2.1.11 Preregistration

​​​​A. Background & Definitions

Preregistration ​​refers to a process of registration of study protocol and data analysis plan before conducting a study.

Registered Report is a maximal form of registration, in which study manuscript that includes the study hypothesis, ration­ale, methods, experimental protocol and a detailed analysis plan is peer reviewed (Stage 1) before study data is collected. After data collection, the final manuscript that includes results and discussion sections undergoes a conventional peer review (Stage 2) where adherence to the original (Stage 1) procedures is confirmed. Following favorable reviews and, regardless of study results, the manuscript is accepted for publication (Munafo et al. 2017​, BMJ Open Science, Registered Reports Guidelines​).

Benefits of preregistration:

• Increases transparency
• Saves resources by avoiding unnecessary duplication of efforts
• Serves to reduce:
  • The risk of publication bias
  • "HARKing" (hypothesizing after the results are known)
  • P-hacking (analytical decisions after the results are known)
  • In case of a Registered Report, registration helps also against "CARKing" (unjustified critique of the article by reviewers after the results are known; Munafo et al. 2017​).

B. Guidance & Expectations

• ​If study is done to inform a knowledge claim (2.1.4 Purpose of research​), it is strongly recommended to preregister the study protocol before data are collected.
• It is strongly recommended to register systematic review protocols.
• Training on planning and benefits of preregistration is highly recommended.

​PL​​EASE DO NOT FORGET

• ​​To consider adding this subject to a training program for new employees or refresher training (if appropriate)​
• To check for risks of disclosing confidential or otherwise sensitive or proprietary information (e.g. in the context of existing or emerging intellectual property)​​

C. Resources

Online registry platforms: ​

• Specialized platforms
  • Preclinicaltrials.eu
  • Animal Study Registry
  • OSF for Reg​​​istere​​d Reports​
  • PROSPERO, a platform for reg​​istering a systema​tic​ review of animal studies​
• Broad scope platforms
  • AsPredicted
  • Center for Open Science
• Platform comparison

Publications:

• Nosek BA, Ebersole CR​​, DeHaven AC et al. (2018) The preregistr​ation revolution. Proc Natl Acad Sci U S A. 115:2600-2606. PubMed [1]
• De V​​ries RBM, Hooijmans CR, Langendam MW, et al. (2015) A protocol format for the preparation, registration and publication of systematic reviews of animal intervention studies. Evid Based Preclin Med. 2:1–9. [2]​
• Pre-registration and Registered Reports - A primer from the UK Reproducibility Network

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