Ethical approval – an opportunity for development?

Jerry Booth is a sociologist who was a Head and Faculty Director in departments of art, design and media until joining a medical school. He is particularly interested in the organisation of learning through practice, and is writing a PhD on how learning outcomes are translated through the curriculum into clinical placements.

OLYMPUS DIGITAL CAMERAThe title of Judy Redman’s Thesis Whisperer posts last year, (Human) ethics applications with a minimum of pain 1 & 2 as she says, probably echoes most academics’ feelings about applying for ethical approval. I want to pick up on her observation that, painful though it may be, ethics applications can, if rigorous enough, improve your research design.

My research will take place in the UK National Health Service – I shall be on hospital wards and in GPs’ surgeries observing teaching – so I have to fill in an Integrated Research Application System (IRAS) form. Without going into too much detail you can be assured that the process is complex, and at the moment made more so by the reorganisation of the health service. For what IRAS terms the core study there are 80 main questions (with plenty of sub-sections) although some get filtered out if like me, you are not undertaking a complex clinical trial. The question-specific guidance notes run to more than 50 pages and the guidance on the project filter nearly 40: each peppered with hyperlinks to other documents.

But the questions you have to answer certainly make you think, and they do so by putting you into the shoes of your research subjects and through relentless question clusters. From the get-go the form is pretty unequivocal about jargon; for the overview of the research it stipulates that you should ‘use language comprehensible to lay reviewers and members of the public’ (A6-1 Summary of the Study) and that you should use no more than 300 words. The guidance notes for this one section not only refer to the classic why, what, who, where and how questions, but provide glosses on each. In all the guidance for this one question covers two single-spaced A4 pages of type.

For the rapidly diminishing band of researchers who are still cosily confined to their collegiate ghettoes where they can communicate in restricted codes, this is salutary indeed.

The guidance on the summary of the main issues exhorts you to consider the choices you made when designing your study, its purpose and design, recruitment, inclusion/exclusion, consent, risks burdens and benefits, confidentiality, conflict of interest and finally what will happen at the end of your study. The use of the past tense in ‘the choices you made’ may be somewhat disingenuous since I imagine most researchers are likely to review their choices in response to this close questioning. It goes on to explore, or rather make you explore your research questions, the objectives and the scientific justification for the research before requesting a ‘clear overview of the research protocol or project plan’ under the heading of design and methodology (A13).

It doesn’t let up. The people who designed this form have evidently done a lot of research and maybe supervised a lot of students as well as a lot of sitting on ethics committees. They know the questions to ask and the supplementaries that will skewer the ill-considered response.  Effectively it’s like a very extended supervision or a particularly rigorous examination, and that’s before you submit the form. Of course once you do, you benefit from the scrutiny of a panel of experts.

What it does then is give you access to a broader reservoir of expertise than you are likely to come across in your daily existence as a PhD student within and especially beyond the university.

I am lucky enough to have a thesis advisory panel which consists of 2 staff apart from my supervisor, and particularly fortunate in that one of them has just been through this still rather new IRAS process and she has been an invaluable guide; she agrees that going through it improved her research too. The process also required me to contact people in the university’s innovation centre and wrestle with data protection legislation. All this before I submit the form to be scrutinised by the experts, most of whom will not share my discipline but all of whom will have wide experience in assessing research. The process may seem a bit daunting but it’s likely to pick up problems which might derail my fieldwork or invalidate the results.

Answering these detailed questions in this way also primes you for writing the information sheets for respondents that have to accompany the application form, and it’s all grist to the mill of explaining your research to your friends, your family or anybody else. You might avoid or at least postpone that moment after a new acquaintance has asked you what you do when you notice their eyes glazing over with incomprehension and boredom.

Like Judy Redman I have sat on an ethics committee and can attest that they provide some of the more interesting committee-based discussions you are likely to encounter in a university. This committee which I chaired for a while, dealt with a wide range of applications, from students wanting to use research monkey for an online survey to full-blown clinical trials for drugs and treatments. In most cases I was impressed both with the amount of work and careful thinking that had gone into many of the applications and with the level of discussion from committee members.

That committee was particularly  fortunate in its recruitment of a lay member whose point of view was invaluable because she asked questions that the academics from a range of different disciplines had not considered. It would not be an exaggeration to say that after some 40 years of sitting on university committees, this one restored my faith in the potential of committees to do interesting and useful work.

So, although it has become something of a management cliché I would encourage you to embrace your application for ethical approval and think of it as an opportunity to widen the audience for your work, receive constructive criticism and think of it as a useful contribution to your development as a researcher.

Related posts

Human research ethics with the minimum of pain (part one)

Human research ethics with the minimum of pain (part two)

2 thoughts on “Ethical approval – an opportunity for development?

  1. Thanks for this great posting. I’m sure none of us wants to harm our participants. Having a sound Ethics Committee scrutinise your application means less chance of doing so. I also found the process valuable – I really had to think hard about every tiny aspect which meant a much better research design. Opportunity, safety, support.

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