Tag: research governance

Activity based funding and student research in the NHS

Yesterday I spent time with a group of MSc students, talking about research review processes. I’ve written on this blog in the past about my experiences of seeking approvals for my PhD, and in Monday’s session I urged people to be exceptionally cautious about planning NHS-related research in pursuit of their Master’s degrees.

Preparing for and securing NHS research ethics committee and R&D office approvals takes time. In this part of the world at least, some healthcare organisations are also likely to ask researchers to cover the costs to the NHS of supporting studies which are not portfolio adopted. Here I’m thinking of, for example, the costs arising when staff leave the workplace to participate in interviews or join focus groups, or suchlike.

The relatively new practice of directly seeking payment from research teams for the costs of studies which are not eligible for portfolio registration has appeared with the shift to activity-based funding. Here in Wales, the National Institute for Social Care and Health Research (NISCHR) has published criteria for entry to its portfolio, which are summarised here and are elaborated on here. It is from this second document that I have snipped the following:

A research study is a structured activity which is intended to provide new knowledge which is generalisable (ie of value to others in a similar situation) and intended for wider dissemination.

Studies eligible for the NISCHR portfolio should involve face to face contact with NHS patients, social care service users or people involved with their care. Studies must be led from and/or recruiting participants from Wales. All studies must already have research funding before they can be included in the Portfolio.  Research Costs cannot be provided by NISCHR CRC.

The following types of study are not eligible for inclusion in the NISCHR Portfolio:

  • audit,
  • needs assessments,
  • quality improvement projects,
  • directly commissioned studies,
  • secondary research such as systematic reviews,
  • purely laboratory based studies,
  • routine biobanking of samples would not be eligible but a hypothesis based sample collection would be if appropriately peer reviewed and funded,
  • own account funded studies,
  • studies closed to recruitment.

MSc projects invariably do not meet these criteria, meaning that numbers of taught postgraduate students get to cut their dissertation teeth on non-NHS research studies or (where academic regulations allow) on other types of project altogether. Examples are service or quality improvements, service evaluations and systematic reviews. And, in my view, these are sufficiently testing options for students working at MSc level, with some (like local quality improvements) having the added advantage of immediately and obviously benefiting the NHS and those who use its services.

However, a problem arises in the case of postgraduate research degrees. In some disciplines, including nursing, these are often undertaken part-time and are carried out with limited or no external grant income. Opportunities for studentships are relatively rare, and where they are available may be financially unattractive to practitioners who have already built careers in the health service. As with MSc projects, ‘own account’ doctorates will struggle to get onto the portfolio. They therefore run the risk (in some circumstances) of not being supported by organisations within the NHS unless their associated costs are explicitly met. One way of achieving this may be for local NHS managers to agree to carry the costs of non-portfolio studies which it is planned will take place within their services. But securing this kind of support is not straightforward, and for would-be research students the added challenge of finding a means of paying costs is hardly an encouragement. And, where MSc students can usually opt for non-research projects this is not so for those aiming for PhDs or Professional Doctorates. These are awards made only to those who generate new knowledge using sound and defensible research methods.

So what does all this mean? It’s early days, but one likely outcome may be a reduction in small-scale research projects within the NHS, along with an increase in the preparations and negotiations which precede data generation. Another may be the proliferation of non-portfolio projects which are explicitly designed to meet ‘research’ criteria for academic award purposes, but which are constructed to be something else (typically ‘service evaluation’) within the context of NHS research governance. A reasonable, longer-term, concern is that research capacity-building in fields like nursing may falter as potential students rethink their plans. And that, in my view, would be a big step backwards.

Doughnut meetings

My esteemed colleague Professor Jane Hopkinson facilitates a Wednesday lunchtime research drop-in, to which people in the School of Healthcare Sciences at Cardiff University are invited. Affectionately known as doughnut meetings (see photo of today’s goodies attached), these provide a loosely-structured, supportive, space for the sharing of ideas and experiences. The gatherings are really very good: informal, but always informed. I make a point of getting along when I can.

Typically those who meet up get to propose themes for future meetings. This afternoon’s topic was ‘research and evaluation’, and more particularly the distinctions between the two. People involved in health services research (or indeed, health services evaluation) will know how important this differentiation is for NHS governance and approval purposes. Projects classified as ‘research’ require independent NHS research ethics committee (REC) approval. Projects classified as ‘evaluation’ do not. The NHS Health Research Authority provides guidance to help people work out what type of project it is that they are proposing, but in my experience making these determinations remains a wholly inexact science.

I have also learned that a project can be ‘evaluation’ in one context (e.g., for NHS research governance and ethics review) and ‘research’ in another (e.g., for academic progression and award purposes). My own PhD was designed, part-funded through open competition, completed and examined as ‘research’: what else could it possibly have been, as a research degree? But it was also categorised as something else when I offered it up for NHS REC approval, as I’ve written about here and (at length) in this paper.

So there we have it. Potentially all rather confusing, and certainly enough to make me want to eat a doughnut.

Acronyms and initialisms abounding

Now we’ve completed our IRAS form and been to REC, its onwards to NIHR CSP and NISCHR PCU. Hopefully the SSI we give to R&D will be OK, and once we’ve been adopted by the CRN and CRC we’ll get help from a CSO or two.

So that’s all clear then, right? Apart from ‘OK’, which I presume needs no introduction, these are acronyms and initialisms associated with the process of applying for approval to conduct research in the NHS, and getting help to recruit participants and generate data once permission has been secured. I could add that, in the case of COCAPP, we’re making these applications because we’re interested in the CPA and CTPs, and that we should probably make links with a CLAHRC, an AHSP and keep in with the RRG. And did I mention the MNM we’ve already started? You don’t know about MNM? Then read the papers coming out of RAMESES.

Of course, in writing all this I am wilfully and rather mischievously seeking to confuse. The point, though, is that words matter. Shortcuts and abbreviations can save the time of people who are already in the know, but can present an impenetrable thicket to the outsider. Perhaps the process of navigating NHS research approvals should be described using only the commonest 1,000 words in the English language.

TTFN.

Snow, research and higher degrees

Red weather warningToday brought the predicted dollop of snow, meaning that yesterday there was no bread to be had in the shops. See this Met Office map of the UK, with its colour-coded weather warnings? See the red blob? That’s where I live, and where I am now.

This has been an interesting, and particularly research-oriented, working week. I spent part of Monday with a group of postgraduates, discussing processes for the review and approval of research and other projects. It has to be said that the opportunities for MSc students to complete small-scale data-generating studies are fewer than they once were, particularly if their plans are to generate data in the NHS. The time needed to secure R&D and research ethics approval can take a serious chunk out of the typical student’s period of candidature. Now, unless studies can be shown to be linked to larger research endeavours there’s also a fair chance that some NHS organisations will want to levy charges for processing R&D applications and for consuming their resources. As I ended up telling this particular MSc group, for NHS governance purposes there are also fine distinctions sometimes to be made between ‘research’ and other activities (like ‘service evaluation’ and ‘audit’) which, on the face of it, can look pretty ‘research-y’.

Monday also brought a meeting with second year, undergraduate, pre-registration mental health nursing students. That was nice, and we got to talk about all manner of things: the history of mental health nursing, developments in local services, experiences of practice.

Tuesday brought a project advisory group meeting chaired by Professor Billie Hunter. Billie’s study is funded by the Royal College of Midwives, and is examining midwives’ resilience. It’s interesting both methodologically and substantively, and one of the things I’m learning about is the generation of research data using social media.

Wednesday was an unusual day, involving a trip to another university to examine a doctoral thesis. People often have lots to say about preparing for vivas from the student point of view, and in every university there will be stories to be heard about students’ (good and bad) doctoral examination experiences. Less is said about the experiences of examiners. In my view the invitation to examine a doctorate is an honour, and the occasion demands careful preparation. After all, we’re talking here about the culmination of years of work, folks. On this week’s and on the few other occasions in which I have examined I have, I hope, combined rigorous enquiry with respectful courtesy. This is certainly how my examiners were on the day of my viva, I’m pleased to say.

Thursday (yesterday) began with a meeting to review a contract, connected to a funded research project I’m involved in which formally commences at the start of next month. I learnt some new stuff along the way, including the distinctions between ‘background’ and ‘foreground’ intellectual property and copyright. Michael Coffey, Aled Jones, Jennifer Egbunike and I met to make practical plans for a segment of another project, led by Alan Simpson. This study is also involving Alison Faulkner (whose website, if she has one, I do not know), Jitka Jancova and (soon) Sally Barlow. All very productive and interesting, and I was pleased to round off the day in the office with an expected conversation with the clinical psychologist, Andrew Vidgen, about his work in early intervention in psychosis, my Connections and consequences paper, and a few other things besides.

January 18th 2013And today the snow came (check out this photo, revealing the red blob’s local snowfall), and as anticipated a large thesis chunk to read and review from my esteemed colleague, Pauline Tang, who is also a research student. Pauline is interested in the use of electronic patient records, and I am again reminded of the discipline and hard work required by part-time doctoral students who have to combine their studies with the day job. The equally esteemed Jane Davies, my longstanding friend and colleague and now a full time (pretty much) PhD student, also sent me some interesting initial reflections relating to her planned study of decision-making in adolescent cancer.

Running looks out of the question this weekend, and, for all I know, the coming week. Today’s deep snow will be tomorrow’s ice, and that stuff’s not to be run on. Long walks look a tantalising possibility, though.

Research ethics and governance

Hannigan and Allen 2003

This week I spent an afternoon in the company of a lively and engaged group of pre-registration mental health nursing students, talking about processes for the ethics review of human participant research studies conducted both in, and out, of the NHS. We discussed the purpose of ethics review and the organisation of research ethics committees (RECs) across the UK, before I invited the group to become a REC and to consider an application placed before it.

As it happens, over the last ten or so days I’ve also been helping prepare a new application for NHS REC and R&D approval, and in my capacity as chair of the Cardiff School of Nursing and Midwifery Studies REC I’ve been steering another proposal through our committee. So all in all I’ve been having something of a personal research ethics-fest.

One of the first papers from my PhD was a piece, written with Davina Allen, rehearsing our experiences of seeking REC and research governance approval for two studies sharing the same design. There’s a version of the full paper available here, via the Cardiff University research repository.

In this article we started by writing about the rise of institutionalised ethics and governance review processes in the UK and globally. We then shared our experiences of ethics committee inconsistency, and of the limited understanding RECs sometimes have of qualitative research.

I now realise that some of the things which happened to my proposal are not as unusual as I thought at the time this paper was written. Not uncommonly projects will be described as ‘research’ in one context (for example, for funding purposes or for progression towards academic awards) but not in others (for example, in the context of NHS research governance and ethics review where they might be classified as ‘service evaluation’ or similar). I also realise, then as now, that ‘[e]thical decision-making is a complex process, and one that is not amenable to the application of formulaic guidelines’. This is a direct quote from our 2003 paper, and it reminds me that we should not expect absolute consistency in decision-making across different committees. But there is something to be said for committees paying attention to precedent. It is also important that RECs are clear in setting out their reasons why studies need to be amended (or indeed, refused). My recent experiences of applying for NHS REC approval have been positive, in that committee members have been open to in-the-round discussions of the issues raised. I’d like to think that researchers who have submitted their proposals to the university REC I chair have felt similarly well-treated.