OHRP Exploratory Workshop

Moderator: Sara F. Goldkind, M.D., M.A.
Goldkind Consulting, L.L.C.

Dr. Goldkind is a bioethics consultant with a background in both research and clinical ethics issues. In 2014, she left the Food and Drug Administration (FDA), where she served as the Senior Bioethicist in the Office of the Commissioner for over ten years. Dr. Goldkind’s clinical research consultations include: innovative clinical trial designs and product development (e.g., novel therapies, vulnerable populations), regulatory compliance, and policy development, principally related to Good Clinical Practice and human “subjects” protections. Prior to working at the FDA, Dr. Goldkind focused on clinical medical ethics. She is a board- certified internist, having completed her internship and residency at Boston City Hospital and her M.D. at the University of Maryland School of Medicine. She obtained an M. A. in religious studies with a concentration in comparative religious ethics and completed a fellowship in clinical ethics at the University of South Florida. She has served as adjunct faculty at the George Washington University School of Medicine, and at the University of South Florida, School of Medicine, Department of Internal Medicine. She has also been a member of institutional review boards and data monitoring committees.

Neil Finer, M.D.
Sharp Mary Birch Hospital for Women and Newborns

As an Emeritus Professor of the Pediatrics Department at the University of California San Diego (UCSD), Dr. Finer has spent his career caring for premature and/or unstable newborn infants, attempting to define the most significant clinical problems that lack high quality evidence for best practices. He has helped develop clinical trials to discover such evidence, targeting neonatal resuscitation and evaluating interventions that may improve delivery room environments and optimize neonatal team performance. Through these trials, Dr. Finer has concluded that transitional care and neonatal resuscitation should begin during delivery, and that clinicians must determine best approaches through randomized trials. Since retiring from active clinical work at UCSD, Dr. Finer joined the recently-created Neonatal Research Institute at Sharp Mary Birch Hospital for Women & Newborns—the largest delivery service in California—as a senior research associate, where he continues to help design trials that will provide essential evidence for better practices.

Mark S. Schreiner, M.D.
The Children’s Hospital of Philadelphia

Dr. Mark Schreiner has been a member of the Department of Anesthesiology and Critical Care Medicine at The Children’s Hospital of Philadelphia since 1984. He received his medical degree from St. Louis University Medical School before completing residencies, as well as a fellowship in pediatric anesthesiology and critical care medicine, at the Children’s Hospital of Philadelphia and University of Pennsylvania Hospital, respectively. From 1998-2005, Dr. Schreiner served as Executive Medical Director of CCRi, an academic CRO conducting multicenter clinical trials. He first served as a member of the Institutional Review Board (IRB) as a pediatric resident and has served on the committee for over 30 years, notably as committee chair for more than a decade and as the current Executive Vice Chair. Dr. Schreiner has published scholarly articles related to IRB function, research bioethics, and comparative effectiveness trials.