Rethinking the Informed Consent Form

Description

There is an inverse relationship between the length of the informed consent form and research subject understanding of a research study, yet the length of consent forms has been increasing over time. This session will present a new way of offering research subjects more information using fewer words.

Learning Objectives:

1. Attendees will learn how to create a one page, combined Informed Consent Form and HIPAA Authorization for minimal risk and registry studies.
2. Attendees will be learn the benefits of a one page Risks Table to clearly explain risks for complex studies that compare a standard with an experimental treatment.
3. Attendees will learn how the use of a Risks Table for a complex surgical trial changed the informed consent process and improved recruitment.

Speaker(s):

• Lyn Goldsmith, MA, RN, BSN, CCRC, Director of Clinical Trials, Department of Surgery, Columbia University Medical Center

Speaker(s):

• Wendy Taddei-Peters, PhD, National Heart, Lung, and Blood Institute