Preregistration (science)
Finally, registered reports include the peer review and in principle acceptance of a study protocol prior to data collection.[8] A number of research practices such as p-hacking, publication bias, data dredging, inappropriate forms of post hoc analysis, and HARKing may increase the probability of incorrect claims.Although the idea of preregistration is old,[9] the practice of preregistering studies has gained prominence to mitigate to some of the issues that are thought to underlie the replication crisis.[10] The registered report format requires authors to submit a description of the study methods and analyses prior to data collection.ClinicalTrials.gov, run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials, and remains the largest and most widely used.First, the then-New York State Attorney General Eliot Spitzer sued GlaxoSmithKline (GSK) because they had failed to reveal results from trials showing that certain antidepressants might be harmful.In 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) clarified the requirements for registration and also set penalties for non-compliance (Public Law 110-85.Released in October 2008, the revised Declaration of Helsinki, states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.[37] WHO states that the international registry's mission is "to ensure that a complete view of research is accessible to all those involved in health care decision making.The non-publication of results gained from animal experiments not only distorts the state of research by reinforcing the publication bias, it further represents an ethical issue.[52] The editor-in-chief also noted that the editorial staff will be asking for replication of studies with surprising findings from examinations using small sample sizes before allowing the manuscripts to be published.[53] European Journal of Personality defines this format: “In a registered report, authors create a study proposal that includes theoretical and empirical background, research questions/hypotheses, and pilot data (if available).[59][60] In addition, preregistration has been shown to encourage better learning of Open Science concepts and students felt that they understood their dissertation and it improved the clarity of the manuscript writing, promoted rigour and were more likely to avoid questionable research practices.[90] Pre-registration imposes rigidity, limiting researchers' ability to adapt to emerging data and evolving contexts, which are essential to capturing the richness of participants' lived experiences (Souza-Neto & Moyle, 2025).[91] Additionally, it conflicts with the inductive and flexible nature of theory-building in qualitative research, constraining the exploratory approach that is central to this methodology (Souza-Neto & Moyle, 2025).[91] Finally, some commentators have argued that, under some circumstances, preregistration may actually harm science by providing a false sense of credibility to research studies and analyses (Devezer et al., 2020; McPhetres, 2020; Pham & Oh, 2020; Szollosi et al., 2020).