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Developing a protocol

Pre-specifying your Research Question and Writing a Study Protocol🔗

Briefly, pre-specifying your research question and developing a study protocol which outlines your methodology is an important open science principle. There are several benefits to developing a protocol:

  • It reduces "researcher degrees of freedom" and minimises the risk of questionable research practices such as "hypothesising after the results are known" (HARKing) or p-hacking;
  • It increases replicability by explaining the “why” of each analytic decision (whereas study code only tells you the “what”);
  • It allows you to get feedback from colleagues and potentially identify problems early on in the process, before writing code;
  • It forces you to think carefully about your planned analysis before it takes place;
  • It can help set a reasonable scope for the project;
  • It makes writing the manuscript easier.

Taken together, this can improve both the quality and credibility of your research. Developing a detailed study plan, including figure and table shells, can be particularly helpful when using a federated analytics platform such as OpenSAFELY, as there is less scope for interactively developing these whilst working with the data.

You can choose to pre-register your protocol formally on OSF or ENCePP, or informally by uploading and committing "locked" and timestamped protocol versions to GitHub. You can see examples of protocols we've written for OpenSAFELY studies on most of our public repositories — for example this inhaled corticosteroid (ICS) research repository or this ethnicity research repository.

If you're interested, two good resources on the benefits, and challenges, of preregistering your research are available here and here.