BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...) a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

This article focuses on emergency medical care in black urban populations, suggesting that the classification of a “community” within clinical trial language is problematic. The article references a cultural history of black Americans with pre-hospital emergency medical treatment as relevant to contemporary emergency medicine paradigms. Part I explores a relationship between “autonomy” and “community.” The idea of community emerges as a displacement for the ethical principle of autonomy precisely at the moment that institutionalized medicine focuses on diversity. Part II examines (...) a clinical trial for the blood substitute PolyHeme® (Northfield Laboratories, Inc., Evanston, IL). It illustrates the ways in which bias in research paradigms and Institutional Review Board decisions attach to the notion and utility of the language of “community.” The conclusion's contemporary anecdote makes apparent the vitality of the issues of prehospital emergency medical care and the ways in which decisions and practices fall too easily into a narrative of culturally biased treatment. (shrink)