Ethics

On this page: Overview | Ethics Advisory Committee | Ethics Declaration | Sex and Gender | Clinical Trials | Authorship | Multi-Author Groups/Workgroups/Consortia | Medical Writers and Industry Employees | Conflict of Interest: Authors | Conflict of Interest: Editors | Plagiarism and Fabrication | Transplantation Studies | Duplicate Publication | Correction and Retraction Policy | Permissions to Republish

Overview

In order to qualify for publication in Genetics in Medicine, all studies involving human participants, individual-level data collected from humans, or biosamples collected from humans must receive approval or explicit exemption from an Institutional Review Board (IRB) or Research Ethics Committee (REC). Research that does not qualify for submission to an IRB or REC in any of the researchers’ jurisdictions may qualify for an exception at the discretion of the editors, but the strong presumption is that research involving humans will be submitted to an IRB or REC, and either receive approval or receive a confirmation that the research is exempt from formal review.

Ethics Advisory Committee

Chair: Kyle B. Brothers, MD, PhD
University of Louisville School of Medicine
ORCID: 0000-0002-8550-9724

Members:
Beth Tarini, MD, MS Children’s National, Washington, DC
Ma’n Zawati, LL.B., LL.M., Ph.D. (DCL), McGill University, Montreal, Canada
Lynn Fleisher, PhD, JD. ACMG, Bethesda, MD

Ethics Declaration

Each manuscript that reports experiments on studies involving human subjects or live vertebrates and/or higher invertebrates, must include a section on ethics. It should be listed after the Acknowledgements, contained at the end of the manuscript file, and be titled “Ethics Declaration”.

Please include in the Ethics Declaration the following items:

  • The name of the Institutional Review Board (IRB) or Research Ethics Committee (REC) that reviewed the study.
  • An explicit statement of whether informed consent was required.
    •  If informed consent was required, the Ethics Declaration should contain an affirmative statement that informed consent was obtained from all participants as required by the IRB or REC.
    • If informed consent was not required, the Ethics Declaration should contain a brief explanation of why it was not required in this case.
  • For research involving the use of individual-level data, including clinical data, state whether the data was de-identified. 
  • If any individual patient/person data is included, the statement must include wording that the author received and archived written patient consent. For research articles, if authors cannot obtain consent to publish individual data, they may only provide summary results. Exclusions to this include:
    • The patients are de-identified
    • The patients are dead
    • There has been a waiver granted by the IRB
  • For samples obtained from biobanks, include information about the biobank and detail what permissions were used to collect samples. Please also include a link to the  biobank’s website and at least one reference reporting on the ethical collection of samples for that biobank.
  • All human studies must adhere to the principles set out in the Declaration of Helsinki.
  • For animal research, please state the name of the Institutional Animal Care and Use Committee (IACUC) or equivalent body approving the research study. If exemptions are being claimed, please also state this and provide the name of the IACUC (or equivalent body) providing the exemption.  

If in doubt about whether permission is required to publish, please contact the editorial office.

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Sex and Gender

GIM encourages our authors to follow the ‘Sex and Gender Equity in Research – SAGER – guidelines’ and to include sex and gender considerations where relevant. The full guidelines are here.

Clinical Trials

GIM follows the guidelines as set out by ICMJE that clinical trials conducted in the US must be registered in a public registry prior to submission and the trial registry number must be included in the manuscript and provided on submission. For non-US based clinical trials registration is also strongly encouraged but GIM will consider these studies if they were started prior to January 2022 and were not registered.

Please note, all clinical trials started after January 2022 must be registered to be considered for publication in GIM.

Acceptable registries are:

Other acceptable registries are listed by the WHO International Clinical Trials Registry Platform (ICTRP).

For questions please contact the editorial office at geneticsinmedicine@acmg.net

Springer Nature endorses the toolkits and guidelines produced by the following bodies:

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Authorship

Requirements for all categories of articles largely conform to “Defining the Role of Authors and Contributors,” developed by the ICMJE. A manuscript will be considered for publication with the understanding that:

  • all named authors have agreed to its submission
  • it is not currently being considered for publication by another journal
  • if the paper is accepted, it will not subsequently be published in the same or similar form in any language without the consent of publisher
  • Each author must have contributed sufficiently to the intellectual content of the submission.

During the submission process. The corresponding author should list all authors and their contributions to the work. Any changes to the author list after submission, such as a change in the order of the authors, or the deletion or addition of authors, will follow the guidelines as set out by COPE. The corresponding author must confirm that he or she has had full access to the data in the study and final responsibility for the decision to submit for ublication. Corresponding authors also take responsibility for the accuracy and veracity of the authorship list. It is the corresponding author’s responsibility to ensure that all authors are aware that the article has been submitted to Genetics in Medicine, that all authors agree to be included as authors and that all authors who merit authorship are included.

The ICMJE recommends that authorship be based on the following 4 criteria:

  1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  2. Drafting the work or revising it critically for important intellectual content; AND
  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.

In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which co-authors are responsible for specific other parts of the work. In addition, authors should have confidence in the integrity of the contributions of their co-authors.

Multi-Author Groups/Workgroups/Consortia

When a large multi-author workgroup or Consortium has conducted the work, we have specific guidelines on how these should be designated and formatted in the submitted paper. See above for further information on authorship criteria. For additional information on consortia authorship and formatting instructions see here. This document provides examples of how to format consortia to ensure all authors are listed and indexed correctly. 

Medical Writers and Industry Employees 

Medical writers and industry employees can be contributors. Their roles, affiliations, and potential conflicts of interest should be included in the author list or noted in the Acknowledgments and/or Contributors section concurrent with their contribution to the work submitted. Signed statements from any medical writers or editors declaring that they have given permission to be named as an author, as a contributor, or in the Acknowledgments section is also required. Failure to acknowledge these contributors can be considered inappropriate, which conflicts with Genetics in Medicine’s editorial policy.

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Conflict of Interest: Authors

In the interests of transparency and to help readers form their own judgments of potential bias, authors must declare whether or not there are any competing financial interests in relation to the work described. This information must be included in the cover letter and in the conflict of interest section of the manuscript. In cases where the authors declare a competing financial interest, a statement to that effect is published as part of the article. If no such conflict exists, the statement will simply read that the authors have nothing to disclose.

For the purposes of this statement, competing interests are defined as those of a financial nature that, through their potential influence on behavior or content, or from perception of such potential influences, could undermine the objectivity, integrity or perceived value of a publication. They can include any of the following:

  • Funding: Research support (including salaries, equipment, supplies, reimbursement for attending symposia, and other expenses) by organizations that may gain or lose financially through this publication. The role of the funding body in the design of the study, collection and analysis of data and decision to publish should be stated.
  • Employment: Recent (while engaged in the research project), present or anticipated employment by any organization that may gain or lose financially through this publication.
  • Personal financial interests: Stocks or shares in companies that may gain or lose financially through publication; consultation fees or other forms of remuneration from organizations that may gain or lose financially; patents or patent applications whose value may be affected by publication.

Following the conflict of interest declaration there must be a listing for each author, detailing the names of organizations, institutions, companies, and individuals, including intermediaries such as subcontractors or conference organizers, from whom they have received compensation for professional services in any of the previous three years, or from whom they anticipate receiving such compensation in the near future, whether or not these affiliations appear to have any relevance to the topic covered in the submission. Neither the precise amount received from each entity nor the aggregate income from these sources needs to be provided. Professional services include any activities for which the individual is, has been, or will be compensated with cash, royalties, fees, stock or stock options in exchange for work performed, advice or counsel provided, or for other services related to the author’s professional knowledge and skills. This would include, but not necessarily be limited to, the identification of organizations from which the author received contracts or in which he or she holds an equity stake if professional services were provided in conjunction with the transaction.

The authors are expected to disclose any other financial holdings or considerations, such as stocks, bonds or donations of supplies or equipment that a reasonable person could construe as possibly influencing the objectivity of the report. When there is uncertainty about what should be listed, it is best to disclose all holdings or affiliations to ensure that there is no question about intent to withhold information. Authors should communicate with the editorial office if they have questions about this policy.

Examples of declarations are:

  1. Disclosure: The authors declare no conflict of interest.
  2. Disclosure: Dr. Caron’s work has been funded by the NIH. He has received compensation as a member of the scientific advisory board of Acadia Pharmaceutical and owns stock in the company. He also has consulted for Lundbeck and received compensation. Dr. Rothman and Dr. Jensen declare no potential conflict of interest.

If subsequent to publication it is learned that relevant information was not disclosed, a corrigendum describing the infraction will be published in the journal and linked to the article in PubMed. In addition, the published article may be retracted with a statement describing the nondisclosure and restrictions may be placed on future publications in the journal, solely at the discretion of the editor and College.

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Conflict of Interest: Editors

A. Editors for GIM disclose all potential conflicts of interest (COI) on an annual basis, and update as necessary during the year. The information is collected, and held on record by, the ACMG. Potential conflicts include serving on the board of another journal, and financial or professional relationships with entities, both for-profit and non-profit.

B. Editors will recuse themselves from the handling or review of any manuscript if a potential conflict of interest exists, including submissions from the editor’s home institution(s); submissions from individuals with whom the editor has closely collaborated in the last 3 years; submissions from entities or individuals with which the editor is significantly financially or professionally involved; or with whom the editor has a close personal relationship; or has a professionally competitive or adverse personal or professional relationship. Clinicians and scientists in our field are often involved in big science or team science, so that they often collaborate with dozens or more co-authors on manuscripts. In addition, some of our editors are prolific authors, publishing dozens of manuscripts annually. Therefore, simple co-authorship is not by itself always grounds for recusal; collaboration defined as a close working relationship in the past three years is grounds for recusal. Any questions about this policy will be adjudicated by the editorial office. 

C. An editor who is an author on any manuscript submitted to GIM will be blinded to that submission in the submission system. Another editor from the board will be assigned to handle such submissions confidentially.

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Plagiarism and Fabrication

Plagiarism is when an author attempts to pass off someone else’s work as his or her own. Duplicate publication, sometimes called self-plagiarism, occurs when an author reuses substantial parts of his or her own published work without providing the appropriate references. Plagiarism without dishonest intent is relatively frequent, for example, when an author reuses parts of an introduction from an earlier paper.

CrossCheck is a multi-publisher initiative to screen published and submitted content for originality. Genetics in Medicine uses CrossCheck to detect instances of overlapping and similar text in accepted submitted manuscripts.

If plagiarism is found, the journal will contact the author and, in some cases, the author’s institute and funding agencies to resolve the issue.

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Transplantation Studies

In the case of articles describing human transplantation studies, authors must include a statement declaring that no organs/tissues were obtained from prisoners and that the study complies with the Declaration of Istanbul.

Duplicate Publication

Papers must be original and not previously published or submitted for publication elsewhere. This rule also applies to non-English language publications. The corresponding author is responsible for alerting the editorial office, in the cover letter, if the manuscript includes subjects about which a previous report has been published or about a manuscript that is submitted to, under review by, in press at, or to be submitted to or published in another journal in the future. All such work must be referred to and referenced in the new paper and a copy of the manuscript and/or cohort should be included with the submission as a supplemental file.

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Correction and Retraction Policy

We recognize our responsibility to correct errors. Content published online (as Advance Online Publication - AOP) or in a print issue is final and cannot be amended. The online and print versions are both part of the published record; therefore, the original version must be preserved and changes to the paper should be made as a formal correction. We communicate only with the Corresponding Author regarding all issues involving corrections and retractions.

Decisions about corrections are made by the Editor (sometimes with advice of peer reviewers) and this sometimes involves author consultation.  Requests to make corrections that do not affect the paper in a significant way or impair the reader’s understanding of the contribution (a spelling mistake or grammatical error, for example) are not considered.

In cases where coauthors disagree about a correction, the Editor will take advice from independent peer reviewers and impose the appropriate correction, noting the dissenting author(s) in the text of the published version.

Retractions are notification of invalid results. The journal follows COPE policy in determining publication misconduct, and will work key stakeholders to pursue and amend according to best practice, up to and including retracting the work if appropriate. The journal adheres to ICMJE guidelines on language and signoff of retraction notices.

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Permissions to Republish

If a table or figure has been published previously, the authors must obtain written permission from the copyright owner to reproduce the material in both print and electronic formats and submit such permission with the manuscript.  This is applicable to quotes, illustrations and other materials taken from previously published works not in the public domain. The original source should be cited in the figure caption or table footnote. Color figures can be reproduced if necessary, but the authors may be expected to contribute toward the cost of publication. A quote will be supplied upon acceptance of the paper.

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Last Updated: November 2020