Abstract
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.
Highlights
In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention
We reviewed the literature cited in Pubmed and PsycINFO, from April 1997, the year in which the discussion of exceptions to informed consent was started in BMJ, to September 2013
We summarized the different arguments given in the literature to make an exception to the general rule of informed consent
Summary
In 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. Despite the widespread agreement on the legal and ethical appropriateness of the general rule of informed consent for human research with an intervention, there are examples of very specific situations in which there are reasons to make an exception. Most of the literature that we found was focused on only one subset of reasons, or reasons given for only one specific type of research in Rebers et al BMC Medical Ethics (2016) 17:9 which the informed consent requirement can be waived. Other papers have focused on reasons not to ask informed consent in the control group of a randomized controlled trial, commonly known as Zelen’s design or a prerandomization design [10]
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