2.2 Authorship and Authorship Responsibilities

Trust is fundamental to scientific communication: trust that the authors have accurately reported their 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. Unfortunately, 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

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 from one scientific discipline to another. This document aims to summarize common principles to guide authorship across scientific disciplines.

Principles related to authorship with general consensus include the following:

  • Identification of authors and other contributors is the responsibility of the people who did the work (the researchers) not the people who publish the work (editors, publishers). Researchers should determine which individuals have contributed sufficiently to the work to warrant identification as an author.
  • Individuals who contributed to the work but whose contributions were not of sufficient magnitude to warrant authorship should be identified by name in an acknowledgments section.
  • All individuals who qualify for authorship or acknowledgment should be identified. Conversely, every person identified as an author or acknowledged contributor should qualify for these roles.
  • Individuals listed as authors should review and approve the manuscript before publication.
  • 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 the reported work.

There is less agreement about the best way to ask about and report contributions, whether being an author implies accountability for only parts of the work they specifically did or for the entire paper, and whether editors should set firm criteria to distinguish authors from acknowledged contributors.

Within biomedicine, many journals have adopted the definition of the International Committee of Medical Journal Editors (ICMJE), 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; and 3) final approval of the version to be published.2 While a person who has made these three contributions clearly warrants byline authorship, there is growing concern about the relevance of this definition as the complexity of scientific research and its communication increases. It is difficult to prescribe a defined set of contributions that meet the minimal conditions for authorship.3-7

Further, the contributions necessary to complete a body of scientific work differ from discipline to discipline and even among different types of studies within a single discipline. The NIH defines authorship a bit more flexibly than the ICMJE. According to the NIH, “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.” 8

The Committee on Publication Ethics (COPE), whose membership includes more than 4000 journals from all research fields, acknowledges that “there is no universally agreed definition of authorship, although attempts have been made … As a minimum, authors should take responsibility for a particular section of the study.”9

The Council of Science Editors, aware of the differences in the requirement for authorship in different fields, began to consider updating authorship and contributorship recommendations during a special Retreat on Authorship at the 2009 CSE Annual Meeting. Journal editors, researchers, and representatives of the academic community from different disciplines presented their experiences and views on authorship and journal authorship policies. The conclusions of the retreat are reflected in the common principles listed above as well as in the statements that follow.

Authors are individuals identified by the research group to have made substantial contributions to the reported work and agree to be accountable for these contributions. 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. In addition, an author should have confidence in the integrity of the contributions of their co-authors. All authors should review and approve the final manuscript.

There is consensus about some types of contributions that do not alone justify identification as an author. Professional writers who participated only in drafting of the manuscript and did not have a role in the design or conduct of the study or the interpretation of results 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). It is unacceptable to neglect to identify such individuals. Other contributions that alone do not justify authorship include: assisting the research by providing advice, providing research space, departmental oversight, obtaining financial support, isolated analyses, or providing reagents/patients/animals/other study materials.

2.2.2 Contributorship Models

In the 1990s as a response to the difficulties with defining authorship in science, some scientific publishing stakeholders began to advocate for a “contributorship model” in which published articles include a contributor list rather than an author byline and an acknowledgments section. Advocates of this model propose that doing so would better enable editors to elicit actual contributions from authors and to convey a more accurate sense of each author’s responsibility for the study.10, 11

This model of “contributorship” has been adopted by a number of major biomedical journals. The general aim of contributorship disclosure is to have authors describe, on the basis of a contributor taxonomy created by journal editors, exactly what each author did during the course of the study from its inception to publication, such as obtaining funding for the study; recruiting subjects; coordinating, collecting, and analyzing the data; and writing and revising the manuscript.1011 Under this model, authors are also expected to designate their functional role within the group (e.g., principal investigator, coinvestigator, statistician, contributing author).10-11 It is argued that this additional layer of disclosure contributes to greater transparency on the part of authors.12

The purpose of contributorship disclosures is to have each author and/or contributor personally affirm his or her role, to disclose publicly to readers what each author did,12 and to gain from authors what Jerome Kassirer has described as “public responsibility for [article] content.”13 While the ICMJE criteria provide guidance about the types of contributions that characterize authors, it is ultimately the role of researchers themselves and not the editors to decide which individuals have contributed sufficiently to earn the designation “author.” Individuals who have made less substantial contributions should be identified in the Acknowledgments.

What authorship problems are editors specifically trying to identify and address? A range of inappropriate types of authorship have been described, including guest authorship, honorary or gift authorship, and ghost authorship.12, 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.

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, 18

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 authorship19 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 basic ICMJE authorship criteria and byline space may preclude such a listing), authors need to think about how to communicate credit and responsibility for content. The editors of JAMA have outlined 2 group authorship models:17

  • Authorship in which each person in the group meets authorship criteria, in which case the group is listed as the author, with the caveat that editors may require at least 1 coauthor to assume 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.17

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.17 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.20

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.20

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.20

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.20

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

kExamples of disclosure forms are available at: http://www.nejm.org/userimages/ContentEditor/1277392443758/ICMJEDisclosureForm0521101RE.pdf (Accessed Accessed March 9, 2012) and http://mts-npp.nature.com/letters/NPPcoi.pdf (Accessed March 9, 2012).
lExamples of a contributorship forms available at: http://www.springer.com/cda/content/document/cda_downloaddocument/ABJSCTAwSigLines.pdf?SGWID=0-0-45-495798-p173705903 (Accessed March 9, 2012).

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.21 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 journals22 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.23, 24 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 manuscript.24 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 Registry25
  • ClinicalTrials.gov26
  • International Standard Randomised Controlled Trial Number (ISRCTN) Register27
  • University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)28
  • Netherlands Trial Register29

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).30, 31 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.20

For most clinical studies, the entry of “basic results” data into the registry is required within 12 months of completion of data collection.32 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.32 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.33 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.34

The NIH public access instructions35 and frequently asked questions36 are available online. There are 4 options for submitting manuscripts to PubMed Central.37 To ensure compliance, NIH Program Officials will check the citations in grant applications, proposals, or progress reports for PubMed Central Identifiers or appropriate alternatives.38

A number of other U.S. and international funding agencies (e.g., the Canadian Institutes of Health Research,39 Howard Hughes Medical Institute,40 Wellcome Trust,41 and the United Kingdom’s Medical Research Council42) 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 Helsinki43 and/or relevant NIH forms.44 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.20Although 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.20

Cell Line Authentication. The problem of cell line contamination and misidentification has been recognized since the 1960s.45 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.45 The NIH, which has published a policy notice on the issue,46 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 ABošnjak LJeroncic 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 March 9, 2012).
  2. International Committee of Medical Journal Editors (ICMJE). Authorship and Contributorship. http://www.icmje.org/ethical_1author.html (Accessed March 9, 2012).
  3. 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 March 9, 2012).
  4. Noble M. the Ethics of Authorship: Policies for Authorship of Articles Submitted to Scientific Journals. Science. March 30 2001. Available at:http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2001_03_30/noDOI.9203462371499238483 (Accessed March 9, 2012).
  5. 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 March 9, 2012).
  6. 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 March 9, 2012).
  7. 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 March 9, 2012).
  8. National Institutes of Health. Guidelines for the conduct of Research in the Intramural Research program at NIH. Available at: http://sourcebook.od.nih.gov/ethic-conduct/Conduct%20Research%206-11-07.pdf (Accessed March 9, 2012).
  9. Albert T, Wager E. How to handle authorship disputes: a guide for new researchers. The COPE Report 2003. Available at:http://publicationethics.org/files/u2/2003pdf12.pdf (Accessed March 9, 2012).
  10. Rennie D, Yank V, Emmanuel L. When authorship fails: a proposal to make contributors accountable. JAMA. 1997;278:579-585.
  11. Yank V, Rennie D. Disclosure of researcher contributions: a study of original research articles in The Lancet. Ann Intern Med. 1999;130:661-670.
  12. Report to the Council of Biology Editors from the Task Force on Authorship. Who’s the author? Problems with biomedical authorship and some possible solutions. Science Editor. 2000;23:111-119.
  13. Kassirer JP. Authorship criteria. Science. 1995;268:785-786.
  14. 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 January 11, 2012).
  15. Committee on Publication Ethics (COPE). How to spot authorship problems (flowchart). Available at: http://publicationethics.org/resources/flowcharts (Accessed March 9, 2012).
  16. Flanagin A, Rennie D. Acknowledging ghosts. JAMA. 1995;273(1):73.
  17. American Medical Association Manual of Style: A Guide for Authors and Editors, 10th edition. Oxford: Oxford University Press; 2007:128-140.
  18. Laine C, Mulrow CD. Exocising ghosts and unwelcome guests. Ann Intern Med. 2005; 143:611-612.
  19. Council of Science Editors (CSE). The CSE recommendations for group-author articles in scientific journals and bibliometric databases. Available at: http://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 March 9, 2012).
  20. Council of Science Editors. Sample correspondence. Available at: http://www.councilscienceeditors.org/resource-library/editorial-policies/sample-correspondence-for-an-editorial-office/ (Accessed March 9, 2012).
  21. Data Sharing Definition http://en.wikipedia.org/wiki/Data_sharing (Accessed March 9, 2012).
  22. 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 March 9, 2012).
  23. 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 March 9, 2012).
  24. International Committee of Medical Journal Editors (ICMJE). Obligation to register clinical trials. Available at: http://www.icmje.org/publishing_10register.html (Accessed March 9, 2012).
  25. Australian New Zealand Clinical Trial Registry. Available at: http://www.anzctr.org.au/Survey/UserQuestion.aspx (Accessed March 9, 2012).
  26. ClinicalTrials.gov. Available at: http://www.clinicaltrials.gov/ (Accessed March 9, 2012).
  27. International Standard Randomised Controlled Trial Number (ISRCTN) Register. Available at: http://isrctn.org/ (Accessed March 9, 2012).
  28. University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). Available at: http://www.umin.ac.jp/ctr/index.htm (Accessed March 9, 2012).
  29. Netherlands Trial Register. Available at: http://www.trialregister.nl/trialreg/index.asp (Accessed March 9, 2012).
  30. WHO International Clinical Trials Registry Platform (ICTRP). Available at: http://www.who.int/ictrp/about/details/en/index.html (Accessed March 9, 2012).
  31. 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 March 9, 2012).
  32. International Committee of Medical Journal Editors (ICMJE). Basic results reporting at ClinicalTrials.gov and “prior publication.” Available at:http://www.icmje.org/update_fdaaa.html (Accessed March 9, 2012).
  33. National Institutes of Health. Public access policy. Available at: http://publicaccess.nih.gov/ (Accessed March 9, 2012).
  34. 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 March 9, 2012).
  35. NIH public access instructions. Available at: http://publicaccess.nih.gov/ (Accessed March 9, 2012).
  36. NIH public access frequently asked questions. Available at: http://publicaccess.nih.gov/FAQ.htm (Accessed March 9, 2012).
  37. NIH public access submission methods. Available at: http://publicaccess.nih.gov/submit_process.htm (Accessed March 9, 2012).
  38. National Institutes of Health Office of Extramural Research. Extramural Nexus. October 2008. Available at: http://grants1.nih.gov/grants/nexus.htm (Accessed March 9, 2012).
  39. The public access requirements of the Canadian Institutes of Health Research. Available at: http://www.cihr-irsc.gc.ca/e/32005.html (Accessed March 9, 2012).
  40. The public access requirements of the Howard Hughes Medical Institute. Available at: http://www.hhmi.org/about/research/sc320.pdf (Accessed March 9, 2012).
  41. 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 March 9, 2012).
  42. The United Kingdom’s Medical Research Council position statement on public access. Available at:http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/Openaccesspublishing/Positionstatement/index.htm (Accessed March 9, 2012).
  43. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. October 22, 2008. Available at:http://www.wma.net/en/30publications/10policies/b3/index.html (Accessed March 9, 2012).
  44. National Institutes of Health, Office of Human Subjects Research (OHSR). OHSR information sheets/forms. Available at: http://ohsr.od.nih.gov/info/info.html (Accessed March 9, 2012).>
  45. Nardone RM. Eradication of cross-contaminated cell lines: A call for action. Cell Biol Toxicol. 2007;23:367-372.
  46. NIH notice regarding authentication of cultured cell lines. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-017.html (Accessed March 9, 2012).

2.2.8 Resources and Case Studies

Committee on Publication Ethics (COPE). Guidelines. Available at: http://publicationethics.org/resources/guidelines (Accessed March 9, 2012).

International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. Available at: http://www.icmje.org (Accessed March 9, 2012).

National Cancer Institute, National Institutes of Health. Informed consent template for cancer treatment trials (English language). May 23, 2006. Available at:http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/page3 (Accessed March 9, 2012).

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 March 9, 2012).

(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.)