be able to provide access to supplementary instruction.


Help with ethics -  In the UK, if you are doing research in health and social care, you are likely to have the lovely experience of attending a Local Research Ethics Committee (LREC). Although ethics committees tend to be forgiving to applicants who are doing Masters degrees, understanding that they are relative novices in research, they will treat doctoral students projects with the same level of rigour that they apply to the studies of experienced researchers. If you are invited,your supervisor should attend the ethics meeting with you. This is partly so that they can provide support for you, partly because they should be able to field any questions that stump you and mainly because ethics committees love it when supervisors attend with their students as it reassures them that a novice researcher has the full support of an experienced one. Even if you are not facing LREC you will probably have to submit your study to the approval of the university ethics panel and you can expect your supervisors help in this too.


Integrating with the wider academic community - Part of the doctoral process is engaging  with the wider intellectual community in your discipline. For most people this usually  means attending a suitable conference. SOME universities (but no means all) have small pots of money that doctoral students can apply for to fund conference attendance. It is worth asking your supervisor if such funds exist and getting them to help you apply or seek other forms of funding if none are available at your university. Another way of engaging with the external community is via publications and you should be able to expect your supervisor to be able to provide guidance on suitable target journals and the writing styles and standards expected.

Be the map reader on your doctoral journey - Your supervisor should be familiar with all the bureaucratic university milestones you are likely to encounter. Obviously it is your responsibility to keep such milestones in mind as well but you should be able to rely on your supervisor to be able to guide you on the preparation of progress or transition reports and, at the end of the process make informed suggestions with regard to the selection of examiners.


I know some doctoral candidates will read this and roll their eyes muttering 'my supervisor didn't do this'. None of the things I have outlined in the blog should be onerous or outside of the remit of the supervisor. But remember, you have to be the proactive one in this scenario, so think carefully about what you want from your supervisor and make your expectations clear to them. You can rest assured they will be making their expectations crystal clear to you!

How to manage your supervisor 2- Entering the lion's den

Once you have found a supervisor that you feel is right for you, you face the challenge of the first supervision meeting. The important thing to remember here is to
start as you mean to go on.  One of the biggest mistakes that many new doctoral students make to is under estimate how much power they have in the doctoral candiate/supervisor relationship. They assume that the association will continue along the pedagogical lines of their previous studies in which the supervisor is all knowing and the student is the passive recipient of their knowledge. This should not be the case. The relationship between supervisor & PhD student is very different from other supervisory relationships, it should be a partnership of equals so negotiation is key. The expectations of both parties should be made clear at the start. If you have found yourself an excitable supervisor who is easily distracted by attractive avenues of discussion (yes, I know all my students are looking at me) take an agenda with you so that you can keep them on topic.


One of the first things to discuss is how often you plan to meet, for how long (two hours is a good start), whether those meeting will be face-to-face or via Skype or e-mail and where they will be (supervision doesn't necessarily have to be on-campus). The frequency of supervision changes across the course of the PhD so you may wish to see your supervisor every month in the early stages but less regularly during data collection or writing up phases. Regardless of frequency it is always a good idea to make your next supervision appointment before you leave. It is easier to cancel an appointment you suddenly find you don't need than to make one urgently.

It is a good idea if you have a broad idea of the focus you plan to take with your thesis but it's not a good idea if you are not open to debating or amending that plan. Many new doctoral students will start their PhD absolutely confident that they know exactly what they are going to be doing over the next 3-6 years. Equally as many complete a thesis which bears no resemblance to those original plans. So, be ready at your first meeting to have a long discussion about your chosen topic and all of the different ways you could explore it. Remember at this early stage nothing is carved in stone.

Most universities have set milestones that you will need to achieve and so it's a good idea, if you can to find out what they are ( they are usually outlined in the Post Graduate Research Regulations and the majority of universities have these available online) and discuss them with your supervisor. 

Even at your first meeting it doesn't hurt to be thinking about papers you will be publishing from your work and to discuss issues around what support your supervisor will be able to provide to help you, especially if you are a publishing virgin. Most supervisors will expect to have their names on papers you publish from you PhD, particularly if they have contributed in a more substantial way than just editing or proof reading but it is not inappropriate for you to expect to be first author.


So, for the first meeting;

1. Negotiate how your relationship is going to work. 
2. Negotiate what you expect from each other. 
3. Be ready to discuss what you want to do and to explore different ways of doing it.
4.  Be clear what the University set milestones are and how they fit into your project plan 
5. Be ready to discuss a publication plan and authorship.

The first supervision session is a bit like a first date - you will probably both be on your best behaviour and trying to impress but you will also get a sense early on as to whether this is a relationship that has potential. Unlike a first date it isn't necessary to buy your supervisor flowers but don't be afraid to take biscuits.