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Ethics Conference on Pediatric Clinical Trials

Ethics Conference on Pediatric Clinical Trials

Reg-Peds-Clinical-Trials-GroupOn June 11, 2013 over 100 research professionals gathered in Kerrigan Auditorium at the Medical College of Wisconsin to attend an ethics conference on pediatric clinical trials. Attendees came from the Medical College of Wisconsin, University of Wisconsin-Milwaukee, Marquette University, Children’s Hospital of Wisconsin, the BloodCenter, and organizations such as Aurora Health Care, Midwest Orthopedic Specialty Hospital, Dominican High School, and Wheaton Franciscan Healthcare.

This conference was presented by the Regulatory Knowledge and Research Ethics Program of the Clinical and Translational Science Institute along with the Southern Wisconsin Chapter of the Association of Clinical Research Professionals (ACRP).

The speaker was renowned pediatric ethicist Robert M. Nelson, M.D., Ph.D., Deputy Director and Senior Pediatric Ethicist, Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration. Before joining the FDA, Dr. Nelson was a Professor of Anesthiology, Critical Care, and Pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine. Before that, he had similar positions at the Medical College of Wisconsin and Children’s Hospital of Wisconsin where he chaired the Pediatric IRB.

Dr. Nelson first presentation “Assessing the Prospect of Direct Benefit in Pediatric Studies and Component Analysis” examined the process for reviewing research interventions that offer the prospect of direct benefit to a pediatric population; discussed application of component analysis in the IRB review of pediatric studies; and outlined the expectations for documenting the prospect of direct benefit and component analysis in review of pediatric studies. His second presentation “Federal Panel Review of Pediatric Studies (21 CFT 50.54) Applying or Suspending Ethical Principles?” went over the origins of federal panel review in the work of The National Commission (1978); examined past and possibly future protocols that have been or will be reviewed by such a federal panel; and discussed the role of parental permission and child assent.

After Dr. Nelson’s presentations, he participated in a panel discussion on the Ethics of Pain Studies with Amy L. Drendel, DO, Assistant Professor of Pediatrics; Amanda Brandow, DO, Assistant Professor of Pediatrics; David Brousseau, MD, Professor of Pediatrics. The discussion was moderated by Bioethicist Ryan Spellecy, PhD, Associate Professor, Institute for Health and Society.

NIH Funding Acknowledgment: Important Reminder – Please acknowledge the NIH when publishing papers, patents, projects, and presentations resulting from the use of CTSI resources by including the NIH Funding Acknowledgement.


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