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Pregnancy and Protection: the Ethics of Limiting a Pregnant Woman’s Participation in Clinical Trials

Lori Allesee & Colleen M. Gallagher

Journal of Clinical Research and Bioethics 2 (2) (2011)

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The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines.Nadine S. J. Stirling & Melanie K. T. Takarangi - forthcoming - Ethics and Behavior.details The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, (...) Download Export citation Bookmark
How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research?Indira S. E. van der Zande, Rieke van der Graaf, Martijin A. Oudijk & Johannes J. M. van Delden - 2021 - Journal of Medicine and Philosophy 46 (5):516-529.details The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) Download Export citation Bookmark 2 citations
‘Experimental pregnancy’ revisited.Anne Drapkin Lyerly - 2022 - Theoretical Medicine and Bioethics 43 (4):253-266.details In this paper, I reflect on an important article by Bob Veatch in the inaugural issue of the Hastings Center Report, entitled “Experimental Pregnancy.” It is a report and elegant analysis of the Goldzieher Study, in which nearly 400 women were randomized to receive hormonal contraception or placebo absent consent or disclosure about placebo use, resulting in several pregnancies. Noting the study’s limited notoriety, I first consider the narratives that have instead dominated bioethics’ approach to pregnancy and research: thalidomide and (...) Download Export citation Bookmark 1 citation
Proposed guidelines for the protection of vulnerable subjects in clinical trials: Protections for decisionally impaired subjects.Gordon D. MacFarlane, Mark C. Herzberg & Laure Campbell - 2015 - Clinical Ethics 10 (3):59-69.details Current regulations and guidelines identify specific subject populations as vulnerable. Regulations and guidelines generally stipulate protections with regard to the process of informed consent. Recent clinical trials suggest that satisfying the legal requirements for additional safeguards may not protect subjects to the extent we may desire. We present proposed guidelines for the protection of decisionally impaired subjects throughout the course of the trial. Download Export citation Bookmark

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