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2020 Agenda

Friday, September 25, 2020 1:40 PM ET

Monitoring the Informed Consent Process – Challenges and Proposed Solutions

Monitoring the informed consent process presents unique challenges; the variability of human interaction directly impacts the success of the process, complicating the practice of obtaining fully-compliant informed consent. Dr. Statler will draw upon her 10 years of monitoring experience, presenting real-world non-compliant informed consent scenarios. The challenges associated with each example will be highlighted and solutions will be offered. Specific recommendations regarding how monitors can help their study teams prevent unanticipated problems within the context of informed consent will be emphasized. 221

Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center

Track: Monitoring

Friday, September 25, 2020 2:30 PM ET

Recognizing Mr. Hyde: Misconduct in Research

Research misconduct not only endangers subjects; it raises legal and compliance risks that range from human subject protection to false claims liability. This session will discuss characteristics of research misconduct, the establishment of a culture that supports disclosure of possible misconduct, and approaches to investigation through the discussion of case studies. 223

Presenter: Melissa Markey, JD, CISSP, Attorney / Shareholder, Hall Render

Track: Monitoring