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Health Literacy and Informed Consent. IRB Education Session Tuesday, September 24 th , 2013 Janice Piazza. Skills vs Demands. Over 1000 studies published indicate that the reading level of health materials generally exceeds the reading skills of adults who graduate from high school
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Health Literacy and Informed Consent IRB Education Session Tuesday, September 24th, 2013 Janice Piazza
Skills vs Demands • Over 1000 studies published indicate that the reading level of health materials generally exceeds the reading skills of adults who graduate from high school • The majority of adults struggles with health information and tasks • Louisiana ranks 49th in literacy and 49th in overall health, 48th in preventable hospitalizations
What is Literacy ? • A moving target and expands with increasing demands of Society • “ a level needed to function on the job and in society” – National Literacy Act , 1991 • 28% of Louisiana Adults are Level 1 • 39% of New Orleans Adults are Level 1
How would you take this medicine? • In a study of over 500 patients in a medicine clinic with multiple medications • 46% did not understand instructions on more than 1 of their prescriptions • 38% with adequate literacy misinterpreted at least one label • Less than 10% attended to warning labels
So What About this Informed Consent Issue ? • Is it really Informed ? • Let’s take a look at some of our consent forms ! • What is our obligation to protect the welfare of human subjects • Are we putting our patients / research subjects at unnecessary / unintended risk ? • What can we do ?