Research protocol

Research proposals usually lack sufficient detail to carry out your research. What you need are operating procedures (why, what, how) that will enable colleagues to take over if you should fall ill or accept another job.

What is a research protocol and why is it imporant?

Research protocols (or plans) are manuals of operation in which details are important. It is really a recipe book, detailing exactly what you are going to measure, when and how. A research protocol may also include several appendices describing exact procedures and measurement instruments such as, for example, a (statistical) analysis plan , questionnaires, scripts for interviews, instructions for handgrip strength measurement, etc. They serve you if you have forgotten particular details of the plan and allow others to take over seamlessly, should you be unavailable for some time. Together with your daily research logbook, a good protocol will also serve you later in writing your report or papers.

We encourage you to make your research proposal publicly available via preregistration .

How to write a research proposal?

Templates for trial protocols include many features that may inspire you even when you are dealing with quite another study design. In particular if you are trying to answer a causal question using an non-randomized design . An internet search (e.g. “irb study protocol template”) on institutional review board (IRB and templates) may uncover helpful advice on how to write a protocol for various types of studies. Studies falling under the WMO may use the CCMO protocol template . For orientation, try to determine what kind of study design you will be using. One may roughly distinguish the following designs:

  1. descriptive (e.g. a survey)
  2. diagnostic (discriminatory performance of some test; test-retest reliability)
  3. prognostic-descriptive (cohort of participants with some characteristic (which may be an illness) followed over time)
  4. prognostic-intervention ((randomized) cohort)
  5. literature reviews
  6. qualitative studies (see the chapter on that)
  7. mixed methods designs (e.g. a combination of #6 and #3)

Additional advice and further reading

  • Consult reporting guidelines for your study design. Although they seem to be designed for the writing phase, chances are that they will give you ideas for what to think of right now, in order to write about it when you start writing papers. E.g. If you are planning a (randomized) trial, consult SPIRIT, the special guideline for trial protocols . If you are planning a systematic review or meta-analysis, consult PRISMA-P, the special guideline for review protocols .
  • Consult risk of bias tools . They too may provide useful ideas on what to measure, when and how.
  • Many studies burden participants with measurements that are not used. So attempts to focus on key variables are useful, also from an ethics, privacy and a cost perspective. Check out the concept of directed acyclic graphs (DAGs) to help you measure those determinants, and those only (efficiency!), that will allow you to draw valid conclusions from your data.
  • If you need formal ethics approval , develop your protocol in that process. Then use (slightly edited) sections of that text for your preregistration activities in NTR or UvA/HvA figshare.

Published by  Urban Vitality 12 June 2023