Article type spotlight: Study Protocols and Registered Reports
| 27 June, 2025 | Jack Nash |
Over recent years, many researchers have alluded to a ‘reproducibility crisis’, where many studies are difficult or impossible to reproduce, raising questions about the findings. 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 Wellcome 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 prevent the manipulation of results and increase the repeatability of published studies.
What is a Study Protocol?
Study Protocols are an article type available to authors publishing with Wellcome 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 which 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 prevents studies from being altered following the collection of data. The ‘reproducibility crisis’ has been recognised for several years now and is believed to be, in part, caused by the publication of altered research to give more favourable results. By publishing the methods in advance, it can help prevent manipulation of results.
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 Wellcome Open Research
Wellcome 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 and Registered Reports on Wellcome Open Research.
Therapeutic drug monitoring for antimicrobial agents for people living with HIV (TAP)
Antimicrobial resistance is rising, putting people with HIV at higher risk due to interactions between antiretrovirals and antibiotics. However, data on antibiotic concentrations in the blood of people with HIV is limited.
Researchers from the Makerere University Infectious Diseases Institute in Uganda propose a study design to determine the concentrations of selected antimicrobial agents in individuals living with HIV who require antimicrobial therapy. Additionally, they aim to assess the utility of therapeutic drug monitoring in achieving therapeutic targets for people living with HIV receiving rifampicin and isoniazid for the treatment of tuberculosis.
Read the full Study Protocol here.
Stage 2 Registered Report: Variation in neurodevelopmental outcomes in children with sex chromosome trisomies: testing the double hit hypothesis
The presence of an extra sex chromosome is associated with an increased rate of neurodevelopmental difficulties involving language. The ‘double hit’ hypothesis proposes that the adverse impact of the extra sex chromosome is amplified when genes that are expressed from the sex chromosomes interact with non-sex chromosomes (autosomes).
Researchers from the University of Oxford, United Kingdom, aimed to test the ‘double hit’ hypothesis by analysing data from children with an additional sex chromosome, for example XXX, XXY and XYY, on their language ability and neurodevelopmental challenges.
Read about their full study, results and conclusion in the following Registered Report.
Join the hundreds of authors already publishing Study Protocols, submit yours to Wellcome Open Research today.