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Upon completion of this activity, learners will be able to:
Understand the impact of health literacy on informed consent.
Review a typical research consent document.
References
Common Rule, Fed Regiser, Vol 82, No 12, p. (Jan. 19, 2017).
DHEW Publication #77-0004. Washington, DC, US Government Printing Office, 1977.
E. Larson, et al, Reading Level & Length of Written Research Consent Forms (Clin Transl Sci 2015)
Health Literacy Media
J Pediatr Pharmacol Ther, 2012. 17(3): p. 228-35.
The Joint Comm’n, What did the Doctor Say? Improving Health Literacy to Protect Patient Safety, p. 34 (2007).
Kutner et al 2006
Pediatrics, 2011. 127(5): p. 917-24.
NPRM for Human Subjects Research (Sept 2015) 80 FR 173 at 53969
“The Top 10 Reasons Physicians are Sued for Malpractice” ProAssurance Corp
Weiss BD. Health Literacy: A Manual for Clinicians. American Medical Association / American Medical Association Foundation, 2003. p. 7.
Winslow & Hagan, Making Research Consent Forms More Readable (https://www.ttuhsc.edu/research/hrpo/irb/files/informed_consent_article.pdf)
Zipf study, 1949
http://www.ncbi.nlm.nih.gov/pubmed/7474271
Speaker(s): Christopher Trudeau, JD
Speaker(s) bio
Professor Christopher Trudeau joined Detroit Mercy Law in 2022 as a Visiting Associate Professor of Law and was promoted to Associate Professor of Law in 2023. He previously served as an Associate Professor of Law at the University of Arkansas at Little Rock, William H. Bowen School of Law. In addition, Professor Trudeau taught at the University of Arkansas for Medical Sciences as an Associate Professor of Medical Humanities & Bioethics. Before his tenure at the University of Arkansas, he spent a decade teaching at Western Michigan University Thomas M. Cooley Law School, where he developed a pro bono legal program to support patrons of the Christo Rey Community Center in Lansing, MI.
An internationally recognized expert in clear legal communication, informed consent, and health literacy, Professor Trudeau is the first lawyer appointed to the National Academies of Science, Engineering, and Medicine’s Roundtable on Health Literacy and the FDA’s Risk Communication Advisory Committee. He is a sought-after speaker on topics such as effective communication in clinical trials, the impact of GDPR and the Revised Common Rule on consent practices, and the integration of health literacy best practices throughout clinical trials.
