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Study Protocol

Criteria

SpringerOpen believes that publishing Study protocols will help to improve the standard of medical research. Study Protocols articles can be for proposed or ongoing research, and should provide a detailed account of the hypothesis, rationale and methodology of the study.
Study protocols concerning proposed research will usually be published without peer review if the study has received ethics approval and a grant from a major funding body. Proof of both ethics and funding will be required and we recommend that authors provide the relevant documentation on submission. Study protocols without major external funding will be peer reviewed. Study protocols without ethical approval will generally not be considered.
Protocols of randomized controlled trials should follow the CONSORT guidelines and must have a trial registration number included as the last line of the abstract, as described in our editorial policies.

Preparing your manuscript

Title page

The title page should:

  • present a title that includes, if appropriate, the study design e.g.:
    • "A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review"
    • or for non-clinical or non-research studies: a description of what the article reports
  • list the full names, institutional addresses and email addresses for all authors
  • if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
  • indicate the corresponding author

Abstract

The abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

  • Background: the context and purpose of the study
  • Methods: how the study will be performed
  • Discussion: a brief summary and potential implications
  • Trial registration: If your article is a systematic review or reports the protocol for a health care intervention on human participants, it must be registered in an appropriate registry and the registration number should be in stated in this section See our editorial policies for more information on trial registration

Keywords

Three to ten keywords representing the main content of the article.

Background

The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study is necessary or its contribution to the field.

Methods/Design

The methods section should include:

  • the aim, design and setting of the study
  • the characteristics of participants or description of materials
  • a clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses
  • the type of statistical analysis used, including a power calculation if appropriate.

Discussion

This should include a discussion of any practical or operational issues involved in performing the study and any issues not covered in other sections.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

  • Ethics approval and consent to participate
  • Consent for publication
  • Availability of data and material
  • Competing interests
  • Funding
  • Authors' contributions
  • Acknowledgements
  • Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.

Ethics approval and consent to participate

Manuscripts reporting studies involving human participants, human data or human tissue must:

  • include a statement on ethics approval and consent (even where the need for approval was waived)
  • include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

Consent for publication

If your manuscript contains any individual person’s data in any form (including individual details, images or videos), consent to publish must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent to publish.

You can use your institutional consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

Availability of data and materials

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

  • The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
  • The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
  • All data generated or analysed during this study are included in this published article [and its supplementary information files].
  • The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
  • Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
  • The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
  • Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here.

SpringerOpen  also requires that authors cite any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:


Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS].[Reference number]

Competing interests

All financial and non-financial competing interests must be declared in this section.

See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors’ initials to refer to each authors' competing interests in this section.

If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.

Funding

All sources of funding for the research reported should be declared. The role of the funding body in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript should be declared.

Authors' contributions

The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies.

Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."

Acknowledgements

Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.

Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

See our editorial policies for a full explanation of acknowledgements and authorship criteria.

If you do not have anyone to acknowledge, please write "Not applicable" in this section.

Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.

Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.

Authors' information

This section is optional.

You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

Endnotes

Endnotes should be designated within the text using a superscript lowercase letter and all notes (along with their corresponding letter) should be included in the Endnotes section. Please format this section in a paragraph rather than a list. 

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

  • Ethics approval and consent to participate
  • Consent for publication
  • Availability of data and material
  • Competing interests
  • Funding
  • Authors' contributions
  • Acknowledgements
  • Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section. 

Ethics approval and consent to participate

Manuscripts reporting studies involving human participants, human data or human tissue must:

  • include a statement on ethics approval and consent (even where the need for approval was waived)
  • include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

Consent for publication

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

Availability of data and materials

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

  • The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
  • The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
  • All data generated or analysed during this study are included in this published article [and its supplementary information files].
  • The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
  • Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
  • The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
  • Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here.

BioMed Central also requires that authors cite any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:


Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS].[Reference number] 

Competing interests

All financial and non-financial competing interests must be declared in this section.

See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors initials to refer to each authors' competing interests in this section.

If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.

Funding

All sources of funding for the research reported should be declared. The role of the funding body in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript should be declared.

Authors' contributions

The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies.

Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."

Acknowledgements

Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.

Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

See our editorial policies for a full explanation of acknowledgements and authorship criteria.

If you do not have anyone to acknowledge, please write "Not applicable" in this section.

Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.

Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.

Authors' information

This section is optional.

You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.


Endnotes

Endnotes should be designated within the text using a superscript lowercase letter and all notes (along with their corresponding letter) should be included in the Endnotes section. Please format this section in a paragraph rather than a list.

References

Examples of the American Psychological Association (APA) reference style are shown below. For further guidance, see the Publication Manual of the American Psychological Association and the respective web site of the Association (http://www.apastyle.org/).

See our editorial policies for author guidance on good citation practice.

Web links and URLs: All web links and URLs, including links to the authors' own websites, should be given a reference number and included in the reference list rather than within the text of the manuscript. They should be provided in full, including both the title of the site and the URL, as well as the date the site was accessed, in the following format: The Mouse Tumor Biology Database. http://tumor.informatics.jax.org/mtbwi/index.do. Accessed 20 May 2013. If an author or group of authors can clearly be associated with a web link, such as for weblogs, then they should be included in the reference.

Example reference style:

Article within a journal

Harris, M., Karper, E., Stacks, G., Hoffman, D., DeNiro, & R., Cruz, P. (2001). Writing labs and the Hollywood connection. Journal of Film Writing, 44(3), 213-245.

Article by DOI (with page numbers)

Slifka, M.K., & Whitton, J.L. (2000). Clinical implications of dysregulated cytokine production. Journal of Molecular Medicine, 78, 74-80 (2000). doi:10.1007/s001090000086.

Article by DOI (before issue publication and without page numbers)

Kreger, M., Brindis, C.D., Manuel, D.M., & Sassoubre, L. (2007). Lessons learned in systems change initiatives: benchmarks and indicators. American Journal of Community Psychology. doi: 10.1007/s10464-007-9108-14.

Article in electronic journal by DOI (no paginated version)

Kruger, M., Brandis, C.D., Mandel, D.M., & Sassoure, J. (2007). Lessons to be learned in systems change initiatives: benchmarks and indicators. American Journal of Digital Psychology. doi: 10.1007/s10469-007-5108-14.

Complete book

Calfee, R.C., & Valencia, R.R. (1991). APA guide to preparing manuscripts for journal publication. Washington, DC: American Psychological Association.

Book chapter, or an article within a book

O'Neil, J.M., & Egan, J. (1992). Men's and women's gender role journeys: Metaphor for healing, transition, and transformation. In B.R. Wainrib (Ed.), Gender issues across the life cycle (pp. 107-123). New York: Springer.

Online First chapter in a series (without a volume designation but with a DOI)

Saito, Y., & Hyuga, H. (2007). Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Topics in Current Chemistry. doi:10.1007/128_2006_108.

Complete book, also showing a translated edition [Either edition may be listed first.]

Adorno, T.W. (1966). Negative Dialektik. Frankfurt: Suhrkamp. English edition: Adorno, TW (1973). Negative Dialectics (trans: Ashton, E.B.). London: Routledge.

Online document

Abou-Allaban, Y., Dell, M.L., Greenberg, W., Lomax, J., Peteet, J., Torres, M., & Cowell, V. (2006). Religious/spiritual commitments and psychiatric practice. Resource document. American Psychiatric Association. http://www.psych.org/edu/other_res/lib_archives/archives/200604.pdf. Accessed 25 June 2007.

Online database

German emigrants database (1998). Historisches Museum Bremerhaven. http://www.deutsche-auswanderer-datenbank.de. Accessed 21 June 2007.

Supplementary material/private homepage

Doe, J. (2006). Title of supplementary material. http://www.privatehomepage.com. Accessed 22 Feb 2007.

FTP site

Doe, J. (1999). Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt. Accessed 12 Feb 2006.

Organization site

ISSN International Centre (2006). The ISSN register. http://www.issn.org. Accessed 20 Feb 2007.

Figures, tables and additional files

See General formatting guidelines for information on how to format figures, tables and additional files.

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