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  1. (1 other version)Motives and risk perceptions of participants in a phase 1 trial for Hepatitis C Virus investigational therapy in pregnancy.Yasaswi Kislovskiy, Catherine Chappell, Emily Flaherty, Megan E. Hamm, Flor de Abril Cameron, Elizabeth Krans & Judy C. Chang - 2022 - Research Ethics 18 (2):132-150.
    Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the study. (...)
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  • An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients.Laurence B. McCullough & Frank A. Chervenak - 2011 - American Journal of Bioethics 11 (5):39-49.
    Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials (...)
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  • Unacceptable Risk in Pregnancy: Whose Choice and Responsibility?Constance Perry - 2011 - American Journal of Bioethics 11 (5):64-65.
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  • (1 other version)Motives and risk perceptions of participants in a phase 1 trial for Hepatitis C Virus investigational therapy in pregnancy.Yasaswi Kislovskiy, Catherine Chappell, Emily Flaherty, Megan E. Hamm, Flor de Abril Cameron, Elizabeth Krans & Judy C. Chang - 2021 - Sage Publications Ltd: Research Ethics 18 (2):132-150.
    Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...)
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  • The Common Rule, Pregnant Women, and Research: No Need to “Rescue” That Which Should Be Revised.Chris Kaposy & Françoise Baylis - 2011 - American Journal of Bioethics 11 (5):60-62.
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  • Who Is A Patient and Why Does It Matter?Ana S. Iltis - 2011 - American Journal of Bioethics 11 (5):62-64.
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