Issues with Consent Documents

Overview: The consent document tends to be the source of much frustration for both research participants, research team members, and the IRB reviewers who must review and approve the document and process before it is implemented. Although the regulations default to a written consent document, consent is more than just a document, it is a process.

Common complaints are that the consent form is not written at a 6th to 8th grade level and that IRB reviewers word-smith the consent form. Other common issues surround the risks section and mandatory language that increase the reading level of a consent document. In this webinar, we will discuss some common literacy trends, issues with consent documents and tips to enhance the consent process.

Why should you attend: According to current statistics, more than 90 million people in the United States have a hard time understanding and using health information. This is as many people as there are in France, Belgium and the Netherlands. To respond to this growing needed, President Obama signed the Plain Writing Act of 2010 and two other executive orders to cover the use of plain language. Use of Plain Language gets researchers closer to the historically used 6th to 8th grade level as the target for written consent documents. There are other tips as well that can improve the readability and acceptably of a consent document. This webinar will provide information to help improve written consent documents and consent processes.

Areas Covered in the Session:

• Information on Health Literacy
• Plain Writing
• Consent as a process
• Increasing readability
• 6 - 8th grade examples
• Exculpatory language
• Tips for using consent templates
• What IRB reviewers like and dislike

Who Will Benefit:

• Principal Investigators / Sub-investigators
• Clinical Research Scientists (PKs, Biostatisticians,)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff
• Clinical Research Data managers
• Human Research Protection professionals 

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. 

MentorHealth

Roger Steven

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