Central Virginia

The FDA allows for charging for investigational products used in clinical research under certain circumstances. The federal regulations also state that participants should be informed of any additional costs that may result from participation in research. Recent “research studies” are using this guidance as a loophole to charge participants for studies that may not create generalizable knowledge. Ms. Oeser will review the ethical issues involved in recent pay-to-participate “research studies” and how these may violate the pillars of respect of persons, beneficence, and justice.

Annette Oeser has worked in clinical research for the past 30 years, primarily in PI initiated research. She currently works as a Clinical/Translational Research Coordinator III in the Division of Clinical Pharmacology at Vanderbilt University Medical Center. She was certified CCRP in 2004 and has been a member of the Greater Nashville Region SoCRA chapter’s Education Committee since 2007, and is currently the Co-Chair. She obtained her Masters of Liberal Arts and Sciences (MLAS) degree from Vanderbilt University in 2011, and completed level 1 of the Vanderbilt Program in Research Administration Development (VPRAD) in 2012. She is currently enrolled in the Bioethics Certificate Program at Loyola University Chicago

1. Define Pay-to-Play Clinical Research
2. Understand the regulations and guidance related to Pay-to-Play Clinical Research
3. Discuss the pros and cons of Pay-to-Play research