Education Level, Primary Language, and Comprehension of the Informed Consent Process

  title={Education Level, Primary Language, and Comprehension of the Informed Consent Process},
  author={Peter E Breese and William J. Burman and Stefan Goldberg and Stephen Weis},
  journal={Journal of Empirical Research on Human Research Ethics},
  pages={69 - 79}
  • P. BreeseW. Burman S. Weis
  • Published 1 December 2007
  • Medicine, Education
  • Journal of Empirical Research on Human Research Ethics
To obtain information on how persons from diverse backgrounds experience the informed consent process, we surveyed adults with a wide variety of educational levels and different primary languages (English, Spanish, or Vietnamese) who had recently enrolled in a study requiring written informed consent. Of the 100 participants, 62 were non-White, 43 had less than a high school education, and 60 had a primary language other than English. The median score for comprehension was 62% (IQR 50–76%); the… 

Tables from this paper

Level of education and preferred language of informed consent for clinical research in a multi-lingual community

Rising education levels of participants were associated with preference for English language usage during initial consent for clinical research studies, and peaked at beyond senior six.

Readability of Informed Consent Documents at University Counseling Centers

The findings support the authors’ exploratory hypotheses that informed consent documents in university counseling centers are rated as challenging to read for college students.

Improving Research Literacy in Diverse Minority Populations with a Novel Communication Tool

The RLS tool may help advance health equity by addressing communication barriers that may impede minority participation in clinical research by addressed communication barriers between researchers and potential participants.

Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

In order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages.

Moving Forward on Consent Practices in Australia

An audit of informed consent practices for medical research in the Australian state of Tasmania is conducted to assess the need for, and current uptake of, supplementary consent strategies.

Patients’ knowledge about their involvement in clinical trials. A non-randomized controlled trial

A prospective, multicenter, non-randomized controlled trial comparative survey conducted on patients enrolled in a clinical trial to evaluate and improve their understanding after an educational intervention was applied to the research staff.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposure to the standard consent.

Are there adverse consequences of quizzing during informed consent for HIV research?

Quizzing during the informed consent process can be problematic for a minority of participants, and problems may be associated with the setting in which research takes place and educational level.

Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial

Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.

Informed consent forms in ESL research: Form difficulty and comprehension

INFORMED CONSENT FORMS IN ESL RESEARCH: FORM DIFFICULTY AND COMPREHENSION By Scott Sterling Background: The concept of informed consent has become a cornerstone for modern research and is generally



Use of a modified informed consent process among vulnerable patients

Lower literacy and minority status are important determinants of understanding consent information, regardless of literacy or language barriers using a modified consent process.

Informed consent for clinical trials: a comparative study of standard versus simplified forms.

Findings in this study raise serious questions regarding the adequacy of the design of written informed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

Are subjects satisfied with the informed consent process? A survey of research participants.

Patients' perspectives of their ability to understand the information presented during a clinical trial are investigated, finding that subjects may prefer to believe that investigators know which treatment they are receiving, and have made a good treatment decision specific to their case, despite having being told about concealed allocation and placebo use.

Informed consent: assessment of comprehension.

These findings demonstrate that when adequate informed consent procedures are established, schizophrenic research subjects are able to understand and retain critical components of informed consent information.

The test of functional health literacy in adults

The Test of Functional Health Literacy in Adults (TOFHLA) is a valid, reliable indicator of patient ability to read health-related materials and data suggest that a high proportion of patients cannot perform basic reading tasks.

Cognitive Interviewing as a Tool for Improving the Informed Consent Process

  • G. Willis
  • Psychology
    Journal of empirical research on human research ethics : JERHRE
  • 2006
It is proposed that researchers adapt cognitive interviewing to evaluate the understandability of consent materials and the way in which subjects use this information to make decisions regarding participation.

Quality of informed consent: a new measure of understanding among research subjects.

The Quality of Informed Consent questionnaire, the QuIC, is a brief, reliable, and valid questionnaire that holds promise as a standardized way to assess the outcome of the informed consent process in cancer clinical trials.

Inadequate functional health literacy among patients at two public hospitals.

Many patients at the authors' institutions cannot perform the basic reading tasks required to function in the health care environment, and inadequate health literacy may be an important barrier to patients' understanding of their diagnoses and treatments, and to receiving high-quality care.

Shame and health literacy: the unspoken connection.