Clinical Research Involving Pregnant Women
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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 : 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.
Clinical Research With Pregnant Women
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Author : Robert Thomas Franceschini
language : en
Publisher:
Release Date : 2017
Clinical Research With Pregnant Women written by Robert Thomas Franceschini and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
The lack of clinical research in pregnancy negatively impacts the ability to provide therapeutic treatments and preventions to pregnant women. This study explores the experiences of investigators who have successfully conducted clinical research in pregnancy to identify factors that facilitate success. Semi-structured, in-depth interviews were conducted with seven biomedical investigators affiliated with the University of Washington. A content analysis was conducted to extract concepts and themes identified by the investigator participants. Four major themes were identified from content analysis: investigator motivations for doing research in pregnancy; financial, scientific, design and legal considerations; relationships; and qualities of a successful investigator. These categories of themes were then analyzed to identify eight factors that enhance the likelihood of successful research in pregnancy. This pilot study identified factors that contribute to successful clinical research with pregnant women. Future research will expand the analysis of investigators' experiences and add examination of the experiences of IRB-affiliated individuals and ethics consultants who have distinct insights into the ethical and legal dimensions of research in pregnancy.
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.
In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.
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.
Clinical Pharmacology During Pregnancy
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Author : Donald Mattison
language : en
Publisher: Academic Press
Release Date : 2012-12-05
Clinical Pharmacology During Pregnancy written by Donald Mattison and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-05 with Medical categories.
Clinical Pharmacology During Pregnancy is written for clinicians, physicians, midwives, nurses, pharmacists and other medical professionals directly involved in the care of women during pregnancy. This book focuses on the impact of pregnancy on drug disposition and also includes coverage of treatments for diseases of specific body systems, as well as essential content on dosing and efficacy. Written in a clear and practical manner, this reference provides easily accessible information and clinical guidance on how best to treat women with medications during pregnancy.
Women And Health Research
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1994-01-01
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 1994-01-01 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.
Advancing Clinical Research With Pregnant And Lactating Populations
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Author : National Academies of Sciences Engineering and Medicine
language : en
Publisher:
Release Date : 2025-01-10
Advancing Clinical Research With Pregnant And Lactating Populations written by National Academies of Sciences Engineering and Medicine and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-10 with Medical categories.
Congress called on the National Academies to convene a committee to examine the real and perceived risks of liability arising from research conducted with pregnant and lactating women. The resulting report, Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks, explores and finds limited evidence of legal liability for inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability. The committee also makes recommendations that could lead to a more robust evidence base about the safety and efficacy of medications for pregnant and lactating women that would facilitate more informed decision making regarding care while mitigating liability.
Pregnancy And The Pharmaceutical Industry
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Author : Kristine E. Shields
language : en
Publisher: Academic Press
Release Date : 2019-06-05
Pregnancy And The Pharmaceutical Industry written by Kristine E. Shields and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-05 with Medical categories.
Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities. Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource. Explores the medical, ethical, scientific and legal rationales behind the inclusion of pregnant women in drug studies Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing Shares views from pharmaceutical industry insiders about company risks, reluctance to implement guidance, and the ultimate need to include pregnant women in studies
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.