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Human experimentation. Protecting patient autonomy through informed consent.

K A Tuthill
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Consent FormsDisclosureEthics Committees, ResearchFederal GovernmentGovernment RegulationHuman ExperimentationHumansInformed ConsentNontherapeutic Human ExperimentationPaternalismPatient AdvocacyPersonal AutonomyResearch SubjectsResearcher-Subject RelationsRisk AssessmentTherapeutic Human ExperimentationUnited StatesBiomedical and Behavioral ResearchLegal ApproachJournal ArticleReview

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K A Tuthill. 1997. Human experimentation. Protecting patient autonomy through informed consent.. https://doi.org/10.1080/01947649709511033

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Consent Forms↗
PubMed2006

Patients' perceptions of written consent: questionnaire study.

OBJECTIVE: To examine patients' understanding of the status, function, and remit of written consent to surgery. DESIGN: Prospective questionnaire study. Questionnaires were sent to patients within one month of surgery. Responses were analysed with frequencies and single variable analyses. SETTING: Large teaching hospital. PARTICIPANTS: 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period. MAIN OUTCOME MEASURES: Patients' awareness of the legal implications of written consent and their views on the function and remit of the consent form. RESULTS: Patients had limited understanding of the legal standing of written consent. Nearly half (46%, 95% confidence interval 43% to 50%) of patients believed the primary function of consent forms was to protect hospitals and 68% (65% to 71%) thought consent forms allowed doctors to assume control. Only 41% (37% to 44%) of patients believed consent forms made their wishes known. CONCLUSIONS: Many patients seem to have limited awareness of the legal implications of signing or not signing consent forms, and they do not recognise written consent as primarily serving their interests. Current consent procedures seem inadequate as a means for the expression of autonomous choice, and their ethical standing and credibility can be called into question.

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