Introducing a New Era of Informed Consent

Visually Enhanced ConsentTo Ensure Rights

and Safety of Study Subjects with Improved Readability

®

Current Informed Consent Forms (ICFs) are usually:

At too high a reading level

Not easily understood, confusing

Too technical, too legalistic

Look like legal documents, discouraging recruitment

Often signed by patients who ask investigators if it’s okay

Used in litigation against study sponsors

May negatively impact retention and study results

The Problems of Current ICFsare Well Known

Most US adults cannot understandinformed consents forms (ICFs)

“The National Adult Literacy Survey of 1992 found that nearly half of the adult population is functionally illiterate at the 8th grade reading level.”

≥9th Grade

≤8th Grade

US Adult Literacy Levels

“Yet study after study reveals that fewer than 10% of informed consent documents are at the 10th grade level or below.”

Findings of the Association of American Medical Colleges (AAMC) Clinical Research Task Force II (2006)

10% 90%

Informed Consent Reading Levels

50% 50%

≥11th Grade ≤10th

Grade

Reading Level Reading Level

4

Developed by communication specialists at Krell Clinical Communications

Professional writers, communicators and designers with experience in healthcare and educational communication

Written in “Plain Language” i.e., simplified English:

• Eliminate ambiguity, simplify sentence structure, rewrite technical languageand lower the vocabulary

Proprietary tools accelerate writing, rewriting, and ensure reading level is down between 6th to 8th grade

Professional graphic designers improve page layout with approvable photographs and visuals, readable typography, and color

VECTER®

Informed Consent Documentsare patient friendly and increase comprehension

Comparison of Readability by Grade Level:Original ICF vs. VECTER

®

Grade Level of Readability(Flesch-Kincaid score)

6.8VECTER

11.7Text ICFs

Lower grade level,better readability

VECTERs are currently being used by 4 of the

world’s top 10 pharma

companies

5 grade levels lower

VECTERs are written at lower grade levels for better readability

VECTERinformed consent

documentsare written and

designed for increased communication and

comprehension

This approach to informed consent documents including the designs, text, methods and processes are the intellectual property of Krell Clinical Communications, LLC. No part may be copied, altered, distributed or used, whether whole or in part, or modified and used, without written agreement from Krell Clinical Communications, LLC.

VECTERSample Page,

Redacted

VECTERSample Page,

Redacted

VECTER® The New Face of Informed Consent

Investigators prefer VECTER®

over text ICFs

80% of Investigators preferred to use a VECTERfor future clinical studies compared to only 8% for Text ICFs.

Results of a site survey during an ongoing, top-5 pharma clinical study (2009)

80% 80% Prefer VECTER

8%

VECTER Text ICF Other

“The VECTER captivates the reader. The images and detail create more interest and increase attention span.

Whereas, the TEXT-ONLY ICF is dull. The participants do not thoroughly read it because it is difficult to get through. This results in a lack of understanding by the patient”

Study Coordinator

Text ICFs

VECTERs Convert Readers into Study Participants

VECTERs have been translated from Englishand have been used in 30 countries

VECTER®

Informed Consent is being used globally

“VECTER is a sea

change. We were thrilled to use it. We have waited

so long for an

improvement to ICFs. VECTER

exceeded all of our

expectations.”

Copernicus

What do central and local IRBsthink about VECTER

®

?

VECTERs Convert Readers into Study ParticipantsWhy you should consider VECTER®

Informed Consent for your clinical studies:

1. Makes it easier for study participants to read

2. Participants will comprehend more than with a traditional text-only ICFs

3. Reduces the likelihood of participant misinterpretation which protects patients and demonstrates sponsor’s concern for patient safety

4. Increased understanding helps reduce study dropouts

5. Increased understanding equals greater transparency and increased trust between investigator, study team, and the potential participant

6. Streamlines internal and IRB review by reducing the need for rewriting

7. Accelerates translations and reduces serious mistranslation problems

8. Contributes to improved enrollment and retention

9. Provides a solid legal defense against possible claims that the study participant could not comprehend the informed consent document

10. Demonstrates sponsor’s willingness to put patients first by replacing difficult text-only ICFs with patient-friendly VECTERs

1. Makes it easier for study participants to read

2. Participants will comprehend more than with a traditional text-only ICFs

3. Reduces the likelihood of participant misinterpretation which protects patients and demonstrates sponsor’s concern for patient safety

4. Increased understanding helps reduce study dropouts

5. Increased understanding equals greater transparency and increased trust between investigator, study team, and the potential participant

6. Streamlines internal and IRB review by reducing the need for rewriting

7. Accelerates translations and reduces serious mistranslation problems

8. Contributes to improved enrollment and retention

9. Provides a solid legal defense against possible claims that the study participant could not comprehend the informed consent document

10. Demonstrates sponsor’s willingness to put patients first by replacing difficult text-only ICFs with patient-friendly VECTERs

Contact: Robert Krell (908) 806-7477Visit our website: www.krellclinical.com

Participate in the forum: www.InformedConsentForum.com

Visually Enhanced ConsentTo Ensure Rights

and Safety of Study Subjects with Improved Readability

®

Use VECTER® The New Face of Informed Consent

To Help Your Study ParticipantsBetter Understand Your Studies