How to write a research protocol

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					How to write a research protocol

Introduction

You will need to write a research protocol to accompany your ethics application –
whether you submit to the IHR ethics committee or to an NHS LREC. You may also
find the production of a protocol useful if you want to include other staff in your
project - for example, as referrers of participants or as interested ward staff – and need
to provide a coherent summary of the project. Essentially the protocol serves as an
introduction to the project content area and as an explicit guide on all aspects of your
proposed methodology. A good protocol will help you in the production of your final
report - partly because you may be able to cut and paste sections (changing all the
tenses, naturally) but mainly because so much of the thinking and planning of the
project will have already been well thought through. A good protocol is evidence that
you have clarified your research project to the point that when it comes to data entry
and analysis, you are confident about the analysis you are going to do and the
implications of this analysis on your research questions.

As I can feel that you are now all convinced of the need for well-written protocols, I
will move on to how to create one.

Structure

A reasonable structure for a protocol would be as follows:

Title
Name of applicant/supervisors/affiliations/version number
Introduction
Method -        Participants
                Design
                Materials
                Procedure
Proposed analysis
Practical issues (e.g., costs/logistics)
Ethical concerns
Timescale
Appendices
References

However, this is reasonably flexible and can be adapted to the specifics of your
project.

Introduction

Note here that I am leaping straight to Introduction but a nice, concise but inclusive
title is always necessary.

Think of the introduction to the protocol as similar to the introduction to a lab report
(remember them?) but instead of outlining what you have done, you are detailing
what you are going to do. Firstly, you need to outline the content area, with relevant
references. In essence you are providing a short literature review. The structure of this
first section of the introduction needs to flow well. Different aspects of the project
need to be coherently linked and not appear as separate paragraphs with no obvious
relation. At the end of the first part of the introduction, your readers need to know 1)
what is the general project area, 2) what relevant research has been done so far and 3)
what is good/bad/indifferent about this research. You should aim to finish this section
with a statement which is a logical summary of the state of play research-wise at the
moment and which makes a solid case for your research project to be carried out. For
example,

‘As has been argued, although concepts of control and attributional style have been
measured in people with Parkinson’s disease, the impact of these on psychological
outcome is still unclear. The small number of studies relating control to psychological
outcome all report different conclusions and are all hampered by methodological
problems such as underpowering, diverse inclusion criteria and the use of
unvalidated outcome measures. Clearly the need to investigate comprehensively
control and attributional style remains an important research objective.’

The next part of the introduction should set out how you aim to rectify these
methodological anomalies. For example,

‘In this study, it is proposed that a sample of 150 is used to address adequately issues
of statistical power. In addition, all assessments will use well-validated outcome
measures, the inclusion criteria are explicit and diagnoses of idiopathic Parkinson’s
disease will be confirmed by a neurology consultant.’

Next to come will be your aims and hypotheses/research questions.

For quantitative projects: You need a formal specification of your hypothesis/es.
Hypotheses should be backed up by the preceding literature review. It is no point
hypothesising gender differences on x, when no justification or lead-up to this has
been included earlier. And don’t specify the null hypothesis – that’s not appropriate at
this level. Don’t go overboard on the number of hypotheses you are making – more
than four would be generally some cause for concern.

For qualitative projects: You need to give the reader some idea of what your research
question(s) are, and how you are going to answer it/them. For example,

‘For this grounded theory study a small sample of people with arachnophobia will be
interviewed about their experiences of the condition and then a theoretical model will
be constructed using the Strauss & Corbin (1998) guidelines. This will then be tested
by interviewing an agoraphobic sample, to see whether it is a model of general
anxiety or whether it has identified something specific about fear of spiders’

Method: Participants

You will need to be explicit about your inclusion and exclusion criteria. Are you
going to include a specific age range? Then be explicit. Remember that ethics
committees don’t like arbitrary older cut-offs – i.e. ‘people from the age of 18-65 will
be included in the study’. How is your sample going to be selected? Especially for
quantitative research, it needs to be as representative as possible with as little
possibility for a biased selection procedure. What demographic details are going to be
taken? How has the number of the participants been decided? If it is a quantitative
study, you need to include a power calculation or, if it is a qualitative study, you need
to justify numbers on a more theoretical basis. If you include a power analysis, make
sure that your hypothesis, power analysis and proposed analysis section all tie up. For
example, it is pointless hypothesising a between group difference and then including a
power analysis done on regression and talking about within subjects t test in the
results.

Method: Design

For a quantitative study, the design section is straightforward – is it a within or
between subjects design? Or a mixed design, which has elements of both? What is/are
the outcome measures? What special ‘design’ features have you included to ensure
the validity of your study?

Similar issues about validity are also relevant in qualitative research. Are you going to
attempt triangulation? Will your analysis include ‘counter–examples? What about
Guba and Lincoln’s three threats to validity – reactivity, respondent biases and
researcher biases/ how will you deal with these?


Method: Materials

For most of you, in quantitative research, your materials will be the questionnaires
you administer or, in qualitative research, the interview schedule. If you are using
standardised questionnaires, you should include information on the questionnaire’s
reliability and validity. This information is usually included in the original paper (or
pack) including the questionnaire. You should also justify the questionnaire’s use with
your sample if your sample is in some way different from the original sample on
which the questionnaire was validated. For example, how useful is the BDI in people
who suffered stroke? As well as giving these details, you would also need to append
the actual questionnaires at the end of your protocol.

Method: Procedure

You need to provide a very detailed account of exactly how patients are going to be
referred into your study, what happens to them during the study (i.e. the ordering of
the administration of the questionnaires, for example) and for how long, and
afterwards, at any follow-up. Consent procedures should also be explicit. In
qualitative research, there could well be some checking of the conclusions with
participants so you will also need to include this. Particularly in qualitative research
you need to be explicit about how you are going to record/transcribe the interviews.
Remember that you need to do this – the course does not encourage or pay for
external transcribers.

Proposed analysis
Obviously you can’t include in the protocol your actual results - unless you have
powers you have omitted to mention at interview. What you do include, though, is
your proposed analysis and in detail. In quantitative studies, for example, it is not
enough for you to say that ANOVA, for example, will be used to analyse the data.
Unless you are using a very simple between group ANOVA then you are likely to
have several main effects or interactions. Which one/s are you predicting will be
significant? A further problem is that although there might be three hypotheses, only
one analysis technique is mentioned. If you have multiple hypotheses then you need
to be explicit about how you are going to analyse each one. Remember that it is also
important to indicate that you will be looking in very close detail at your data before
you plod on with your analyses. How are you going to deal with missing data points?
Are you going to test for normality of distribution if you planning on using a
parametric tests (YES!)?

In qualitative research, it is important to specify the data analytic techniques which
will be used. How are you going to identify themes, for example? You need to back
up your strategy with references from key theorists from the particular paradigm you
wish to employ. In grounded theory research, for example, the data analytic strategy is
likely to include open coding, axial coding and the generation of a theoretical model.
Ensure that there is sufficient detail in your proposed strategy section for readers to be
convinced that you know what you are talking about.

Practical issues

Will you need training before you can administer any of the tests? Have you got room
bookings sorted out so you know where you are going to be seeing your participants?
Are you making home visits – in which case have you consulted with your Trust’s
home visits policy? Who is going to cover the costs of photocopying? (usually the
course). Where is the data going to be stored and does this comply with legislation
and good practice policy? Think logistically about the practicalities of your research
and indicate that you have thought things through.

Ethical concerns

Provide a realistic assessment of the ethical considerations of your project. If you are
asking for any indication of mood, this could have implications – how would you deal
with someone getting very upset after the completing the BDI? Is it ethical to offer an
intervention to one group and not another? If you are including any type of deception
(false feedback etc), could this be avoided? What could be the after-effects of your
project? Are you asking for details (e.g., socio-economic data) which some
participants might find intrusive? If you find evidence of abuse in a project involving
children how will you deal with this?

Timescale

When will your project start and when will it end? Is there any eventuality in which
the data collection period might be extended? When and how will the results be fed
back to participants?
Appendices

You need to list the appendices you have included with your protocol. These should
include paper versions of all the tests you are using. If you are using computerised
versions of tests, provide a verbal description. You should also append participant
information sheets (and there could be several depending on the type of study you are
doing), patient consent forms (ditto) and any advertising materials (i.e. posters to put
around campus). You might also wish to append supporting statements – e.g., from
clinicians who would be referring your study’s patients.

For example:

Appendix 1:    Beck Depression Inventory (BDI: Beck et al., 1967)
Appendix 2:    Love of Chocolate Questionnaire (LCQ: Lindt et al, 1921)
Etc

References

You need to include full references for all your cited works.


Conclusions

The aim of your protocol is to provide a comprehensive guide to your project so
interested parties understand all the relevant details. You need to have the following
objectives in your mind when you write it:

1) will the reader be convinced there is a real need to do this research?
2) will the reader think my suggested methodology is appropriate?
3) will the reader be able to understand what I propose to do?
4) will the reader be convinced that I have thought about all the practical aspects of
the project
5) will the reader think this is an ethical project and that if there are slight risks
(which, let’s face it, are inherent in most research) that these are outweighed by the
potential longer term benefits?

Excluding appendices, 6-10 pages would be about appropriate although this should be
spread across the various sections. Two pages of introduction are likely to be the
maximum you should include. Readers want concise introductions - not long
rambling tracts which include whole sections from DSMlV. Robson (2002) suggests
regarding the reader of your protocol as a cross between an intelligent layperson and a
generalist in the discipline and this seems about right in terms of the tone of your
protocol.


References

Brooks, N. (1996). Writing a grant application. In G.Parry & F.N.Watts (Eds.),
Behavioural and Mental Health Research: A Handbook of Skills and Methods (second
edition). Hove Erlbaum.
Robson, C. (2002). Real world research (second edition). Oxford: Blackwell. See
Appendix A: Writing a research proposal (pp 526-533).