Agency and communication challenges in discussions of informed consent in pediatric cancer research.

In this article we examine the discourse of four focus groups we conducted at a pediatric research hospital in which we queried teenage patients, parents, nurses, and physicians about their perceptions of the informed consent process in research. Autonomy, as the goal of informed consent, is a murky concept, with some ethicists questioning the possibility that it can ever be attained. We argue that it might be more productive to consider agency, which we define as language and action that are constructed, negotiated, and maintained through effective communication. Our goal was to understand how individuals rhetorically constructed agency in discussions of informed consent experiences. After transcribing and coding the focus group interviews, we identified six aspects of agency in participants' discourse: (a) defining roles, (b) seeking information, (c) providing information, (d) supporting others, (e) making decisions, and (f) claiming agency for self. Examining these aspects of agency indicated that efforts to improve the informed consent process must address: (a) status differentials, (b) role definitions, (c) information flow, and (d) relationships.

Challenges faced by research ethics committees in El Salvador: results from a focus group study.

OBJECTIVE: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. METHODS: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. RESULTS: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. CONCLUSIONS: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.

Establishment of ethical oversight of human research in El Salvador: lessons learned.

Human research is necessary for establishing the best approaches to health care, and should be overseen by a functional research ethics committee. However, in most low-income countries these committees are inadequate in providing the guidelines needed to ensure that ethics remain a prominent feature of human research. We developed a model of interaction with key institutions in low-income countries that had an interest in improving the infrastructure of human participant research. As a result, a research ethics committee was established at three hospitals in El Salvador. The skills gained from developing these committees and the interest shown by the Salvadoran government in rigorous ethical oversight of research involving human participants has allowed the creation of a national ethics committee, which serves as an entity to establish norms and guidelines for further development of research ethics committees in El Salvador. This model of interaction can also be used by institutions in high-income countries to create and strengthen the capacity for ethics in human research in low-income countries.