{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T14:30:55Z","timestamp":1793457055860,"version":"4.5.0"},"reference-count":68,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100001659","name":"German Research Foundation","doi-asserted-by":"publisher","award":["Project 470816212\/KFG43"],"award-info":[{"award-number":["Project 470816212\/KFG43"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Studies in History and Philosophy of Science"],"published-print":{"date-parts":[[2026,10]]},"DOI":"10.1016\/j.shpsa.2026.102206","type":"journal-article","created":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T22:17:29Z","timestamp":1787091449000},"page":"102206","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["On epistemic risks in research method validation"],"prefix":"10.1016","volume":"119","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8779-6256","authenticated-orcid":false,"given":"Doohyun","family":"Sung","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib1","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1177\/026119291504300504","article-title":"Barriers to the uptake of human-based test methods, and how to overcome them","volume":"43","author":"Archibald","year":"2015","journal-title":"Alternatives to Laboratory Animals"},{"issue":"2","key":"10.1016\/j.shpsa.2026.102206_bib2","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1162\/POSC_a_00200","article-title":"Inductive risk, epistemic risk, and overdiagnosis of disease","volume":"24","author":"Biddle","year":"2016","journal-title":"Perspectives in Science"},{"issue":"3","key":"10.1016\/j.shpsa.2026.102206_bib3","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1086\/697749","article-title":"\u201cAntiscience zealotry\u201d? Values, epistemic risk, and the GMO debate","volume":"85","author":"Biddle","year":"2018","journal-title":"Philosophy of Science"},{"issue":"3","key":"10.1016\/j.shpsa.2026.102206_bib4","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1017\/can.2020.27","article-title":"On predicting recidivism: Epistemic risk, tradeoffs, and values in machine learning","volume":"52","author":"Biddle","year":"2022","journal-title":"Canadian Journal of Philosophy"},{"key":"10.1016\/j.shpsa.2026.102206_bib5","series-title":"Exploring inductive risk: Case studies of values in science","first-page":"215","article-title":"The geography of epistemic risk","author":"Biddle","year":"2017"},{"key":"10.1016\/j.shpsa.2026.102206_bib6","series-title":"New waves in philosophy of science","first-page":"172","article-title":"Value judgments and the estimation of uncertainty in climate modeling","author":"Biddle","year":"2010"},{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib7","doi-asserted-by":"crossref","first-page":"A195","DOI":"10.1289\/ehp.1001969R","article-title":"ICCVAM: Birnbaum and stokes respond","volume":"118","author":"Birnbaum","year":"2010","journal-title":"Environmental Health Perspectives"},{"issue":"6","key":"10.1016\/j.shpsa.2026.102206_bib8","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1016\/j.nbt.2016.06.1458","article-title":"Mapping ethical and social aspects of cancer biomarkers","volume":"33","author":"Blanchard","year":"2016","journal-title":"New Biotechnology"},{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib9","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pbio.1002156","article-title":"Testing chemical safety: What is needed to ensure the widespread application of non-animal approaches?","volume":"13","author":"Burden","year":"2015","journal-title":"PLoS Biology"},{"key":"10.1016\/j.shpsa.2026.102206_bib10","series-title":"Valid analytical methods and procedures","author":"Burgess","year":"2001"},{"key":"10.1016\/j.shpsa.2026.102206_bib11","series-title":"Inventing temperature: Measurement and scientific progress","author":"Chang","year":"2004"},{"key":"10.1016\/j.shpsa.2026.102206_bib12","series-title":"Science after the practice turn in the philosophy, history, and social studies of science","first-page":"67","article-title":"Epistemic activities and systems of practice: Units of analysis in philosophy of science after the practice turn","author":"Chang","year":"2014"},{"key":"10.1016\/j.shpsa.2026.102206_bib13","series-title":"Regulating toxic substances: A philosophy of science and the law","author":"Cranor","year":"1993"},{"key":"10.1016\/j.shpsa.2026.102206_bib14","series-title":"Toxic torts: Science, law and the possibility of justice","author":"Cranor","year":"2006"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib15","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1080\/21550085.2019.1581414","article-title":"Can we comply with the ideal of value-freedom? A reply to Miller's critique of the ideal of value-freedom in science","volume":"22","author":"Dj\u00f8rup","year":"2019","journal-title":"Ethics, Policy & Environment"},{"issue":"10092","key":"10.1016\/j.shpsa.2026.102206_bib16","doi-asserted-by":"crossref","first-page":"415","DOI":"10.1016\/S0140-6736(16)31592-6","article-title":"Progress in evidence-based medicine: A quarter century on","volume":"390","author":"Djulbegovic","year":"2017","journal-title":"The lancet"},{"issue":"4","key":"10.1016\/j.shpsa.2026.102206_bib17","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1086\/392855","article-title":"Inductive risk and values in science","volume":"67","author":"Douglas","year":"2000","journal-title":"Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib18","series-title":"Science, policy, and the value-free ideal","author":"Douglas","year":"2009"},{"issue":"2","key":"10.1016\/j.shpsa.2026.102206_bib19","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1016\/j.shpsa.2011.12.034","article-title":"Epistemic and methodological iteration in scientific research","volume":"43","author":"Elliott","year":"2012","journal-title":"Studies In History and Philosophy of Science Part A"},{"key":"10.1016\/j.shpsa.2026.102206_bib20","series-title":"Exploring inductive risk: Case studies of values in science","first-page":"261","article-title":"Exploring inductive risk: Future questions","author":"Elliott","year":"2017"},{"key":"10.1016\/j.shpsa.2026.102206_bib21","series-title":"Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) final report","year":"1998"},{"key":"10.1016\/j.shpsa.2026.102206_bib22","first-page":"67","article-title":"Stem cell toxicology: Ethical and epistemic constraints on in vitro models","volume":"27","author":"Fisher","year":"2021","journal-title":"HYLE- An International Journal for the Philosophy of Chemistry"},{"key":"10.1016\/j.shpsa.2026.102206_bib23","article-title":"In U.S., few alternatives to testing on animals: Panel has produced 4 options in 10 years","author":"Gaul","year":"2008","journal-title":"Washington Post"},{"issue":"2","key":"10.1016\/j.shpsa.2026.102206_bib24","doi-asserted-by":"crossref","first-page":"75","DOI":"10.14573\/altex.2009.2.75","article-title":"Food for thought\u2026 on evidence-based toxicology","volume":"26","author":"Hartung","year":"2009","journal-title":"ALTEX-Alternatives to Animal Experimentation"},{"key":"10.1016\/j.shpsa.2026.102206_bib26","series-title":"Aspects of scientific explanation and other essays in the philosophy of science","first-page":"81","article-title":"Science and human values","author":"Hempel","year":"1965"},{"issue":"Suppl 23","key":"10.1016\/j.shpsa.2026.102206_bib27","doi-asserted-by":"crossref","first-page":"5825","DOI":"10.1007\/s11229-019-02483-4","article-title":"An ethical obligation to ignore the unreliable","volume":"198","author":"Holman","year":"2021","journal-title":"Synthese"},{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib28","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1086\/694037","article-title":"Experimentation by industrial selection","volume":"84","author":"Holman","year":"2017","journal-title":"Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib29","series-title":"The Oxford handbook of philosophy of medicine","first-page":"448","article-title":"Evidence in medicine","author":"Holman","year":"2025"},{"key":"10.1016\/j.shpsa.2026.102206_bib30","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1016\/j.shpsa.2021.11.011","article-title":"The new demarcation problem","volume":"91","author":"Holman","year":"2022","journal-title":"Studies in History and Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib31","series-title":"Validation and regulatory acceptance of toxicological test methods: A report of the ad hoc interagency coordinating committee on the validation of alternative methods (ICCVAM) (NIH publication no. 97-3981)","year":"1997"},{"key":"10.1016\/j.shpsa.2026.102206_bib32","series-title":"ICCVAM evaluation of in vitro test methods for detecting potential endocrine disruptors: Estrogen receptor and androgen receptor binding and transcriptional activation assays (NIH publication no. 03-4503)","year":"2002"},{"key":"10.1016\/j.shpsa.2026.102206_bib34","series-title":"ICCVAM test method evaluation report: The LUMI-CELL\u00ae ER (BG1Luc ER TA) test method: An in vitro assay for identifying human estrogen receptor agonist and antagonist activity of chemicals (NIH publication no. 11-7850)","year":"2011"},{"key":"10.1016\/j.shpsa.2026.102206_bib35","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1007\/s11229-014-0554-7","article-title":"Inductive risk and the contexts of communication","volume":"192","author":"John","year":"2015","journal-title":"Synthese"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib36","doi-asserted-by":"crossref","first-page":"241","DOI":"10.1016\/j.etap.2015.06.009","article-title":"A review on endocrine disruptors and their possible impacts on human health","volume":"40","author":"Kabir","year":"2015","journal-title":"Environmental Toxicology and Pharmacology"},{"key":"10.1016\/j.shpsa.2026.102206_bib37","series-title":"Science, truth, and democracy","author":"Kitcher","year":"2001"},{"issue":"35","key":"10.1016\/j.shpsa.2026.102206_bib38","first-page":"1","article-title":"EPA approval of EDSP test highlights critics' attacks on review panel","volume":"19","author":"Kollipara","year":"2012","journal-title":"Inside EPA's Risk Policy Report"},{"key":"10.1016\/j.shpsa.2026.102206_bib39","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1016\/j.shpsa.2021.12.001","article-title":"Distinguishing between legitimate and illegitimate roles for values in transdisciplinary research","volume":"91","author":"Koskinen","year":"2022","journal-title":"Studies in History and Philosophy of Science"},{"issue":"S1","key":"10.1016\/j.shpsa.2026.102206_bib40","doi-asserted-by":"crossref","first-page":"S129","DOI":"10.2105\/AJPH.2004.044727","article-title":"The weight of scientific evidence in policy and law","volume":"95","author":"Krimsky","year":"2005","journal-title":"American Journal of Public Health"},{"issue":"11","key":"10.1016\/j.shpsa.2026.102206_bib41","doi-asserted-by":"crossref","first-page":"4409","DOI":"10.1007\/s11229-017-1405-0","article-title":"Infertility, epistemic risk, and disease definitions","volume":"196","author":"Kukla","year":"2019","journal-title":"Synthese"},{"issue":"30","key":"10.1016\/j.shpsa.2026.102206_bib42","first-page":"4","article-title":"EPA draws slew of challenges over endocrine testing proposal","volume":"15","author":"Lacey","year":"2008","journal-title":"Inside EPA\u2019s Risk Policy Report"},{"key":"10.1016\/j.shpsa.2026.102206_bib43","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1007\/s10516-018-9386-2","article-title":"Roles for values in scientific activities","volume":"28","author":"Lacey","year":"2018","journal-title":"Axiomathes"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib44","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1039\/c2tx20011b","article-title":"Validation and quality control of replacement alternatives\u2013current status and future challenges","volume":"1","author":"Leist","year":"2012","journal-title":"Toxicology Research"},{"key":"10.1016\/j.shpsa.2026.102206_bib45","series-title":"EURACHEM guide: The fitness for purpose of analytical methods: A laboratory guide to method validation and related topics","author":"Magnusson","year":"2014"},{"key":"10.1016\/j.shpsa.2026.102206_bib46","series-title":"Error and the growth of experimental knowledge","author":"Mayo","year":"1996"},{"issue":"48","key":"10.1016\/j.shpsa.2026.102206_bib47","first-page":"1","article-title":"Sisyphean science: Why value freedom is worth pursuing","volume":"13","author":"Menon","year":"2023","journal-title":"European Journal For Philosophy Of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib48","series-title":"Toxicity testing in the 21st century: A vision and a strategy","year":"2007"},{"key":"10.1016\/j.shpsa.2026.102206_bib49","series-title":"Toxicity-pathway-based risk assessment: Preparing for paradigm change: A symposium summary","year":"2010"},{"key":"10.1016\/j.shpsa.2026.102206_bib50","series-title":"Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment (OECD series on testing and assessment no. 34). Environment directorate","year":"2005"},{"key":"10.1016\/j.shpsa.2026.102206_bib51","series-title":"Test no. 455: Performance-based test guideline for stably transfected transactivation in vitro assays to detect estrogen receptor agonists and antagonists (OECD guidelines for testing of chemicals, section 4)","year":"2021"},{"key":"10.1016\/j.shpsa.2026.102206_bib52","doi-asserted-by":"crossref","DOI":"10.1016\/j.comtox.2020.100144","article-title":"The role of validation in establishing the scientific credibility of predictive toxicology approaches intended for regulatory application","volume":"17","author":"Patterson","year":"2021","journal-title":"Computational Toxicology"},{"key":"10.1016\/j.shpsa.2026.102206_bib55","series-title":"Exploring inductive risk: Case studies of values in science","first-page":"239","article-title":"The inductive risk of \u201cdemasculinization.\u201d","author":"Powers","year":"2017"},{"key":"10.1016\/j.shpsa.2026.102206_bib56","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1016\/j.chroma.2011.10.050","article-title":"Is it really necessary to validate an analytical method or not? That is the question","volume":"1232","author":"Rambla-Alegre","year":"2012","journal-title":"Journal of Chromatography A"},{"key":"10.1016\/j.shpsa.2026.102206_bib57","series-title":"Methodological pragmatism: A systems-theoretic approach to the theory of knowledge","author":"Rescher","year":"1977"},{"issue":"4","key":"10.1016\/j.shpsa.2026.102206_bib58","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1179\/oeh.2008.14.4.299","article-title":"Evidence-based toxicology: \u201csound science\u201d in new disguise","volume":"14","author":"Rud\u00e9n","year":"2008","journal-title":"International Journal of Occupational and Environmental Health"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib59","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1086\/287231","article-title":"The scientist qua scientist makes value judgments","volume":"20","author":"Rudner","year":"1953","journal-title":"Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib60","author":"Russell"},{"key":"10.1016\/j.shpsa.2026.102206_bib61","series-title":"Summary minutes SACATM meeting June 16-17, 2011 Arlington Hilton, Arlington, VA","year":"2011"},{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib62","doi-asserted-by":"crossref","DOI":"10.1289\/ehp.1001969","article-title":"ICCVAM: Not doing enough","volume":"118","author":"Sandler","year":"2010","journal-title":"Environmental Health Perspectives"},{"issue":"164","key":"10.1016\/j.shpsa.2026.102206_bib63","first-page":"1","article-title":"Values, bias and replicability","volume":"203","author":"Sikorski","year":"2024","journal-title":"Synthese"},{"key":"10.1016\/j.shpsa.2026.102206_bib64","series-title":"Science after the practice turn in the philosophy, history, and social studies of science","first-page":"80","article-title":"Towards a framework for the analysis of scientific practices: Commentary on \u201cepistemic activities and systems of practice: Units of analysis in philosophy of science after the practice turn\u201d, by Hasok Chang","author":"Soler","year":"2014"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib65","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1086\/650206","article-title":"Epistemic values and the argument from inductive risk","volume":"77","author":"Steel","year":"2010","journal-title":"Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib66","series-title":"Philosophy and the precautionary principle: Science, evidence, and environmental policy","author":"Steel","year":"2015"},{"key":"10.1016\/j.shpsa.2026.102206_bib67","series-title":"Current controversies in values and science","first-page":"49","article-title":"Qualified epistemic priority: Comparing two approaches to values in science","author":"Steel","year":"2017"},{"issue":"5","key":"10.1016\/j.shpsa.2026.102206_bib68","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1017\/psa.2023.40","article-title":"Against evidential pluralism in pharmaceutical regulation","volume":"90","author":"Sung","year":"2023","journal-title":"Philosophy of Science"},{"key":"10.1016\/j.shpsa.2026.102206_bib69","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/j.shpsa.2022.02.001","article-title":"No one solution to the \u201cnew demarcation problem\u201d?: A view from the trenches","volume":"92","author":"Wagner","year":"2022","journal-title":"Studies in History and Philosophy of Science"},{"issue":"2","key":"10.1016\/j.shpsa.2026.102206_bib70","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1093\/bjps\/axs007","article-title":"Epistemic trust in science","volume":"24","author":"Wilholt","year":"2013","journal-title":"The British Journal for the Philosophy of Science"},{"issue":"1","key":"10.1016\/j.shpsa.2026.102206_bib71","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1093\/toxsci\/kfr145","article-title":"Application of an integrated testing strategy to the US EPA endocrine disruptor screening program","volume":"123","author":"Willett","year":"2011","journal-title":"Toxicological Sciences"},{"key":"10.1016\/j.shpsa.2026.102206_bib72","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/S0378-4274(02)00493-9","article-title":"Validation and acceptance of new and revised tests: A flexible but transparent process","volume":"140","author":"Zeiger","year":"2003","journal-title":"Toxicology Letters"}],"container-title":["Studies in History and Philosophy of Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0039368126000920?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0039368126000920?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T13:49:54Z","timestamp":1793454594000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0039368126000920"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":68,"alternative-id":["S0039368126000920"],"URL":"https:\/\/doi.org\/10.1016\/j.shpsa.2026.102206","relation":{},"ISSN":["0039-3681"],"issn-type":[{"value":"0039-3681","type":"print"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"On epistemic risks in research method validation","name":"articletitle","label":"Article Title"},{"value":"Studies in History and Philosophy of Science","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.shpsa.2026.102206","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"102206"}}