| Study protocol
BioMed Central believes that publishing study protocols will help to improve the standard of medical research. Study protocol articles can be for proposed or ongoing research, and should provide a detailed account of the hypothesis, rationale and methodology of the study. By publishing your protocol in BMC Cancer, it becomes a fully citable open-access article – freely and universally accessible online, permanently archived, with copyright resting with the authors. It will also be included in PubMed and archived in PubMed Central, further increasing its visibility.
Study protocol articles 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. If accepted, the reviewers’ reports will be posted online with the published article as part of the pre-publication history (open peer review).
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.
For more information on why publishing study protocols is important, see: Publishing study protocols: making them visible will improve registration, reporting and recruitment. BMC News and Views 2001 2:4.
Manuscript sections for Study protocol articles
Manuscripts for Study protocol articles submitted to BMC Cancer should be divided into the following sections
The Accession Numbers of any nucleic acid sequences, protein sequences or atomic coordinates cited in the manuscript should be provided, in square brackets and include the corresponding database name; for example, [EMBL:AB026295, EMBL:AC137000, DDBJ:AE000812, GenBank:U49845, PDB:1BFM, Swiss-Prot:Q96KQ7, PIR:S66116].
The databases for which we can provide direct links are: EMBL Nucleotide Sequence Database (EMBL), DNA Data Bank of Japan (DDBJ ), GenBank at the NCBI (GenBank), Protein Data Bank (PDB), Protein Information Resource (PIR) and the Swiss-Prot Protein Database (Swiss-Prot).
This should list the title of the article and the full names, institutional addresses and e-mail addresses for all authors. The corresponding author should also be indicated.
This should not exceed 350 words and should be structured into separate sections headed Background, Methods/Design, Discussion (if appropriate). Please do not use abbreviations or references in the abstract. Trial Registration, if your study protocol is a protocol of a controlled health care intervention, please list the trial registry, along with the unique identifying number, e.g. Trial registration: Current Controlled Trials ISRCTN73824458. Please note that there should be no space between the letters and numbers of your trial registration number.
The background section should be written from the standpoint of researchers without specialist knowledge in that area and must clearly state – and, if helpful, illustrate – the background to the research and its aims.
This should include the design of the study, the setting, the type of participants or materials involved, a clear description of all interventions and comparisons, and the type of analysis used, including a power calculation if appropriate.
This can include discussion of any practical or operational issues involved in performing the study, and any other issues linked to the study that do not fall within the previous two headings.
List of abbreviations
If abbreviations are used in the text, either they should be defined in the text where first used, or a list of abbreviations can be provided, which should precede the competing interests and authors’ contributions.
A competing interest exists when your interpretation of data or presentation of information may be influenced by your personal or financial relationship with other people or organizations. Authors should disclose any financial competing interests but also any non-financial competing interests that may cause them embarrassment were they to become public after the publication of the manuscript.
Authors are required to complete a declaration of competing interests. All competing interests that are declared will be listed at the end of published articles. Where an author gives no competing interests, the listing will read ‘The author(s) declare that they have no competing interests’.
When completing your declaration, please consider the following questions:
Financial competing interests
- In the past five years have you received reimbursements, fees, funding, or salary from an organization that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? Is such an organization financing this manuscript (including the article-processing charge)? If so, please specify.
- Do you hold any stocks or shares in an organization that may in any way gain or lose financially from the publication of this manuscript, either now or in the future? If so, please specify.
- Do you hold or are you currently applying for any patents relating to the content of the manuscript? Have you received reimbursements, fees, funding, or salary from an organization that holds or has applied for patents relating to the content of the manuscript? If so, please specify.
- Do you have any other financial competing interests? If so, please specify.
Non-financial competing interests
Are there any non-financial competing interests (political, personal, religious, ideological, academic, intellectual, commercial or any other) to declare in relation to this manuscript? If so, please specify.
If you are unsure as to whether you or one of your co-authors has a competing interest, please discuss it with the editorial office.
In order to give appropriate credit to each author of a paper, the individual contributions of authors to the manuscript should be specified in this section.
An “author” is generally considered to be someone who has made substantive intellectual contributions to a published study. To qualify as an author one should 1) have made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) have been involved in drafting the manuscript or revising it critically for important intellectual content; and 3) have given final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship.
We suggest the following kind of format (please use initials to refer to each author’s contribution): AB carried out the molecular genetic studies, participated in the sequence alignment and drafted the manuscript. JY carried out the immunoassays. MT participated in the sequence alignment. ES participated in the design of the study and performed the statistical analysis. FG conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.
All contributors who do not meet the criteria for authorship should be listed in an acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support.
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.
Please acknowledge anyone who contributed towards the study by making substantial contributions to conception, design, acquisition of data, or analysis and interpretation of data, or who was involved in drafting the manuscript or revising it critically for important intellectual content, but who does not meet the criteria for authorship. Please also include their source(s) of funding. Please also acknowledge anyone who contributed materials essential for the study.
The role of a medical writer must be included in the acknowledgements section, including their source(s) of funding.
Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements.
Please list the source(s) of funding for the study, for each author, and for the manuscript preparation in the acknowledgements section. Authors must describe the role of the funding body, if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.
All references must be numbered consecutively, in square brackets, in the order in which they are cited in the text, followed by any in tables or legends. Reference citations should not appear in titles or headings. Each reference must have an individual reference number. Please avoid excessive referencing. If automatic numbering systems are used, the reference numbers must be finalized and the bibliography must be fully formatted before submission.
Only articles and abstracts that have been published or are in press, or are available through public e-print/preprint servers, may be cited; unpublished abstracts, unpublished data and personal communications should not be included in the reference list, but may be included in the text and referred to as “unpublished data”, “unpublished observations”, or “personal communications” giving the names of the involved researchers. Notes/footnotes are not allowed. Obtaining permission to quote personal communications and unpublished data from the cited author(s) is the responsibility of the author. Journal abbreviations follow Index Medicus/MEDLINE. Citations in the reference list should contain all named authors, regardless of how many there are.
Examples of the BMC Cancer reference style are shown below. Please take care to follow the reference style precisely; references not in the correct style may be retyped, necessitating tedious proofreading.
Web links and URLs should be included in the reference list. They should be provided in full, including both the title of the site and the URL, in the following format: The Mouse Tumor Biology Database [http://tumor.informatics.jax.org/mtbwi/index.do]
BMC Cancer reference style
Style files are available for use with popular bibliographic management software:
Article within a journal
1. Koonin EV, Altschul SF, Bork P: BRCA1 protein products: functional motifs. Nat Genet 1996, 13:266-267.
Article within a journal supplement
2. Orengo CA, Bray JE, Hubbard T, LoConte L, Sillitoe I: Analysis and assessment of ab initio three-dimensional prediction, secondary structure, and contacts prediction. Proteins 1999, 43(Suppl 3):149-170.
In press article
3. Kharitonov SA, Barnes PJ: Clinical aspects of exhaled nitric oxide. Eur Respir J, in press.
4. Zvaifler NJ, Burger JA, Marinova-Mutafchieva L, Taylor P, Maini RN: Mesenchymal cells, stromal derived factor-1 and rheumatoid arthritis [abstract]. Arthritis Rheum 1999, 42:s250.
Article within conference proceedings
5. Jones X: Zeolites and synthetic mechanisms. In Proceedings of the First National Conference on Porous Sieves: 27-30 June 1996; Baltimore. Edited by Smith Y. Stoneham: Butterworth-Heinemann; 1996:16-27.
Book chapter, or article within a book
6. Schnepf E: From prey via endosymbiont to plastids: comparative studies in dinoflagellates. In Origins of Plastids. Volume 2. 2nd edition. Edited by Lewin RA. New York: Chapman and Hall; 1993:53-76.
Whole issue of journal
7. Ponder B, Johnston S, Chodosh L (Eds): Innovative oncology. In Breast Cancer Res 1998, 10:1-72.
Whole conference proceedings
8. Smith Y (Ed): Proceedings of the First National Conference on Porous Sieves: 27-30 June 1996; Baltimore. Stoneham: Butterworth-Heinemann; 1996.
9. Margulis L: Origin of Eukaryotic Cells. New Haven: Yale University Press; 1970.
Monograph or book in a series
10. Hunninghake GW, Gadek JE: The alveolar macrophage. In Cultured Human Cells and Tissues. Edited by Harris TJR. New York: Academic Press; 1995:54-56. [Stoner G (Series Editor): Methods and Perspectives in Cell Biology, vol 1.]
Book with institutional author
11. Advisory Committee on Genetic Modification: Annual Report. London; 1999.
12. Kohavi R: Wrappers for performance enhancement and oblivious decision graphs. PhD thesis. Stanford University, Computer Science Department; 1995.
Link / URL
13. The Mouse Tumor Biology Database [http://tumor.informatics.jax.org/mtbwi/index.do]
Last revised: 21 February 2005
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