Power Difference and Risk Perception: Mapping Vulnerability within the Decision Process of Pregnant Women towards Clinical Trial Participation in an Urban Middle‐Income Setting

Abstract

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.

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review

“…Additional reasons for participation mentioned were: ability to withdraw , advice from physician , community involvement , cultural acceptability , creating a feeling of community , low pressure decision , need for treatment , research involving a non‐invasive procedure , peer enrolment , low perception of risk , result availability , guarantee of confidentiality , being unaware of voluntariness of participation , research outcome, and finally seeing research participation as motivation to avoid risky behaviour .…”

“…Additional reasons for participation mentioned were: ability to withdraw [91], advice from physician [20,27,77,85], community involvement [34,[61][62][63]66], cultural acceptability [63,91], creating a feeling of community [44], low pressure decision [75], need for treatment [77], research involving a non-invasive procedure [46,81], peer enrolment [33,44,84], low perception of risk [54,70], result availability [20], guarantee of confidentiality [23,33,34,62], being unaware of voluntariness of participation [46], research outcome, [60,62,66,84] and finally seeing research participation as motivation to avoid risky behaviour [59]. The most important reasons for non-participation were safety concerns, inconvenience, stigmatisation, lack of social support, confidentiality concerns, physical pain, efficacy concerns and distrust.…”

Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

“…For many participants, trust in the healthcare providers was a significant element in decision-making about research participation. The role of trust regarding research participation has been observed in multiple settings [16,[27][28][29]. In other contexts, it seems that mistrust is a more important element that needs to be addressed in communities where research takes place [30,31].…”

Vulnérabilité des femmes enceintes en éthique de la recherche : un problème sémantique

“…Si plusieurs visions en recherche clinique contribuent à la catégorisation des femmes enceintes comme vulnérables, la plus répandue actuellement serait peut-être celle liée au fait d'un risque possiblement plus élevé lors de leur participation aux processus de recherche [2,3,[11][12][13]. Cette conception de la vulnérabilité répond à la vision internationale de la vulnérabilité liée aux risques potentiels auxquels s'exposent potentiellement les participants.…”

“…Le point le plus pertinent étant que les femmes enceintes doivent « être protégées durant la recherche et non pas de la recherche elle-même » [14]. Le statut des femmes enceintes en recherche est qualifié de « vulnérabilité paradoxale » [13] car la majorité des médications prescrites aux femmes durant la grossesse ne sont pas agréées pour être utilisées chez les femmes enceintes [3][4]. Dans certains cas, seul l'état de grossesse induit une iniquité face à la participation potentielle des femmes enceintes à la recherche.…”