Conflict of Interest Principles for Gastrointestinal Endoscopy

John Baillie, MD
Michael L. Kochman, MD
George Triadafilopoulos, MD

Index:

Preamble
Recommendations and Definitions
Principles for Authors' Disclosure
Principles for Reviewers' Disclosure
Principles for Associate Editors' Disclosure
Principles for Editor Responsibilities and Disclosure

Implementation of this document will be at the direction of the ASGE Governing Board and the responsibility of the GIE Editor.

Preamble:
Actual or potential conflicts of interest may impact on all participants in the process of publication. Not identifying the actual or potential conflicts may bring actual or potential harm to patients, have embarrassing consequences for the Journal, reviewers, and the Society, and bring disrepute to the investigators and those involved in the editorial process. As a step toward avoiding this, the ASGE and its journal GIE abide by the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” as listed in the Instructions to Authors. Additionally, disclosure of these actual or potential conflicts is made yearly by all of the Officers, Committee members, Editors and Editorial Board members and is posted on the public ASGE website.

An actual or potential conflict regarding publication occurs when a competing interest (financial, competitive or otherwise) may influence (intentionally or not) the interests of safety, veracity, or interpretation of data and results. It is recognized that many authors have competing interests, and it is often not clear to journal readers, and often to the researchers themselves, when a competing interest affectsdecision-making.

Readers may have varying perspectives about whether a competing interest has affected the validity of a research finding. Making these decisions is a complex process. Two readers when presented with the same information may arrive at different conclusions. Disclosure of all of the actual or potential conflicts allows the reader to make an informed judgment. The principles below are embodied within the Uniform Requirement and accepted COI practice for major journals.

If an editor has an actual or potential conflict of interest, that editor is prohibited from having any influence on, or contact with, the paper during the review process. Examples of these conflicts would include patent or license holders, receipt of honoraria or in kind support, other financial interests, papers under consideration from other members of the Editor’s staff, or if the author is from the same institution as the responsible editor.

All authors must disclose actual or potential conflicts related to all aspects of the report. This includes any actual or potential competing interest related to the design, conduct, and interpretation of the data. All articles and abstracts published in GIE will be accompanied by a disclosure statement.

Reviewers must also disclose actual or potential conflicts of interest and recuse themselves when they are requested for a review unless the reviewer can provide an objective assessment in the opinion of the editor; in that case the editor may be able to manage the actual or potential conflict. For example, the actual or potential conflicts may include personal, professional, research or other financial conflicts, which would be difficult to defend under scrutiny. Reviewers will be asked to complete a statement for each review disclosing actual or potential conflicts or stating that none exist. The editors will review these disclosures and may withdraw an invitation, and use them to verify that each review is unbiased as each received review is evaluated.

Recommendations:
The following competing interests or relationships should be disclosed for all individuals involved in the publication process:

Nota Bena: Persons Related to Authors/Reviewers/Editors: For any person listed and thus considered a "covered individual", other persons related to them shall also be considered a "covered individual" if they have a relationship as spouse, dependent child, or adult child employed by the sponsor, or any other relationship involving the actual or potential sharing of income or assets.

1. Leadership Position: Employment or service as an officer or board member for an entity having an investment, licensing, or other commercial interest in the subject matter under consideration must be disclosed.
2. Consultant/Advisory Role: Arrangements with an entity having an investment, licensing, or other commercial interest in the subject matter under consideration must be disclosed if performed or payments made within 2 years or anticipated to be paid in the upcoming year.
3. Stock Ownership: Any ownership interest including stock, options, and warrants (except when invested in a publicly traded fund not controlled by the covered individual) in any publicly traded or privately held company must be disclosed if the company is an entity having an investment, licensing, or other commercial interest in the subject matter under consideration.
4. Honoraria: Disclosure of honoraria for specific speeches, seminar presentations, or appearances is required when paid directly to the covered individual by an entity (or agent of the entity) having an investment, licensing, or other commercial interest in the subject matter under consideration and when provided within 2 years or anticipated to be paid in the upcoming year.
5. Research Funding: Payments associated with the conduct of the clinical research project in question must be disclosed if provided by the trial sponsor or agent of the entity.
6. Expert Testimony: Provision of expert testimony must be disclosed when the testimony relates to the subject matter under consideration.
7. Other Compensation: Trips, travel, gifts, or other inkind payments not directly related to specific research activities must be disclosed (if not disclosed as related to research related funding) if received from an entity having an investment, licensing, or other commercial interest in the subject matter under consideration and when received within 2 years of the activity or subject matter in question or anticipated to be received within 1 year after submission. Payments totaling less than $100 per incident are excluded from disclosure requirements.

1. Principles for Authors' Disclosure

1. Summary disclosure will accompany each article and be published for all journal content. Failure to provide appropriate disclosure will result in non-publication and other appropriate actions. Allegations of inappropriate disclosure will be investigated.
2. Both positive and negative disclosures are published.
3. Authors with questions should contact the Editorial Office prior to manuscript submission.
4. Electronic and hard-copy forms will be combined. Previous barriers now are resolved. This will be resolved by the Editor and Managing Editor.

   Authors' COI Implementation Wording for Each Submission

   1. Attestation of Investigator Independence/Accountability
      
      Did the authors have full access to all study data, take full responsibility for the accuracy of the data analysis, and have authority over manuscript preparation and decisions to submit the manuscript for publication?
      
      Yes
      No, please describe below and provide additional detail in cover letter if necessary
      
      
   2. Institutional Conflicts of Interest
      
      Are you aware that any of the authors' academic institutions or employers has any financial interest in or a financial conflict with the subject matter or materials discussed in this manuscript?
      
      No
      Yes, please describe below and provide additional detail in cover letter if necessary
      
      
   3. Authors' Financial Conflicts of Interest (must be completed for each author)
      
      If an author has had any of the listed relationships with an entity that has a financial interest in the subject matter discussed in this manuscript, write the author's name in the appropriate "yes" box below. If none of the authors has a listed relationship, check the appropriate "no" box. Explain any listed relationships in the cover letter. Please consider the past 2 years through the present and one year into the future when answering this question.
      
      No
      Yes
      
      Employment
      Consultancies
      Honoraria
      Stock ownership or options (other than mutual funds)
      Expert testimony
      Grants received
      Grants pending
      Patents received
      Patents pending
      Royalties
      Other (including in-kind)
      
      

Examples of Wording to Accompany Publications

• For no relevant disclosures:

  "The authors report that there are no disclosures relevant to this publication."

• For disclosures of actual or potential conflict for some authors:

  "The following authors report that they have no disclosures relevant to this publication: AA, BB, CC. The following authors have disclosed actual or potential conflicts: DD (patent), EE (patent, honoraria, stock ownership)."

• For disclosures of actual or potential conflict for all listed authors:

  "The authors report the following conflicts: patent (AA, BB), honoraria (CC)."

2. Principles for Reviewers' Disclosure

1. Each acceptance of assignment should include acknowledgment of actual or potential conflicts.
2. Reviewers with questions should contact the Editorial Office prior to accepting assignment.

Reviewer's COI Implementation Wording for Each Assignment

1. Institutional Conflicts of Interest
   Are you aware that your institution or employer has any financial interest in or a financial conflict with the subject matter or materials discussed in this manuscript?
2. Reviewers' Financial Conflicts of Interest
   If the reviewer has had any of the listed relationships with an entity that has a financial interest in the subject matter discussed in this manuscript, write the author's name in the appropriate "yes" box below. If the reviewer does not have a listed relationship, check the appropriate "no" box. Explain any listed relationships in the cover letter. Please consider the past 2 years through the present and one year into the future when answering this question.
   Employment
   Consultancies
   Honoraria
   Stock ownership or options (other than mutual funds)
   Expert testimony
   Grants received
   Grants pending
   Patents received
   Patents pending
   Royalties
   Other (including in-kind)
   
   
3. Reviewers' Other Conflicts of Interest
   
   Personal
   Professional
   Research
   
   No.
   Yes, an actual or potential COI exists. A COI does not preclude serving as reviewer as the Editors will review for evidence of bias.

3. Principles for Associate Editors' Disclosure

1. Submit Annual Disclosure to the Journal Office and Society. Update when significant changes occur.
2. Review and manage all disclosure and statements from the authors and reviewers for each manuscript under their purview.
3. AEs with questions should contact the Editorial Office prior to accepting assignment.

AE's COI Implementation Wording for Each Assignment

1. Institutional Conflicts of Interest
   Are you aware that your institution or employer has any financial interest in or a financial conflict with the subject matter or materials discussed in this manuscript?
2. Associate Editors' Financial Conflicts of Interest
   If an editor has had any of the listed relationships with an entity that has a financial interest in the subject matter discussed in this manuscript, fill-in the appropriate "yes" box below. If not, check the appropriate "no" box. Explain any listed relationships. Please consider the past 2 years through the present and one year into the future when answering this question.
   
   Employment
   Consultancies
   Honoraria
   Stock ownership or options (other than mutual funds)
   Expert testimony
   Grants received
   Grants pending
   Patents received
   Patents pending
   Royalties
   Other (including in-kind)
3. Associate Editors' Other Conflicts of Interest
   
   Personal
   Professional
   Research
   
   No
   Yes

4. Principles for Editor Responsibilities and Disclosure

1. Submit Annual Disclosure to the Journal Office and Society. Update when significant changes occur.
2. Review all disclosures and statements.
3. Ultimately responsible for the entire content of the Journal with adherence to the Uniform Requirements.

Approved by:

John Baillie, MD
Chair, Publications Committee, on behalf of the Publications Committee

Michael L. Kochman, MD
Chair, Gastrointestinal Endoscopy Editorial Board, on behalf of the GIE Editorial Board

George Triadafilopoulos, MD
Editor, Gastrointestinal Endoscopy, on behalf of the GIE Editors ASGE Governing Board, approved February 12, 2006