{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T04:02:13Z","timestamp":1784606533488,"version":"3.55.0"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T00:00:00Z","timestamp":1784592000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Monash Bioeth. Rev."],"DOI":"10.1007\/s40592-026-00299-w","type":"journal-article","created":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T03:13:04Z","timestamp":1784603584000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Deliberate infection in research: ethical perspective of controlled human infection studies"],"prefix":"10.1007","author":[{"given":"Govind","family":"Mishra","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hina","family":"Lal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arpita","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,21]]},"reference":[{"key":"299_CR1","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1093\/phe\/phv026","volume":"9","author":"Ben Bambery","year":"2016","unstructured":"Bambery, Ben, Michael Selgelid, Charles Weijer, Julian Savulescu, and Andrew J. Pollard. 2016. Ethical Criteria for Human Challenge Studies in Infectious Diseases. Public Health Ethics 9: 92\u2013103. https:\/\/doi.org\/10.1093\/phe\/phv026.","journal-title":"Public Health Ethics"},{"key":"299_CR2","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1016\/j.biologicals.2021.09.002","volume":"74","author":"Isabelle Bekeredjian-Ding","year":"2021","unstructured":"Bekeredjian-Ding, Isabelle, Jean-Hugues Trouvin, Hilde Depraetere, Carine La, Akamol E. Suvarnapunya, Alan Bell, Alex Mann et al. 2021. Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain. Biologicals 74: 16\u201323. https:\/\/doi.org\/10.1016\/j.biologicals.2021.09.002.","journal-title":"Biologicals"},{"key":"299_CR3","doi-asserted-by":"publisher","first-page":"840","DOI":"10.1016\/S1473-3099(15)00068-7","volume":"15","author":"Thomas C Darton","year":"2015","unstructured":"Darton, Thomas C, J. Christoph, S. Blohmke, Vasee, Daniel M Moorthy, G. Altmann, Frederick, Elizabeth A Hayden, M. Clutterbuck, Myron, V. S. Levine, Adrian, Hill, and Andrew J Pollard. 2015. Design, recruitment, and microbiological considerations in human challenge studies. The Lancet Infectious Diseases 15: 840\u2013851. https:\/\/doi.org\/10.1016\/S1473-3099(15)00068-7.","journal-title":"The Lancet Infectious Diseases"},{"key":"299_CR4","doi-asserted-by":"publisher","unstructured":"Deming, Meagan E., L. Nelson, Merlin Michael, Myron S. Robb, Cohen, and Kathleen M. Neuzil. 2020. Accelerating Development of SARS-CoV-2 Vaccines \u2014 The Role for Controlled Human Infection Models. New England Journal of Medicine 383. https:\/\/doi.org\/10.1056\/NEJMp2020076.","DOI":"10.1056\/NEJMp2020076"},{"key":"299_CR5","doi-asserted-by":"publisher","first-page":"262","DOI":"10.25259\/IJMR_985_2024","volume":"160","author":"Jake Eberts","year":"2024","unstructured":"Eberts, Jake, Nir Daniel, Eyal, and Sayantan Banerjee. 2024. Ethics & utility of controlled human infection studies (CHIS) in low- & middle-income countries. The Indian Journal of Medical Research 160: 262\u2013266. https:\/\/doi.org\/10.25259\/IJMR_985_2024.","journal-title":"The Indian Journal of Medical Research"},{"key":"299_CR6","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1002\/cpt.1970","volume":"109","author":"Kathryn T Hall","year":"2021","unstructured":"Hall, Kathryn T., Lene Vase, Deirdre K. Tobias, T. Hesam, Jan Dashti, Ted J. Vollert, Kaptchuk, and Nancy R. Cook. 2021. Historical Controls in Randomized Clinical Trials: Opportunities and Challenges. Clinical Pharmacology and Therapeutics 109: 343\u2013351. https:\/\/doi.org\/10.1002\/cpt.1970.","journal-title":"Clinical Pharmacology and Therapeutics"},{"key":"299_CR7","unstructured":"Indian Council of Medical Research. 2023. ICMR policy statement on the ethical conduct of controlled human infection studies (chis) in india. https:\/\/ethics.ncdirindia.org\/\/asset\/pdf\/ICMR_CHIS_Policy_Document.pdf. Accessed 8 January 2026."},{"key":"299_CR8","doi-asserted-by":"publisher","first-page":"655","DOI":"10.1016\/S2666-5247(24)00025-9","volume":"5","author":"Susan Jackson","year":"2024","unstructured":"Jackson, Susan, Julia L Marshall, Andrew Mawer, Raquel Lopez-Ramon, Stephanie A Harris, Iman Satti, Eileen Hughes et al. 2024. Safety, tolerability, viral kinetics, and immune correlates of protection in healthy, seropositive UK adults inoculated with SARS-CoV-2: a single-centre, open-label, phase 1 controlled human infection study. The Lancet Microbe 5: 655\u2013668. https:\/\/doi.org\/10.1016\/S2666-5247(24)00025-9.","journal-title":"The Lancet Microbe"},{"key":"299_CR9","doi-asserted-by":"publisher","first-page":"797","DOI":"10.1111\/bioe.12802","volume":"34","author":"Euzebiusz Jamrozik","year":"2020","unstructured":"Jamrozik, Euzebiusz, and Michael J. Selgelid. 2020a. Ethical issues surrounding controlled human infection challenge studies in endemic low-and middle\u2010income countries. Bioethics 34: 797\u2013808. https:\/\/doi.org\/10.1111\/bioe.12802.","journal-title":"Bioethics"},{"key":"299_CR10","doi-asserted-by":"publisher","first-page":"e198","DOI":"10.1016\/S1473-3099(20)30438-2","volume":"20","author":"Euzebiusz Jamrozik","year":"2020","unstructured":"Jamrozik, Euzebiusz, and Michael J Selgelid. 2020b. COVID-19 human challenge studies: ethical issues. The Lancet Infectious Diseases 20: e198\u2013e203. https:\/\/doi.org\/10.1016\/S1473-3099(20)30438-2.","journal-title":"The Lancet Infectious Diseases"},{"key":"299_CR11","doi-asserted-by":"publisher","first-page":"e69","DOI":"10.1016\/S1473-3099(20)30020-7","volume":"20","author":"Marijke CC Langenberg","year":"2020","unstructured":"Langenberg, Marijke, C. C, Olaf M Dekkers, and Meta Roestenberg. 2020. Are placebo controls necessary in controlled human infection trials for vaccines? The Lancet Infectious Diseases 20: e69\u2013e74. https:\/\/doi.org\/10.1016\/S1473-3099(20)30020-7.","journal-title":"The Lancet Infectious Diseases"},{"key":"299_CR12","unstructured":"Marion, J. D., and A. D. Althouse. 2019. Use of historical controls in clinical trials. In JAMA Guide to Statistics and Methods, ed. E. H. Livingston, and R. J. Lewis. McGraw-Hill Education. https:\/\/jamaevidence.mhmedical.com\/content.aspx?bookid=2742&sectionid=288726822."},{"key":"299_CR13","doi-asserted-by":"publisher","first-page":"4256","DOI":"10.1016\/j.vaccine.2019.06.009","volume":"37","author":"Roshan Ramanathan","year":"2019","unstructured":"Ramanathan, Roshan, Scott Stibitz, Douglas Pratt, and Jeff Roberts. 2019. Use of controlled human infection models (CHIMs) to support vaccine development: US regulatory considerations. Vaccine 37: 4256\u20134261. https:\/\/doi.org\/10.1016\/j.vaccine.2019.06.009.","journal-title":"Vaccine"},{"issue":"2","key":"299_CR14","doi-asserted-by":"publisher","first-page":"704","DOI":"10.1186\/s13063-019-3844-z","volume":"20","author":"Malick M Raymond Meriel","year":"2019","unstructured":"Raymond Meriel, Malick M. Gibani, Nicholas P. J. Day, Phaik Yeong Cheah. 2019. Typhoidal Salmonella human challenge studies: ethical and practical challenges and considerations for low-resource settings. Trials 20 (2): 704. https:\/\/doi.org\/10.1186\/s13063-019-3844-z.","journal-title":"Trials"},{"key":"299_CR15","doi-asserted-by":"publisher","first-page":"S216","DOI":"10.1093\/cid\/ciad382","volume":"77","author":"Annette Rid","year":"2023","unstructured":"Rid, Annette, J. Jordan, T. Feld, Jake Liang, and Charles Weijer. 2023. Ethics of Controlled Human Infection Studies with Hepatitis C Virus. Clinical Infectious Diseases 77: S216\u2013S223. https:\/\/doi.org\/10.1093\/cid\/ciad382.","journal-title":"Clinical Infectious Diseases"},{"key":"299_CR16","doi-asserted-by":"publisher","first-page":"e312","DOI":"10.1016\/S1473-3099(18)30177-4","volume":"18","author":"Meta Roestenberg","year":"2018","unstructured":"Roestenberg, Meta, Marie-Astrid Hoogerwerf, M. Daniela, Benjamin Ferreira, Mordm\u00fcller, and Maria Yazdanbakhsh. 2018. Experimental infection of human volunteers. The Lancet Infectious Diseases 18: e312\u2013e322. https:\/\/doi.org\/10.1016\/S1473-3099(18)30177-4.","journal-title":"The Lancet Infectious Diseases"},{"key":"299_CR17","doi-asserted-by":"publisher","first-page":"S74","DOI":"10.1016\/j.ijid.2019.01.013","volume":"84","author":"Anuradha Rose","year":"2019","unstructured":"Rose, Anuradha, and Amrita Sekhar. 2019. Bioethics of establishing a CHIM model for dengue vaccine development. International Journal of Infectious Diseases 84: S74\u2013S79. https:\/\/doi.org\/10.1016\/j.ijid.2019.01.013.","journal-title":"International Journal of Infectious Diseases"},{"key":"299_CR18","doi-asserted-by":"publisher","first-page":"101429","DOI":"10.1016\/j.smim.2020.101429","volume":"50","author":"Amrita Sekhar","year":"2020","unstructured":"Sekhar, Amrita, and Gagandeep Kang. 2020. Human challenge trials in vaccine development. Seminars in Immunology 50: 101429. https:\/\/doi.org\/10.1016\/j.smim.2020.101429.","journal-title":"Seminars in Immunology"},{"key":"299_CR19","doi-asserted-by":"publisher","first-page":"263","DOI":"10.20529\/IJME.2018.073","volume":"3","author":"Michael J Selgelid","year":"2018","unstructured":"Selgelid, Michael J., and Euzebiusz Jamrozik. 2018. Ethical challenges posed by human infection challenge studies in endemic settings. Indian journal of medical ethics 3:263\u2013266. https:\/\/doi.org\/10.20529\/IJME.2018.073.","journal-title":"Indian journal of medical ethics"},{"key":"299_CR20","doi-asserted-by":"publisher","first-page":"745","DOI":"10.1111\/bioe.12801","volume":"34","author":"Seema K Shah","year":"2020","unstructured":"Shah, Seema K., and Annette Rid. 2020. Ethics of controlled human infection studies: Past, present and future. Bioethics 34: 745\u2013748. https:\/\/doi.org\/10.1111\/bioe.12801.","journal-title":"Bioethics"},{"key":"299_CR21","doi-asserted-by":"publisher","first-page":"209","DOI":"10.12688\/wellcomeopenres.17968.2","volume":"7","author":"Abhishek Sharma","year":"2023","unstructured":"Sharma, Abhishek, Aditi Apte, Medha Rajappa, Manjulika Vaz, Vina Vaswani, Shifalika Goenka, Samir Malhotra et al. 2023. Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration. Wellcome Open Research 7: 209. https:\/\/doi.org\/10.12688\/wellcomeopenres.17968.2.","journal-title":"Wellcome Open Research"},{"key":"299_CR22","doi-asserted-by":"publisher","first-page":"107","DOI":"10.3389\/fcimb.2019.00107","volume":"9","author":"Amy Sherman","year":"2019","unstructured":"Sherman, Amy, Aneesh Caryn, Neal W. Mehta, J. Dickert, Evan, and Anderson, Nadine Rouphael. 2019. The Future of Flu: A Review of the Human Challenge Model and Systems Biology for Advancement of Influenza Vaccinology. Frontiers in Cellular and Infection Microbiology 9: 107. https:\/\/doi.org\/10.3389\/fcimb.2019.00107.","journal-title":"Frontiers in Cellular and Infection Microbiology"},{"key":"299_CR23","doi-asserted-by":"publisher","first-page":"439","DOI":"10.1080\/22221751.2021.1896956","volume":"10","author":"Shan Su","year":"2021","unstructured":"Su, Shan, Yiming Shao, and Shibo Jiang. 2021. Human challenge trials to assess the efficacy of currently approved COVID-19 vaccines against SARS-CoV-2 variants. Emerging Microbes & Infections 10: 439\u2013441. https:\/\/doi.org\/10.1080\/22221751.2021.1896956.","journal-title":"Emerging Microbes & Infections"},{"key":"299_CR24","doi-asserted-by":"publisher","first-page":"e085250","DOI":"10.1136\/bmjopen-2024-085250","volume":"15","author":"Danny Toomey","year":"2025","unstructured":"Toomey, Danny, Jupiter Adams-Phipps, James Wilkinson, John Pietro, Jake Littman, Steffen Kamenicek, Daniel Kaufman et al. 2025. An analysis of controlled human infection studies registered on ClinicalTrials.gov. British Medical Journal Open 15: e085250. https:\/\/doi.org\/10.1136\/bmjopen-2024-085250.","journal-title":"British Medical Journal Open"},{"key":"299_CR25","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1007\/s40592-020-00121-1","volume":"39","author":"Manjulika Vaz","year":"2021","unstructured":"Vaz, Manjulika, Olinda Timms, Avita Rose Johnson, S. Rathna Kumari, Mala Ramanathan, and Mario Vaz. 2021. Public perceptions on Controlled Human Infection Model (CHIM) studies\u2014a qualitative pilot study from South India. Monash Bioethics Review 39: 68\u201393. https:\/\/doi.org\/10.1007\/s40592-020-00121-1.","journal-title":"Monash Bioethics Review"},{"key":"299_CR26","unstructured":"World health organization. 2020. Key criteria for the ethical acceptability of COVID-19 human challenge studies. https:\/\/www.who.int\/publications\/i\/item\/WHO-2019-nCoV-Ethics_criteria-2020.1. Accessed 8 January 2026."},{"key":"299_CR27","unstructured":"World health organization. 2021. WHO guidance on the ethical conduct of controlled human infection studies. https:\/\/www.who.int\/publications\/i\/item\/9789240037816. Accessed 5 January 2026."},{"key":"299_CR28","unstructured":"World health organization. 2025. Key criteria for the ethical acceptability of controlled human infection studies during public health emergencies. https:\/\/www.who.int\/publications\/i\/item\/9789240109063. Accessed 5 January 2026."}],"container-title":["Monash Bioethics Review"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40592-026-00299-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40592-026-00299-w","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40592-026-00299-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T03:13:09Z","timestamp":1784603589000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40592-026-00299-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,21]]},"references-count":28,"alternative-id":["299"],"URL":"https:\/\/doi.org\/10.1007\/s40592-026-00299-w","relation":{},"ISSN":["1321-2753","1836-6716"],"issn-type":[{"value":"1321-2753","type":"print"},{"value":"1836-6716","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,21]]},"assertion":[{"value":"3 February 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 July 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 July 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The authors declare no competing interests.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}]}}