Central Virginia

Central Virginia SOCRA Chapter Meeting
 
Title:            Pay to Play: The Ethics of Volunteers Paying to Participate in Clinical Trials
Date:              Wednesday, May 19, 2021
Time:            10:30 AM - 11:30 AM
Location:       Zoom, Registration required
                             
Speaker: Annette Oeser, BS, MLAS, CCRP
Clinical/Translational Coordinator III, Division of Clinical Pharmacology
Vanderbilt University, Nashville, TN

 

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

ObjectivesParticipants will be able to:
  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

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. 

Please share this announcement with your colleagues.
SOCRA members and non-members welcomed!

Central Virginia SOCRA Chapter Chair
Shirley Helm, MS, CCRP                                                              
804-628-2942                                                                                      
Shirley.helm@vcuhealth.org                                                         

Chapter Chairperson:

Shirley L.T. Helm, MS, CCRP
Phone: 804-628-2942
Email

Patricia A. Feldt, CCRP
Phone: 804-628-1902
Email