Publications: A study protocol

In my last post I discussed authorship and credit and the difficult situations we can find ourselves in. This type of thing can sometimes be avoided with planning. You may not have this level of control in every project you’re involved in. But if you can even suggest creating a protocol at the beginning of the project, this will go a long way in avoiding hassles at the end.

The World Health Organization has a suggested format for a study protocol that you could use. It may work for you, but it may not.

I was given a rough template by my supervisor that I’ve ended up modifying quite a bit for my purposes. I thought I’d list out the headings I use in this document as you might find them helpful too. (N.B., this is for psychology research, so you may need more headings/different headings etc, depending on your area).

Rationale and background information

This is a brief literature review and background on the topic directly relevant to the study. I often end up cutting and pasting this into the ethics application and using a modified version of this in the final paper too. This section often ends up about 2 pages, double spaced (roughly).

Study aims, objectives, and hypotheses

This is pretty self-explanatory, but it is good to get these clear from the outset rather than running a study and then trying to work out what your aim was.

Study design and participants

I like to write out the design (i.e., experimental? Correlational? Between-subjects design? Within-subjects design? Mixed design?) and describe the target sample. Are you using rats? Humans? First year psychology students? MTurk participants? Are you paying them? Are they volunteering their time? How will you recruit them? I also like to include a power analysis in this section.

Procedure

Here I list the procedure of the study. I like to do this in bullet points, like steps in a recipe. But I modify this when writing it up in the paper. But for the protocol I like to write it out in whatever way makes sense. So this may be a diagram, a flowchart, or bullet points. This includes a list of measures I will use. For example, if step 1 is “personality assessment”, I list all the measures I intend to use and cite them properly.

Statistical analysis

Here I write out how I intend to analyse the data. Sometimes, if it is complicated, I will list each variable that I expect to see in my dataset, how it is measured (categorical? continuous?), and what the outcomes or dependent variables are. Other times I keep if a little vague, knowing I will do a regression or an ANOVA etc.

Safety considerations

Are there any risks to yourself or your participants in this project that you should be mindful of? List them here.

Data management

Where will the data be stored? Online repository (I.e. open access?)  Identified or de-identified or anonymous? Who will have access to it? 

Duration of the project

How long do you think it will take to run the study?

Project management

This is where I bring in the he CRediT (Contributor Roles Taxonomy) that I mentioned in my previous post.

Budget and funding

Insert budget if necessary

Other

Any conflicts of interests? Which journal are you aiming for with this paper?

References

Insert a reference list

List of measures used

This section really helps me to visualise the study and spot potential problems. I will write out each measure that the participants will see, in the order they will see it. Write out tasks that they will undertake etc.

That is how I structure my study protocols. I don’t see any of it as a waste of time. Most of the sections you write here will probably be used in your ethics application or in your final paper. Otherwise, writing it out in full here can help you spot potential problems early. Lastly, it may help with the authorship issue if it is clear from the beginning who is in charge of what. Do you use a study protocol? What has helped you in this planning process?

– Alessa

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