Article type spotlight: Study Protocols and Registered Reports
| 3 December, 2025 | Jack Nash |
Over recent years, many researchers have alluded to a ‘reproducibility crisis’, where many studies are difficult or impossible to reproduce. So, how can researchers make their work more reproducible? We’ve covered some methods in a previous blog post; however, the diverse article types available to authors publishing on Gates Open Research also offer a solution to this challenge.
In this blog post, we discuss Study Protocols and Registered Reports, and how they can be utilised to provide a permanent and detailed record of methods so others can better evaluate, assess, and reproduce their research.
What is a Study Protocol?
Study Protocols are an article type available to authors publishing with Gates Open Research that describe in detail any study design. This includes the experimental design of basic and applied research, systematic reviews, or protocols defining research questions and empirical methods.
Study Protocols typically contain the introduction and methods sections of a standard Research Article (or other article types, such as Systematic Reviews), without including the results and discussion sections. In most cases, this is because the authors have not yet begun collecting their data; however, there are exceptions, such as when cohort data is to be analysed as part of the research.
Why should I publish my research as a Study Protocol?
One of the main advantages of publishing your research as a Study Protocol is that the methods can be peer reviewed before undertaking the work described within it. Reviewers will evaluate the outlined Protocol, including any statistical analyses you plan to perform on the collected data, and provide feedback that you can consider when performing the methods outlined in the Study Protocol.
It’s not just you, as the author, who benefits from publishing your work as a Study Protocol; the wider research community also benefits, as it provides a permanent and detailed record of methods, allowing others to evaluate and reproduce your research.
Publishing a Study Protocol doesn’t mean you have to publish the results in the same journal or even publish them at all. Your circumstances may change between publishing the Study Protocol and performing the work outlined in the Protocol. Any methods published are still a useful contribution to academic literature, allowing the work to be used and cited by other groups with similar ideas in the future.
How are Registered Reports related to Study Protocols?
Registered Reports follow on from the published Study Protocol and ensure that there is consistency between the Study Protocol and the full Research Article, with no manipulation of the results (such as the exclusion of negative or null results) or changes to the hypothesis to fit the results. Any changes or additions are clearly outlined for readers to see, which helps mitigate publication bias.
As such, Registered Reports are carried out in 2 stages:
- Stage 1: Study Protocol submission, publication and peer review
- Stage 2: Research Article submission, publication and peer review
Submitting your work as a Stage 2 Registered Report is very similar to a traditional Research Article submission, with the following additions:
- “Stage 2 Registered Report” included in the title
- Abstract links to the Approved Study Protocol
- If any additional analyses not outlined in the Study Protocol were carried out when preparing the Research Article, these should be outlined in a separate section within the results titled “Exploratory analyses”
The same peer reviewers who reviewed the Study Protocol will be invited to review the full Registered Report. This approach is best for transparency, ensuring that readers can trust the methods have been followed as described in the initial Protocol (unless a justification has been provided) and preventing the analysis and outcomes from being manipulated to obtain the desired results.
Study Protocols and Registered Reports on Gates Open Research
Gates Open Research’s approach to Registered Reports means that both stages of the Registered Report are available as citable publications, as well as the peer review reports and any changes, either between versions or stages.
Below, we’ve highlighted some examples of Study Protocols on Gates Open Research.
Study protocol for UNICEF and WHO estimates of global, regional, and national low birthweight prevalence for 2000 to 2020
Reducing low birthweight (LBW, weight at birth less than 2,500g) prevalence by at least 30% between 2012 and 2025 is a target endorsed by the World Health Assembly that can contribute to achieving Sustainable Development Goal 2 (Zero Hunger) by 2030. The 2019 LBW estimates indicated a global prevalence of 14.6% (20.5 million newborns) in 2015. However, much of the data needed to attain accurate estimates globally is not available.
The following Method Article aims to develop updated methods to estimate low birthweight (LBW) prevalence globally, regionally, and nationally for the years 2000 to 2020. The study will utilize national administrative data and population-based surveys, employing a Bayesian multilevel-mixed regression model for estimation while highlighting existing data gaps, particularly in low- and middle-income countries. Updated estimates are crucial for tracking progress towards nutrition targets and improving birthweight measurement practices.
Read the full Study Protocol here.
The Brain Imaging for Global Health (BRIGHT) Project: Longitudinal cohort Study Protocol
The first 1000 days of life, which describes the developmental period between conception and two years of age, is a critical window for brain development, during which influence from environmental factors is at its greatest. According to UNICEF, 19.5% of the world’s children live in poverty, the majority of whom reside within sub-Saharan Africa (51.7%) and South Asia (35.7%). Infants and children growing up in poverty may be exposed to a range of biological and/or psychosocial risk factors both pre- and postnatally. Such risk factors include lower parental income and educational level, parental mental health issues, reduced access to recreational and educational activities (particularly in rural communities), undernutrition, food insecurity, environmental hazards and poor sanitation.
The Brain Imaging for Global Health (BRIGHT) project aims to establish brain function reference curves for infants in the UK and rural Gambia, focusing on the impact of early adversity on developmental trajectories. By utilizing portable neuroimaging techniques, the Study Protocol outlines methodologies to understand how various contextual factors, such as family support and undernutrition, influence cognitive development in impoverished settings. The research involves longitudinal data collection from 265 families, with follow-ups planned into early childhood to inform targeted interventions.
Read the full Study Protocol here.
Join other Gates-funded authors already publishing Study Protocols, submit yours to Gates Open Research today.
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