title: How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.
abstract: Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.
authors.affiliation: Clinical Ethics and Law, Faculty of Medicine, Southampton General Hospital, University of Southampton, Room AB 203, MP 801, South Academic Block, Tremona Road, Southampton, SO16 6YD, UK. s.dheensa@soton.ac.uk.
authors.forename: Sandi
authors.identifier: 0000-0002-6412-696X
authors.initials: S
authors.lastname: Dheensa
authors.affiliation: Clinical Ethics and Law, Faculty of Medicine, Southampton General Hospital, University of Southampton, Room AB 203, MP 801, South Academic Block, Tremona Road, Southampton, SO16 6YD, UK.|Wessex Clinical Genetic Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
authors.forename: Gillian
authors.initials: G
authors.lastname: Crawford
authors.affiliation: Wessex Clinical Genetic Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Salter
authors.affiliation: The Ethox Centre, Institute of Health Sciences, University of Oxford, Old Rd, Oxford, OX3 7LF, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Parker
authors.affiliation: Clinical Ethics and Law, Faculty of Medicine, Southampton General Hospital, University of Southampton, Room AB 203, MP 801, South Academic Block, Tremona Road, Southampton, SO16 6YD, UK.
authors.forename: Angela
authors.initials: A
authors.lastname: Fenwick
authors.affiliation: Clinical Ethics and Law, Faculty of Medicine, Southampton General Hospital, University of Southampton, Room AB 203, MP 801, South Academic Block, Tremona Road, Southampton, SO16 6YD, UK.|Wessex Clinical Genetic Service, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
authors.forename: Anneke
authors.initials: A
authors.lastname: Lucassen
mesh_terms: D032962:Consent Forms / Q000592:standards*; D030881:Disclosure / Q000941:ethics / Q000331:legislation & jurisprudence*; D005190:Family; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D033162:Incidental Findings; D009386:Neoplastic Syndromes, Hereditary / Q000175:diagnosis* / Q000235:genetics / Q000517:prevention & control; D017410:Practice Guidelines as Topic; D036301:Qualitative Research; D006113:United Kingdom
keywords: Clinical ethics; Confidentiality; Consent; Genomics