{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T19:26:23Z","timestamp":1788809183134,"version":"build-2803163510"},"reference-count":45,"publisher":"Elsevier BV","issue":"5","license":[{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,9,1]],"date-time":"2024-09-01T00:00:00Z","timestamp":1725148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,9,16]],"date-time":"2024-09-16T00:00:00Z","timestamp":1726444800000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["clinicalkey.fr","clinicalkey.jp","clinicalkey.es","clinicalkey.com.au","clinicalkey.com","brainstimjrnl.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Brain Stimulation"],"published-print":{"date-parts":[[2024,9]]},"DOI":"10.1016\/j.brs.2024.09.010","type":"journal-article","created":{"date-parts":[[2024,9,23]],"date-time":"2024-09-23T21:00:02Z","timestamp":1727125202000},"page":"1145-1154","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":8,"title":["Where is the exit? The ethical importance of exit plans in clinical trials with neural implants"],"prefix":"10.1016","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6195-4903","authenticated-orcid":false,"given":"Franziska Britta","family":"Sch\u00f6nweitz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja Kathrin","family":"Ruess","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"McLennan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alena","family":"Buyx","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8835-5444","authenticated-orcid":false,"given":"Marcello","family":"Ienca","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib1","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1196\/annals.1305.016","article-title":"Neurotechnology and society (2010\u20132060)","volume":"1013","author":"Lynch","year":"2004","journal-title":"Ann N Y Acad Sci"},{"issue":"5","key":"10.1016\/j.brs.2024.09.010_bib2","article-title":"Towards new human rights in the age of neuroscience and neurotechnology","volume":"13","author":"Ienca","year":"2017","journal-title":"Life Sci Soc Pol"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib3","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1109\/MPRV.2008.16","article-title":"Security and privacy for implantable medical devices","volume":"7","author":"Halperin","year":"2008","journal-title":"IEEE Pervasive Comput"},{"key":"10.1016\/j.brs.2024.09.010_bib4","unstructured":"ClinicalTrials.gov. ClinicalTrials.gov is a Place to Learn About Clinical Studies from around the World. https:\/\/clinicaltrials.gov."},{"key":"10.1016\/j.brs.2024.09.010_bib5","unstructured":"EU Clinical Trials Register. EU Clinical Trials Register. https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search."},{"issue":"4","key":"10.1016\/j.brs.2024.09.010_bib6","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1080\/21507740.2021.1938293","article-title":"Exit from brain device research: a modified grounded theory study of researcher obligations and participant experiences","volume":"13","author":"Sankary","year":"2022","journal-title":"AJOB Neurosci"},{"issue":"3","key":"10.1016\/j.brs.2024.09.010_bib7","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1016\/j.brs.2023.04.016","article-title":"How I became myself after merging with a computer: does human-machine symbiosis raise human rights issues?","volume":"16","author":"Gilbert","year":"2023","journal-title":"Brain Stimulation"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib8","doi-asserted-by":"crossref","DOI":"10.1186\/s12910-021-00690-8","article-title":"The ethics of explantation","volume":"22","author":"Hansson","year":"2021","journal-title":"BMC Med Ethics"},{"issue":"3\u20134","key":"10.1016\/j.brs.2024.09.010_bib9","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1177\/08830738231167736","article-title":"Use of invasive brain-computer interfaces in pediatric neurosurgery: technical and ethical considerations","volume":"38","author":"Bergeron","year":"2023","journal-title":"J Child Neurol"},{"issue":"5","key":"10.1016\/j.brs.2024.09.010_bib10","doi-asserted-by":"crossref","first-page":"759","DOI":"10.1016\/j.neuron.2019.08.024","article-title":"Device removal following brain implant research","volume":"103","author":"Sierra-Mercado","year":"2019","journal-title":"Neuron"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib11","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1007\/s12152-012-9161-9","article-title":"Involuntary & voluntary invasive brain surgery: ethical issues related to acquired aggressiveness","volume":"6","author":"Gilbert","year":"2013","journal-title":"Neuroethics"},{"issue":"2","key":"10.1016\/j.brs.2024.09.010_bib12","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1007\/s12152-014-9224-1","article-title":"Self-estrangement & deep brain stimulation: ethical issues related to forced explantation","volume":"8","author":"Gilbert","year":"2015","journal-title":"Neuroethics"},{"issue":"4","key":"10.1016\/j.brs.2024.09.010_bib13","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1080\/21507740.2022.2126544","article-title":"Not-so-straightforward decisions to keep or explant a device: when does neural device removal become patient coercion?","volume":"13","author":"Gilbert","year":"2022","journal-title":"AJOB Neurosci"},{"key":"10.1016\/j.brs.2024.09.010_bib14","article-title":"Abandoned: the human cost of neurotechnology failure","author":"Drew","year":"2022","journal-title":"Springer Nat"},{"issue":"12","key":"10.1016\/j.brs.2024.09.010_bib15","doi-asserted-by":"crossref","first-page":"1506","DOI":"10.1001\/jamaneurol.2019.3523","article-title":"Ethical challenges of risk, informed consent, and posttrial responsibilities in human research with neural devices: a review","volume":"76","author":"Hendriks","year":"2019","journal-title":"JAMA Neurol"},{"issue":"20","key":"10.1016\/j.brs.2024.09.010_bib16","doi-asserted-by":"crossref","first-page":"3143","DOI":"10.1016\/j.neuron.2023.07.008","article-title":"Continuing trial responsibilities for implantable neural devices","volume":"111","author":"Hendriks","year":"2023","journal-title":"Neuron"},{"key":"10.1016\/j.brs.2024.09.010_bib17","doi-asserted-by":"crossref","unstructured":"World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310(20), 2191-2194.","DOI":"10.1001\/jama.2013.281053"},{"key":"10.1016\/j.brs.2024.09.010_bib18","unstructured":"CIOMS\/WHO. International Ethical Guidelines for Health-related Research Involving Humans. Prepared by the CIOMS and the WHO. CIOMS. https:\/\/cioms.ch\/wp-content\/uploads\/2017\/01\/WEB-CIOMS-EthicalGuidelines.pdf."},{"key":"10.1016\/j.brs.2024.09.010_bib19","series-title":"Principles of biomedical ethics","author":"Beauchamp","year":"2019"},{"key":"10.1016\/j.brs.2024.09.010_bib20","unstructured":"Cochrane. Cochrane Rapid Reviews: Interim Guidance from the Cochrane Rapid Reviews Methods Group.http:\/\/methods.cochrane.org\/sites\/methods.cochrane.org.rapidreviews\/files\/uploads\/cochrane_rr_-_guidance-23mar2020-final.pdf."},{"key":"10.1016\/j.brs.2024.09.010_bib21","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1016\/j.jclinepi.2020.10.007","article-title":"Cochrane rapid reviews methods group offers evidence-informed guidance to conduct rapid reviews","volume":"130","author":"Garritty","year":"2021","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"10.1016\/j.brs.2024.09.010_bib22","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1001\/jama.280.3.278","article-title":"Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals","volume":"280","author":"Jadad","year":"1998","journal-title":"JAMA"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib23","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1186\/2046-4053-4-4","article-title":"Reviews: rapid! Rapid! Rapid! \u2026and systematic","volume":"4","author":"Sch\u00fcnemann","year":"2015","journal-title":"Syst Rev"},{"key":"10.1016\/j.brs.2024.09.010_bib24","series-title":"Developing PRISMA-RR, a reporting guideline for rapid reviews of primary studies (protocol)","author":"Stevens","year":"2018"},{"key":"10.1016\/j.brs.2024.09.010_bib25","first-page":"2206","article-title":"Reconstructing the giant: on the importance of rigour in documenting the literature search process","volume":"9","author":"Vom Brocke","year":"2009","journal-title":"ECIS"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib26","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1111\/j.1365-2648.2007.04569.x","article-title":"The qualitative content analysis process","volume":"62","author":"Elo","year":"2008","journal-title":"J Adv Nurs"},{"issue":"5","key":"10.1016\/j.brs.2024.09.010_bib37","doi-asserted-by":"crossref","first-page":"1029","DOI":"10.1016\/j.brs.2022.07.051","article-title":"Post-trial access in implanted neural device research: device maintenance, abandonment, and cost","volume":"15","author":"L\u00e1zaro-Mu\u00f1oz","year":"2022","journal-title":"Brain Stimul"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib40","article-title":"Post-trial access to implantable neural devices: an exploratory international survey","volume":"6","author":"Higgins","year":"2024","journal-title":"BMJ Surg Interv Health technol"},{"issue":"20","key":"10.1016\/j.brs.2024.09.010_bib39","doi-asserted-by":"crossref","first-page":"3143","DOI":"10.1016\/j.neuron.2023.07.008","article-title":"Continuing trial responsibilities for implantable neural devices","volume":"111","author":"Hendriks","year":"2023","journal-title":"Neuron"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib27","doi-asserted-by":"crossref","DOI":"10.1186\/s12901-019-0066-7","article-title":"Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility","volume":"19","author":"Marx","year":"2019","journal-title":"BMC Ear Nose Throat Disord"},{"key":"10.1016\/j.brs.2024.09.010_bib28","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2019-030100","article-title":"Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study protocol for Australian stakeholder involvement in the design of a randomised controlled trial","volume":"9","author":"Rapport","year":"2019","journal-title":"BMJ Open"},{"issue":"3","key":"10.1016\/j.brs.2024.09.010_bib29","doi-asserted-by":"crossref","first-page":"174","DOI":"10.1136\/medethics-2016-103655","article-title":"Medical and bioethical considerations in elective cochlear implant array removal","volume":"44","author":"Owoc","year":"2018","journal-title":"J Med Ethics"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib30","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1136\/medethics-2019-106052","article-title":"Incoming ethical issues for deep brain stimulation: when long-term treatment leads to a \u2018new form of the Disease\u2019","volume":"47","author":"Gilbert","year":"2021","journal-title":"J Med Ethics"},{"issue":"4","key":"10.1016\/j.brs.2024.09.010_bib31","doi-asserted-by":"crossref","first-page":"582","DOI":"10.1089\/jpm.2019.0129","article-title":"Deep brain stimulation at end of life: clinical and ethical considerations","volume":"23","author":"Sankary","year":"2020","journal-title":"J Palliat Med"},{"issue":"6","key":"10.1016\/j.brs.2024.09.010_bib32","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1111\/ner.12634","article-title":"Multicenter retrospective study of neurostimulation with exit of therapy by explant","volume":"20","author":"Pope","year":"2017","journal-title":"Neuromodulation: Technol Neural Interface"},{"issue":"7","key":"10.1016\/j.brs.2024.09.010_bib43","doi-asserted-by":"crossref","first-page":"642","DOI":"10.1111\/ner.12642","article-title":"Therapy-related explants after spinal cord stimulation: results of an international retrospective chart review study","volume":"20","author":"Van Buyten","year":"2017","journal-title":"Neuromodulation : Journal Int Neuromodulation Soc"},{"issue":"4","key":"10.1016\/j.brs.2024.09.010_bib41","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2024.8654","article-title":"Definition of implanted neurological device abandonment: a systematic review and consensus statement","volume":"7","author":"Okun","year":"2024","journal-title":"JAMA Netw Open"},{"key":"10.1016\/j.brs.2024.09.010_bib42","series-title":"Journal of medical ethics","article-title":"Non-voluntary BCI explantation: assessing possible neurorights violations in light of contrasting mental ontologies","author":"Cassinadri","year":"2024"},{"issue":"1","key":"10.1016\/j.brs.2024.09.010_bib44","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1002\/hast.1566","article-title":"Brain pioneers and moral entanglement: an argument for post-trial responsibilities in neural-device trials","volume":"54","author":"Goering","year":"2024","journal-title":"Hastings Cent Rep"},{"issue":"6","key":"10.1016\/j.brs.2024.09.010_bib38","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1038\/s41583-018-0004-5","article-title":"Continued access to investigational brain implants","volume":"19","author":"L\u00e1zaro-Mu\u00f1oz","year":"2018","journal-title":"Nat Rev Neurosci"},{"issue":"3","key":"10.1016\/j.brs.2024.09.010_bib45","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1016\/j.brs.2023.04.016","article-title":"How I became myself after merging with a computer: does human-machine symbiosis raise human rights issues?","volume":"16","author":"Gilbert","year":"2023","journal-title":"Brain Stimul"},{"key":"10.1016\/j.brs.2024.09.010_bib33","doi-asserted-by":"crossref","DOI":"10.3389\/fnhum.2020.581090","article-title":"Publication of study exit procedures in clinical trials of deep brain stimulation: a focused literature review","volume":"14","author":"Sankary","year":"2020","journal-title":"Front Hum Neurosci"},{"key":"10.1016\/j.brs.2024.09.010_bib34","unstructured":"Bundesinstitut f\u00fc\u00fcr Arzneimittel und Medizinprodukte. Elektronische Rekrutierung, Patientenaufkl\u00e4rung und Patienteneinwilligung. https:\/\/www.bfarm.de\/SharedDocs\/Downloads\/DE\/Service\/Termine-und-Veranstaltungen\/dialogveranstaltungen\/dialog_2021\/210526\/10_Beckerling_Ruppert.pdf?__blob=publicationFile."},{"key":"10.1016\/j.brs.2024.09.010_bib35","unstructured":"National Institute for Health and Care Research. Clinical Trials Guide. https:\/\/www.nihr.ac.uk\/documents\/clinical-trials-guide\/20595."},{"key":"10.1016\/j.brs.2024.09.010_bib36","unstructured":"U.S. Food & Drug Administration. Recruiting Study Subjects. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/recruiting-study-subjects."}],"container-title":["Brain Stimulation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1935861X24001645?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1935861X24001645?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,11,22]],"date-time":"2024-11-22T08:54:56Z","timestamp":1732265696000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1935861X24001645"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9]]},"references-count":45,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["S1935861X24001645"],"URL":"https:\/\/doi.org\/10.1016\/j.brs.2024.09.010","relation":{},"ISSN":["1935-861X"],"issn-type":[{"value":"1935-861X","type":"print"}],"subject":[],"published":{"date-parts":[[2024,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Where is the exit? The ethical importance of exit plans in clinical trials with neural implants","name":"articletitle","label":"Article Title"},{"value":"Brain Stimulation","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.brs.2024.09.010","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}