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Ethical and Legal Considerations 

Ethical and Legal Considerations

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

DOI:
10.1093/jama/9780195176339.003.0005
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  1. 5.1 Authorship Responsibility

    1. 5.1.1 Authorship: Definition, Criteria, Contributions, and Requirements

    2. 5.1.2 Guest and Ghost Authors

    3. 5.1.3 Unsigned Editorials, Anonymous Authors, Pseudonymous Authors

    4. 5.1.4 Number of Authors

    5. 5.1.5 Order of Authorship

    6. 5.1.6 Changes in Authorship

    7. 5.1.7 Group and Collaborative Authorship

  2. 5.2 Acknowledgments

    1. 5.2.1 Acknowledging Support, Assistance, and Contributions of Those Who Are Not Authors

    2. 5.2.2 Group and Collaborative Author Lists

    3. 5.2.3 Author Contributions

    4. 5.2.4 Authors’ Conflicts of Interests and Financial Disclosures

    5. 5.2.5 Access to Data Statement

    6. 5.2.6 Funding and Role of Sponsors

    7. 5.2.7 Acknowledgment Elements and Order of Elements

    8. 5.2.8 Permission to Name Individuals

    9. 5.2.9 Personal Communication and Credit Lines

  3. 5.3 Duplicate Publication

    1. 5.3.1 Secondary Publication

    2. 5.3.2 Editorial Policy for Preventing and Handling Allegations of Duplicate Publication

  4. 5.4 Scientific Misconduct

    1. 5.4.1 Misrepresentation: Fabrication, Falsification, and Omission

    2. 5.4.2 Misappropriation: Plagiarism and Breaches of Confidentiality

    3. 5.4.3 Inappropriate Manipulation of Digital Images

    4. 5.4.4 Editorial Policy and Procedures for Detecting and Handling Allegations of Scientific Misconduct

    5. 5.4.5 Retractions, Expressions of Concern

    6. 5.4.6 Allegations Involving Unresolved Questions of Scientific Misconduct

    7. 5.4.7 Allegations Involving Manuscripts Under Editorial Consideration

  5. 5.5 Conflicts of Interest

    1. 5.5.1 Requirements for Authors

    2. 5.5.2 Reporting Funding and Other Support

    3. 5.5.3 Reporting the Role of the Sponsor

    4. 5.5.4 Access to Data Requirement

    5. 5.5.5 Requirements for Reporting Industry-Sponsored Studies

    6. 5.5.6 Requirements for Peer Reviewers

    7. 5.5.7 Requirements for Editors and Editorial Board Members

    8. 5.5.8 Handling Failure to Disclose Financial Interest

  6. 5.6 Intellectual Property: Ownership, Access, Rights, and Management

    1. 5.6.1 Ownership and Control of Data

    2. 5.6.2 Open-Access Publication and Scientific Journals

    3. 5.6.3 Copyright: Definition, History, and Current Law

    4. 5.6.4 Types of Works and Copyright Duration in the United States

    5. 5.6.5 Copyright Assignment or License

    6. 5.6.6 Copyright Notice and Registration

    7. 5.6.7 Copying, Reproducing, Adapting, and Other Uses of Content

    8. 5.6.8 Publishing Transcripts of Discussions, Symposia, and Conferences

    9. 5.6.9 Permissions for Reuse

    10. 5.6.10 Standards for Commercial Reprints and E-prints

    11. 5.6.11 Standards for Licensed International Editions

    12. 5.6.12 International Copyright Protection

    13. 5.6.13 Moral Rights

    14. 5.6.14 Copyright Resources

    15. 5.6.15 Patents

    16. 5.6.16 Trademark

  7. 5.7 Confidentiality

    1. 5.7.1 Confidentiality During Editorial Evaluation and Peer Review and After Publication

    2. 5.7.2 Confidentiality in Allegations of Scientific Misconduct

    3. 5.7.3 Confidentiality in Legal Petitions and Claims for Privileged Information

    4. 5.7.4 Confidentiality in Selecting Editors and Editorial Board Members

  8. 5.8 Protecting Research Participants’ and Patients’ Rights in Scientific Publication

    1. 5.8.1 Ethical Review of Studies and Informed Consent

    2. 5.8.2 Patients’ Rights to Privacy and Anonymity

    3. 5.8.3 Rights in Published Reports of Genetic Studies

    4. 5.8.4 Patients’ Rights in Essays and News Reports in Biomedical Journals

  9. 5.9 Defamation, Libel

    1. 5.9.1 Living Persons and Existing Entities

    2. 5.9.2 Public and Private Figures

    3. 5.9.3 Groups of Individuals

    4. 5.9.4 Statements of Opinion

    5. 5.9.5 Works of Fiction

    6. 5.9.6 Republication and News Reporting

    7. 5.9.7 Defense Against Libel

    8. 5.9.8 Minimizing the Risk of Libel

    9. 5.9.9 Demands to Correct, Retract, or Remove Libelous Information

    10. 5.9.10 Other Liability Concerns

  10. 5.10 Editorial Freedom and Integrity

    1. 5.10.1 Maintaining Editorial Freedom: Cases of Editorial Interference and the Rationale for Mission, Trust, and Effective Oversight and Governance

    2. 5.10.2 Ensuring a Trust Relationship Between Journal Editors, Publishers, and Owners

  11. 5.11 Editorial Responsibilities, Roles, Procedures, and Policies

    1. 5.11.1 The Editor’s Responsibilities

    2. 5.11.2 Acknowledging Manuscript Receipt

    3. 5.11.3 Editorial Responsibility for Manuscript Assessment

    4. 5.11.4 Editorial Responsibility for Peer Review

    5. 5.11.5 Editorial Responsibility for Rejection

    6. 5.11.6 Editorial Responsibility for Revision

    7. 5.11.7 Editorial Responsibility for Acceptance

    8. 5.11.8 Correspondence (Letters to the Editor)

    9. 5.11.9 Corrections (Errata)

    10. 5.11.10 Role of the Editorial Board

    11. 5.11.11 Disclosure of Editorial Practices, Procedures, and Policies

    12. 5.11.12 Editorial Audits and Research

    13. 5.11.13 Editorial Quality Review

  12. 5.12 Advertisements, Advertorials, Sponsorship, Supplements, Reprints, and E-prints

    1. 5.12.1 Advertisements

    2. 5.12.2 Criteria for Advertisements Directed to Physicians and Other Health Care Professionals

    3. 5.12.3 Advertorials

    4. 5.12.4 Sponsored Supplements

    5. 5.12.5 Other Forms of Sponsorship

    6. 5.12.6 Advertising and Sponsorship in Online Publications

    7. 5.12.7 Reprints and E-prints

  13. 5.13 Release of Information to the Public and Journal/Author Relations With the News Media

    1. 5.13.1 Release of Information to the Public

    2. 5.13.2 Expedited Publication and Release of Information Early Online

    3. 5.13.3 Embargo

    4. 5.13.4 Suggestions for Authors Interacting With the News Media

    5. 5.13.5 News Releases

This chapter is intended to provide guidance to authors, editors, reviewers, and publishers in the fields of biomedicine, health, and the life sciences. The discussion focuses on ethical and legal issues involved in publication.

According to Lundberg,2 human behavior is regulated by 3 forces: morality, ethics, and law. If personal morality does not regulate acceptable and appropriate behavior, we can rely on ethics. Ethical behavior is determined by norms, principles, guidelines, and policies. This chapter cites examples of the determinants of ethical behavior as they relate to scientific publication. If ethics do not regulate behavior, we are forced to rely on public laws. Examples of cases involving scientific publication when laws have been invoked or enforced are also provided in this chapter.

Those ethical and legal considerations and dilemmas most commonly encountered in scholarly scientific publication are the focus of this chapter. References to sources for additional guidance and information not discussed in this chapter are also provided within the text and at the end of each subsection.

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