When is it impractical to ask informed consent? A systematic review
Clinical Trials, vol. 19, pp. 545–560
Abstract
BACKGROUND: Informed consent is one of the cornerstones of biomedical research with human subjects. Research ethics committees may allow for a modification or a waiver of consent when the research has social value, involves minimal risk, and if consent is impractical to obtain. While the conditions of social value and minimal risk have received ample attention in research ethics literature, the impractical condition remains unclear. There seem to be different interpretations of the meaning of impractical within academic literature. To address this lack of clarity, we performed a systematic review on the interpretation of impractical. METHODS: First, we examined international research ethics guidelines on their usage and interpretation of impractical. Next, we used international ethical guidelines to identify synonyms of the term "impractical." Accordingly, PubMed, Embase, and Web of Science were searched for articles that included "informed consent" and "impractical" or one of its synonyms. RESULTS: We found that there were only a few international ethics guidelines that described what could be considered impractical. Out of 2329 identified academic articles, 42 were included. Impractical was used to describe four different conditions: (1) obtaining informed consent becomes too demanding for researchers, (2) obtaining informed consent leads to invalid study outcomes, (3) obtaining informed consent harms the participant, and (4) obtaining informed consent is meaningless for the participant. CONCLUSION: There are conditions that render conventional informed consent truly impractical, such as untraceable participants or harm for participants. At the same time, researchers have a moral responsibility to design an infrastructure in which consent can be obtained, even if they face hardship in obtaining consent. In addition, researchers should seek to minimize harm inflicted upon participants when harm may occur as a result of the consent procedure. Invalidity of research due to consent issues should not be regarded as impractical but as a condition that limits the social value of research. Further research is essential for when a waiver of informed consent based on impractical is also reasonable.
Authors 7
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden University, Leiden, The Netherlands
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