{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T16:08:57Z","timestamp":1788797337536,"version":"build-2803163510"},"reference-count":54,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:00:00Z","timestamp":1788739200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T00:00:00Z","timestamp":1788739200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100003521","name":"Department of Education, Australian Government","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003521","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Bioethics"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    The issue of post\u2010trial responsibility is about what is owed to research participants after a clinical trial ends, who is responsible, and how long this responsibility must endure. Despite two decades of international guidance on this issue, research involving novel high\u2010risk interventions\u2014such as implantable neurotechnologies\u2014raises underexplored ethical tensions. Trials of implantable devices carry surgical risks and require access to multidisciplinary teams and specialised clinical infrastructures. These factors can foster participant dependence on investigator teams and trial institutions for post\u2010trial care and support. With research and development in this area accelerating, actionable ethical guidance on the post\u2010trial responsibilities of trial stakeholders is urgently needed. Recent normative commentaries have examined the post\u2010trial responsibilities of clinical trial investigators, who play a central role in study design, trial coordination, and follow\u2010up. A persistent challenge is demarcating investigator responsibilities of research integrity from those of therapeutic care when developing ethical guidance on post\u2010trial responsibilities. Recognising the value of empirical engagement for informing further ethical reflection, we conducted qualitative semi\u2010structured interviews with\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200921 investigators involved in neurosurgical device trials. We contend that investigators frequently experience institutional and regulatory pressures that shape how they interpret and enact responsibilities for participants' post\u2010trial wellbeing, often in ways that extend beyond standard expectations of clinical research practice.\n                  <\/jats:p>","DOI":"10.1111\/bioe.70186","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T15:20:24Z","timestamp":1788794424000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Post\u2010Trial Responsibilities for Participants Implanted With Neurosurgical Devices: A Qualitative Study"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3412-8892","authenticated-orcid":false,"given":"Nathan","family":"Higgins","sequence":"first","affiliation":[{"name":"School of Psychological Sciences Monash University Clayton Victoria Australia"},{"name":"Monash Bioethics Centre, School of Philosophical, Historical, and Indigenous Studies Monash University Clayton Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3593-0772","authenticated-orcid":false,"given":"Adrian","family":"Carter","sequence":"additional","affiliation":[{"name":"School of Psychological Sciences Monash University Clayton Victoria Australia"},{"name":"Monash Bioethics Centre, School of Philosophical, Historical, and Indigenous Studies Monash University Clayton Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7417-348X","authenticated-orcid":false,"given":"John","family":"Gardner","sequence":"additional","affiliation":[{"name":"Monash Bioethics Centre, School of Philosophical, Historical, and Indigenous Studies Monash University Clayton Victoria Australia"},{"name":"School of Social Sciences Monash University Clayton Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,7]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnhum.2024.1320806"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0128-2"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp-2013-306580"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-021-01243-7"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s44222-024-00239-5"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-024-03440-6"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/phe\/phr013"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-8519.2009.01736.x"},{"key":"e_1_2_9_10_1","volume-title":"International Ethical Guidelines for Health\u2010Related Research Involving Humans","author":"World Health Organization","year":"2017"},{"key":"e_1_2_9_11_1","volume-title":"Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects [Internet]","author":"World Medical Association","year":"2000"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brs.2023.04.016"},{"key":"e_1_2_9_13_1","doi-asserted-by":"crossref","first-page":"27","DOI":"10.1007\/978-3-031-26801-4_3","volume-title":"Policy, Identity, and Neurotechnology [Internet]","author":"Tubig P.","year":"2023"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2019.3523"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41583-018-0004-5"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuron.2019.08.024"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/hast.1566"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/hast.1567"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuron.2023.07.008"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.8654"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000000345"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brs.2022.07.051"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12152-024-09549-2"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/21507740.2021.2001084"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0199451"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-018-4738-6"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjsit-2024-000262"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11135-017-0574-8"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-026-01475-7"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1080\/2159676X.2019.1628806"},{"key":"e_1_2_9_31_1","unstructured":"World Medical Association WMA Declaration of Helsinki\u2014Ethical Principles for Medical Research Involving Human Participants.2024."},{"key":"e_1_2_9_32_1","unstructured":"International Organization for Standardization ISO 14155:2020(en) Clinical Investigation of Medical Devices for Human Subjects\u2014Good Clinical Practice [Internet] 2020 https:\/\/www.iso.org\/obp\/ui\/en\/#iso:std:iso:14155:ed-3:v1:en."},{"key":"e_1_2_9_33_1","volume-title":"Principles of Biomedical Ethics","author":"Beauchamp T. L.","year":"2019"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-021-00581-y"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1080\/105294199277860"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.4103\/cjhr.cjhr_47_19"},{"key":"e_1_2_9_37_1","doi-asserted-by":"crossref","DOI":"10.1093\/acprof:oso\/9780195388930.001.0001","volume-title":"Moral Entanglements: The Ancillary\u2010Care Obligations of Medical Researchers [Internet]","author":"Richardson H. S.","year":"2012"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1353\/pbm.2020.0019"},{"issue":"2","key":"e_1_2_9_39_1","first-page":"10","article-title":"Revisiting the Belmont Report: The Ethical Significance of the Distinction Between Clinical Research and Medical Care","volume":"5","author":"Miller F. G.","year":"2006","journal-title":"Newsletter on Philosophy and Medicine"},{"key":"e_1_2_9_40_1","volume-title":"The Jubilee Centre Framework for Virtue\u2010Based Professional Ethics","author":"Arthur J.","year":"2023"},{"key":"e_1_2_9_41_1","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1017\/9781108649247.009","volume-title":"Beyond Autonomy","author":"Oakley J.","year":"2019"},{"key":"e_1_2_9_42_1","doi-asserted-by":"crossref","DOI":"10.1093\/oso\/9780195082890.001.0001","volume-title":"The Virtues in Medical Practice","author":"Pellegrino E. D.","year":"1993"},{"key":"e_1_2_9_43_1","first-page":"190","volume-title":"Researching With Integrity: The Ethics of Academic Enquiry","author":"Macfarlane B.","year":"2009"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1111\/1467-8519.00281"},{"key":"e_1_2_9_45_1","first-page":"240","volume-title":"The Virtuous Psychiatrist: Character Ethics in Psychiatric Practice","author":"Radden J.","year":"2010"},{"key":"e_1_2_9_46_1","first-page":"537","volume-title":"The Oxford Handbook of Ethical Theory [Internet]","author":"Held V.","year":"2007"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1093\/neuros\/nyx361"},{"key":"e_1_2_9_48_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.14650"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12152-023-09536-z"},{"key":"e_1_2_9_50_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyg.2023.1108333"},{"key":"e_1_2_9_51_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10728-020-00398-7"},{"key":"e_1_2_9_52_1","doi-asserted-by":"publisher","DOI":"10.1093\/jmp\/jhae045"},{"key":"e_1_2_9_53_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11019-024-10198-8"},{"key":"e_1_2_9_54_1","doi-asserted-by":"publisher","DOI":"10.2147\/OAJCT.S345482"},{"key":"e_1_2_9_55_1","doi-asserted-by":"publisher","DOI":"10.1136\/jme-2023-109719"}],"container-title":["Bioethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bioe.70186","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bioe.70186","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bioe.70186","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T15:20:28Z","timestamp":1788794428000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bioe.70186"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,7]]},"references-count":54,"alternative-id":["10.1111\/bioe.70186"],"URL":"https:\/\/doi.org\/10.1111\/bioe.70186","archive":["Portico"],"relation":{},"ISSN":["0269-9702","1467-8519"],"issn-type":[{"value":"0269-9702","type":"print"},{"value":"1467-8519","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,7]]},"assertion":[{"value":"2025-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"bioe.70186"}}