Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.

We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.

Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.

The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

We aimed to improve the research consenting process by developing and evaluating simplified consent forms.

Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.

At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (p<0.001).

Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

To assess elective surgery consent practices amongst senior house officers from a selection of UK ENT departments, and to compare results with similar surveys in 2002 and 2005.

A telephone survey of senior house officers in 40 UK ENT departments was conducted to assess departmental consent policies and knowledge of complications of common ENT operations.

A total of 77.5 per cent of responding senior house officers were responsible for consenting, reduced from 92.5 per cent in 2002 (p = 0.06). There had been a significant improvement in the use of patient information sheets, from 25 per cent of departments in 2002 to 65 per cent in 2008 (p = 0.0002). There had been no improvement in training or in the use of standard National Health Service consent forms, and the senior house officers' knowledge of specific complications remained poor. Of the senior house officers surveyed, 37.5 per cent were foundation trainees.

There has been some improvement in information delivery to patients during the consent process, in accordance with General Medical Council, Department of Health and Modernising Medical Careers guidelines. However, most senior house officers are still required to obtain patient consent without appropriate training.

To assess elective surgery consent practices amongst senior house officers from a selection of UK ENT departments, and to compare results with those obtained in a similar survey in 2002.

A telephone survey of senior house officers in 40 UK ENT departments was carried out to assess departmental consent policies and knowledge of complications of common ENT operations.

Over 80 per cent of the senior house officers surveyed remained responsible for obtaining consent for routine surgery. Since 2002, there had been a significant increase in the proportion of departments which: used the Department of Health model consent form; provided patient information leaflets; and had an established informed consent protocol. Senior house officers' knowledge of specific complications remained poor.

There has been a small change in the practice of obtaining informed consent, in accordance with General Medical Council guidelines. Many senior house officers continue to perform this duty, however, and the majority are poorly trained.