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  1. The Fetus as a Patient and the Ethics of Human Subjects Research: Response to Commentaries on “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):W3-W7.
    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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  • Ethical Challenges in Designing, Conducting, and Reporting Research to Improve the Mental Health of Pregnant Women: The Voices of Investigators and IRB Members.Anna R. Brandon, Geetha Shivakumar, Stephen J. Inrig, John Z. Sadler & Simon J. Craddock Lee - 2014 - AJOB Empirical Bioethics 5 (2):25-43.
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  • The Fetus as a Research Subject.Kenji Matsui, Keiichiro Yamamoto & Tomohide Ibuki - 2022 - American Journal of Bioethics 22 (3):76-78.
    Interventions performed on a pregnant woman's body can affect the fetus in multiple ways. Such effects can be harmful to beneficial to the fetus. Unfortunately, the effects of new drugs and compoun...
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  • Restrictions on Abortion, Social Justice and the Ethics of Research in Maternal-Fetal Therapy Trials.Mary Faith Marshall, Alaia Verite & Anne D. Lyerly - 2022 - American Journal of Bioethics 22 (3):78-81.
    At no time in recent decades has more attention been paid to ethical issues in pregnancy. Particularly riveting—and alarming, to many—was the passage of Senate Bill 8, a Texas law banning abortion...
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  • Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’.Carleigh B. Krubiner & Ruth R. Faden - 2017 - Journal of Medical Ethics 43 (10):664-665.
    A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There (...)
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  • Systematic review of ethical issues in perinatal mental health research.Mickie de Wet, Susan Hannon, Kathleen Hannon, Anna Axelin, Susanne Uusitalo, Irena Bartels, Jessica Eustace-Cook, Ramón Escuriet & Deirdre Daly - 2023 - Nursing Ethics 30 (4):482-499.
    Background Maternal mental health during the peripartum period is critically important to the wellbeing of mothers and their infants. Numerous studies and clinical trials have focused on various aspects of interventions and treatments for perinatal mental health from the perspective of researchers and medical health professionals. However, less is known about women’s experiences of participating in perinatal mental health research, and the ethical issues that arise. Aim To systematically review the literature on the ethical issues that emerge from pregnant and/or (...)
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