Background:Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory...

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

The federal regulations of human research were written to permit the use of discretion so that research can fit the circumstances under which it is conducted. For example, the researcher and institutional review board could waive or alter some informed consent elements if they deem this the morally and scientifically best way to conduct the research. To do so, however, researchers and IRBs would first have to use mature moral and scientific judgment. They might also have to rely on empirical (...) research to discover the most effective way to act on their moral sense. On discovering the most ethical way to proceed, they would then need to look to the federal regulations of human research to discover how to document their decision and justify it within that somewhat flexible regulatory structure. Unfortunately, many IRBs and researchers fail to take these sensible steps to solve ethical problems and proceed immediately to a default requirement of the regulations that places science at odds with the regulations and, ostensibly, with ethics. The following articles in this special issue are about the process of learning to engage in ethical problem solving and using the flexibility permitted by the federal regulations. These articles extricate researchers from the mindset that has gotten them into trouble, and, ideally, provoke them to use mature common sense and moral judgment. (shrink)

Background: Privacy has been recognized as a basic human right and a part of quality of care. However, little is known about the privacy of Somali asylum seekers in healthcare, even though they are one of the largest asylum seeker groups in the world. Objectives: The aim of the study was to describe the content and importance of privacy and its importance in healthcare from the perspective of Somali asylum seekers. Research design: The data of this explorative qualitative study were (...) collected by four focus group interviews with 18 Somali asylum seekers with the help of an interpreter. The data were analysed by inductive content analysis. Ethical considerations: Research permissions were obtained from the director of the reception centre and from the Department of Social Services. Ethical approval was obtained from the Ethics Committee of Turku University. Findings: The content of privacy includes visual privacy, physical privacy and informational privacy. All contents can be shared with healthcare professionals. The importance of privacy includes respect, dignity and freedom. Discussion: Privacy is strongly connected to the collectivism of Somali culture and religion. Unlike the Western cultures, privacy is not important only for the individual; most of all, it is seen to support collectivism. Conclusion: Even though all contents of privacy can be shared with healthcare professionals, it is important to recognize the cultural aspect of privacy especially when using interpreters with Somali background. (shrink)