TY - JOUR
T1 - Power Difference and Risk Perception
T2 - Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle-Income Setting
AU - Den hollander, Geerte C.
AU - Browne, Joyce l.
AU - Arhinful, Daniel
AU - van der Graaf, Rieke
AU - Klipstein-Grobusch, Kerstin
N1 - Publisher Copyright:
© 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.
PY - 2018/6
Y1 - 2018/6
N2 - To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision-making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context-specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.
AB - To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision-making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context-specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner.
KW - Clinical trials
KW - Cultural competency
KW - Decision process
KW - Low-and middle-income countries (LMICs)
KW - Pregnant women
KW - Research conduct
KW - Vulnerability
UR - http://www.scopus.com/inward/record.url?scp=84992456098&partnerID=8YFLogxK
U2 - 10.1111/dewb.12132
DO - 10.1111/dewb.12132
M3 - Article
C2 - 27761986
SN - 1471-8731
VL - 18
SP - 68
EP - 75
JO - Developing world bioethics
JF - Developing world bioethics
IS - 2
ER -