Preregistration leads to a time-stamped, non-modifiable, public record of your research protocol (and analysis plan). Preregistration counteracts selective publication or suppression of results.

What is preregistration?

Preregistration leads to a time-stamped, non-modifiable record of detailed research (and analysis) plans made publicly available very early in the research process. As such, it is an important building block in a wider system to counteract the suppression (or selective publication) of research results and (harmful) publication bias .

Preregistration in qualitative research?

One may argue that, in qualitative and action-oriented research, preregistration of research designs and analysis plans is less relevant, because qualitative research is flexible and the research processes are iterative. Still, we propose you preregister your general research plan for qualitative research too, because making the plan available for the research community will enhance transparency and credibility. Still skeptical? Read

Why is preregistration important?

Pre-registration is no cure-all. There is excellent research that has not been preregistered and research that has been preregistered can be poor. Nevertheless, we believe that if used correctly, preregistration will help making the world’s total scientific record more reliable. Preregistration counteracts suppression (or selective publication) of results and publication bias . It helps provide an unbiased public record of all research findings worldwide. Preregistration also prevents data dredging and finally, with preregistration you provide examples for others who are writing a protocol or analysis plan.

What may happen if you do not preregister?

That depends. If you want to publish in a journal that follows the International Committee of Medical Journal Editors (ICMJE) policies, preregister on a platform that ICMJE recognizes. For the list of journals, see . On the homepage, under the "Resources" section, find a link to the "Journals stating that they follow the ICMJE Recommendations". See under ‘Where should you preregister?’ in the current document’ to learn which platforms ICMJE accepts.

If you foresee to publish elsewhere (your study is either not a clinical trial as defined by ICMJE or outcomes are not measured at the patient level, see below), we still advise you to preregister, but no editor will prevent you from publishing if you don’t. See under ‘Where should you preregister?’ in the current document’ to learn which other platforms may be used besides

So, apart from the broader consequences for the reliability of the global scientific record, you and your team may face consequences from not preregistering because the International Committee of Medical Journal Editors (ICMJE) requires preregistration for clinical trials. A very large number of medical journals are members of ICMJE . ICMJE defines a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups (our underlining), to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include [..], devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.” ICMJE also states that “Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal.” What if the subjects in your project are healthcare providers and not patients? ICMJE requires that “if the purpose of the trial is to examine the effect of the provider intervention on the health outcomes of the providers' patients, then investigators should register the trial. If the purpose is to examine the effect only on the providers (for example, provider knowledge or attitudes), then registration is not necessary.”

To summarize, if your study is a clinical trial (according to ICMJE criteria) and at least one outcome measurement is at the patient level, preregister at an ICMJE approved platform to prevent problems at the publication stage in ICMJE member journals. In all other cases, please do preregister, but choose a platform of your preference (see below).

How might preregistration of the research protocol and analysis plan benefit you?

First, preregistration creates a strong incentive to carefully write your protocol and analysis plan (early). It also serves as proof (trial registration number, DOI) to editors, reviewers and others that you stuck to your (last amended and time-stamped) protocol/plan. Second, it creates a stronger incentive to do as you promised and to stick to your protocol/plan. Third, preregistration can prove priority of ideas , which still is important to many scholars. Fourth, preregistration increases your readers’ confidence that you are reporting honestly and, therefore, the impact of your work. Fifth, you contribute to the reliability of systematic reviews in which your research may end up.

First, if you make your plans public, others may see what you are planning and scoop you (i.e. copy the idea, do the work and publish (results) before you). Second, preregistration is like voluntarily tying your hands and restricts your flexibility (during data analysis). Sadly, finding fewer statistically significant results might hurt your research career. Let us put these seemingly strong arguments into perspective. First, only seldom will you have truly unique plans. Ideas are in the air most of the time and colleagues are working on very similar stuff. Second, we already explained that voluntarily reducing your data-analytic flexibility is not a bad thing (you gain time and there is less opportunity for data-dredging). Finally, the focus on statistically significant findings is a very poor focus. If you want to understand more about the misinterpretations of p-values and the behaviors that it brings about read what the American Statistical Association has to say on this.

What, when and where?

What should you preregister?

  • For quantitative research: preregister a research protocol and the plan for data analysis (SAP).

  • For qualitative and action-oriented research: preregister the research plan including the study design.

When should you preregister?

  • According to the ICMJE, “best practice dictates registration by the time of first participant consent.”

  • Preregister before data collection starts. Preregister after you have obtained ethics approval by an ethics committee to incorporate any changes that seeking ethics approval may bring about.

  • Should you read this only after your data collection has started, preregister as soon as possible. Registration of a clinical trial protocol after data-analysis started is not considered pre-registration and may prevent you from publishing in journals that follow ICMJE guidance.

Where should you preregister?

  • go to this website and tick the ‘accept’ box and enter ‘Amsterdam’ as Organization (Amsterdam University of Applied Sciences will appear)

  • fill out your name, lectorate, phone number and email address

  • You will receive an email within a few minutes with the following information: Anne de Jong ; Gerben ter Riet

  • They will support you navigating the preregistration platform, although filling out the 24 required fields is your own responsibility.

  • If all fails, contact to support you with obtaining a Protocol Registration and Results System (PRS) account or contact us via this link .

  • In all other cases, we recommend preregistering in UvA/HvA figshare . Note, however, that ICMJE does not recognize a Figshare DOI as a valid preregistration.

  • If you dislike and UvA/HvA figshare for preregistration, consider using the Open Science Framework (OSF). Here are examples of preregistrations on OSF.

Alternatives to preregistration via UvA/HvA figshare or OSF?

You may submit your protocol/plan to

  • an Open Access journal as a formal publication (amendments cannot easily be made, but this approach can be combined with the use of UvA/HvA figshare)

  • a preprint server such as medRχiv . Here you can check if your target journal will accept your manuscript after it has been out on a preprint server.

  • a journal accepting registered reports .

  • a journal that is between a preprint server and a traditional journal, such as F1000 .

Published by  Urban Vitality 24 July 2023