Protecting Human Research Subjects: An International Perspective

Abstract

not new. As early as 1898, Albert Neisser in Prussia, who discovered gonococcus, attempted to test serum therapy to prevent syphilis by injecting cell-free serum into patients, most of whom were prostitutes, without their knowledge and consent (Vollmann & Winau, 1996). Eventually some of those injected developed syphilis. Since the end of World War II, cutting ethical corners in human experimentation such as this has prompted the international community to call for protecting human research subjects and issuing ethical codes and regulations on the basis of informed consent (Nelson-Marten & Rich, 1999; Oddi & Cassidy, 1990). What kinds of rights do human beings have when they participate in research studies as subjects? What are researchers' moral and legal obligations toward their human subjects? How can researchers ensure the rights of human subjects are being protected? These questions become even more critical as the trend toward international collaborations in research increases (Wichman, Smith, Mills, & Sandler, 1997). To date, researchers in more than 100 countries in the world have collaborated with researchers in the United States. To extend scientific knowledge across countries is to simultaneously extend ethical sensitivity to all involved in research. To this end, this column explores ethical standards, their applications, and the challenges in protecting human subjects in an international arena.

Ethical Considerations in International Nursing Research: a report from the international centre for nursing ethics

“…19,48 Because individualism is so deeply embedded in the western understanding of humanity and ethics, the use of alternatives to informed consent remains perhaps the most difficult issue for western people to confront and, thus far, ethical guidelines and literature considering international research ethics consistently include a strong endorsement of individual informed consent. 1,3,49,50 Obtaining proper informed consent, as it is conceived in the West, requires shared assumptions about the nature of decision making, and at least some degree of shared understanding of the meaning of the research and the nature of the risks and benefits involved in the particular study. Reliance on informed consent is problematic when the assumptions of researchers and participants differ in any of these areas.…”