The Nemours Foundation

NEMOURS POLICY AND PROCEDURE MANUAL

SUBJECT: Authorship on Scientific Papers No. 5.9.2

EFFECTIVE DATE: September 6, 2006 SUPERSEDES: N/A SECTION: Corporate Ethics and DEPARTMENT: Research Integrity Responsibility NAME/TITLE: David J. Bailey, MD, MBA, President and Chief Executive Officer

SIGNATURE: DATE APPROVED: September 6, 2006

1. PURPOSE: To establish Nemours’ authorship standards and procedures for preparing scientific papers and abstracts related to Nemours-approved research studies or protocols for submission and publication in medical, scientific, policy, business, and professional books, periodicals, or journals.

2. POLICY: In addition to the specific procedures set forth below, Nemours shall follow the ethical principles and guidelines set forth in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, as updated February 2006, published by the International Committee of Medical Journal Editors (“Uniform Requirements”), which are attached as Exhibit “A”.

3. DEFINITIONS: 3.1. Abstract - a short summary of the approved research study or protocol which contains key features and findings of the study or protocol, and has been published in a scientific book, periodical, or journal. 3.2. Acknowledgments - written statements in the proposed manuscript granting recognition to those individuals who made contributions to a research study, but not necessarily to the major intellectual aspects of the study. 3.3. Author - a participant in an approved research study or protocol who writes a portion of a proposed scientific paper and who has made significant substantive intellectual contributions to the research study which is the subject of the paper. 3.4. Co-author - a participant in an approved research study or protocol who writes a portion of a proposed scientific paper and who has made some substantive intellectual contributions to the research study that is the subject of the paper, to a lesser extent than the Senior Author. 3.5. Contributor - an individual who contributed data, or participated in the research study or protocol but did not significantly participate in writing or developing the proposed scientific paper or abstract.

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3.6. Principal Investigator (“PI”) - the person approved by the appropriate research oversight committee, pursuant to Nemours policy # 5.9.3 “Principal Investigator Eligibility” as the person responsible for the administrative, financial, procedural and scientific aspects of a research study or protocol. 3.7. Project Leader - the person who is leading a research project or effort which does not involve human subjects, animals, or otherwise does not fall under the responsibility of a research oversight committee. 3.8. Proposed Scientific Paper or Abstract - a draft scientific paper or abstract, which the author(s) is submitting for possible publication in a scientific book, periodical, or journal. 3.9. Scientific Paper - a manuscript prepared by a Senior Author and other authors containing an introduction, methodology, data, analysis, and conclusions related to an approved research study or protocol, which has been published in a scientific book, periodical, or journal. 3.10. Senior Author - the leader of the research study or protocol who makes a major contribution to both the writing of a proposed scientific paper and to the substantive intellectual work and conclusions of the study.

4. PROCEDURES: 4.1. The PI or Project Leader, in collaboration with the other participants in a research study or protocol, shall decide during the study design phase the responsibilities of individual participants related to writing and contribution to the proposed scientific paper(s) or abstract(s) which will comment on or are related to the research study/protocol. The PI/Project Leader will designate the senior author, co-author(s) and other author(s) in accordance with the Uniform Requirements. The PI/Project Leader will also make any necessary changes to the responsibilities or author designations during the course of the research study/protocol and preparation of the proposed paper or abstract. 4.2. If a co-author, author, study participant or contributor disputes the designations made by the PI/Project Leader, including designation of the PI/Project Leader as Senior Author, every attempt to resolve the dispute should be made among the PI/ Project Leader and the research study participants. In the event the dispute cannot be resolved to the satisfaction of all authors and study participants, a written request should be submitted to the Chairman of the Committee for Research Integrity (“CRI”) for a final resolution of the authorship designations. The decision of the CRI regarding an authorship dispute will be considered final with respect to the proposed scientific paper or abstract at issue. 4.3. Proposed scientific papers or abstracts should be drafted in accordance with the Uniform Requirements. Appropriate acknowledgments or citations will be made in the proposed scientific paper or abstract to recognize contributions and participation by a Contributor. 4.4. Final drafts of proposed papers or abstracts will be circulated amongst all listed authors prior to submission for possible publication to any scientific book, periodical, or journal. Authors must disclose any personal or financial conflicts of interest to the PI/Project Leader, who will determine whether the author designations or the final content must be altered. 4.5. Each author listed on the proposed scientific paper or abstract must support and grant his/her approval for the entire content and conclusions of the proposed

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scientific paper or abstract and should be prepared to explain and/or defend the entire proposed paper or abstract. In the event an author disagrees with or otherwise cannot approve the entire content of a proposed paper or abstract, the PI/ Project Leader and the Senior Author will consider whether changes should be made to the proposed paper or abstract to alleviate the author’s concerns. In the event the PI/Project Leader or Senior Author determines the concerns cannot be alleviated, that author’s name will be removed as a listed author from the proposed paper or abstract and the author’s contributions will be noted in the Acknowledgments or cited appropriately in the body of the scientific paper or abstract. 4.6. External sponsors of approved research studies or protocols may be given the right to review a proposed scientific paper or abstract prior to submission for publication if the executed agreement between the PI/Project Leader and the external sponsor grants a right to the external sponsor for such review. The PI/Project Leader or Senior Author will attempt to resolve any concerns raised regarding the proposed scientific paper or abstract by the external sponsor, but the PI/Project Leader or Senior Author will make the final determination regarding the substantive content, unless agreed otherwise in the executed agreement.

Review/Revision Dates:

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EXHIBIT “A”

Supporting and Source Documentation (if applicable): Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, Updated February 2006. Link: http://www.icmje.org/index.html