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<div class="hero__bottom"> </div> </div> </div> </div> <div class="page-main"> <div class="page-main__row"> <div class="page-main__col"> <main> <section id="content" class="region region-content"> <div id="block-system-main" class="block block-system clearfix"> <div class="content"> <div class="node-case node node-case view-mode-full "> <div class="node-case__left node-case__fields"> <div class="field field--short"> <div class="field-label">Case number:</div> <div class="field-item">23-17</div> </div> </div> <div class="node-case__body"> <div class="sidebar sidebar--offset"> <div class="sidebar__body"> <div class="node-case__fields"> <div class="field field-name-field-anonymised-text-of-the-ca field-type-text-long field-label-above"><div class="field-label">Case text (Anonymised): </div><div class="field-items"><div class="field-item even"><p>A journal has received a submission which is based on patient data (CT scan images). The data have been found to have been taken from an open-source repository. The authors are refusing to sign an Ethics Approval and Consent for Authors form.</p> <p><em>Questions for the Forum</em></p> <ul> <li> <p>Is a signature in these cases compulsory?</p> </li> <li> <p>How would the Forum recommend we handle this case?</p> </li> </ul> </div></div></div><div class="field field-name-field-advice field-type-text-long field-label-above"><div class="field-label">Advice: </div><div class="field-items"><div class="field-item even"><p><em>Advice on this case is from a small number of COPE Council Members. Most cases on the COPE website are presented to the <a href="https://publicationethics.org/copeforum">COPE Forum</a> where advice is offered by a wider group of COPE Members and COPE Council Members. Advice on individual cases is not formal COPE guidance.</em></p> <p>Ethics Approval and Consent is required for reporting of human data, especially that which could be attributed or identified to one person. Without this, the submission should be rejected.<br /> 聽<br /> However, for public databases such as national health surveys, secondary use does not need permission or ethical approval but the provenance and purpose of the data source need to be clearly stated.聽<br /> 聽<br /> In this case of publicly shared CT scans, the authors may cite the data source clearly and explain the data are (presumably) anonymised and patient consent was already originally given for study participation and also public sharing. The authors of the open-source data should have provided information about the approval for collecting AND sharing these data. Usually, such sources should have consent for secondary use of personal data for research.<br /> 聽<br /> The editors should also ask why the authors are refusing to sign the ethics form. If they are convinced that they do not have to do so because this is a secondary use and covered by the ethics and consent processes in the original study then the editors can make a decision on that basis. If there is a more fundamental objection then the editors may need to probe more fully whether the necessary permissions have been secured for the data to appear on the open source platform, or if there are other factors present which need to be considered.</p> <h3> Related resources</h3> <ul> <li><a href="https://publicationethics.org/case/secondary-analysis-medical-records-and-ethics-committee-approval-0">Secondary analysis of medical records and ethics committee approval</a>聽COPE Member's case</li> <li><a href="https://publicationethics.org/case/use-secondary-data-without-proper-attribution">Use of secondary data without proper attribution</a>聽COPE Member's case</li> <li><a href="https://publicationethics.org/case/ethics-committee-approval-necessary-retrospective-clinical-studies">Is ethics committee approval necessary for retrospective clinical studies?</a>聽COPE Member's case</li> </ul> </div></div></div><div class="field field-name-field-resolution field-type-list-text field-label-above"><div class="field-label">Resolution: </div><div class="field-items"><div class="field-item even">On-going</div></div></div><div class="field field-name-taxonomy-vocabulary-9 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Year: </div><div class="field-items"><div class="field-item even"><a href="/taxonomy/term/4435">2023</a></div></div></div><div class="field field--classifications field--short"><div class="field-label">Core practices:</div><div class="item-list"><ul><li class="first last"><a href="/oversight" title="View all "Ethical oversight" content">Ethical oversight</a></li> </ul></div></div> </div> <aside class="sidebar__aside"> <div class="sidebar__aside__col"> <div class="sidebar__aside__inner"> <div class="contextual-links-region"><h3>COPE Forum</h3><div class="entity entity-bean bean-editable"> <div > <div class="field field-name-field-block-text field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>COPE Members:<br /> do you have a publication ethics case and need help with next steps?<br /> <a href="https://publicationethics.org/copeforum">Submit your case</a></p> <p>Registration is now open for the 9 December Forum where new cases are discussed. 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