Rehabilitation approaches used for children with spinal muscular atrophy: A scoping review based on the F-words framework.

The informed consent process is a foundational element of ethical clinical research. Informed consent forms (ICFs) are critical to this entire process for three reasons. Prospective participants are routinely given and read ICFs before considering enrolling in a study. While research staff conversations are intended to expand on the written ICF and ensure that prospective participants are adequately informed about a study, the written ICFs typically guide study staff explanations and conversations with prospective participants. Written ICFs serve as the first resource for participants to consult with questions about the study when they are away from the study site. Furthermore, although conversations with research staff play an important part in informing participants, institutional review boards (IRBs) can have no prior or concomitant review, oversight, assessment, or accountability of these discussions. Written ICFs are the only part of the informed consent process IRBs assess and make suggestions for revision. Appropriately, ICFs have been subject to careful study and evaluation. In practice, ICFs frequently fall short of Good Clinical Practice Guidelines for informed consent documents to be clear, concise, and avoid unnecessary volume and complexity. They are often excessively long, legalistic, and written at reading levels too high for the general population. For example, ICFs for phase III COVID-19 vaccine trials averaged over 8000 words. A 2024 study found that the average readability level of ICFs corresponds to the 11th grade, whereas the literacy skills of 54% of US adults fall below a sixth-grade level. Globally, across Organisation for Economic Co-operation and Development member countries, an average of 26% of adults demonstrate similar limited literacy. Consequently, many participants lack adequate comprehension of critical research concepts such as randomization and risk. Research studies since at least 1969 suggest that shortened and simplified ICFs either improve or maintain participant comprehension while increasing satisfaction. Despite promising indications, broad adoption of shorter and simplified ICFs remains limited. Why?