Preregistration

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 https://www.tandfonline.com/doi/full/10.1080/08989621.2019.1580147

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 www.icmje.org . 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 clinicaltrials.gov.

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).