When is it impractical to ask informed consent? A systematic review

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.

A Narrative Review of the Rationale for Conducting Neonatal Emergency Studies with a Waived or Deferred Consent Approach

“…In a systematic review of 42 studies, Laurijssen et al found that "impractical" was most commonly used to describe four scenarios that made the informed consent process too demanding for the researchers. These included situations where a full informed process was not possible because (1) patients were too unwell or the guardians too stressed to understand the study; (2) it led to biased selection of patients that invalidates study outcomes; (3) it led to possible harm to the participant (e.g., delaying a potentially life-saving treatment); and (4) it was meaningless for the participant because it did not add to their knowledge about the procedure [25].…”

Proxy measures for the assessment of psychotic and affective symptoms in studies using electronic health records

“…41,42 Such integration with artificial intelligence with natural language processing algorithms could somewhat alleviate the ongoing ethical dilemma in biomedical EHR-based research regarding the extraction of data from patients' medical records without informed consent. 43,44 In summary, we conclude that standardised psychometric assessments are essential for patients with FEP. Therefore, our proposal of a proxy instrument based on clinical records for the assessment of psychotic and affective symptoms offers a feasible, valid and reliable alternative to standard psychometric procedures in realworld practice settings.…”

“… 41 , 42 Such integration with artificial intelligence with natural language processing algorithms could somewhat alleviate the ongoing ethical dilemma in biomedical EHR-based research regarding the extraction of data from patients’ medical records without informed consent. 43 , 44 …”

Navigating Informed Consent Requirements and Expectations in Cluster Randomized Trials: Research Ethics Board Members’ and Researchers’ Views

“…They emphasized the cost to society when excessive focus on consent prevents beneficial CRTs that may be necessary to measure, compare, and improve quality of care. Echoing other studies that revealed challenges of reaching meaningful outcomes when a study is unable to include enough participants due to informed consent requirement or when consent procedures introduce selection bias, 35 most interviewees—with the exception of one REB member with a legal background—used a broader interpretation of burdens and costs in determining whether consent requirements are impractical for a particular CRT. This may be especially relevant to health services trials conducted with smaller clusters by necessity (e.g., due to lower population density), whereby not collecting or including the data from all patients may skew the representativeness of the sample and subsequent study results.…”