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#toc-49261 - Ethics approval" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Ethics approval</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49262" data-track="click" data-track-action="click - #toc-49262 - Retrospective ethics approval" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Retrospective ethics approval</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49263" data-track="click" data-track-action="click - #toc-49263 - Ethics approval for retrospective studies" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Ethics approval for retrospective studies</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49264" data-track="click" data-track-action="click - #toc-49264 - Ethics approval for case studies" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Ethics approval for case studies</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49265" data-track="click" data-track-action="click - #toc-49265 - Cell lines" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Cell lines</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49266" data-track="click" data-track-action="click - #toc-49266 - Research Resource Identifiers (RRID)" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Research Resource Identifiers (RRID)</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49267" data-track="click" data-track-action="click - #toc-49267 - Clinical Trial Registration" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Clinical Trial Registration</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49268" data-track="click" data-track-action="click - #toc-49268 - Standards of reporting" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Standards of reporting</span> </a> </li> <li class="c-toc__item u-mt-8 u-mb-8"> <a href="#toc-49269" data-track="click" data-track-action="click - #toc-49269 - Summary of requirements" data-track-category="toc links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-down.svg#i-arrow-down"></use> </svg> <span>Summary of requirements</span> </a> </li> </ul> </nav> <h2 id="toc-49261">Ethics approval</h2> <div class="c-content"><p>When reporting a study that involved human participants, their data or biological material, authors should include a statement that confirms that the study was approved (or granted exemption) by the appropriate institutional and/or national research ethics committee (including the name of the ethics committee) and certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. If doubt exists whether the research was conducted in accordance with the 1964 Helsinki Declaration or comparable standards, the authors must explain the reasons for their approach, and demonstrate that an independent ethics committee or institutional review board explicitly approved the doubtful aspects of the study. If a study was granted exemption from requiring ethics approval, this should also be detailed in the manuscript (including the reasons for the exemption).<br> </p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49262">Retrospective ethics approval</h2> <div class="c-content"><p>If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor's discretion.<br> </p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49263">Ethics approval for retrospective studies</h2> <div class="c-content"><p>Although retrospective studies are conducted on already available data or biological material (for which formal consent may not be needed or is difficult to obtain) ethics approval may be required dependent on the law and the national ethical guidelines of a country. Authors should check with their institution to make sure they are complying with the specific requirements of their country.<br> </p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49264">Ethics approval for case studies</h2> <div class="c-content"><p>Case reports require ethics approval. Most institutions will have specific policies on this subject. Authors should check with their institution to make sure they are complying with the specific requirements of their institution and seek ethics approval where needed. Authors should be aware to secure informed consent from the individual (or parent or guardian if the participant is a minor or incapable) See also section on <a href="https://www.springer.com/gp/editorial-policies/informed-consent" target="_self" class="is-external">Informed Consent</a>.</p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49265">Cell lines</h2> <div class="c-content"><p>If human cells are used, authors must declare in the manuscript: what cell lines were used by describing the source of the cell line, including when and from where it was obtained, whether the cell line has recently been authenticated and by what method. If cells were bought from a life science company the following need to be given in the manuscript: name of company (that provided the cells), cell type, number of cell line, and batch of cells.<br> It is recommended that authors check the NCBI database for misidentification and contamination of human cell lines. This step will alert authors to possible problems with the cell line and may save considerable time and effort.<br> Further information is available from the International Cell Line Authentication Committee (ICLAC).<br> Authors should include a statement that confirms that an institutional or independent ethics committee (including the name of the ethics committee) approved the study and that informed consent was obtained from the donor or next of kin.<br> </p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49266">Research Resource Identifiers (RRID)</h2> <div class="c-content"><p>Research Resource Identifiers (RRID) are persistent unique identifiers (effectively similar to a DOI) for research resources. Springer Nature encourages authors to adopt RRIDs when reporting key biological resources (antibodies, cell lines, model organisms and tools) in their manuscripts.</p> <p><strong>Examples: </strong></p> <p><strong>Organism:</strong> <em>Filip1<sup>tm1a(KOMP)Wtsi</sup></em><strong> RRID:MMRRC_055641-UCD</strong></p> <p><strong>Cell Line:</strong> RST307 cell line<strong> RRID:CVCL_C321</strong></p> <p><strong>Antibody:</strong> Luciferase antibody DSHB Cat# LUC-3,<strong> RRID:AB_2722109</strong></p> <p><strong>Plasmid:</strong> mRuby3 plasmid <strong>RRID:Addgene_104005</strong></p> <p><strong>Software:</strong> ImageJ Version 1.2.4<strong> RRID:SCR_003070</strong></p> <p>RRIDs are provided by the <a href="https://scicrunch.org/resources" class="is-external">Resource Identification Portal</a>. Many commonly used research resources already have designated RRIDs. The portal also provides authors links so that they can quickly <a href="https://scicrunch.org/resources/about/resource" class="is-external">register a new resource</a> and obtain an RRID.</p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49267">Clinical Trial Registration</h2> <div class="c-content"><p>The World Health Organization (WHO) definition of a clinical trial is "<em>any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes</em>". The WHO defines health interventions as “<em>A health intervention is an act performed for, with or on behalf of a person or population whose purpose is to assess, improve, maintain, promote or modify health, functioning or health conditions” </em>and a health-related outcome is generally defined as a change in the health of a person or population as a result of an intervention.</p> <p>To ensure the integrity of the reporting of patient-centered trials, authors must register prospective clinical trials (phase II to IV trials) in suitable publicly available repositories. For example <a href="http://www.clinicaltrials.gov" class="is-external">www.clinicaltrials.gov</a> or any of the primary registries that participate in the <a href="http://www.who.int/ictrp/network/primary/en/" class="is-external">WHO International Clinical Trials Registry Platform</a>.</p> <p>The trial registration number (TRN) and date of registration should be included as the last line of the manuscript abstract.</p> <p>For clinical trials that have not been registered prospectively, authors are encouraged to register retrospectively to ensure the complete publication of all results. The trial registration number (TRN), date of registration and the words 'retrospectively registered’ should be included as the last line of the manuscript abstract.</p> <p>Purely observational trials will not require registration.</p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49268">Standards of reporting</h2> <div class="c-content"><p>Springer Nature advocates complete and transparent reporting of biomedical and biological research and research with biological applications. Authors are recommended to adhere to the minimum reporting guidelines hosted by the <a href="http://www.equator-network.org/" class="is-external">EQUATOR Network</a> when preparing their manuscript.</p> <p>Exact requirements may vary depending on the journal; please refer to the journal’s Instructions for Authors.</p> <p>Checklists are available for a number of study designs, including:</p> <p>Randomised trials (<a href="http://www.equator-network.org/reporting-guidelines/consort/" class="is-external">CONSORT</a>) and Study protocols (<a href="http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/" class="is-external">SPIRIT</a>) </p> <p>Observational studies (<a href="http://www.equator-network.org/reporting-guidelines/strobe/" class="is-external">STROBE</a>) </p> <p>Systematic reviews and meta-analyses (<a href="http://www.equator-network.org/reporting-guidelines/prisma/" class="is-external">PRISMA</a>) and protocols (<a href="http://www.equator-network.org/reporting-guidelines/prisma-protocols/" class="is-external">PRISMA-P</a>) </p> <p>Diagnostic/prognostic studies (<a href="http://www.equator-network.org/reporting-guidelines/stard/" class="is-external">STARD</a>) and (<a href="http://www.equator-network.org/reporting-guidelines/tripod-statement/" class="is-external">TRIPOD</a>) </p> <p>Case reports (<a href="http://www.equator-network.org/reporting-guidelines/care/" class="is-external">CARE</a>)</p> <p>Clinical practice guidelines (<a href="http://www.equator-network.org/reporting-guidelines/the-agree-reporting-checklist-a-tool-to-improve-reporting-of-clinical-practice-guidelines/" class="is-external">AGREE</a>) and (<a href="http://www.equator-network.org/reporting-guidelines/right-statement/" class="is-external">RIGHT</a>) </p> <p>Qualitative research (<a href="http://www.equator-network.org/reporting-guidelines/srqr/" class="is-external">SRQR</a>) and (<a href="http://www.equator-network.org/reporting-guidelines/coreq/" class="is-external">COREQ</a>) </p> <p>Animal pre-clinical studies (<a href="http://www.equator-network.org/reporting-guidelines/improving-bioscience-research-reporting-the-arrive-guidelines-for-reporting-animal-research/" class="is-external">ARRIVE</a>) </p> <p>Quality improvement studies (<a href="http://www.equator-network.org/reporting-guidelines/squire/" class="is-external">SQUIRE</a>) </p> <p>Economic evaluations (<a href="http://www.equator-network.org/reporting-guidelines/cheers/" class="is-external">CHEERS</a>)</p></div> <p> <a class="u-button" href="#nav-49260" data-track="click" data-track-action="click - #nav-49260 - back to top" data-track-category="content links" data-track-label="gp/editorial-policies/research-involving-human-and-or-animal-participants"> Back to top <span class="u-visually-hidden">of Research involving human participants, their data or biological material</span> <svg class="u-icon" width="22" height="22" aria-hidden="true" focusable="false"> <use xlink:href="/public/images/icons/arrow-up.svg#i-arrow-up"></use> </svg> </a> </p> <h2 id="toc-49269">Summary of requirements</h2> <div class="c-content"><p>The above should be summarized in a statement and included a section<strong> </strong>entitled “<strong><span class="underline">Declarations</span></strong>” before the reference list. Other declarations include Funding, Conflicts of interest/competing interests, Ethics approval, Consent, Data and/or Code availability and Authors’ contribution statements.</p> <p>Please see the various examples of wording below and revise/customize the sample statements according to your own needs.</p> <table class="MsoTableGrid" role="presentation"> <tbody> <tr> <td> <p>Provide “<strong>Ethics approval</strong>” as a heading (<strong>see template</strong>)</p></td> </tr> <tr> <td> <p>Examples of ethics approval obtained:</p></td> </tr> <tr> <td> <p>All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Bioethics Committee of the Medical University of A (No. ...).</p></td> </tr> <tr> <td> <p>This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of University B (Date.../No. ...).</p></td> </tr> <tr> <td> <p>Approval was obtained from the ethics committee of University C. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.</p></td> </tr> <tr> <td> <p>The questionnaire and methodology for this study was approved by the Human Research Ethics committee of the University of C (Ethics approval number: ...).</p></td> </tr> </tbody> </table> <table class="MsoTableGrid" role="presentation"> <tbody> <tr> <td> <p>Examples of a retrospective study:</p></td> </tr> <tr> <td> <p>Ethical approval was waived by the local Ethics Committee of University A in view of the retrospective nature of the study and all the procedures being performed were part of the routine care.</p></td> </tr> <tr> <td> <p>This research study was conducted retrospectively from data obtained for clinical purposes. We consulted extensively with the IRB of XYZ who determined that our study did not need ethical approval. An IRB official waiver of ethical approval was granted from the IRB of XYZ.</p></td> </tr> <tr> <td> <p>This retrospective chart review study involving human participants was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The Human Investigation Committee (IRB) of University B approved this study.</p></td> </tr> </tbody> </table> <table class="MsoTableGrid" role="presentation"> <tbody> <tr> <td> <p>Examples no ethical approval required/exemption granted:</p></td> </tr> <tr> <td> <p>This is an observational study. The XYZ Research Ethics Committee has confirmed that no ethical approval is required.</p></td> </tr> <tr> <td> <p>The data reproduced from Article X utilized human tissue that was procured via our Biobank AB, which provides de-identified samples. This study was reviewed and deemed exempt by our XYZ Institutional Review Board. The BioBank protocols are in accordance with the ethical standards of our institution and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.</p></td> </tr> </tbody> </table> <p>If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section.</p> <p>Authors are responsible for correctness of the statements provided in the manuscript. See also Authorship Principles. 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