Fair Inclusion Of Pregnant Women In Clinical Research

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Fair Inclusion Of Pregnant Women In Clinical Research

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Author :
language : en
Publisher:
Release Date : 2018

Fair Inclusion Of Pregnant Women In Clinical Research written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.

Clinical Research Involving Pregnant Women

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Author : Françoise Baylis
language : en
Publisher: Springer
Release Date : 2017-01-02

Clinical Research Involving Pregnant Women written by Françoise Baylis and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-01-02 with Medical categories.

This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.

Women And Health Research

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1994-02-01

Women And Health Research written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-02-01 with Medical categories.

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.

How The Cioms Guidelines Contribute To Fair Inclusion Of Pregnant Women In Research

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Author : Rieke Van Der Graaf
language : en
Publisher:
Release Date : 2019

How The Cioms Guidelines Contribute To Fair Inclusion Of Pregnant Women In Research written by Rieke Van Der Graaf and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with categories.

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well-recognized organizations, the health needs of pregnant women in research remain grossly under-researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under-represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women's health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change.

Women And Health Research

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Author : Anna C. Mastroianni
language : en
Publisher: National Academies Press
Release Date : 1994

Women And Health Research written by Anna C. Mastroianni and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Health & Fitness categories.

Annotation Examines the facts on women's participation as subjects in medical research and explores issues related to maintaining justice in clinical studies. Experts in ethics, research, medicine and industry present general principles for the ethical conduct of research on women while highlighting the limitations of science, legal liabilities, and relevant governmental policies. Offers an historical overview treating topics such as thalidomide and DES research. Annotation c. by Book News, Inc., Portland, Or.

Women And Health Research

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Author : Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies
language : en
Publisher: National Academies Press
Release Date : 1994-01-15

Women And Health Research written by Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-01-15 with Medical categories.

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.

Inclusion Of Pregnant And Lactating Persons In Clinical Trials Proceedings Of A Workshop

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Author : National Academies Of Sciences Engineeri
language : en
Publisher:
Release Date : 2023-09-15

Inclusion Of Pregnant And Lactating Persons In Clinical Trials Proceedings Of A Workshop written by National Academies Of Sciences Engineeri and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-09-15 with Medical categories.

Not Wanted In The Study

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Author : Zoé Costa-von Aesch
language : en
Publisher:
Release Date : 2007

Not Wanted In The Study written by Zoé Costa-von Aesch and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with categories.

"Review and analysis of current clinical research practice suggests a general trend towards excluding pregnant women from clinical research studies. Although exclusionary research practices are premised upon concerns for the well-being of the fetus and the pregnant women, such practices can also produce various inadvertent harms to both parties. In particular, exclusion of pregnant women from clinical research limits the quality of care provided to pregnant women by impeding individual access to innovative research protocols and by limiting data collection applicable to the pregnant population. A review and analysis of relevant historical, legal, ethical, clinical, scientific and political documents suggests that various changes should be made to current clinical practice. To produce many such changes there is a need for a comprehensive, progressive Canadian health policy to be used to guide and direct researchers and research ethics boards in the appropriate inclusion of pregnant women in clinical research studies." --

Women And Health Research

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Author : Anna C. Mastroianni
language : en
Publisher:
Release Date : 1994

Women And Health Research written by Anna C. Mastroianni and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Human experimentation in medicine categories.

General Considerations For The Clinical Evaluation Of Drugs

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Author : United States. Food and Drug Administration. Bureau of Drugs
language : en
Publisher:
Release Date : 1977

General Considerations For The Clinical Evaluation Of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with Drugs categories.