D12 - Ain't No Mountain High Enough”—Ensuring a Successful Informed Consent Process Throughout the Life of the Study

Thursday, November 18, 2021

1:30 PM – 2:30 PM ET

Location: On-Demand

This session will discuss the critical need to carry out a robust consent process from cradle to grave. For study participants, reading consent forms can seem daunting and overwhelming like scaling a mountain. But, for a successful research encounter to effectively reach its summit, one that truly has respect for persons at the forefront, the process needs to be meaningful, pulling out all the stops. Audience, amount of information, circumstances, setting,and a wide range of other factors can contribute (or not) to a successful consent process.

Learning Objectives:

Define the principle of respect as related to the informed consent and the value it affords the participant, as well as the success of a study
Discuss the elements of informed consent and which ones matter to who (subject, institution, and sponsor)
Explore best practices and practical tips for standard consents, waivers and nuances of different regulations

Presenter(s)

Cynthia Gates, JD, ADN, CIP

University of Miami
University of Miami
North Bay Village, FL
John D. Horigan, MA, CIP

National Institutes of Health
Rockville, MD
Yvonne Lau, MBBS, MBHL, PhD

HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Rockville, MD