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“Pregnant women get ill, sick women get pregnant.” Clinicians have meager evidence on which to base treatment of pregnant women. Clinical research investigates mechanisms of human disease, and tests therapeutic interventions. However, pregnant women are often excluded from clinical studies, and few studies are designed to address health concerns and questions relevant to pregnant women. This results in a lack of evidence to inform health care and treatment decisions. The Office of Research on Women’s Health (ORWH) is convening this forum to address the ethical/Institutional Review Board (IRB) and recruitment issues that investigators face in the conceptualization, initiation, and conduct of clinical research studies enrolling pregnant women.
The goal of this forum is to challenge the audience to address gaps in knowledge about medical treatment and pregnancy, to increase the evidence base on the inclusion of pregnant women in clinical research, and to conduct appropriate scientifically and ethically designed clinical research. Medical ethicists, clinical investigators, academic researchers, and those with an interest in and concern about clinical research in women, will provide information related to risk perception, risk reasoning, and the ethics of balancing risks and benefits in the clinical arena. Additionally, presenters will share examples of challenges and strategies for overcoming barriers to clinical research in treating pregnant women with chronic or infectious diseases, or on the evaluation of preventive measures such as vaccines in pregnancy. This information is intended to guide the development of new protocols, enrich interactions with local IRBs, enhance the formulation of recruitment plans, and facilitate the conduct of clinical research in pregnant women.
Runtime:
06:36:59
NLM Title:
Enrolling pregnant women : issues in clinical research [electronic resource] / Office of Research on Women's Health, NIH.
Author:
National Institutes of Health (U.S.). Office of Research on Women's Health.
Publisher:
[Bethesda, Md. : National Institutes of Health, 2010]
Abstract:
(CIT): General Statement for Online Registration Page "Pregnant women get ill, sick women get pregnant." Clinicians have meager evidence on which to base treatment of pregnant women. Clinical research investigates mechanisms of human disease, and tests therapeutic interventions. However, pregnant women are often excluded from clinical studies, and few studies are designed to address health concerns and questions relevant to pregnant women. This results in a lack of evidence to inform health care and treatment decisions. The Office of Research on Women"s Health (ORWH) is convening this forum to address the ethical/Institutional Review Board (IRB) and recruitment issues that investigators face in the conceptualization, initiation, and conduct of clinical research studies enrolling pregnant women. The goal of this forum is to challenge the audience to address gaps in knowledge about medical treatment and pregnancy, to increase the evidence base on the inclusion of pregnant women in clinical research, and to conduct appropriate scientifically and ethically designed clinical research. Medical ethicists, clinical investigators, academic researchers, and those with an interest in and concern about clinical research in women, will provide information related to risk perception, risk reasoning, and the ethics of balancing risks and benefits in the clinical arena. Additionally, presenters will share examples of challenges and strategies for overcoming barriers to clinical research in treating pregnant women with chronic or infectious diseases, or on the evaluation of preventive measures such as vaccines in pregnancy. This information is intended to guide the development of new protocols, enrich interactions with local IRBs, enhance the formulation of recruitment plans, and facilitate the conduct of clinical research in pregnant women.
Subjects:
Clinical Trials as Topic Pregnant Women Research Subjects
