Exploring the Gap Between a Morally Valid and a Legally Adequate Consent; Investigating Latino Understanding of an Informed Consent Conference

Abstract

Abstract Enrollment of members of minority communities in clinical trials is an important step towards the elimination of health disparities and increases the generalizability of research results. Latinos are disproportionally affected by a number of health issues such as diabetes. Having Latinos participate in research is essential since limited participation leads to limited data specific for this population. Furthermore, for some patients, inclusion in clinical trials represents an opportunity to receive new therapies not otherwise available. This project explores Latinos’ understanding of the informed consent conference considered on a broad level, including oral, textual, and visual components. Grounded theory is used as the analytic methodology. This bioethics question is explored by situating the theory within relevant literature in bioethics, rhetoric, scientific and technical communication, and intercultural communication. Data was gathered in three studies using the methodology of analogue participants. A simulation of a healthy patient consent conference was used in Study 1 and Study 2, while a simulation of a multi-arm diabetes trial was used in Study 3. The analogue participants were recruited from urban Catholic parishes that serve a large immigrant Latino population. In order to secure a moral consent and honor the autonomy of members of this community during trial enrollment, the researcher must thoroughly understand the social context that forms the identity of the Latino community member. Although the level of autonomy varies with each individual, the social context shaped by this data suggests a compromised autonomy. The social context of this community is complex and dynamic. Latino immigrants in this study live in a closely-knit community, sharing a culture, language, faith, for the most part their country of origin, and the immigrant experience. These community members demonstrate care and concern for one another in their shared struggles to acculturate while living with a steady sense of disquietude surrounding the immigration status of themselves, family members, or friends. An undocumented status affects all areas of an immigrant’s life, limiting many potential opportunities. The grounded theory resulting from the data gathered in Study 1, Study 2, and Study 3 suggests a culturally specific way to present trial information to members of this community, describes how that information might be understood, and illustrates the community’s social context. Understanding the social context is necessary to understand how to present trial information and to understand the autonomy of community members.