Improving the Informed Consent Process Through the Use of a Question and Answer Tool

Publication Date


Type of Culminating Activity


Degree Title

Master of Health Science, General Research

Major Advisor

Sarah E. Toevs


Elizabeth L. Hannah


Ingrid A. Brudenell


Medical progress depends largely on experimentation involving human subjects. The informed consent document is a required part of such research and must be signed by all research volunteers. Recent subject deaths in the United States should signal researchers that loss of trust and litigation will dramatically increase due to failures to fully inform study subjects of research risks and benefits (Lemonick & Goldstein 2002; Getz 2002). Criticisms against traditional informed consent processes are numerous: consent forms may be complex and difficult to understand, subject comprehension of information is difficult to assess and there is a documented lack of standardization in obtaining consent. Methods to improve informed consent and uphold the reputation of good clinical practice must be explored. The purpose of this study was to develop and evaluate an informed consent questionnaire based on an IRB-approved consent form in an effort to provide evidence for this method of reinforcing and assessing consent information comprehension.

A prospective process and impact evaluation study using an informed consent questionnaire based on a protocol established for a study of antibiotic resistance was conducted in this study. Upon completion of the through the informed consent process for an antibiotic resistance study, subjects were asked to complete the informed consent questionnaire. Results were analyzed using both quantitative and qualitative techniques to answer process and impact questions.

One hundred and thirty-seven informed consent questionnaires were completed and returned for analysis. The mean age of respondents was 35.77 ± SD10.97 years (range 19-67). Slightly more females (n=80) than males (n=57) completed the informed consent questionnaires. Generally the subject population was white (n=118) and well educated with 71% of the subjects reporting at least some college or more as their highest level of education completed. Twenty-five percent (n=34) of subjects reported a household income of $20,000-$34,000. Regarding comprehension, 82% of subjects (n=113) answered all 4 questions pertaining to the informed consent correctly, indicating a high level of understanding of the antibiotic resistance consent. The majority of subjects (n=130) rated the antibiotic resistance consent form as either very easy or easy to understand and found the follow-up knowledge portion of the consent process to be worthwhile. An interview was conducted with the research coordinator who administered the questionnaire and reported the informed consent questionnaire was self-explanatory, took less than one minute to administer and would be used again, if available.

Complacency regarding informed consent and surrounding documentation is unacceptable. Researchers must continue to build trust and confidence in their subjects via the use of meaningful informed consent discussions. Findings from this study suggest that implementing a question and answer tool similar to the one evaluated in this project would enhance the informed consent process. The informed consent questionnaire has numerous positive attributes including ease of use; ease of implementation and positive reception from both subjects and researchers involved in administering the questionnaire.

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