Guidelines for Article Preparation for Submission
Preparing a Study Protocol article
This page provides information about writing a Study Protocol article for Gates Open Research, including the key sections
that must be present in the article and details of figure and table formats
. Please also refer to Gates Open Research’s editorial policies
Gates Open Research’s scope covers all original research in any of the areas funded by the Gates Foundation, including global health and development, agriculture and education, and we welcome protocols for any study design in these Gates-funded areas. This includes experimental design of basic, translational and applied research, epidemiological studies and systematic reviews, or protocols defining research questions and empirical methods in global development, economics or education.
Study protocols for pilot and feasibility studies will also be considered.
All protocols for randomised clinical trials must be registered and follow the SPIRIT guidelines
. Protocols for systematic reviews should be registered and must follow the PRISMA-P guidelines
Submission to Gates Open Research is limited to Gates-funded researchers.
All articles must be written in good English. Please note that the article will not undergo editing by Gates Open Research before publication and a manuscript may be rejected during the initial checking process if it is deemed unintelligible and hence not suitable for peer review.
For authors whose first language is not English, it may be beneficial to have the manuscript read by a native English speaker with scientific expertise. There are many commercial editing services that can provide this service at a cost to the authors.
- Main Body
- Data (and Software) Availability
- Reporting Guidelines (if applicable)
- Author Contributions
- Competing Interests
- Grant Information
- Acknowledgments (optional)
- Supplementary Material
- Figures and Tables (if applicable)
- Images (if applicable)
Please list all authors who played a significant role in developing the points presented in the article.
- provide full affiliation information (full institutional address and ZIP code, and e-mail address) for all authors, and
- indicate who is/are the corresponding author(s).
Criteria for authorship are based on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals
. Being an author implies full responsibility for the article’s content and that the work conforms to our editorial policies
. For large, multi-centre collaborations, the individuals who accept direct responsibility for the manuscript must be listed as authors.
Details of each author’s contribution must be listed in the Author contributions
Anyone who has contributed but does not meet the criteria for authorship should be listed in the Acknowledgments
section. The involvement of any professional medical writer assistance must be declared.
Please provide a concise and specific title that clearly reflects the content of the article.
Abstracts should be up to 300 words long and provide a succinct summary of the article. Although the abstract should explain why the article might be interesting, the importance of the work should not be over-emphasized. Citations should not be used in the abstract. Abbreviations, if needed, should be spelled out. For original research, we suggest that (if applicable) abstracts are structured into Background, Methods, Results, and Conclusions.
Authors should supply up to eight relevant keywords that describe the subject of their article. These will improve the visibility of your article.
The format of the main body of the article is flexible: it should be concise, making it easy to read and review, and presented in a format that is appropriate for the type of study presented.
For most Study Protocols, the following standard format will be the most appropriate:
Please include a clear rationale for the study, as well as a detailed description of the protocol, including:
- How the sample is to be selected
- Interventions to be measured
- Sample size calculation - i.e. expected number of participants to make the outcome significant
- Primary outcomes to be measured, as well as a list of secondary outcomes
- Data analysis and statistical plan
- Details of any ethical issues relating to the study (and of the ethical approval received).
- Plans for dissemination of the study outcome (including the associated data) once completed.
All research must have been conducted within an appropriate ethical framework. Details of approval by the authors’ institution or an ethics committee must be provided in the Methods section. Please refer to the detailed ’Ethics’ section in our editorial policies
for more information.
If the data associated with your article relate to a clinical trial then the Trial Registration details must be provided: name of registry, registry number, registration date and URL of the trial in the registry database. We support the public disclosure of all clinical trial results (as mandated in the US FDA Amendments Act, 2007), for example on a public website, such as clinicaltrials.gov. The disclosure of results on such sites does not preclude the publication of articles reporting and/or analyzing the same datasets in Gates Open Research. For further details about trial registration, see our editorial policies
. Articles in Gates Open Research that report randomised clinical trial protocols must follow the SPIRIT guidelines
. For reporting of the intervention methodology itself, Gates Open Research endorses the TIDieR checklist
, an extension of the CONSORT statement. We ask authors to include a completed SPIRIT checklist with their study protocol, which will be included in the Reporting Guidelines section of the article when published.
Systematic reviews: Gates Open Research encourages authors to register the protocol for their Systematic Review prospectively in the PROSPERO database. Details of the protocol registration should be included in the final systematic review article.
Gates Open Research endorses the PRISMA-P Statement; protocols for systematic reviews and meta-analyses must follow the PRISMA-P guidelines. Authors should include a completed PRISMA-P checklist
with their study protocol and this will be included in the Reporting Guidelines section of the article when published.
Sex and gender equity in research:
Gates Open Research endorses the SAGER guidelines
for reporting sex and gender information in study design, data analyses and results. Briefly:
- Authors should ensure that the terms sex and gender are used correctly throughout the article.
- Title/abstract: it should be clear if the results can only be applied to one sex or gender.
- Introduction: if sex and gender differences are expected in the results, these should be stated.
- if sex and gender differences were taken into consideration for the design of the study these should be stated. If they were not taken into consideration, the rationale should be given.
- explanation of how sex of participants was defined should be stated, either based on self-report, assigned following external or internal examination of body characteristics, or through genetic testing or other means.
- Results: data should be presented disaggregated by sex and gender.
- Discussion: implications of sex and gender differences in the results should be discussed. If sex or gender analysis was not conducted, the rationale should be given.
We encourage authors to consult the guidelines before performing their research and when writing their article. Our SAGER guideline checklist can be found here
Data (and Software) Availability
All articles must include a Data Availability statement, even where there is no data associated with the article - see our data guidelines
for more information.
The Data Availability statement should provide full details of how, where, and under what conditions the data underlying the results can be accessed; for practical guidance please see Add a Data Availability statement to your manuscript
. See also Prepare your Data
and Select a Repository
for further guidance on data presentation, formatting and deposition.
If your article has no associated data, the statement should read:
“No data are associated with this article.”
If you are describing new software, please make the source code available on a Version Control System (VCS) such as GitHub, BitBucket or SourceForge, and provide details of the repository and the license under which the software can be used in the article.
For other scenarios, such as where data cannot be shared, please see Add a Data Availability statement to your manuscript
for details of what must be indicated in your Data Availability statement.
There are no figure or table limits for articles in Gates Open Research. Additional materials that support the key claims in the paper but are not absolutely required to follow the study design and analysis of the results, e.g. questionnaires, supporting images or tables, can be included as extended data; descriptions of the materials and methods should be in the main article. Extended data should be in a format that supports reuse under a CC0
license. Care should be taken to ensure that the publication of extended data in this instance does not preclude primary publication elsewhere.
If you have any extended data, please deposit these materials in an approved repository
and include the title, the name of the repository, the DOI or accession number, and license in the manuscript under the subheading ‘Extended data’. Please also include citations to extended data in the main body of the article. For practical guidance please see Add a Data Availability statement to your manuscript
. See also Prepare your Data
and Select a Repository
for further guidance on data presentation, formatting and deposition.
Please note, information which can be used to directly identify participants should not be included in underlying and extended datasets, unless they have provided explicit permission to share their details. Please see our data guidelines for further information.
Articles in Gates Open Research must comply with consensus-based minimum reporting guidelines for research. Comprehensive lists of available reporting guidelines can be found on the EQUATOR network website
for health research.
Checklists are available for a number of reporting guidelines, including:
Please deposit completed reporting checklists and flow charts in an approved general repository; include the guideline type, name of the repository, the DOI, and license in the manuscript’s Data availability statement in the style of, for example:
We are using the CRediT Taxonomy to capture author contributions as we believe that having more detail of who did what brings transparency, enables recognition for researchers, and provides greater accountability for all involved. For more information click here
You do not need to include an Author Contributions section in your manuscript: on submission, you will be asked for the contributions made by each author, to be selected from the list below. Anyone who has contributed but does not meet the criteria for authorship
should be listed in the Acknowledgments
||Ideas; formulation or evolution of overarching research goals and aims.
|Data Curation||Management activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it is necessary for interpreting the data itself) for initial use and later reuse.
||Application of statistical, mathematical, computational, or other formal techniques to analyze or synthesize study data.
||Acquisition of the financial support for the project leading to this publication.
||Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection.
||Development or design of methodology; creation of models.
||Management and coordination responsibility for the research activity planning and execution.
||Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools.
||Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components.
||Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team.
||Verification, whether as a part of the activity or separate, of the overall replication/reproducibility of results/experiments and other research outputs.
||Preparation, creation and/or presentation of the published work, specifically visualization/data presentation.
|Writing – Original Draft Preparation
|| Creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation).
|Writing – Review & Editing
||Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review, commentary or revision – including pre- or post-publication stages.
Articles published in Gates Open Research must not contain content that could be perceived as ‘advertising’ and must include a Competing Interests section. Any financial, personal, or professional competing interests for any of the authors that could be construed to unduly influence the content of the article must be disclosed and will be displayed alongside the article. More information on what might be construed as a competing interest is available in our editorial policies
If you do not have any competing interests, add the text ‘No competing interests were disclosed’.
Please provide details of the Gates Foundation grant(s) that supported the work presented in your article in the following example format:
Bill & Melinda Gates Foundation [OPP124589, OPP438721].
If applicable, please also list any other funders or employers who funded the work. For each funder, please state the funder’s name, the grant number where applicable and known, and the individual to whom the grant was assigned.
Please do not list funding that you have that is not relevant to this specific piece of research.
This section should acknowledge anyone who contributed to the research or the writing of the article but who does not qualify as an author
; please clearly state how they contributed. Authors should obtain permission to include the name and affiliation, from all those mentioned in the Acknowledgments section. Please note that grant funding should not be listed here.
To ensure all materials associated with a manuscript are visible, FAIR, and subject to peer review, Gates Open Research does not accept supplementary material. Additional materials that support the key claims in the paper but are not absolutely required to follow the study design and analysis of the results, e.g. questionnaires, or supporting images or tables, can be included as extended data. Extended data should be deposited in an approved repository and listed as part of the data availability statement. For more information, please see extended data
References can be listed in any standard referencing style as long as it is consistent between references within a given article. However, basic requirements include:
- Journal abbreviations should follow the Index Medicus/MEDLINE abbreviation approach.
- Preprints can be cited and listed in the reference list.
- Only articles, books and book chapters, datasets and abstracts that have been published or are in press, or are available through public e-print/preprint servers/data repositories, may be cited. Unpublished abstracts, papers that have been submitted to a journal but not yet accepted, and personal communications should instead be included in the text; they should be referred to as ‘personal communications’ or ‘unpublished reports’ and the researchers involved should be named. Authors are responsible for getting permission to quote any personal communications from the cited individuals.
- Web links, URLs, and links to the authors’ own websites should be included as hyperlinks within the main body of the article, and not as references.
- References to trials on a clinical trial database should be as follows: [Authors/name of group], [title of the trial], In: ClinicalTrials.gov [cited year month date], Available from [URL of the link from ClinicalTrials.gov].
- Datasets published or deposited elsewhere (for example, in figshare, Dryad, etc.) should be listed in the "References" section and the citation to the dataset should follow one of these examples.
Figures and Tables
All figures and tables should be cited and discussed in the article text. There is no limit to the number of figures and tables you can have. Figure legends and tables should be added at the end of the manuscript.
Tables should be formatted using the ‘insert table’ function in Word, or provided as an Excel file. For larger tables or spreadsheets of data, please see our data guidelines
. Files for figures are usually best uploaded as separate files through the submission system (see below for information on formats).
Any photographs must be accompanied by written consent to publish from the individuals involved. Any distinguishing features, including medical record numbers or codes in the case of clinical images that could be used to identify the patient or participant concerned must be removed from the images.
Titles and legends: Each figure or table should have a concise title of no more than 15 words. A legend for each figure and table should also be provided that briefly describes the key points and explains any symbols and abbreviations used. The legend should be sufficiently detailed so that the figure or table can stand alone from the main text.
Permissions: If reusing a figure or table from a previous publication, the authors are responsible for obtaining permission from the copyright holder and for the payment of any fees (if applicable). Please include a note in the legend to state that: ‘This figure/table has been reproduced with permission from [include original publication citation]’.
Figure formats: For all figures, the color mode should be RGB or grayscale.
Line art: Examples of line art include graphs, diagrams, flow charts and phylogenetic trees. Please make sure that text is at least 8pt, the lines are thick enough to be clearly seen at the size the image will likely be displayed (between 75-150 mm width, which converts to one or two columns width, respectively), and that the font size and type is consistent between images. Figures should be created using a white background to ensure that they display correctly online.
If you submit a graph, please export the graph as an EPS file using the program you used to create the graph (e.g. SPSS). If this is not possible, please send us the original file in which the graph was created (e.g. if you created the graph in Excel, send us the Excel file with the embedded graph).
If you submit other forms of line art such as flow charts, diagrams or text to be displayed as an image, please export the image as an EPS file (e.g. if creating phylogenetic trees with specialized programs), or send us the original file that was used to create the image (e.g. EPS or AI files if Adobe Illustrator was used, or a DOC, DOCX, PPT, PPTX or equivalent file if Word or PowerPoint was used).
If none of the above options is possible then we also accept uncompressed TIFFs with a resolution of at least 600dpi at the size they are likely to be displayed at (see above).
Images (if applicable)
Photographs and microscopy images: Photographs and microscopy images should be submitted as uncompressed TIFFs with a resolution of at least 300dpi at the size they are likely to be displayed (see above).
Mixed images: Images that are a mix of half-tone images and line art (e.g. annotated gels or images with scale bars) should be submitted as TIFF files at a resolution of 500dpi or vector files (e.g. EPS or Adobe Illustrator files). Please ensure that the text size is at least 8pt and lines are thick enough to be clearly visible at the size the image will be displayed.
Images to be used as data: If you are submitting photographic images as part of your raw dataset, please submit them as uncompressed TIFF files.
Electronic manipulation of images:
The clarity of figures may be improved using image-editing software, but this must be done transparently and without misrepresenting the data (and the original, unaltered source data must be provided with the article). Brightness, contrasts or color balance may be used to enhance electronic images, but such changes must be applied to the whole image; any non-linear adjustments must be made explicit in the figure legend. Specific features within an image must not be added or changed (e.g. amplified, removed or obscured); and if figures are composed from images that have come from different sources, such as different gels, or from different parts of the same source, this must be made clear on the figure (e.g. by adding dividing lines). Authors are required to include details of all modifications made to images published as figures or uploaded as data in the Methods section of an article, including the name of the software (with version number) used to make these modifications. Please see our Policies on Image Manipulation
for more information.