Improving interorganizational communication to raise standards for human subjects protection in El Salvador: A focus group study with research ethics committee members and parents of children with cancer.

摘要

Ethical review of research involving human subjects is a necessary but complicated endeavor, especially amid the proliferation of biomedical research in low-income countries. Past abuses in international biomedical research have led to international guidelines and federal laws requiring independent review of research by research ethics committees (RECs) in both the country that sponsors the research and the country that hosts it. Yet, this joint review of international research is complex. Not only must the sponsor country REC conduct the usual evaluation of risk and the oversight of the informed consent process, it must also collaborate with the host country REC to consider special circumstances, such as how cultural differences impact the informed consent process and, especially, how to resolve disagreements about what constitutes ethical research. Such collaboration to protect humans in research requires sustained inter-REC communication, but this rarely occurs.;The purpose of this dissertation research was to develop a model of interorganizational communication between host country RECs in El Salvador and a sponsor country IRB at St. Jude Children's Research Hospital. To achieve this purpose, I used focus groups to understand the perceived communication needs during the ethical review process of collaborative human research among Salvadoran REC members, to understand the communication needs of parents of pediatric oncology patients in El Salvador who have gone or will go through the informed consent process, and to develop strategies to improve communication between RECs in El Salvador and the St. Jude IRB for collaborative review of St. Jude-sponsored research in El Salvador.;The qualitative content analysis of the focus group transcripts revealed five themes to consider in the joint review of international research in El Salvador: (1) Communication and decision making about health and research; (2) Cultural idiosyncrasy; (3) Need for support in bioethics; (4) Improving inter-REC communication; and (5) Vulnerability. These themes indicate the presence of perceived resource interdependency and interorganizational trust, which are two important conditions for the emergence of an interorganizational relationship, and suggest the need for a third condition, which is the development of sustainable representative inter-REC linkages. I recommend that an interorganizational communication alliance can allow host country and sponsor country RECs to raise the standard of ethical protections in international biomedical research to a new level.