Preregistration of animal study protocols
ThemesPreregistration of animal study protocols
What is this about?
Preregistration is the act of registering research protocols before conducting the experiments. It enables to state in advance the type of study (exploratory or confirmatory), hypotheses, methodological design and statistical plan that are going to be used.
Preregistration of animal studies belongs to the Open Science movement and enables a comprehensive overview of all (registered) studies, including those that might otherwise remain unpublished. Therefore, it promotes transparency and research rigour.
Although this process is rather common in clinical research, it is not yet standard practice in the preclinical field. According to recent reviews, initiatives are present to promote preregistration of animal studies, but the uptake remains slow [1]
[1] Baker M. Animal registries aim to reduce bias. Nature. 2019;573(7773):297-8, doi:10.1038/d41586-019-02676-4Why is this important?
Preregistration prevents several biases often occurring in preclinical experiments and promote responsible & robust animal research. By reducing these biases, researchers increase the value and reliability of their studies and contribute to better science.
- The overview created by preregistration enables to counter publication bias by making these studies available regardless of their results.
- Preregistration enables to compare final publications and (pre)registered protocols, which increase transparency and reduce reporting bias, such as selective outcomes reporting.
- By stating in advance hypotheses and statistical plans, preregistration reduces misconducts like HARKing (Hypothesis After Results are Known) and p-hacking.
- The free access of study protocols enables to verify which studies are or were conducted and hence permits to avoid unnecessary duplication of animal studies.
- Most preregistration forms request information linked to internal validity (e.g., randomisation, blinding, sample size calculation), which may impact study design robustness and reporting.
For whom is this important?
What are the best practices?
The best practice is to preregister study protocols online in a registry. When describing their study designs, researchers should be as transparent and complete as possible.
To date, only two reliable animal registries are available:Preclinicaltrials.eu and the Animal Study Registry.
It is also possible to use general registries, e.g. the Open Science Framework, however the registration forms will not be tailored to animal studies specifically.
If a study could not be preregistered, it is still worthwhile to register its protocol at a later stage; especially if the study could not be published. Although, prospective registration (i.e., registration before the experiments) should be encouraged.In Detail
Preclinicaltrials.eu is an international registration platform dedicated to animal studies that was launched in 2018 by a team of Dutch researchers. With several features, the platform permits a fast and efficient (pre)registration, data sharing, and collaboration:
- Free to access and use, with a short and focussed form to facilitate preregistration.
- Preregistration under embargo is available to protect privacy and intellectual property. Protocols also receive a time-stamp to prove authenticity.
- Track changed amendments are available to enable flexibility.
- Anonymised personal details and required login to view protocols ensure confidentiality.
- Protocol get a persistent identifier to use in grants or papers, which promotes FAIR data.
- Researchers from the same field or working on similar topics can reach each other via encrypted messages and form collaborations.
Moreover, preclinicaltrials.eu provides several resources to guide researchers with their preregistration.
To know more about this registry, you may check their introduction video: https://www.youtube.com/watch?v=xYjLvDBTsV4
More knowledge on how to use the platform can be seen on this walkthrough: https://www.youtube.com/watch?v=qLu1fXYumyk
For further information on preregistering at Preclinicaltrials.eu, you may check the registry's website: www.preclinicaltrials.eu or e-mail the Preclinicaltrials.eu team at info@preclinicaltrials.euJulia contributed to this theme. Latest contribution was Jul 14, 2021
