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)

It is increasingly suggested that shortages in the supply chain for human blood could be met by the development of techniques to manufacture human blood ex vivo. These techniques fall broadly under the umbrella of synthetic biology. We examine the biopolitical context surrounding the ex vivo culture of red blood cells through the linked concepts of alienation, immunity, bio-value and biosecuritization. We engage with diverse meanings of synthetic blood, and questions about how the discourses of biosecurity and privatization of risk (...) are linked to claims that the technology will address unmet needs and promote social justice. Through our discussion we contrast communitarian ideas that culturing red blood cells ‘extends the gift’ of adult blood donation with understandings of the immunitary logics that underpin the cord-blood economy. (shrink)