title: The ethics of withdrawal: the case of follow-up from first-in-human clinical trials.
abstract: This paper aims to analyze whether patients should be allowed to veto research-related use of medical data collected during routine follow-ups after their withdrawal from first-in-human clinical trials. Forms of withdrawal are identified and it is argued that the right to withdraw might be limited to some of these. The paper concludes that if veto right is denied, then: the research participant should be informed about the potential use of his/her follow-up data in case of his/her withdrawal and consent to it; follow-up should not be initiated for research purposes; compulsory use of follow-up data should imply the use of data anyway collected, requiring no additional effort from the patient; and before deciding about the veto right, investigation of concerned patients' value preferences is needed.
authors.affiliation: Medical Ethics, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, BMC I12, 22184 Lund, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Hug
authors.affiliation: Medical Ethics, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, BMC I12, 22184 Lund, Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Johansson
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D004992:Ethics, Medical; D005500:Follow-Up Studies; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D045808:Refusal to Participate / Q000941:ethics*
keywords: cell replacement therapies; ethics; first-in-human clinical trials; follow-up; informed consent; withdrawal from research