How to write a research protocol

Introduction

You will need to write a research protocol to accompany your ethics application - whether you submit to Lancaster University's Faculty or University ethics committee or though the NHS IRAS system. 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 use and expand on some 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 collection 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 (if relevant)
    • 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. The title should sum up the project.

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 be convinced that your research project: 1) is necessary - and that it is timely; 2) that it should be done in the way that you propose to do it. 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.' Or something similar. The next part of the introduction should set out how you aim to rectify these methodological anomalies. For example, 'Consequently, this study will aim to look at the issues of control and attributional style in people with PD but will address previous methodological inadequacies. For example, 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. 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 the thesis, then think one global hypothesis rather than several smaller ones. If your work is qualitative then again, one research question will probably be enough.

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?

Issues about validity are also relevant in qualitative research. However, make sure that you write these in a way which is consistent with the ethos and methodology of qualitative research. For example, be wary of trying to convince the reader that you are going to eliminate 'bias'. Instead, be more mindful of the need to create audit trails evidencing from where your themes, for example, have emerged, to provide a thoughtful analysis and reflexive analysis and to show how you will attempt to engage your participants in the analysis.

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 have experienced stroke? As well as giving these details, you would also need to append the actual questionnaires at the end of your protocol. If you are appending an interview schedule (e.g., for qualitative research) then please remember that a list of topic areas is fine and you do not have to specific every single question you will ask. Also, please note that a study's 'research question' is different from the questions you indicate in the interview schedule.

Method: Procedure

You need to provide a very detailed account of exactly how participants 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 interview and how you will store the data.

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 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 bring out, themes, for example? You need to back your strategy up with references from key theorists from the particular paradigm you wish to employ. In grounded theory research, for example, the data analytic strategy include open coding, axial coding and the production of a conditional matrix. 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 are 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? What will you do if you uncover worrying aspects of someone's practice? Should your supervisor see transcripts from participants if the Ps are evaluating some aspect of your supervisor's practice? (probably not).

Timescale

When will your project start and when will it end? Is there any eventuality in which data collection period might be extended? When 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), consent to contact forms (if relevant) and any advertising materials (i.e. posters to put around campus/in GP surgeries). You might also wish to append supporting statements - e.g., from clinicians who would be referring your study's participants.

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. You don't have to do these in APA style but you might want to get into the habit early... Work at this stage can mean one less thing to do when you are approaching the submission stage.

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 (double-spaced) 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).