Issues with Consent Documents 2016 - Issues with Consent Documents-By Compliance Global Inc

Overview:
Common rule 45 CFR 46 and 21 CFR 50 rule, both require informed consent documents for research participants. Studies that are FDA regulation governed will predominately use a written consent document.
The consent document tends to be the source of much frustration for both research participants, research team members, and the IRB approval 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.
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.
Areas Covered in this Webinar:
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.
Learning Objectives:
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 led 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.