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Improving the Informed Consent Process

Clinical Operations

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:

Room Number:



Improving the Informed Consent Process

Kathleen Findlen
Head of Clinical Operations and Project Management
Piramal Life Sciences, United States

In this symposium, we will describe and discuss needed guidelines, address concrete ways to obtain effective consent in acute settings while respecting the potential participant, study design and enrollment numbers, and examine data-informed solutions to address the most effective key strategies to improving comprehension of the informed consent.

Learning Objective(s):
Provide practical, clear, and concise guidelines that clinical trial personnel can use to decide when they could include subjects who cannot consent in a clinical trial; Describe three solutions to obtaining appropriate informed consent from potential participants who are in an acute health care setting; Discuss methods and strategies to improve comprehension of informed consent in clinical trials.

Presentation(s) & Speaker(s):
Research Consent in Acute Settings: What Works?
Mitchell E. Parrish, JD, RAC
Regulatory Attorney
Quorum Review IRB, United States

Can Subjects Who Cannot Sign Informed Consent Be Enrolled in My Trial?
Ricardo Nunez, DrMed
Director, Medical. Central Nervous System.
Quintiles Inc., United States

Strategies to Improve the Informed Consent Process to Enhance Comprehension and Recruitment of Ethnically Diverse Populations
Brenda Jamerson, PharmD
Center Fellow, Biobehavioral and Social Aspects of Health Disparities
Duke University, United States