Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is innovative, mechanism-based, hypothesis-driven, and supported by sound experimental design, methodology, and data interpretation. Pharmaceutical Research publishes articles containing novel research concepts, ideas, and findings of broad interest to the scientific community in drug discovery, clinical testing, and regulatory evaluation.
Research Papers are the foundation of Pharmaceutical Research. Priority is given to papers focusing on current areas of interest, which include the following:
Transport/Metabolism: Regulation of transporters and enzymes, disease states, SNPs, transporter genomics/genomics, protein structure and function, transporter-/enzyme-mediated toxicity, drug-drug interactions, preclinical-to-clinical translation.
Drug Delivery and Targeting: Multifunctional nanosystems; stimuli-responsive, image-guided, and organelle-targeted delivery systems; laser lithography; molecular imprinting; electrospinning; supercritical fluid technology; quantification in organelles; noninvasive monitoring; new measures for quantifying delivery system interactions with biological tissues; and whole animal quantification of cell/organelle targeting; identification and validation of new mechanisms for uptake, efflux, and transcytosis; and identification of new clearance mechanisms.
Pharmacology, Genomics, and Biotechnology: Genomics, proteomics, and metabolonomics of new/novel therapeutic agents; biotechnology of SiRNA, microRNAs, and new antibodies.
Modeling/PK/PD/Simulations: Increased mechanistic understanding of PK/PD models, novel QSAR, QSPR on ADME/Tox properties, improving PK/PD prediction-method development.
Biopharmaceutics: Advancing physio-chemical models of drug and formulation performance with emphasis on molecular details of physiology and chemical processes, contributing to mechanistic interpretation of physiological and chemical process models, well-developed examples of novel mechanistic model building and validation of molecular details.
Preformulation: Application of new physical methods with the goal of uncovering new molecular details of condensed media, molecular-based studies of the control of surface chemistry of solid particles in the micrometer and nanometer range, elucidation of molecular mechanisms of solubilization of poorly-soluble molecules from dispersed systems, derivation, evaluation and validation new physicochemical models of condensed state material, evaluation and validation of new physicochemical models of condensed state materials with emphasis on molecular details, molecular-level evaluation and consequences of water-drug interactions.
Formulation: Application of new formulation approaches with relevant evaluation of proposed mechanisms, molecular evaluation of novel formulation excipients in biologically-relevant in vivo models, focus on the molecular details of formulation approaches of drug targeting, demonstration of relevant and validated IVIVC correlations based on molecular characteristics of formation.
Papers that are merely descriptive or confirmatory in nature, are poorly written, lack a hypothesis, fail to offer new insights, or contain conclusions that are not supported by data are unlikely to be accepted for publication in Pharmaceutical Research.
In addition to research papers, Pharmaceutical Research also publishes Expert Reviews, Perspectives, and Commentaries by invitation or consent of the Expert Review Editor, Joseph Nicolazzo
Letters to the Editor provide a forum for scientists to exchange views on work previously published in Pharmaceutical Research. Periodically, authors are invited to submit papers on highly relevant and interesting topics to be included in Theme Issues.
For Research Papers and Expert Reviews, there is no limit to the number of pages, words, tables, or figures. Nevertheless, the manuscript presentation must be concise, and research papers should contain no more than approximately 40 references.
Commentaries should be limited to 1,500 words, less than ten references, and no more than one table or figure.
Perspectives should be limited to 2,500 words, less than 20 references, and no more than a total of two tables and/or figures.
All manuscripts must be double-spaced. Acceptable file formats include .doc, .docx, and .rtf, Please do not upload .pdf files. Your manuscript will be converted to a .pdf file by our submission management program, Editorial Manager.
Each manuscript should be accompanied by a cover letter addressed to the Editor-in-Chief, Dr. Peter Swaan, and signed by the corresponding author on behalf of all authors. The cover letter should explicitly state that the manuscript has not been previously published in any language anywhere and that it is not under simultaneous consideration by another journal. The cover letter should also disclose if the manuscript has been previously rejected either by Pharmaceutical Research or another journal and should include a justification for resubmission. Authors may also use the cover letter to explain why the manuscript is suitable for publication in Pharmaceutical Research or to communicate any additional information of relevance.
The title page should include the title of the article, authors’ full first and last names (no degrees), and affiliations, and suggested running head (of less than 50 characters, including spaces). Authors’ affiliations should include the department, institution (usually university or company), city, and state (or nation) and should be included as a footnote to the authors’ name. Please indicate the corresponding author designated to receive all communications and review proofs, and provide his/her complete mailing address, office/cellular telephone number, fax number, and e-mail address.
Research Papers require a structured abstract of 200 words or less arranged under the following headings: Purpose, Methods, Results, Conclusions.
Sample structured abstract:
Purpose: The purpose of a structured abstract is to assist the authors in organizing their thoughts so as to highlight their work as well as to aid the readers to quickly grasp the essence of the paper
Methods: The abstract is organized into four distinct sections: Purpose, Methods, Results, and Conclusions.
Results: A more informative abstract results.
Conclusions: Requiring a structured abstract is a sound idea.
Expert Reviews and Perspectives also require an abstract, but it need not be structured. An abstract is not required of Commentaries or Letters to the Editor.
For all manuscripts, please provide a list of no more than 5 keywords.
Research Papers should be organized as follows: Abbreviations, Introduction, Materials and Methods, Results, Discussion, Conclusion, Acknowledgments, References. Combining Results and Discussion is discouraged. Please avoid using more than three levels of headings.
An accurate description of each set of data that is shown must be provided and must include the number of biological replicates, the number of experiments performed, and the description and use of appropriate statistical methods. Appropriate statistical methods should be used to test the significance of differences in results. The term “significant” should not be used unless statistically analyses were performed, and the probability value used to identify significance (generally P values) should be specified. The editors will not accept representative single experiments without the author’s written agreement to make available all of the replicate data upon request. Manuscripts submitted without evidence of reproducibility will be rejected without formal review.
All acknowledgments, including those for financial support, should be listed in a section to precede the References. Authors of manuscripts submitted to Pharmaceutical Research are requested to state the source of all funding that enabled the described research to be undertaken.
Use abbreviations sparingly. Provide an Abbreviations section, a list of all nonstandard abbreviations, before the Introduction section. Use the metric system for all measurements. Express metric abbreviations in lowercase letters without periods (cm, ml, sec). Define all symbols used in equations and formulas. When symbols are used extensively, include a list of all symbols in the notation section.
References should conform to Vancouver Style (International Committee of Medical Journal Editors). Abbreviations for journal names should conform to those in the Bibliographic Guide for Editors and Authors (American Chemical Society, Washington, D.C.).
References to unpublished peer-reviews, personal communications, including conference abstracts, and papers in preparation or in review, cannot be listed, but can be notated parenthetically in the text.
1. Kohane DS, Anderson DG, Yu C, Langer R. pH triggered release of macromolecules from spraydried polymethacrylate microparticles. Pharm Res. 2003;20(10):1533-1538. [Journal Article]
2. Swarbrick J, Boylan JC. Encyclopedia of pharmaceutical technology. New York: Marcel Dekker; 2001. [Book]
3. Lee VHL. Ocular epithelial models. In: Borchardt RT, Smith PL, Wilson G, editors. Models for assessing drug absorption and metabolism. New York: Plenum; 1996. p. 425-436. [Contribution to a Book]
4. Weisstein EW. Molecular orbital theory. Eric Weisstein's World of Science.; 2003 December 15. Available from: http://scienceworld.wolfram.com/chemistry/MolecularOrbital-Theory.html. [Website]
Tables should be numbered (with Roman numerals) and referred to by number in the text. Center the title above the table, and type explanatory footnotes (indicated by superscript lowercase letters) below the table.
Figures (including photographs, drawings, diagrams, and charts) are to be numbered in one consecutive series of Arabic numerals in the order in which they are cited in the text. The captions for illustrations should be separated from the text, and collated in a separate section called “Legend to Figures.” Electronic artwork should be in .tif, .eps, or .jpg format (1200 dpi for line and 300 dpi for half-tones and gray-scale art).
Footnotes should be avoided. When their use is absolutely necessary, footnotes should be numbered consecutively using Arabic numerals and should be typed at the bottom of the page to which they refer. Place a line above the footnote, so that it is set off from the text. Use the appropriate superscript numeral for citation in the text.
Appendices and Supplementary Material
Authors who wish to publish electronic supplementary material to their article (Excel files, images, audio/video files) may submit these files along with the manuscript via our online submission system. For more information, go to this
Manuscripts should be submitted online to http://www.editorialmanager.com/pharmres. This web-based manuscript management system offers easy and straightforward login and submission procedures. It also allows you to track the progress of manuscript review in real time. After submitting a manuscript, you will need to review the converted PDF to ensure that all text, formulas, figures, and tables have been converted without errors. The manuscript will not be officially submitted to the journal until you have reviewed and approved the PDF.
If you are submitting an invited Expert Review, Commentary, Perspective, or Theme Issue manuscript, it is important that you do so through the invitations menu. After logging in as an author, click on “My Accepted Invitations” under the Invited Submissions head, then click “Submit Invited Manuscript” under the Action/Action Links menu for the theme issue invitation, select the appropriate theme issue title from the Article Type drop-down menu, and proceed through the submission process according to the system’s prompts.
After you have approved the PDF of your manuscript, it will be screened to ensure that all components have been submitted. Screened manuscripts then undergo an initial review, during which the Editor-in-Chief will either reject the manuscript if its quality and content are not in line with the aims of Pharmaceutical Research, or pass it along to an appropriate editor for further review. Papers that may not be granted a full review include, but are not limited to, those that are routine, are descriptive, are deficient in presentation, offer no insight, or appeal to a specialty audience.
Before a publication decision is made, your manuscript will be reviewed by at least two independent, anonymous peers in the field, in addition to the assigned editor. During the initial submission of your manuscript, you have the opportunity to suggest appropriate reviewers for your manuscript, as well as to list any to whom you are opposed. This phase of the review process typically takes about three to four weeks to complete.
The editor will use the reviewers’ comments and recommendations to assist him or her in making a publication decision for your manuscript. At this point, the manuscript may be rejected, be accepted as is, or require minor or major revisions. In all cases, you may have access to the reviewers’ comments.
If the editor returns your manuscript with the request for minor or major revisions, you will have 30 days to revise and return your manuscript. If you need longer than the 30 days to conduct additional research, you must contact your editor immediately in order to be granted an extension. You will be provided with reviewers’ comments and suggestions for revision in order to help you improve your manuscript.
After your revised manuscript is submitted, the editor and/or reviewers will review it again, and a new publication decision will be rendered. Revised manuscripts are not guaranteed acceptance; your revised manuscript may be rejected, be accepted, or require additional revisions.
If your paper is accepted, approximately two weeks later, you will receive an email from the production department alerting you that your page proofs are ready to be reviewed. Follow the instructions in this email to access your proofs and submit any changes. During this stage, you should proofread your paper for any typos, verify that all authors’ names and affiliations are accurate and spelled correctly, and confirm that all tables, figures, and formulas have been properly formatted. Authors are responsible for all statements in their work, including changes made by the copyeditor after a manuscript is accepted, so please review your proofs carefully.
All articles published in the journal will follow the Springer Online First production workflow, enabling publication on the SpringerLink website after receipt of author corrections to page proofs.
Finally, accepted papers will appear in a print issue of Pharmaceutical Research.
Each manuscript must be accompanied by a cover letter signed by the corresponding author on behalf of all the authors. The cover letter should explicitly state that the manuscript has not been previously published in any language anywhere and that it is not under simultaneous consideration by another journal. Moreover, Pharmaceutical Research will not publish any manuscript unless the chemical structures of all compounds are fully disclosed, either by reference to prior work providing such data or by enclosure of such data in the manuscript.
Authors with accepted papers may choose to transfer copyright to Springer or participate in Open Choice. For more information about Open Choice, go to http://www.springer.com/open+access/open+choice?SGWID=0-40359-0-0-0.
ETHICS IN ANIMAL AND CLINICAL INVESTIGATIONS
Investigations using experimental animals must state in the Methods section that the research adhered to the ’’Principles of Laboratory Animal Care’’ (NIH publication #85-23, revised in 1985). Investigation with human subjects must state in the Methods section that the research followed the tenets of the Declaration of Helsinki promulgated in 1964 and was approved by the institutional human experimentation committee or equivalent, and that informed consent was obtained.
SPRINGER PUBLISHING POLICIES
For information about the publisher’s policies, go to http://www.springer.com/authors/journal+authors?SGWID=0-154202-0-0-0.
A submission to the journal implies that materials described in the manuscript, including all relevant raw data, will be freely available to any researcher wishing to use them for non-commercial purposes, without breaching participant confidentiality.
The journal strongly encourages that all datasets on which the conclusions of the paper rely should be available to readers. We encourage authors to ensure that their datasets are either deposited in publicly available repositories (where available and appropriate) or presented in the main manuscript or additional supporting files whenever possible. Please see Springer Nature’s information on recommended repositories.
General repositories - for all types of research data - such as figshare and Dryad may be used where appropriate.
Datasets that are assigned digital object identifiers (DOIs) by a data repository may be cited in the reference list. Data citations should include the minimum information recommended by DataCite: authors, title, publisher (repository name), identifier.
Where a widely established research community expectation for data archiving in public repositories exists, submission to a community-endorsed, public repository is mandatory. Persistent identifiers (such as DOIs and accession numbers) for relevant datasets must be provided in the paper
For the following types of data set, submission to a community-endorsed, public repository is mandatory:
The journal encourages authors to provide a statement of Data availability in their article. 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. Data availability statements can also indicate whether data are available on request from the authors and where no data are available, if appropriate.
Data Availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):
1. The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
2. The datasets generated during 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.
3. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
4. Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
5. All data generated or analysed during this study are included in this published article [and its supplementary information files].
More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available:
Springer Nature provides a research data policy support service for authors and editors, which can be contacted at firstname.lastname@example.org.
This service provides advice on research data policy compliance and on finding research data repositories. It is independent of journal, book and conference proceedings editorial offices and does not advise on specific manuscripts.
This journal is committed to upholding the integrity of the scientific record. As a member of the Committee on Publication Ethics (COPE) the journal will follow the COPE guidelines on how to deal with potential acts of misconduct.
Authors should refrain from misrepresenting research results which could damage the trust in the journal, the professionalism of scientific authorship, and ultimately the entire scientific endeavour. Maintaining integrity of the research and its presentation is helped by following the rules of good scientific practice, which include*:
The manuscript should not be submitted to more than one journal for simultaneous consideration.
The submitted work should be original and should not have been published elsewhere in any form or language (partially or in full), unless the new work concerns an expansion of previous work. (Please provide transparency on the re-use of material to avoid the concerns about text-recycling (‘self-plagiarism’).
A single study should not be split up into several parts to increase the quantity of submissions and submitted to various journals or to one journal over time (i.e. ‘salami-slicing/publishing’).
Concurrent or secondary publication is sometimes justifiable, provided certain conditions are met. Examples include: translations or a manuscript that is intended for a different group of readers.
Results should be presented clearly, honestly, and without fabrication, falsification or inappropriate data manipulation (including image based manipulation). Authors should adhere to discipline-specific rules for acquiring, selecting and processing data.
No data, text, or theories by others are presented as if they were the author’s own (‘plagiarism’). Proper acknowledgements to other works must be given (this includes material that is closely copied (near verbatim), summarized and/or paraphrased), quotation marks (to indicate words taken from another source) are used for verbatim copying of material, and permissions secured for material that is copyrighted.
Important note: the journal may use software to screen for plagiarism.
Authors should make sure they have permissions for the use of software, questionnaires/(web) surveys and scales in their studies (if appropriate).
Authors should avoid untrue statements about an entity (who can be an individual person or a company) or descriptions of their behavior or actions that could potentially be seen as personal attacks or allegations about that person.
Research that may be misapplied to pose a threat to public health or national security should be clearly identified in the manuscript (e.g. dual use of research). Examples include creation of harmful consequences of biological agents or toxins, disruption of immunity of vaccines, unusual hazards in the use of chemicals, weaponization of research/technology (amongst others).
Authors are strongly advised to ensure the author group, the Corresponding Author, and the order of authors are all correct at submission. Adding and/or deleting authors during the revision stages is generally not permitted, but in some cases may be warranted. Reasons for changes in authorship should be explained in detail. Please note that changes to authorship cannot be made after acceptance of a manuscript.
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Upon request authors should be prepared to send relevant documentation or data in order to verify the validity of the results presented. This could be in the form of raw data, samples, records, etc. Sensitive information in the form of confidential or proprietary data is excluded.
If there is suspicion of misbehavior or alleged fraud the Journal and/or Publisher will carry out an investigation following COPE guidelines. If, after investigation, there are valid concerns, the author(s) concerned will be contacted under their given e-mail address and given an opportunity to address the issue. Depending on the situation, this may result in the Journal’s and/or Publisher’s implementation of the following measures, including, but not limited to:
If the manuscript is still under consideration, it may be rejected and returned to the author.
If the article has already been published online, depending on the nature and severity of the infraction:
- an erratum/correction may be placed with the article
- an expression of concern may be placed with the article
- or in severe cases retraction of the article may occur.
The reason will be given in the published erratum/correction, expression of concern or retraction note. Please note that retraction means that the article is maintained on the platform, watermarked “retracted” and the explanation for the retraction is provided in a note linked to the watermarked article.
The author’s institution may be informed
A notice of suspected transgression of ethical standards in the peer review system may be included as part of the author’s and article’s bibliographic record.
Authors have an obligation to correct mistakes once they discover a significant error or inaccuracy in their published article. The author(s) is/are requested to contact the journal and explain in what sense the error is impacting the article. A decision on how to correct the literature will depend on the nature of the error. This may be a correction or retraction. The retraction note should provide transparency which parts of the article are impacted by the error.
Suggesting / excluding reviewers
Authors are welcome to suggest suitable reviewers and/or request the exclusion of certain individuals when they submit their manuscripts. When suggesting reviewers, authors should make sure they are totally independent and not connected to the work in any way. It is strongly recommended to suggest a mix of reviewers from different countries and different institutions. When suggesting reviewers, the Corresponding Author must provide an institutional email address for each suggested reviewer, or, if this is not possible to include other means of verifying the identity such as a link to a personal homepage, a link to the publication record or a researcher or author ID in the submission letter. Please note that the Journal may not use the suggestions, but suggestions are appreciated and may help facilitate the peer review process.
These guidelines describe authorship principles and good authorship practices to which prospective authors should adhere to.
The Journal and Publisher assume all authors agreed with the content and that all gave explicit consent to submit and that they obtained consent from the responsible authorities at the institute/organization where the work has been carried out, before the work is submitted.
The Publisher does not prescribe the kinds of contributions that warrant authorship. It is recommended that authors adhere to the guidelines for authorship that are applicable in their specific research field. In absence of specific guidelines it is recommended to adhere to the following guidelines*:
All authors whose names appear on the submission
1) made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work;
2) drafted the work or revised it critically for important intellectual content;
3) approved the version to be published; and
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All authors are requested to include information regarding sources of funding, financial or non-financial interests, study-specific approval by the appropriate ethics committee for research involving humans and/or animals, informed consent if the research involved human participants, and a statement on welfare of animals if the research involved animals (as appropriate).
The decision whether such information should be included is not only dependent on the scope of the journal, but also the scope of the article. Work submitted for publication may have implications for public health or general welfare and in those cases it is the responsibility of all authors to include the appropriate disclosures and declarations.
All authors are requested to make sure that all data and materials as well as software application or custom code support their published claims and comply with field standards. Please note that journals may have individual policies on (sharing) research data in concordance with disciplinary norms and expectations. Please check the Instructions for Authors of the Journal that you are submitting to for specific instructions.
Role of the Corresponding Author
One author is assigned as Corresponding Author and acts on behalf of all co-authors and ensures that questions related to the accuracy or integrity of any part of the work are appropriately addressed.
The Corresponding Author is responsible for the following requirements:
ensuring that all listed authors have approved the manuscript before submission, including the names and order of authors;
managing all communication between the Journal and all co-authors, before and after publication;*
providing transparency on re-use of material and mention any unpublished material (for example manuscripts in press) included in the manuscript in a cover letter to the Editor;
making sure disclosures, declarations and transparency on data statements from all authors are included in the manuscript as appropriate (see above).
* The requirement of managing all communication between the journal and all co-authors during submission and proofing may be delegated to a Contact or Submitting Author. In this case please make sure the Corresponding Author is clearly indicated in the manuscript.
Please check the Instructions for Authors of the Journal that you are submitting to for specific instructions regarding contribution statements.
In absence of specific instructions and in research fields where it is possible to describe discrete efforts, the Publisher recommends authors to include contribution statements in the work that specifies the contribution of every author in order to promote transparency. These contributions should be listed at the separate title page.
Examples of such statement(s) are shown below:
• Free text:
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [full name], [full name] and [full name]. The first draft of the manuscript was written by [full name] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
For review articles where discrete statements are less applicable a statement should be included who had the idea for the article, who performed the literature search and data analysis, and who drafted and/or critically revised the work.
For articles that are based primarily on the student’s dissertation or thesis, it is recommended that the student is usually listed as principal author:
The primary affiliation for each author should be the institution where the majority of their work was done. If an author has subsequently moved, the current address may additionally be stated. Addresses will not be updated or changed after publication of the article.
Changes to authorship
Authors are strongly advised to ensure the correct author group, the Corresponding Author, and the order of authors at submission. Changes of authorship by adding or deleting authors, and/or changes in Corresponding Author, and/or changes in the sequence of authors are not accepted after acceptance of a manuscript.
Please note that author names will be published exactly as they appear on the accepted submission!
Please make sure that the names of all authors are present and correctly spelled, and that addresses and affiliations are current.
Adding and/or deleting authors at revision stage are generally not permitted, but in some cases it may be warranted. Reasons for these changes in authorship should be explained. Approval of the change during revision is at the discretion of the Editor-in-Chief. Please note that journals may have individual policies on adding and/or deleting authors during revision stage.
Authors are recommended to use their ORCID ID when submitting an article for consideration or acquire an ORCID ID via the submission process.
Deceased or incapacitated authors
For cases in which a co-author dies or is incapacitated during the writing, submission, or peer-review process, and the co-authors feel it is appropriate to include the author, co-authors should obtain approval from a (legal) representative which could be a direct relative.
Authorship issues or disputes
In the case of an authorship dispute during peer review or after acceptance and publication, the Journal will not be in a position to investigate or adjudicate. Authors will be asked to resolve the dispute themselves. If they are unable the Journal reserves the right to withdraw a manuscript from the editorial process or in case of a published paper raise the issue with the authors’ institution(s) and abide by its guidelines.
Authors should treat all communication with the Journal as confidential which includes correspondence with direct representatives from the Journal such as Editors-in-Chief and/or Handling Editors and reviewers’ reports unless explicit consent has been received to share information.
To ensure objectivity and transparency in research and to ensure that accepted principles of ethical and professional conduct have been followed, authors should include information regarding sources of funding, potential conflicts of interest (financial or non-financial), informed consent if the research involved human participants, and a statement on welfare of animals if the research involved animals.
Authors should include the following statements (if applicable) in a separate section entitled “Compliance with Ethical Standards” when submitting a paper:
Disclosure of potential conflicts of interest
Research involving Human Participants and/or Animals
Please note that standards could vary slightly per journal dependent on their peer review policies (i.e. single or double blind peer review) as well as per journal subject discipline. Before submitting your article check the instructions following this section carefully.
The corresponding author should be prepared to collect documentation of compliance with ethical standards and send if requested during peer review or after publication.
The Editors reserve the right to reject manuscripts that do not comply with the above-mentioned guidelines. The author will be held responsible for false statements or failure to fulfill the above-mentioned guidelines.
Authors must disclose all relationships or interests that could have direct or potential influence or impart bias on the work. Although an author may not feel there is any conflict, disclosure of relationships and interests provides a more complete and transparent process, leading to an accurate and objective assessment of the work. Awareness of a real or perceived conflicts of interest is a perspective to which the readers are entitled. This is not meant to imply that a financial relationship with an organization that sponsored the research or compensation received for consultancy work is inappropriate. Examples of potential conflicts of interests that are directly or indirectly related to the research may include but are not limited to the following:
Research grants from funding agencies (please give the research funder and the grant number)
Honoraria for speaking at symposia
Financial support for attending symposia
Financial support for educational programs
Employment or consultation
Support from a project sponsor
Position on advisory board or board of directors or other type of management relationships
Financial relationships, for example equity ownership or investment interest
Intellectual property rights (e.g. patents, copyrights and royalties from such rights)
Holdings of spouse and/or children that may have financial interest in the work
In addition, interests that go beyond financial interests and compensation (non-financial interests) that may be important to readers should be disclosed. These may include but are not limited to personal relationships or competing interests directly or indirectly tied to this research, or professional interests or personal beliefs that may influence your research.
The corresponding author collects the conflict of interest disclosure forms from all authors. In author collaborations where formal agreements for representation allow it, it is sufficient for the corresponding author to sign the disclosure form on behalf of all authors. Examples of forms can be found
The corresponding author will include a summary statement in the text of the manuscript in a separate section before the reference list, that reflects what is recorded in the potential conflict of interest disclosure form(s).
See below examples of disclosures:
Funding: This study was funded by X (grant number X).
Conflict of Interest: Author A has received research grants from Company A. Author B has received a speaker honorarium from Company X and owns stock in Company Y. Author C is a member of committee Z.
If no conflict exists, the authors should state:
Conflict of Interest: The authors declare that they have no conflict of interest.
Research involving human participants, their data or biological material
When reporting a study that involved human participants, their data or biological material, authors should include a statement that confirms that the study was approved (or granted exemption) by the appropriate institutional and/or national research ethics committee (including the name of the ethics committee) and certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. If doubt exists whether the research was conducted in accordance with the 1964 Helsinki Declaration or comparable standards, the authors must explain the reasons for their approach, and demonstrate that an independent ethics committee or institutional review board explicitly approved the doubtful aspects of the study. If a study was granted exemption from requiring ethics approval, this should also be detailed in the manuscript (including the reasons for the exemption).
Retrospective ethics approval
If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor's discretion.
Ethics approval for retrospective studies
Although retrospective studies are conducted on already available data or biological material (for which formal consent may not be needed or is difficult to obtain) ethics approval may be required dependent on the law and the national ethical guidelines of a country. Authors should check with their institution to make sure they are complying with the specific requirements of their country.
Ethics approval for case studies
Case reports require ethics approval. Most institutions will have specific policies on this subject. Authors should check with their institution to make sure they are complying with the specific requirements of their institution and seek ethics approval where needed. Authors should be aware to secure informed consent from the individual (or parent or guardian if the participant is a minor or incapable) See also section on Informed Consent.
If human cells are used, authors must declare in the manuscript: what cell lines were used by describing the source of the cell line, including when and from where it was obtained, whether the cell line has recently been authenticated and by what method. If cells were bought from a life science company the following need to be given in the manuscript: name of company (that provided the cells), cell type, number of cell line, and batch of cells.
It is recommended that authors check the NCBI database for misidentification and contamination of human cell lines. This step will alert authors to possible problems with the cell line and may save considerable time and effort.
Authors should include a statement that confirms that an institutional or independent ethics committee (including the name of the ethics committee) approved the study and that informed consent was obtained from the donor or next of kin.
Research Resource Identifiers (RRID)
Research Resource Identifiers (RRID) are persistent unique identifiers (effectively similar to a DOI) for research resources. This journal encourages authors to adopt RRIDs when reporting key biological resources (antibodies, cell lines, model organisms and tools) in their manuscripts.
The World Health Organization (WHO) definition of a clinical trial is "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes". The WHO defines health interventions as “A health intervention is an act performed for, with or on behalf of a person or population whose purpose is to assess, improve, maintain, promote or modify health, functioning or health conditions” and a health-related outcome is generally defined as a change in the health of a person or population as a result of an intervention.
The trial registration number (TRN) and date of registration should be included as the last line of the manuscript abstract.
For clinical trials that have not been registered prospectively, authors are encouraged to register retrospectively to ensure the complete publication of all results. The trial registration number (TRN), date of registration and the words 'retrospectively registered’ should be included as the last line of the manuscript abstract.
Purely observational trials will not require registration.
Standards of reporting
Springer Nature advocates complete and transparent reporting of biomedical and biological research and research with biological applications. Authors are recommended to adhere to the minimum reporting guidelines hosted by the EQUATOR Network when preparing their manuscript.
Exact requirements may vary depending on the journal; please refer to the journal’s Instructions for Authors.
Checklists are available for a number of study designs, including:
The above should be summarized in a statement and included on a title page that is separate from the manuscript with a section entitled “Declarations” when submitting a paper. Having all statements in one place allows for a consistent and unified review of the information by the Editor-in-Chief and/or peer reviewers and may speed up the handling of the paper. Declarations include Funding, Conflicts of interest/competing interests, Ethics approval, Consent, Data and/or Code availability and Authors’ contribution statements. Please use the following template title page for providing the statements.
Once and if the paper is accepted for publication, the production department will put the respective statements in a distinctly identified section clearly visible for readers.
Please see the various examples of wording below and revise/customize the sample statements according to your own needs.
• Provide “Ethics approval” as a heading (see template)
Examples of ethics approval obtained:
• All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of the Medical University of A (No. ...).
• This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of University B (Date.../No. ...).
• Approval was obtained from the ethics committee of University C. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.
• The questionnaire and methodology for this study was approved by the Human Research Ethics committee of the University of C (Ethics approval number: ...).
Examples of a retrospective study:
• Ethical approval was waived by the local Ethics Committee of University A in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.
• This research study was conducted retrospectively from data obtained for clinical purposes. We consulted extensively with the IRB of XYZ who determined that our study did not need ethical approval. An IRB official waiver of ethical approval was granted from the IRB of XYZ.
• This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Human Investigation Committee (IRB) of University B approved this study.
Examples no ethical approval required/exemption granted:
• This is an observational study. The XYZ Research Ethics Committee has confirmed that no ethical approval is required.
• The data reproduced from Article X utilized human tissue that was procured via our Biobank AB, which provides de-identified samples. This study was reviewed and deemed exempt by our XYZ Institutional Review Board. The BioBank protocols are in accordance with the ethical standards of our institution and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.
Authors are responsible for correctness of the statements provided in the manuscript. See also Authorship Principles. The Editor-in-Chief reserves the right to reject submissions that do not meet the guidelines described in this section.
All individuals have individual rights that are not to be infringed. Individual participants in studies have, for example, the right to decide what happens to the (identifiable) personal data gathered, to what they have said during a study or an interview, as well as to any photograph that was taken. This is especially true concerning images of vulnerable people (e.g. minors, patients, refugees, etc) or the use of images in sensitive contexts. In many instances authors will need to secure written consent before including images. Identifying details (names, dates of birth, identity numbers and other information) of the participants that were studied should not be published in written descriptions, photographs, and genetic profiles unless the information is essential for scholarly purposes and the participant (or parent or guardian if the participant is incapable) gave written informed consent for publication. Complete anonymity is difficult to achieve in some cases. Detailed descriptions of individual participants, whether of their whole bodies or of body sections, may lead to disclosure of their identity. Under certain circumstances consent is not required as long as information is anonymized and the submission does not include images that may identify the person.
Informed consent for publication should be obtained if there is any doubt. For example, masking the eye region in photographs of participants is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic profiles, authors should provide assurance that alterations do not distort scientific meaning.
Exceptions where it is not necessary to obtain consent:
• Images such as x rays, laparoscopic images, ultrasound images, brain scans, pathology slides unless there is a concern about identifying information in which case, authors should ensure that consent is obtained.
• Reuse of images: If images are being reused from prior publications, the Publisher will assume that the prior publication obtained the relevant information regarding consent. Authors should provide the appropriate attribution for republished images.
Consent and already available data and/or biologic material
Regardless of whether material is collected from living or dead patients, they (family or guardian if the deceased has not made a pre-mortem decision) must have given prior written consent. The aspect of confidentiality as well as any wishes from the deceased should be respected.
Data protection, confidentiality and privacy
When biological material is donated for or data is generated as part of a research project authors should ensure, as part of the informed consent procedure, that the participants are made what kind of (personal) data will be processed, how it will be used and for what purpose. In case of data acquired via a biobank/biorepository, it is possible they apply a broad consent which allows research participants to consent to a broad range of uses of their data and samples which is regarded by research ethics committees as specific enough to be considered “informed”. However, authors should always check the specific biobank/biorepository policies or any other type of data provider policies (in case of non-bio research) to be sure that this is the case.
Please note that the use of a language editing service is not a requirement for publication in this journal and does not imply or guarantee that the article will be selected for peer review or accepted.
If your manuscript is accepted it will be checked by our copyeditors for spelling and formal style before publication.