Survey From CDRH Officials Finds Informed Consent Process Needs Improving

Regulatory NewsRegulatory News | 26 August 2019 |  By 

Informed consent forms (ICFs) may meet the necessary regulatory requirements but are often not written in a way to promote comprehension among clinical trial participants, a new research article from six officials in the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) found.

The officials surveyed 399 ICFs from investigational device exemption (IDE) applications for fiscal years 2015 and 2016, finding that overall, the ICFs were written at a higher-than-recommended grade level (the mean grade level was at least equivalent to the 10th-grade reading level). And the research study’s statistical analysis showed that there were significant differences in readability among the ICFs written for a specific clinical study design or medical device type.

The ICFs also varied considerably. For example, the mean number of ICF pages was 13, “but ranged from a minimum of 2 pages to a maximum of 37 pages. Even larger variations could be seen when we analyzed other variables related to ICF structure and content including, the total number of words, (minimum: 790; maximum: 17,115; mean: 4,882.9) words per sentence, and the total number of words in distinct sections,” they explained.

The authors also noted how the Agency for Healthcare Research and Quality’s Informed Consent and Authorization Toolkit for Minimal Risk Research offers suggestions for simplifying the structure and content of the ICF, such as including “the use of plain language, simple sentence structure, short sentences, (e.g., no more than 8 to 10 words) as well as the use of pictures, tables, and diagrams. In our data set, the average sentence length was double that recommendation and each informed consent had on average less than one table, diagram, or figure,” they wrote.

And FDA allows different approaches to ICFs to better enhance patient comprehension. “For example, FDA welcomes the use of electronic systems and processes that may employ multiple types of electronic media to obtain informed consent. In addition to oral informed consent, current trends also demonstrate that the use of electronic or video-based approaches during the IC process can enhance comprehension,” the CDRH officials wrote.

And although the CDRH officials noted that current thinking in the human subject research community “strongly suggests that past and current processes of obtaining informed consent are not working,” they also explain how studies show that patients prefer less information than is typically provided in a standard written ICF.

“Our survey has shown that while the informed consent forms evaluated in this survey met FDA’s regulatory requirements, their readability and comprehension levels were found to be high and may have impeded participant understanding, thereby needing improvement,” the authors added. 



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