Speakers/Panelists

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SPEAKERS/PANELISTS


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Nichelle Cobb, PhD

Nichelle is the Senior Advisor for Strategic Initiatives for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and was previously a site visitor for AAHRPP and member of AAHRPP’s Council on Accreditation.

Prior to joining AAHRPP, she served was the Director of the Health Sciences Institutional Review Boards (IRBs) for 16 years. Nichelle has been involved in single IRB work for more than a decade and currently is a Senior Advisor and Ambassador for SMART IRB, a federally funded project that supports the implementation of single IRB. In addition, Nichelle is a member of the SMART IRB Harmonization Steering Committee and has co-led working groups to harmonize IRB and Human Research Protection Program (HRPP) practices, such as reportable events, ancillary reviews, and continuing review. Nichelle also served the co-chair for PRIM&R’s Workshop and Didactic Subcommittee and has taught PRIM&R courses for new IRB administrators.

Bruce Gordon, MD

Bruce Gordon, MD

Bruce is UNMC's Assistant Vice Chancellor for Regulatory Affairs and a Professor of Pediatrics in the section of Pediatric Hematology/Oncology and Stem Cell Transplantation at the UNMC. Dr. Gordon has been a member of the UNMC Institutional Review Board since 1992 and served as Chair since 1996, and Executive Chair since 2011. He organized and is first Chair of a Joint Pediatric IRB with the Children's Hospital and Medical Center in Omaha.

He has served on a variety of national committees and task forces (including the DHHS Secretary's Advisory Committee on Human Research Protections Subpart A subcommittee) and served as the first chairman of the National Cancer Institute Pediatric Central IRB. He has been faculty at PRIM&R regional and national meetings, served as the co-chair for the 2009 PRIM&R national conference, and is the author of numerous original papers, review articles and abstracts regarding human subjects protection and research ethics.

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Stephanie Henderson, CIP

Stephanie is the manager of the Human Research Protection Program with the Ochsner Health System. Ochsner Health is Louisiana’s largest non-profit, academic, healthcare system providing high-quality clinical and hospital patient care to Louisiana residents since 1942. The Ochsner HRPP includes all functions of the Institutional Review Board, research quality monitoring and research education. She serves as a member of the Ochsner Research Conflict of Interest Committee and is an active member of the Louisiana Clinical & Translational Science Center (LA CaTS) Ethics and Regulatory Knowledge Core.

Stephanie attended the College of Notre Dame of Maryland and obtained her Certified IRB Professional Certification in 2004. She has over 20 years of experience in human subject research protections. Prior to joining Ochsner Health, she served as an IRB Education Specialist for the Johns Hopkins School of Medicine. She started her career at the Johns Hopkins Bloomberg School of Public Health as an IRB Coordinator. She has particular interest in streamlining IRB processes and collaborating to find flexibility in the human subject protection regulations.

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Robert Hood, PhD

Dr. Robert Hood serves as Director of Accreditation and Global Outreach at AAHRPP, ensuring that the AAHRPP Accreditation Standards are consistent with evolving research ethics guidelines, laws and professional practice standards in the U.S. and internationally, and providing education and support for site visitors and clients seeking accreditation. Dr. Hood is a bioethicist with experience in academia, government, and not-for-profit organizations. He has served as an IRB chair, and directed the HRPP at the Florida Department of Health, the first public health agency to obtain accreditation.

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Elisa A. Hurley, PhD

Elisa is the executive director of Public Responsibility in Medicine and Research (PRIM&R), leading the organization in the execution of its mission to advance the highest ethical standards in the conduct of research through educational, professional development, and public policy programs that serve the human subjects protections and animal care and use communities.

In addition to directing the strategic, programmatic, and operational activities of the organization, Elisa writes, lectures, and teaches on a range of issues in research ethics. A moral philosopher by training, Elisa was previously an assistant professor of philosophy at Western University in London, Ontario. She received a BA from Brown University, a PhD from Georgetown University, and held a Greenwall Fellowship in Bioethics and Health Policy at the Johns Hopkins Berman Institute of Bioethics and Georgetown University's Kennedy Institute of Ethics. Elisa is a co-editor of the 3rd edition of IRB Management and Function (Jones & Bartlett, 2021) and a member of the Consortium to Advance Effective Research Ethics Oversight (AEREO), a collaboration of leaders in human research protections aiming to evaluate and improve the effectiveness of IRBs through empirical study.

Christopher Kratochvil, MD

Chris is the Associate Vice Chancellor for Clinical Research at the University of Nebraska Medicine (UNMC), Vice President for Research for Nebraska Medicine, Chief Medical Officer for UNeHealth, member of the Nebraska Biocontainment Unit Leadership Team, and a Professor of Psychiatry and Pediatrics at UNMC. 

As Associate Vice Chancellor for Clinical Research at UNMC and Vice President for Research for the clinical enterprise, he leads many of the campus clinical research activities. He is the Director of the Center for Clinical and Translational Research, Medical Director of the Clinical Research Center, Director of the Nebraska Biobank, coordinates clinical research activities for the Nebraska Biocontainment Unit, and serves on the BioNebraska Board of Directors.

Dr. Kratochvil is the Chief Medical Officer for UNeHealth, a not-for-profit corporation representing Nebraska Medicine, UNMC, and UNMC-Physicians.  UNeHealth was formed to serve as a point of contact for commercial clinical research partnerships and growth.

He received both his Bachelor of Arts and medical degrees from Creighton University, completed a residency in Psychiatry at the Creighton-Nebraska Joint Residency Program, and went to Duke University Medical Center, where he completed a residency in Child & Adolescent Psychiatry.

Dr. Kratochvil has authored or co-authored over 100 manuscripts, and co-edited Pediatric Psychopharmacology: Principles and Practice, 2nd Edition, Oxford Press, 2011. His research interests include clinical research and drug development, and he serves on the FDA Psychopharmacology Drug Panel.

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Lauren Sauer, MSc

Lauren is an Associate Professor in the College of Public Health, Department of Enviornmental, Agricultural, and Occupational Health, at the University of Nebraska Medical Center and Core Faculty of the UNMC Global Center for Health Security.  She is an Adjunct Associate Professor of Emergency Medicine in the Johns Hopkins School of Medicine, and the director of the Special Pathogens Research Network.

She previously served as Director of Operations for the Johns Hopkins Office of Critical Event Preparedness where she ran the inpatient COVID19 biobank and served on the COVID19 research steering committee for JHU.  Lauren’s research focuses on human subjects research in bio-emergencies and disasters.  Her work is focused on the ethical implementation of human subjects research and navigating the regulatory environment in disasters. Her research has focused on providing healthcare systems tools that facilitate implementation of policy requirements and clinical trials in emergencies.