The patient's perspective on the need for informed consent for minimal risk studies: Development of a survey-based measure
| Autor: | Sherrie H. Kaplan, Lauren Shimelman, Adrijana Gombosev, Sheila Fireman, Rebecca E. Kaganov, James E. Sabin, Thomas Tjoa, Kathryn Osann, Lauren Heim, Susan S. Huang |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Health (social science) business.industry Health Policy media_common.quotation_subject Psychological intervention Sample (statistics) 06 humanities and the arts 0603 philosophy ethics and religion Institutional review board 03 medical and health sciences Philosophy 0302 clinical medicine Clinical research Informed consent Family medicine Health care medicine Quality (business) 060301 applied ethics 030212 general & internal medicine business Reliability (statistics) media_common |
| Zdroj: | AJOB Empirical Bioethics. 7:116-124 |
| ISSN: | 2329-4523 2329-4515 |
| DOI: | 10.1080/23294515.2016.1161672 |
| Popis: | Background: Recent efforts to study quality improvement (QI) efforts to improve the effectiveness and efficiency of healthcare have raised important questions about ethical boundaries for waiving informed consent. Confusion exists because similar projects can be undertaken for research or QI purposes, a distinction currently used to define Institutional Review Board oversight. However, patients are not aware of such distinctions. We sought to evaluate patients' views of waiving consent for non-invasive projects to improve healthcare quality and delivery. Methods: We developed a 32-item measure of patient thresholds for waiving consent for different types of QI interventions, including those involving changes to: 1) the hospital environment; 2) hospital policies or procedures; 3) objects used by patients; 4) medications or devices; and 5) use of patient information. In a sample of 200 hospitalized patients, we tested and confirmed the reliability and validity of subscales representing each of the 5... |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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