Issues with Consent Documents

Duration: 60 Minutes
Instructor: Sarah Fowler-Dixon
Webinar Id: 801117


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This webinar will provide information to help improve written consent documents and consent processes, It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision, Informed consent is a process for getting permission before conducting a healthcare intervention on a person.


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.

Why should you Attend: 45 CFR 46 and 21 CFR 50 both require informed consent documents for research participants. Studies that are FDA governed will predominately use a written 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

Speaker Profile
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.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

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