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
CE: 1.0 CE credit hour for SOCRA CCRP Renewal. Only SOCRA members receive Certificates of Attendance. The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
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SOCRA members and non-members welcomed!
Central Virginia SOCRA Chapter Chair
Shirley Helm, MS, CCRP