Good Clinical Practice

When is an Informed Consent Truly Informed?


Christian Marks, PhD, CIP


Social and Behavioral Research Program

University at Buffalo

Tuesday, April 24, 2018

5:00 – 7:00 p.m.

Clinical and Translational Research Center

875 Ellicott Street, Buffalo, NY 14203

Rm. 6003 A + B

This workshop will cover the 5 W’s of obtaining truly informed consent. We will begin by looking at what should be covered through an examination of the correspondence between the HRP-503 Protocol Template and the HRP-502 Consent Template. We will then look at considerations related to who should be involved in the consent process, when and where different parts of the consent process should take place, and how to conduct the consent process so that understanding and free choice are achieved. Underlying each of these will be information as to why these areas need to be considered.

Finally, a guide for developing an Informed Consent Process by systematically considering the factors involved in obtaining informed consent will be presented. A team exercise will then occur where each group will be asked to share its analysis of a unique scenario involving a difficulty in achieving the goal of obtaining truly informed consent.

ACCREDITATION: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences is accredited by the ACCME to provide continuing medical education for physicians.

CERTIFICATION: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences designates this live activity for a maximum of 2.0 AMA PRA Category 1 Credit(s)TM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CREDIT: This program is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001412.