The challenges of informed consent for rapid HIV testing in labor

Denise J. Jamieson, Mary Jo O'Sullivan, Robert Maupin, Mardge Cohen, Mayris P. Webber, Steven Nesheim, Margaret Lampe, Patricia Garcia, Michael Lindsay, Marc Bulterys

Research output: Contribution to journalArticle

12 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)889-895
Number of pages7
JournalJournal of Women's Health
Volume12
Issue number9
StatePublished - Nov 2003

Fingerprint

Informed Consent
HIV
Mothers
Centers for Disease Control and Prevention (U.S.)
Focus Groups
Research
Counseling

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Jamieson, D. J., O'Sullivan, M. J., Maupin, R., Cohen, M., Webber, M. P., Nesheim, S., ... Bulterys, M. (2003). The challenges of informed consent for rapid HIV testing in labor. Journal of Women's Health, 12(9), 889-895.

The challenges of informed consent for rapid HIV testing in labor. / Jamieson, Denise J.; O'Sullivan, Mary Jo; Maupin, Robert; Cohen, Mardge; Webber, Mayris P.; Nesheim, Steven; Lampe, Margaret; Garcia, Patricia; Lindsay, Michael; Bulterys, Marc.

In: Journal of Women's Health, Vol. 12, No. 9, 11.2003, p. 889-895.

Research output: Contribution to journalArticle

Jamieson, DJ, O'Sullivan, MJ, Maupin, R, Cohen, M, Webber, MP, Nesheim, S, Lampe, M, Garcia, P, Lindsay, M & Bulterys, M 2003, 'The challenges of informed consent for rapid HIV testing in labor', Journal of Women's Health, vol. 12, no. 9, pp. 889-895.
Jamieson DJ, O'Sullivan MJ, Maupin R, Cohen M, Webber MP, Nesheim S et al. The challenges of informed consent for rapid HIV testing in labor. Journal of Women's Health. 2003 Nov;12(9):889-895.
Jamieson, Denise J. ; O'Sullivan, Mary Jo ; Maupin, Robert ; Cohen, Mardge ; Webber, Mayris P. ; Nesheim, Steven ; Lampe, Margaret ; Garcia, Patricia ; Lindsay, Michael ; Bulterys, Marc. / The challenges of informed consent for rapid HIV testing in labor. In: Journal of Women's Health. 2003 ; Vol. 12, No. 9. pp. 889-895.
@article{7ae50e7d6425404bb907752c313f8603,
title = "The challenges of informed consent for rapid HIV testing in labor",
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.",
author = "Jamieson, {Denise J.} and O'Sullivan, {Mary Jo} and Robert Maupin and Mardge Cohen and Webber, {Mayris P.} and Steven Nesheim and Margaret Lampe and Patricia Garcia and Michael Lindsay and Marc Bulterys",
year = "2003",
month = "11",
language = "English (US)",
volume = "12",
pages = "889--895",
journal = "Journal of Women's Health",
issn = "1540-9996",
publisher = "Mary Ann Liebert Inc.",
number = "9",

}

TY - JOUR

T1 - The challenges of informed consent for rapid HIV testing in labor

AU - Jamieson, Denise J.

AU - O'Sullivan, Mary Jo

AU - Maupin, Robert

AU - Cohen, Mardge

AU - Webber, Mayris P.

AU - Nesheim, Steven

AU - Lampe, Margaret

AU - Garcia, Patricia

AU - Lindsay, Michael

AU - Bulterys, Marc

PY - 2003/11

Y1 - 2003/11

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=10744230696&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=10744230696&partnerID=8YFLogxK

M3 - Article

C2 - 14670168

AN - SCOPUS:10744230696

VL - 12

SP - 889

EP - 895

JO - Journal of Women's Health

JF - Journal of Women's Health

SN - 1540-9996

IS - 9

ER -