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The challenges of informed consent for rapid HIV testing in labor.

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Title: The challenges of informed consent for rapid HIV testing in labor.
Authors: Jamieson DJ (AUTHOR), O'Sullivan MJ (AUTHOR), Maupin R (AUTHOR), Cohen M (AUTHOR), Webber MP (AUTHOR), Nesheim S (AUTHOR), Lampe M (AUTHOR), Garcia P (AUTHOR), Lindsay M (AUTHOR), Bulterys M (AUTHOR)
Source: Journal of Women's Health (15409996). Nov2003, Vol. 12 Issue 9, p889-895. 7p.
Subjects: HIV infections, Mother-infant relationship, Retrovirus diseases, Diseases in women, Medical care, Communicable diseases
Abstract: BACKGROUND: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. METHODS: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. RESULTS: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. CONCLUSIONS: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Women's Health (15409996) is the property of Mary Ann Liebert, Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: The challenges of informed consent for rapid HIV testing in labor.
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+Women's+Health+%2815409996%29%22">Journal of Women's Health (15409996)</searchLink>. Nov2003, Vol. 12 Issue 9, p889-895. 7p.
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  Data: <searchLink fieldCode="DE" term="%22HIV+infections%22">HIV infections</searchLink><br /><searchLink fieldCode="DE" term="%22Mother-infant+relationship%22">Mother-infant relationship</searchLink><br /><searchLink fieldCode="DE" term="%22Retrovirus+diseases%22">Retrovirus diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Diseases+in+women%22">Diseases in women</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+care%22">Medical care</searchLink><br /><searchLink fieldCode="DE" term="%22Communicable+diseases%22">Communicable diseases</searchLink>
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  Data: BACKGROUND: Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor. METHODS: To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study. RESULTS: In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study. CONCLUSIONS: We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Journal of Women's Health (15409996) is the property of Mary Ann Liebert, Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Nov2003
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