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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