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: