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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">Int. J. Public Health</journal-id>
<journal-title-group>
<journal-title>International Journal of Public Health</journal-title>
<abbrev-journal-title abbrev-type="pubmed">Int. J. Public Health</abbrev-journal-title>
</journal-title-group>
<issn pub-type="epub">1661-8564</issn>
<publisher>
<publisher-name>Frontiers Media S.A.</publisher-name>
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<article-id pub-id-type="publisher-id">1608622</article-id>
<article-id pub-id-type="doi">10.3389/ijph.2025.1608622</article-id>
<article-version article-version-type="Corrected Version of Record" vocab="NISO-RP-8-2008"/>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Letter to the Editor</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Ethical Approval Waiver in the Shivamogga KFD Outbreak Investigation: Concerns and Call for Expedited Ethics Review Framework</article-title>
<alt-title alt-title-type="left-running-head">Praveen Kumar</alt-title>
<alt-title alt-title-type="right-running-head">Outbreak Investigation: Ethical Concerns</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author" corresp="yes">
<name>
<surname>Kumar S.</surname>
<given-names>Praveen</given-names>
</name>
<xref ref-type="aff" rid="aff1"/>
<xref ref-type="corresp" rid="c001">&#x2a;</xref>
<uri xlink:href="https://loop.frontiersin.org/people/3040393"/>
</contrib>
</contrib-group>
<aff id="aff1">
<institution>Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS)</institution>, <city>Mangalagiri</city>, <country country="IN">India</country>
</aff>
<author-notes>
<corresp id="c001">
<label>&#x2a;</label>Correspondence: S. Praveen Kumar, <email xlink:href="human.pk04@gmail.com">human.pk04@gmail.com</email>
</corresp>
</author-notes>
<pub-date publication-format="electronic" date-type="pub" iso-8601-date="2025-07-14">
<day>14</day>
<month>07</month>
<year>2025</year>
</pub-date>
<pub-date publication-format="electronic" date-type="corrected" iso-8601-date="2026-02-09">
<day>09</day>
<month>02</month>
<year>2026</year>
</pub-date>
<pub-date publication-format="electronic" date-type="collection">
<year>2025</year>
</pub-date>
<volume>70</volume>
<elocation-id>1608622</elocation-id>
<history>
<date date-type="received">
<day>18</day>
<month>04</month>
<year>2025</year>
</date>
<date date-type="accepted">
<day>30</day>
<month>06</month>
<year>2025</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright &#xa9; 2025 Praveen Kumar.</copyright-statement>
<copyright-year>2025</copyright-year>
<copyright-holder>Praveen Kumar</copyright-holder>
<license>
<ali:license_ref start_date="2025-07-14">https://creativecommons.org/licenses/by/4.0/</ali:license_ref>
<license-p>This is an open-access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License (CC BY)</ext-link>. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.</license-p>
</license>
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<related-article id="RA1" related-article-type="letter" journal-id="Int. J. Public Health" journal-id-type="nlm-ta" xlink:href="10.3389/ijph.2024.1606715" ext-link-type="doi">A Letter to the Editor on <article-title>Kyasanur Forest Disease: An Epidemiological Investigation and Case-Control Study in Shivamogga, Karnataka, India-2022</article-title> by Vedachalam SK, Rajput BL, Choudhary S, Narayanaswamy D, Chandra S, D. M. P, Rajagopal PM and Dikid T (2024) Int J Public Health 69:1606715. doi: <object-id>10.3389/ijph.2024.1606715</object-id>
</related-article>
<kwd-group>
<kwd>ethical approval</kwd>
<kwd>ethical issues</kwd>
<kwd>expedited ethics review</kwd>
<kwd>outbreak investigation</kwd>
<kwd>public health emergencies</kwd>
<kwd>research ethics</kwd>
</kwd-group>
<funding-group>
<funding-statement>The author(s) declare that no financial support was received for the research and/or publication of this article.</funding-statement>
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</front>
<body>
<p>Dear Editor,</p>
<p>I am writing this letter to express my concerns on the ethical practises in the article titled &#x201c;Kyasanur Forest Disease: An Epidemiological Investigation and Case-Control Study in Shivamogga, Karnataka, India --2022&#x201d; by Vedachalam et al., which was published in International Journal of Public Health on 18 October 2024 [<xref ref-type="bibr" rid="B1">1</xref>]. The study gives insights on risk factors for Kyasanur Forest Disease (KFD), I find the decision to waive Institutional Ethics Committee (IEC) approval for this research concerning.</p>
<p>The authors justified the waiving of Institutional Ethics Committee (IEC) approval by National Centre for Disease Control (NCDC) citing Epidemic Diseases Act No. 3, 1897, which grants power to the state or central government, to take special measures and prescribe regulations for dangerous epidemic diseases. The study is stated as &#x201c;public health non-research activity&#x201d;, addressing urgent health crisis. However, the study generates generalizable knowledge, extending beyond a public health outbreak investigation. The Indian Council of Medical Research (ICMR) ethical guidelines state that research during humanitarian emergencies, including outbreak investigations may have a need to undertake research quickly, &#x201c;this should not impact scientific validity and the need to uphold ethical requirements&#x201d; [<xref ref-type="bibr" rid="B2">2</xref>]. The World Health Organization (WHO) also state that such studies require IEC review and measures to provide timely ethical approval is to be done by collaboration with local and international bodies, even during outbreaks [<xref ref-type="bibr" rid="B3">3</xref>]. So there is no clear explanation for wavering, which raises important ethical questions about transparency and accountability.</p>
<p>However, the authors obtained informed consent and adhered to data protection protocols, still steps alone do not replace the need for independent ethical oversight. An expedited IEC review could have been got to ensure participant protection considering the urgency of the investigation. By waiving IEC approval, it might establish an instance that could weaken ethical standards in future outbreak research, particularly in resource poor settings where oversight of getting IEC approval is already challenging.</p>
<p>To address this, I suggest the journal adopt a policy requiring detailed justification for any IEC waivers in future submissions. Encouraging authors to seek expedited ethical reviews and approval even in emergency contexts. Nationally, clearer guidelines on ethical oversight for outbreak investigations could further ensure that public health research has standards of integrity.</p>
<p>Thank you for considering these concerns. I hope this letter gets a constructive discussion on how we can strengthen ethical practices in public health research while responding effectively to urgent health challenges.</p>
<p>Sincerely,</p>
<p>Dr. Praveen Kumar S.</p>
</body>
<back>
<sec sec-type="author-contributions" id="s1">
<title>Author Contributions</title>
<p>The author confirms being the sole contributor of this work and has approved it for publication.</p>
</sec>
<sec sec-type="COI-statement" id="s3">
<title>Conflict of Interest</title>
<p>The author declares that they do not have any conflicts of interest.</p>
</sec>
<sec id="s4">
<title>Correction note</title>
<p>This article has been corrected with minor changes. These changes do not impact the scientific content of the article.</p>
</sec>
<sec sec-type="ai-statement" id="s5">
<title>Generative AI Statement</title>
<p>The author(s) declare that no Generative AI was used in the creation of this manuscript.</p>
</sec>
<fn-group>
<fn fn-type="custom" custom-type="edited-by">
<p>
<bold>Edited by:</bold> <ext-link ext-link-type="uri" xlink:href="https://loop.frontiersin.org/people/1002523/overview">Olaf von dem Knesebeck</ext-link>, University Medical Center Hamburg-Eppendorf, Germany</p>
</fn>
</fn-group>
<ref-list>
<title>References</title>
<ref id="B1">
<label>1.</label>
<mixed-citation publication-type="journal">
<person-group person-group-type="author">
<name>
<surname>Vedachalam</surname>
<given-names>SK</given-names>
</name>
<name>
<surname>Rajput</surname>
<given-names>BL</given-names>
</name>
<name>
<surname>Choudhary</surname>
<given-names>S</given-names>
</name>
<name>
<surname>Narayanaswamy</surname>
<given-names>D</given-names>
</name>
<name>
<surname>Chandra</surname>
<given-names>S</given-names>
</name>
<name>
<surname>D.M.</surname>
<given-names>P</given-names>
</name>
<name>
<surname>Rajagopal</surname>
<given-names>PM</given-names>
</name>
<name>
<surname>Dikid</surname>
<given-names>T</given-names>
</name>
</person-group>. (<year>2024</year>). <article-title>Kyasanur Forest Disease: An Epidemiological Investigation and Case-Control Study in Shivamogga, Karnataka, India-2022</article-title>. <source>Int J Public Health</source> <volume>69</volume>:<fpage>1606715</fpage>. <pub-id pub-id-type="doi">10.3389/ijph.2024.1606715</pub-id>
<pub-id pub-id-type="pmid">39494093</pub-id>
</mixed-citation>
</ref>
<ref id="B2">
<label>2.</label>
<mixed-citation publication-type="book">
<source>ICMR_National_Ethical_Guidelines.pdf</source>. <comment>Available online at: <ext-link ext-link-type="uri" xlink:href="https://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf">https://ethics.ncdirindia.org//asset/pdf/ICMR_National_Ethical_Guidelines.pdf</ext-link>. (Accessed</comment>: <comment>April 18, 2025)</comment>.</mixed-citation>
</ref>
<ref id="B3">
<label>3.</label>
<mixed-citation publication-type="book">
<collab>World Health Organization</collab>. <source>Guidance for Managing Ethical Issues in Infectious Disease Outbreaks</source>. <publisher-loc>Geneva</publisher-loc>: <publisher-name>World Health Organization</publisher-name> (<year>2016</year>). <comment>Available online at: <ext-link ext-link-type="uri" xlink:href="https://iris.who.int/handle/10665/250580">https://iris.who.int/handle/10665/250580</ext-link> (Accessed April 18, 2025)</comment>.</mixed-citation>
</ref>
</ref-list>
</back>
</article>
