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Clinical Research Involving Pregnant Women

Clinical Research Involving Pregnant Women PDF Author: Françoise Baylis
Publisher: Springer
ISBN: 3319265121
Category : Medical
Languages : en
Pages : 301

Book Description
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.

Clinical Research Involving Pregnant Women

Clinical Research Involving Pregnant Women PDF Author: Françoise Baylis
Publisher: Springer
ISBN: 3319265121
Category : Medical
Languages : en
Pages : 301

Book Description
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

Women and Health Research PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904992X
Category : Medical
Languages : en
Pages : 286

Book Description
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.

Clinical Pharmacology During Pregnancy

Clinical Pharmacology During Pregnancy PDF Author: Donald Mattison
Publisher: Academic Press
ISBN: 0123860075
Category : Medical
Languages : en
Pages : 496

Book Description
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.

General Considerations for the Clinical Evaluation of Drugs

General Considerations for the Clinical Evaluation of Drugs PDF Author: United States. Food and Drug Administration. Bureau of Drugs
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 20

Book Description


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 396

Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience

WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience PDF Author: World Health Organization
Publisher:
ISBN: 9789241549912
Category : Medical
Languages : en
Pages : 0

Book Description
Within the continuum of reproductive health care, antenatal care provides a platform for important health-care functions, including health promotion, screening and diagnosis, and disease prevention. It has been established that, by implementing timely and appropriate evidence-based practices, antenatal care can save lives. Endorsed by the United Nations Secretary-General, this is a comprehensive WHO guideline on routine antenatal care for pregnant women and adolescent girls. It aims to complement existing WHO guidelines on the management of specific pregnancy-related complications. The guidance captures the complex nature of the antenatal care issues surrounding healthcare practices and delivery, and prioritizes person-centered health and well-being --- not only the prevention of death and morbidity --- in accordance with a human rights-based approach.

Research on the Fetus: Appendix

Research on the Fetus: Appendix PDF Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Fetus
Languages : en
Pages : 876

Book Description


Research on Women's Health

Research on Women's Health PDF Author:
Publisher:
ISBN:
Category : Women
Languages : en
Pages : 84

Book Description


The Making of the Unborn Patient

The Making of the Unborn Patient PDF Author: Monica J. Casper
Publisher: Rutgers University Press
ISBN: 9780813525167
Category : Medical
Languages : en
Pages : 290

Book Description
It is now possible for physicians to recognize that a pregnant woman's fetus is facing life-threatening problems, perform surgery on the fetus, and if it survives, return it to the woman's uterus to finish gestation. Although fetal surgery has existed in various forms for three decades, it is only just beginning to capture the public's imagination. These still largely experimental procedures raise all types of medical, political and ethical questions. The Making of the Unborn Patient examines two important and connected events of the second half of the 20th century: the emergence of fetal surgery as a new medical specialty and the debut of the unborn patient.

International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans PDF Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0

Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.