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Informed Consent Forms

Transform your informed consent form to a plain language visual document.

Empower potential participants with clear and understandable clinical trial information so they know what to expect and can make an informed, confident decision.

The Problem

Informed consent forms are often not easy for participants to understand.

A survey by the National Assessment of Adult Literacy reported that the average reading level of US adults is eighth grade or below. However, most research-related consent forms are written at a level much higher than that. A recent review of written consent forms revealed that most are currently written at a 10th grade reading level or higher across all medical specialties.1

8th Grade Reading Level

Recommended for research-related documents

CISCRP's Solution

We create a general plain language ICF template (including graphic design) that study teams can populate and customize for every clinical trial.

Our approach is to simplify the written content by eliminating jargon and using familiar language that is easy to understand. In addition, we use a pilot project to ensure the templates are usable by study teams that are tasked with leveraging the ICF template for their study specific consent process. 

Allow everyone to make an informed decision about participation by providing easy-to-read and understandable information to patients. Instead of providing printed or electronic forms, the industry should move to including videos and infographics to make the process engaging. 

How this helps patients, study staff and the public:

  • Empower potential trial participants with clear and understandable information so they know what to expect and can make an informed, confident decision.

  • Enhance the consent and decision-making processes and support improved retention and adherence.

Start Your Project

Drugviu

Click on the resources listed below to download the full versions of Drugviu’s materials. 

Pandemic Response Network Flyer: English

Red de Respuesta a una Pandemia: Español

Peer Plus

Click on the resources listed below to download the full versions of these materials. 

Peer Plus: Mission and Capabilities

Latino Union of Chicago

Click on the resources listed below to download the full Latino Union of Chicago Annual Report. 

 

Advocate Aurora Health

Click on the resources listed below to download the full versions of Advocate’s materials. 

  • Dominantly Inherited Alzheimer’s Network Trial Unit 

Dominantly Inherited Alzheimer’s Disease Brochure
Expanded Registry Flyer (English)

Enfermedad de Alzheimer de herencia dominante
Expanded Registry Flyer (Spanish)

  • Clarity AD Clinical Study Information

Forgetting the Little Things
Concerned About Memory Loss?

   

Allergy & Asthma Network

Click on the resources listed below to download the full versions of the Allergy & Asthma Network’s materials. 
 

Institute for Population and Precision Health (IPPH)

Click on the resources listed below to download the full versions of IPPH’s materials. 
 

Einstein Healthcare Network

Click on the resources listed below to learn more about Einsteing Healthcare Network’s resources. 

TREND Community

Click on the resources listed below to download the full versions of the TREND Community’s materials. 

 

Community Voice Report July 2020: COVID-19 Positive

 

Community Voice Report August 2020: Pericarditis

Fox Chase Cancer Center - Temple Health

Click on the resources listed below to download the full versions of the Fox Chase Cancer Center’s materials. 
Be the Breakthrough: Understanding Clinical Trials

Allergy & Asthma Network

Click on the resources listed below to download the full versions of the Allergy & Asthma Network’s materials. 
 

Lung Cancer Initiative of North Carolina

Click on the resources listed below to view the full versions of LCI’s materials. 

Lung Cancer Risk Assessment Handout

PRA Health Sciences

Click on the resources listed below to view the full versions of PRA’s materials. 

Duke Health

Click on the resources listed below to view the full versions of Duke’s materials. 

Visit Discover Duke Research on Facebook

Download the handout below in English or Spanish

North Carolina Clinical Research

Visit North Carolina Clinical Research’s website 

Missy Hansen

Missy Hansen MSN, APRN, CPNP, CPHON, joined ICON in 2019 as a pediatric strategy liaison. She has 25+ years of experience as a pediatric nurse practitioner, including 17+ years in pediatric hematology/oncology at Children’s Minnesota, the largest hematology/oncology service line in the region, providing care for infants through young adults diagnosed with hematologic and/or oncology conditions. Ms. Hansen gained expertise working in inpatient, outpatient, and urgent care type settings. Ms. Hansen has in-depth experience working with the Children’s Oncology Group—the largest consortium with the most open pediatric studies around the world. She also has experience working with other consortia that conduct trials for pediatric to young adult patients.