title: Intervening in clinical research to prevent the onset of psychoses: conflicts and obligations.
abstract: A prevailing issue in clinical research is the duty clinicians have to treat or prevent the progression of disease during a study that they are conducting. While all clinical researchers have a duty of care for the patients who participate in clinical research, intervening at the onset or progression of disease may skew results and have a negative impact on the scientific validity of a study. Extreme examples of failures to intervene can be found in the Tuskegee syphilis study and in an attempt to determine if cervical smears were an accurate predictor of cancer, which was uncovered by the Cartwright Inquiry. However, the issue arises in all research where delay in intervention can cause harm. A current study in Singapore is investigating the significance of an 'ultra-high risk' state that may constitute the prodromal phase of psychosis. This project called 'The Longitudinal Youth at Risk Study' is potentially contentious because it is recruiting young people who are identified as being 'at risk' of developing psychosis. In this paper, the decision to offer treatment to all participants as well as a fast track for those who are assessed to have developed serious mental illness into treatment is discussed. It is argued that this approach is ethically justified because of the duty of care that is owed to research participants, and suggests that the principle of equipoise may be used to guide intervention decisions in other clinical research protocols.
authors.affiliation: Centre for Biomedical Ethics, National University of Singapore, Singapore 119228. tamra.lysaght@nuhs.edu.sg
authors.forename: Tamra
authors.initials: T
authors.lastname: Lysaght
authors.forename: Benjimen James
authors.initials: BJ
authors.lastname: Capps
authors.forename: Alastair Vincent
authors.initials: AV
authors.lastname: Campbell
authors.forename: Mythily
authors.initials: M
authors.lastname: Subramaniam
authors.forename: Siow-Ann
authors.initials: SA
authors.lastname: Chong
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D002986:Clinical Trials as Topic / Q000941:ethics*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D001523:Mental Disorders / Q000150:complications / Q000628:therapy*; D009483:Neuropsychological Tests; D011618:Psychotic Disorders / Q000209:etiology / Q000517:prevention & control*; D035842:Research Subjects; D018570:Risk Assessment; D012307:Risk Factors; D012846:Singapore; D057212:Therapeutic Equipoise; D055815:Young Adult