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Attention is also given to how social context should affect ethical risk-benefit decisions, especially in the afterbirth period.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/drug-delivery-through-placenta-and-then-breastmilk-for-fetal-cystic-fibrosis-collateral-benefit-and-social-good/446877/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/drug-delivery-through-placenta-and-then-breastmilk-for-fetal-cystic-fibrosis-collateral-benefit-and-social-good/446877.png","ImageObject",300,407,{"name":42,"@type":43},"Well Done","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-31","2026-09-29",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",7,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"Why is collateral benefit central to the risk-benefit assessment in this trial?","Question",{"text":63,"@type":64},"The analysis argues that conventional risk-benefit frameworks omit collateral benefits. It examines how participation may generate individual knowledge and psychological gains for the pregnant volunteer and how these could factor into the overall balance of risks and benefits.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"How does altruism influence ethical evaluation for the pregnant volunteer?",{"text":68,"@type":64},"The text states that pregnant people and new parents can be highly motivated by altruism to improve the health of their unborn child and newborn. This altruism requires explicit consideration of collateral benefits rather than assuming only risk.",{"name":70,"@type":61,"acceptedAnswer":71},"How should social context influence ethical decision-making in clinical research?",{"text":72,"@type":64},"The discussion treats social good as an ethical justification but emphasizes that research must still be rigorous and methodologically sound to support generalizability. It questions whether and how the social context should guide decisions when participants—pregnant people, fetuses, and newborns—have historically been excluded as “therapeutic orphans.”","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},446877,1790828210,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,109,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":107,"slug":108},40,"healthcare",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},8,"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":55,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":33,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":123,"preview_page_count":4},5909892210082,"https://ap-avatar.wpscdn.com/avatar/56001069da27c9f41e8?x-image-process=image/resize,m_fixed,w_180,h_180&k=1789614185077863061","Author Manuscript Author Manuscript Author Manuscript Author Manuscript  \n\n| | HHS Public Access\u003Cbr>Author manuscript\u003Cbr>Am J Bioeth. Author manuscript; available in PMC 2026 January 06. |\n| --- | --- |\n\nPublished in final edited form as:  \nAm J Bioeth. 2025 October ; 25(10): 102–104. doi:10.1080/15265161.2025.2543720 .  \nDrug Delivery Through Placenta and Then Breastmilk for Fetal Cystic Fibrosis: Collateral Benefit and Social Good Do Not Make  \nan Acceptable Risk: Benefit Ratio  \nTeri L. Hernandeza, Michael V. Zaretsky,  \nBrian M. Jackson, Gianna G. Morales, Curtis R. Coughlin II, David Badesch, Matthew DeCamp  \na University of Colorado Anschutz Medical Campus  \nCASE INTRODUCTION  \nThe proposed clinical trial is an investigator-initiated non-randomized, two-arm comparative prospective study (Dawson et al. 2025) . Careful ethical consideration of risks and benefits is necessary. Here we focus on two questions: (1) Do collateral benefits “count” in the risk-benefit assessment for the pregnant person and after delivery?; and (2) To what extent, if any, should the social context influence ethical decision making? In our assessment, despite the potential for collateral benefits to the healthy volunteer, limited generalizability of benefits to the fetus/infant that would contribute to social good, and concerns over voluntary and fair inclusion make the study as proposed unacceptable—especially in the period afterbirth.  \nALTRUISM AND COLLATERAL BENEFITS  \nIn this trial, the person who is pregnant and then provides the drug via breastmilk is a healthy volunteer. We ought not assume that this individual experiences all risk and no benefit. True, the side effects of ETI are significant enough that many living with CF are unable to tolerate the therapy (Bathgate et al. 2023). However, pregnant people and new parents are highly motivated by altruism to positively influence the health of their unborn child and newborn. This altruism requires addressing the role of“collateral” benefits of participation, which are not included in conventional risk-benefit assessments (van Rijssel et  \nFull Terms & Conditions of access and use can be found at [https://www.tandfonline.com/action/journalInformation?](https://www.tandfonline.com/action/journalInformation?)[ ](https://www.tandfonline.com/action/journalInformation?)journalCode=uajb20This is an Open Access article distributed under the terms of the Creative Commons Attribution License ([http://](http://)[ ](http://)[creativecommons.org/licenses/by/4.0/](creativecommons.org/licenses/by/4.0/)), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.  \nCONTACT Teri L. Hernandez teri.hernandez@cuanschutz.edu College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.  \nDISCLOSURE STATEMENT  \nNo potential conflict of interest was reported by the author(s) .  \nAuthor Manuscript Author Manuscript Author Manuscript Author Manuscript  \nHernandez et al. Page 2  \nal. 2025) . Collateral benefits have been defined as,“individual benefits arising from study participation, but not from the intervention that is studied,”(p.4) (van Rijssel et al. 2025) including individual knowledge gains (i.e., related to the disease), and psychological benefits (i.e., hope and altruism) .  \nIn this circumstance, the person who is pregnant and then provides the drug via breastmilk may benefit (collaterally) by helping to understand the disease affecting their child and others’, or from improved psychological health through the study. Indeed, because the fetus has the potential to benefit from ETI treatment through the pregnant person–and the fetus while in utero is part of the pregnant person—psychological benefit might not be a collateral benefit at all; it might be direct. Expectant pa","cbCainqxpyY414sb","https://ap.wps.com/l/cbCainqxpyY414sb","pdf",43588,"English","# Case Introduction\n# Altruism and Collateral Benefits\n# The Role of Social Context","[{\"question\":\"Why is collateral benefit central to the risk-benefit assessment in this trial?\",\"answer\":\"The analysis argues that conventional risk-benefit frameworks omit collateral benefits. It examines how participation may generate individual knowledge and psychological gains for the pregnant volunteer and how these could factor into the overall balance of risks and benefits.\"},{\"question\":\"How does altruism influence ethical evaluation for the pregnant volunteer?\",\"answer\":\"The text states that pregnant people and new parents can be highly motivated by altruism to improve the health of their unborn child and newborn. This altruism requires explicit consideration of collateral benefits rather than assuming only risk.\"},{\"question\":\"How should social context influence ethical decision-making in clinical research?\",\"answer\":\"The discussion treats social good as an ethical justification but emphasizes that research must still be rigorous and methodologically sound to support generalizability. It questions whether and how the social context should guide decisions when participants—pregnant people, fetuses, and newborns—have historically been excluded as “therapeutic orphans.”\"}]","Drug Delivery Through Placenta and Then Breastmilk for Fetal Cystic Fibrosis - Collateral Benefit and Social Good | PDF",1790717477]