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2.2 Authorship and Authorship Responsibilities

Trust is fundamental to scientific communication: Trust that the authors have accurately reported their contributions, methods and findings; trust that authors have disclosed all potential conflicts of interest; and trust that editors have exercised sufficient diligence to ensure accurate reporting and disclosure by authors.

Problems with authorship are not uncommon and can threaten the integrity of scientific research.1 With the aim to decrease such problems, this section focuses on principles to guide authorship-related decisions, policies, practices, and responsibilities.

2.2.1 Authorship

Journal editors best serve readers and promote integrity in scientific publication when they ensure accurate reporting and disclosures by authors. The first step in creating transparency for readers is accurate identification of those who participated in the research and the reporting.

Authors are generally defined as persons who have contributed sufficiently to a scientific report to be listed on the byline of the published report. Many journals provide guidelines on authorship in their instructions for authors. Some professional and research funding organizations and academic institutions also provide such guidance. Principles, customs, and practices regarding authorship differ across cultures and scientific disciplines and sometimes within disciplines. This document aims to summarize common principles to guide authorship across scientific disciplines.

Principles common to most guidelines on authorship include the following:

  • It is the prerogative of journal editors to define authorship and contributorship criteria; journals are encouraged to use one of the widely accepted sets of criteria for authorship, such as that from ICMJE2 or proposed by McNutt et al.,3 but the editor of the journal may vary the criteria if appropriate for the scientific discipline. It is key that the criteria be clearly defined to the authors.
  • Identification of authors and other contributors is the responsibility of the researchers who performed the work based on the criteria of the journal to which the work is submitted.  Researchers should determine which individuals have contributed sufficiently, according to the authorship criteria, to warrant authorship. Individuals who contributed to the work but whose contributions were not of sufficient magnitude to warrant authorship should be identified by name in a contributors appendix, a co-investigators appendix, or an acknowledgments section; Authors should also ensure they have notified/obtained permission from those they have named within the Acknowledgements section. Clarifying contributions to these sections may be aided by a methodology such as the Contributors Roles Taxonomy (CRediT).4
  • All individuals who qualify for authorship or acknowledgment should be identified. Every person identified as an author or acknowledged contributor should qualify for these roles.
  • Individuals listed as authors should review and approve the final manuscript before publication.
  • In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which of their co-authors are responsible for specific other parts of the work.
  • Editors should require authors and those acknowledged to identify their contributions to the work and make this information available to readers.
  • The ultimate reason for identification of authors and other contributors is to establish accountability for and transparency surrounding the reported work.

There is some disagreement about best practices in setting criteria for authorship, other types of contributorship, and contributions that are mentioned in the Acknowledgments. A paper by McNutt et al.3 recommends the following statement as best practice for crediting all authors on a paper:

“Each author is expected to have made substantial contributions to the conception OR design of the work; OR the acquisition, analysis, OR interpretation of data; OR have drafted the work or substantively revised it; AND to have approved the submitted version (and any substantially modified version that involves the author’s contribution to the study); AND to have agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.”

This statement was adapted and broadened from the definition of the International Committee of Medical Journal Editors (ICMJE),2,5-9 which defines authorship by the following criteria: 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; 3) final approval of the version to be published, and 4) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.2

While a person who has made these four ICMJE-defined contributions clearly warrants byline authorship, there is growing concern about the universality of this definition as the complexity of scientific research and its communication increases. The contributions necessary to complete a body of scientific work differ from discipline to discipline. With the increase of contributors from multi-disciplines, and specialty writers (often paid) who frame and help to analyze the research for submissions to journals,2,5-9 the ICMJE criteria are not always practical, and often “honorary” authors not meeting the criteria are included. The recommendation by McNutt et al. is more practical and more accurately includes those who have made significant contributions to a research paper.

Other more flexible authorship criteria include those by the NIH, which states “For each individual the privilege of authorship should be based on a significant contribution to the conceptualization, design, execution, and/or interpretation of the research study, as well as on the drafting or substantively reviewing, or revising the research article, and a willingness to assure responsibility for the study.”10 The Committee on Publication Ethics (COPE), whose membership includes more than 12,000 journals from all research fields, acknowledges that “the minimum requirements for authorship, common to all definitions, are 1) substantial contribution to the work and 2) accountability for the work that was done and its presentation in a publication. It is important that authors know, understand, and adhere to the criteria for authorship within their respective disciplines.”11

Some journals have adopted criteria closely aligned with McNutt et al.’s recommended best practice and also require medical writers who wrote the first draft of a manuscript (the intellectual framework for all future revisions) or responded to the reviewers’ comments to be included in the author byline and make full disclosure to provide transparency to readers.12 Other journals maintain that the role of professional writers who participated in drafting of the manuscript should be identified in the acknowledgements section along with information about potential conflicts of interest including whether they were compensated for the writing assistance and, if so, by which entity(ies).5-9

Contributorship Models. Consensus holds that some types of contributions do not alone justify identification as an author. These include assisting the research by providing advice, research space, or departmental oversight; obtaining financial support; performing isolated analyses; or providing reagents/patients/animals/other study materials. These contributions should be listed in the Acknowledgments.

2.2.2 Other Authorship Issues

Inappropriate types of authorship include guest authorship, honorary or gift authorship, and ghost authorship.13,14,15

Guest Authorship. Guest authorship has been defined as authorship based solely on an expectation that inclusion of a particular name will improve the chances that the study will be published or increase the perceived status of the publication. The “guest” author makes no discernible contributions to the study, so this person meets none of the criteria for authorship.

Artificial Intelligence Authorship. Machine Learning and Artificial Intelligence (AI) tools (such as ChatGPT or chatbots) should not be listed as authors because a non-human cannot be responsible or accountable for the accuracy, integrity, and originality of the work, and these responsibilities are required for authorship as outlined in 2.2.1 Authorship and the ICMJE Roles and Responsibilities for Authorship. AI assisted tools are unable to hold or transfer copyright.

Honorary or Gift Authorship. Honorary or gift authorship has been defined as authorship based solely on a tenuous affiliation with a study. A salient example would be “authorship” based on one’s position as the head of a department in which the study took place.

Ghost Authorship. Ghost authors participate in the research, data analysis, and/or writing of a manuscript but are not named or disclosed in the author byline or Acknowledgments. Examples of ghost authors include undisclosed contributors who are employees of pharmaceutical or device companies, medical writers, marketing and public relations writers, and junior staff writing for elected or appointed officials.16 Any person who makes a substantial contribution to a manuscript should be listed in the author byline, if appropriate, or in the Acknowledgments, along with the individuals’ institutional affiliations, if relevant.17

Authorship for Sale. Some instances have been reported in which non-authors have attempted to buy authorship from an author of a paper, often after the paper has been invited for revision or provisionally accepted. Editors should be aware of changes made in the author byline during the review process. If a change is requested, the corresponding author of the paper should provide an explanation for the request, and all authors on a paper should approve any author changes.

Anonymous Authorship. Because authorship should be transparent and requires public accountability, it is not appropriate to use pseudonyms or to publish scientific reports anonymously. In extremely rare cases, when the author can make a credible claim that attaching his or her name to the document could cause serious hardship (e.g., threat to personal safety or loss of employment), a journal editor may decide to publish anonymous content.

Other categories of authorship that may be acceptable in certain circumstances include group authorship and the inclusion of deceased or incapacitated authors.

Group Authorship. Group authorship18 may be appropriate when a group of researchers has collaborated on a project, such as a multicenter trial, a consensus document, or an expert panel. Because it can be inaccurate and impossible to list all collaborators (some would not meet a journal’s authorship criteria, and byline space may preclude such a listing), authors need to think about how to communicate credit and responsibility for content. Editors have outlined 2 group authorship models:18

  • Authorship in which each person in the group meets authorship criteria, in which case the group is listed as the author, with at least 1 coauthor assuming the role of content guarantor.
  • Authorship in which a select subgroup of the whole is listed in the byline on behalf of the whole.

Deceased or Incapacitated Authors. For cases in which a coauthor dies or is incapacitated during the writing, submission, or peer-review process, coauthors should obtain disclosure and copyright documentation from a familial or legal proxy.16

2.2.3 Acknowledgments

In an Acknowledgments section, authors may wish to include the names and contributions of those whose involvement in a study did not qualify them for authorship or, because of journal policy on the number of authors in the author byline, cannot be included in the author byline. An example of this would be technical laboratory or writing assistance; the specific contribution should be noted. Authors should have each person listed in the acknowledgment sign a disclosure form or other statement acknowledging that they agree to have their names appear. Those acknowledged should disclose potential conflicts of interest.

2.2.4 Order of Authors

The order of authors in the byline is a collective decision of the authors or study group. Disagreements about author order should be resolved by the authors before the article is submitted for publication. Disputes that arise after submission could delay or prevent publication. Authors should not expect editors to become embroiled in disputes among authors over name placement in the byline.

Much has been written about the meaning of each place in the byline listing, particularly among the first 6 authors.16 Some journals specify how many authors they will accept in the author byline. Sample correspondence related to this topic is available on the CSE website.19

2.2.5 Changes to the Author Byline

Any changes the authors wish to make to the author byline after the initial submission of a manuscript should be made in writing and the document should be signed by all authors, including those being added or removed. The new author list should be stated directly along with a justification for the change. Sample correspondence related to this topic is available on the CSE website.19

2.2.6 Author Responsibilities

Confidentiality. The author-editor relationship is founded on confidentiality. Authors should hold all communication between themselves and the journal in confidence. Authors should designate a specific contact for all communication about the manuscript throughout peer review and (if accepted) the publication process. Authors should observe journal policy on communication with external peer reviewers (the policy may vary depending on whether a journal uses masked or nonmasked peer review) and should observe journal policy on prepublication embargoes (see section 2.6 on responsibilities to the media).

Originality. The authors should provide a statement attesting to the originality of the study they have submitted for consideration. Originality is crucial, because many journals have limited space and editors may give a low priority to studies that, regardless of scientific accuracy and validity, do not advance the scientific enterprise. Some journals may ask authors to provide copies of reports on other studies (articles, manuscripts, and abstracts) related to the study under consideration. Sample correspondence related to this topic is available on the CSE website.19

Disclosures. Authors have a responsibility to be forthright when complying with journal submission requirements. This entails disclosure about the originality of the content, a statement of an author’s actual contribution to the study, and financial and conflict of interest disclosures. Some journals also require statements on the regulatory status of any drugs or devices used in the study. Authors should expect editors to publish all relevant disclosures with their accepted manuscript. Sample correspondence related to this topic is available on the CSE website.19

Many journals require authors to disclose sources of funding for the study they wish to report. Authors should disclose all sources of funding (government, corporate, other) and any products or services (such as materials and equipment, statistical analysis, and scientific writing) provided by third parties in the course of the research, analysis, or reporting. Some journals stipulate that authors disclose financial relationships in dollar amounts and set specific dollar thresholds. Items to be disclosed include employment, consultancies, stock ownership, honoraria, expert testimony, and patents.k

Some journals use a contributorship form, wherein authors attest to their specific contributions. Authors may expect that editors will publish these statements with their accepted manuscript.l

k. Example of a disclosure form: http://www.nejm.org/doi/suppl/10.1056/NEJMe1006030/suppl_file/nejme1006030_disclosures.pdf (Accessed November 14, 2019)
l. Example of a contributorship form: https://www.elsevier.com/__data/promis_misc/OPHTHA_Contributorship.pdf (Accessed November 14, 2019).

Copyright Assignment. In medical publishing, authors are usually expected to assign copyright to the journal publishing their study. Assignment of copyright is a legal document in which the authors assign certain rights to the publisher. Alternatively, some journals may use a licensing agreement. Although individual arrangements vary, these agreements generally allow the authors to retain certain rights to the material. In either case, the content in question must be original and not otherwise under copyright elsewhere (in whole or in part). Authors should ensure that the study under consideration is original and does not contain plagiarized content. In addition, authors must avoid duplicate publication, which is reproducing verbatim content from their other publications. Some journal editors may not be willing to consider submissions containing content the authors have published elsewhere, because it may violate copyright and could be an indication that the study contributes only marginally to the literature.

Permissions. Authors frequently wish to reuse previously published images and other copyrighted material. It is the author’s responsibility to follow journal or publisher guidelines to reuse any copyrighted material and provide proper attribution. This includes the author’s own work if the copyright was ever transferred to a publisher or journal. Authors should contact the journal or publisher of the source material or consult the “permissions” information that can be found on many of their web sites. Permission should be granted in writing and the authors should retain this documentation. The editor may request a copy of this notification as well.

Multiple Submissions. In the biomedical sciences, it is not acceptable for authors to submit the report of a study to several journals at the same time, including a manuscript undergoing peer review that has not been formally rejected by the original journal to which the manuscript was submitted. Authors who do not follow this standard may find that editors reject their papers as a violation of policy. In addition, this practice can be a violation of copyright.

If authors want to submit their article to another journal while it is under consideration elsewhere, then they must send formal notification to the editor of the journal in which it is under consideration, requesting that their study be withdrawn from further consideration (see section 3.1.3). All coauthors must agree to the request for withdrawal and this agreement must be made clear to the editor of the journal with which the study is under consideration. Authors should request formal acknowledgment from the journal to the effect that the editors understand the manuscript has been withdrawn from future consideration. On receipt of notification from the journal acknowledging the withdrawal, the authors may submit their manuscript elsewhere. They should retain a copy of the notification.

Data Sharing. Data sharing is the practice of making data used for scholarly research available to other investigators.20 Authors should be aware of their data sharing responsibilities imposed by their funding agencies. The goal of this policy is to promote reproducibility and availability of underlying data sets. At the beginning of a study the authors should consider where they will submit their data and should consider the journals they may want to submit their study and review the data sharing policies for each journal.

Registration of Clinical Trials. ICMJE’s member journals21 and many others require that to be considered for publication, any prospective, interventional clinical research study must have been appropriately recorded in an approved trial registry before enrollment of the first subject.22,23 The goal of this policy is to promote the public availability of a comprehensive database of clinical trials. Registry is undertaken by trial investigators or sponsors (see section 2.4 on sponsor roles and responsibilities). The ICMJE recommends that journals publish the trial registration number at the end of the abstract and that authors specify the registration number the first time they use a trial acronym in a manuscript23. Before the start of a study, the authors should consider whether the journals to which they may want to submit their study report have adopted this policy.

The ICMJE accepts registration in the following registries:

  • Australian New Zealand Clinical Trial Registry24
  • ClinicalTrials.gov25
  • International Standard Randomised Controlled Trial Number (ISRCTN) Register26
  • University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)27
  • Netherlands Trial Register28

In addition to the above registries, the ICMJE accepts registration in any of the primary registries that participate in the WHO International Clinical Trials Registry Platform (ICTRP).29,30 Authors should check periodically to identify any registries that may be added to this list. Sample correspondence related to this topic is available on the CSE website.19

For most clinical studies, the entry of “basic results” data into the registry is required within 12 months of completion of data collection.31 The ICMJE does not consider results posted in a trial’s registry as previous publication if they are presented only as a brief (less than 500 words) structured abstract or table. Journals that are not members of ICMJE are urged to follow the same guideline.31 When submitting a paper, authors should fully disclose to editors all posting of results of the submitted work or closely related work in registries. When deciding whether to consider a trial report for publication, journal editors may review the study’s data fields to ensure that they are complete and informative.

Public Access Requirements of Funding Agencies.

United States federal law requires that an electronic version of all peer-reviewed journal manuscripts reporting studies funded wholly or in part by the National Institutes of Health (NIH) must be submitted to the National Library of Medicine’s PubMed Central upon acceptance for publication. The material is to be made publicly available no later than 12 months after the official date of publication.32 The purpose of this policy is to ensure public access to the peer-reviewed, published results of all NIH-funded research; to create an archive of peer-reviewed research publications resulting from NIH funding; and to create a searchable compendium of NIH-funded research to help the agency manage and monitor scientific productivity and set priorities.33

The NIH public access instructions34 and frequently asked questions35 are available online. There are 4 options for submitting manuscripts to PubMed Central.36 To ensure compliance, NIH Program Officials will check the citations in grant applications, proposals, or progress reports for PubMed Central Identifiers or appropriate alternatives.37

A number of other U.S. and international funding agencies (e.g., the Canadian Institutes of Health Research,38 Howard Hughes Medical Institute,39 Wellcome Trust,40 and the United Kingdom’s Medical Research Council41) have public access requirements. It is the author’s responsibility to understand and adhere to the requirements of any agency funding the author’s research.

Human Subjects Research. All journals should require formal affirmation that human subject’s research on which a submission is based was approved by an institutional review board (IRB) or complied with the Declaration of Helsinki42 and/or relevant NIH forms43. The researchers must have conducted the study according to the approved protocol and acceptable research standards, including having obtained informed consent of study subjects. Sample correspondence related to this topic is available on the CSE website.19 Although some IRBs may consider certain types of studies, such as case reports, to be exempt from their approval, IRB review may still be necessary to make that determination. Journal editors may request a copy of the IRB determination letter during manuscript submission. Additionally, authors should obtain written informed consent from the subjects of case reports and written permission to use any identifiable images.

Animal Research. All journals should require formal affirmation that any research involving animals was approved by an animal care and use committee and was conducted according to the approved protocol and acceptable research standards for animal experimentation. Sample correspondence related to this topic is available on the CSE website.19

Cell Line Authentication. The problem of cell line contamination and misidentification has been recognized since the 1960s.43 The issue remains unresolved and there is growing concern over the ongoing, widespread use of misidentified cell lines. Although there is general agreement in the scientific community that this is a serious problem, there is less agreement on the possible solutions.

Cell line authentication is the use of appropriate methods to verify that cell lines used in specific research studies are properly identified. It has been proposed that research using unauthenticated cell lines should not be funded or published.44 The NIH, which has published a policy notice on the issue,45 finds that solution impractical, relying instead on peer reviewers of grants and manuscripts. Their role, in part, is to examine the experimental methods used by researchers and assure that they are appropriate.

Authors should be aware of the potential problem to ensure that they are presenting valid research. Journal editors and publishers are currently determining how to address the issue of cell line authentication, so guidelines may be developed in the future.

2.2.7 References

  1. Marušic A, Bošnjak L, Jeroncic A. A systematic review of research on the meaning, ethics and practices of authorship across scholarly disciplines. PLoS One. 2011;6(9):e23477. Epub 2011 Sep 8. Available at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0023477 (Accessed June 8, 2020).
  2. International Committee of Medical Journal Editors (ICMJE). Defining the Role of Authors and Contributors. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html (Accessed September 10, 2019).
  3. Marcia K. McNutt, Monica Bradford, Jeffrey M. Drazen, Brooks Hanson, Bob Howard, Kathleen Hall Jamieson, Véronique Kiermer, Emilie Marcus,  Barbara Kline Pope,  Randy Schekman, Sowmya Swaminathan, Peter J. Stang, and Inder M. Verma. PNAS March 13, 2018 115 (11) 2557-2560, https://doi.org/10.1073/pnas.171537411 (Accessed June 8, 2020)
  4. Casrai: Contributor Roles Taxonomy. docs.casrai.org/CRediT (Accessed Aug 12, 2019)
  5. Cottingham K. The Ethics of Authorship: Feature Overview—How Should Authorship be Decided? Science. March 30, 2001. Available at: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2001_03_30/noDOI.1470170286102423077 (Accessed June 8, 2020).
  6. Noble M. the Ethics of Authorship: Policies for Authorship of Articles Submitted to Scientific Journals. Science. March 30 2001. Available at: http://www.sciencemag.org/careers/2001/03/ethics-authorship-policies-authorship-articles-submitted-scientific-journals (Accessed June 8, 2020).
  7. Wilcox L. The Ethics of Authorhip: An Ombudsperson’s Perspective. Science. March 30, 2001. Available at: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2001_03_30/noDOI.14314302689040751822 (Accessed June 8, 2020).
  8. The Ethics of Authorship: Does it Take a Village to Write a Paper? Science. March 30, 2001. Available at: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2001_03_30/noDOI.2580479737297545632 (Accessed June 8, 2020).
  9. Gottesman M. The Ethics of Authorship: Authorship by prior Agreement—Principles and Pitfalls. Science. March 30, 2001. Available at: http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2001_03_30/noDOI.17090511604525562351 (Accessed June 8, 2020).
  10. National Institutes of Health. Guidelines for the conduct of Research in the Intramural Research program at NIH. Available at: https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-conduct_research.pdf (Accessed June 8, 2020.
  11. Committee on Publication Ethics. Current Definitions of Authorship. https://publicationethics.org/files/COPE_DD_A4_Authorship_SEPT19_SCREEN_AW.pdf (Accessed November 10, 2019)
  12. Baskin PK, Gross, RA. Honorary and ghost authorship, BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d6223 (Accessed June 8, 2020)
  13. Committee on Publication Ethics (CPE). What to do if you suspect ghost, guest or gift authorship (flowchart). Available at: http://publicationethics.org/resources/flowcharts (Accessed June 8, 2020).
  14. Committee on Publication Ethics (COPE). How to spot authorship problems (flowchart). Available at: http://publicationethics.org/resources/flowcharts (Accessed June 8, 2020).
  15. Flanagin A, Rennie D. Acknowledging ghosts. JAMA. 1995;273(1):73, doi: https://doi.org/10.1001/jama.1995.03520250089041 (Accessed June 8, 2020).
  16. American Medical Association Manual of Style: A Guide for Authors and Editors, https://www.amamanualofstyle.com/  (Accessed June 8, 2020).
  17. Laine C, Mulrow CD. Exorcising ghosts and unwelcome guests. Ann Intern Med. 2005; 143:611-612, doi: https://doi.org/10.7326/0003-4819-143-8-200510180-00013 (Accessed June 8, 2020).
  18. Council of Science Editors (CSE). The CSE recommendations for group-author articles in scientific journals and bibliometric databases. Available at: https://www.councilscienceeditors.org/resource-library/editorial-policies/cse-policies/approved-by-the-cse-board-of-directors/cse-recommendations-for-group-author-articles-in-scientific-journals-and-bibliometric-databases/ (Accessed June 8, 2020).
  19. Council of Science Editors. Sample correspondence. Available at: https://www.councilscienceeditors.org/resource-library/editorial-policies/sample-correspondence-for-an-editorial-office/ (Accessed June 8, 2020).
  20. Data Sharing Definition http://en.wikipedia.org/wiki/Data_sharing (Accessed June 8, 2020).
  21. Journals that have requested inclusion on the list of publications that follow the ICMJE’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Available at: http://www.icmje.org/journals.html (Accessed June 8, 2020).
  22. International Committee of Medical Journal Editors (ICMJE). Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. May 2005. Available at: http://www.nejm.org/doi/full/10.1056/NEJMe058127 (Accessed June 8, 2020).
  23. International Committee of Medical Journal Editors (ICMJE). Clinical trials. Available at: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html (Accessed June 8, 2020).
  24. Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/TrialSearch.aspx (Accessed June 8, 2020).
  25. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ (Accessed June 8, 2020).
  26. International Standard Randomised Controlled Trial Number (ISRCTN) Register. Available at: http://isrctn.org/ (Accessed June 8, 2020).
  27. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). Available at: http://www.umin.ac.jp/ctr/ (Accessed June 8, 2020).
  28. Netherlands Trial Register. Available at: http://www.trialregister.nl/trialreg/index.asp (Accessed June 8, 2020).
  29. WHO International Clinical Trials Registry Platform (ICTRP). Available at: http://www.who.int/ictrp/about/details/en/index.html (Accessed June 8, 2020).
  30. International Committee of Medical Journal Editors (ICMJE). Clinical trial registration: looking back and moving ahead. Ann Intern Med. 2007; 147:275-7. Available at: http://www.nejm.org/doi/full/10.1056/NEJMe078110 (Accessed June 8, 2020)..
  31. International Committee of Medical Journal Editors (ICMJE). Basic results reporting at ClinicalTrials.gov and “prior publication.” Available at: http://www.icmje.org/news-and-editorials/update_fdaaa_jun2008.html (Accessed June 8, 2020).
  32. National Institutes of Health. Public access policy. Available at: http://publicaccess.nih.gov/ (Accessed June 8, 2020).
  33. National Institutes of Health. Policy on enhancing public access to archived publications resulting from NIH-funded research. Notice Number: NOT-OD-05-022, February 3, 2005. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html (Accessed June 8, 2020).
  34. NIH public access instructions. Available at: http://publicaccess.nih.gov/ (Accessed June 8, 2020).
  35. NIH public access frequently asked questions. Available at: http://publicaccess.nih.gov/FAQ.htm (Accessed June 8, 2020).
  36. NIH public access submission methods. Available at: http://publicaccess.nih.gov/submit_process.htm (Accessed June 8, 2020).
  37. National Institutes of Health Office of Extramural Research. Extramural Nexus. October 2008. Available at: http://grants1.nih.gov/grants/nexus.htm (Accessed June 8, 2020).
  38. The public access requirements of the Canadian Institutes of Health Research. Available at: http://www.cihr-irsc.gc.ca/e/32005.html (Accessed June 8, 2020).
  39. The public access requirements of the Howard Hughes Medical Institute. Available at: http://www.hhmi.org/about/research/sc320.pdf (Accessed June 8, 2020).
  40. The public access requirements of the Wellcome Trust. Available at: http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTD002766.htm (Accessed June 8, 2020).
  41. The United Kingdom’s Medical Research Council position statement on public access. Available at: https://mrc.ukri.org/about/policy/mrc-position-statements/ (Accessed June 8, 2020).
  42. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (Accessed June 8, 2020).
  43. National Institutes of Health, Office of Human Subjects Research (OHSR). OHSR information sheets/forms. Available at: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html (Accessed June 8, 2020).
  44. Nardone RM. Eradication of cross-contaminated cell lines: A call for action. Cell Biol Toxicol. 2007;23:367-372, doi: https://doi.org/10.1007/s10565-007-9019-9 (Accessed June 8, 2020).
  45. NIH notice regarding authentication of cultured cell lines. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-017.html (Accessed June 8, 2020).

2.2.8 Resources and Case Studies

  • Committee on Publication Ethics (COPE). Guidelines. Available at: http://publicationethics.org/resources/guidelines (Accessed June 8, 2020).
  • International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. Available at: http://www.icmje.org (Accessed June 8, 2020).
  • National Cancer Institute, National Institutes of Health. Informed consent template for cancer treatment trials (English language). Available at https://ctep.cancer.gov/protocolDevelopment/informed_consent.htm. (Accessed June 8, 2020).
  • Utiger RD, for the Education Committee of the World Association of Medical Editors (WAME). A syllabus for prospective and newly appointed editors. Available at: http://www.wame.org/syllabus.htm#policies/resources/editor-s-syllabus (Accessed June 8, 2020).

(Authorship: Michael Vasko took the lead in writing this section of the white paper on behalf of the CSE Editorial Policy Committee. Kristi Overgaard and Sharon Naron revised this section for the 2009 update. Christine Laine and Jennifer Mahar revised this section for the 2012 update. Members of the Editorial Policy Committee and the CSE Board of Directors reviewed and commented on it. This section was formally approved by the CSE Board of Directors on March 30, 2012.

Patricia Baskin led the revision for this section for the June, 2020 update. Members of the Editorial Policy Committee and the CSE Board of Directors reviewed and commented on it. This section was formally approved by the CSE Board of Directors on March 13, 2020.)