Regulatory Knowledge and Ethics (RKE)

This unit (Biomedical Regulatory and Ethical Support) focuses on the ways in which the Delaware Valley Institute for Clinical and Translational Science (DVICTS) will develop systems to ensure the highest quality research is conducted, fully compliant with federal, state, and institutional regulations, and that the highest ethical standards are practiced by all of the partner institutions and investigators. This will be carried out through the development and operation of a Delaware Valley Resources for Regulatory Knowledge and Ethics (DVR-RKE), which will also ensure the highest quality, interinstitutional business practices, with innovation and cooperation among all DVICTS partners.

Overview and Objectives: The objectives of DVR-RKE are as follows:

  • Objective 1: Enhance and improve the interinstitutional educational resources and opportunities for researchers, students, staff, and the public using the considerable and varied expertise available in regulatory affairs and clinical/translational ethics across the DVICTS partner institutions.


  • Objective 2: Innovate, enhance, and improve the administrative processes for researchers, students, staff, and the public in all phases of translational research from the initiation of project design to completion, including regulatory, ethical, and business activities and decisions.


  • Objective 3: Provide a forum for public and investigator advocacy for issues arising in regulatory and ethical arenas in translational research.


The collaborative formation of DVICTS, by integrating and building on the clinical and translational science and educational capabilities of the University of Delaware (UD), Thomas Jefferson University (TJU) and its hospital network, the Christiana Care Health System (CCHS), and Nemours (most particularly the Alfred I. duPont Hospital for Children, [Nemours/AIDHC]), will allow these institutions to share regulatory knowledge and resources, to promote best practices, and to introduce new technologies and ideas into their institutions and throughout the Delaware Valley. The development of a coordinated and consistent system of regulatory knowledge and support, as well as research ethics, will be critical to the effective functioning of DVICTS, particularly, as noted in the introduction, because it is built on 4 separate partner institutions.

Personnel: Many DVICTS faculty and administrators have expertise in coordinating regulatory and ethical systems and teaching about these issues, and therefore bring great strength to DVR-RKE. The key faculty for the Regulatory and Ethics Support unit are listed below.

  • Brian Little, MD, PhD, Section Director, Vice President, Office of Academic Affairs and Research, CCHS: He has held leadership positions in IRBs, biomedical research and regulatory management, and medical education at 5 major teaching hospitals and medical schools during the past 30+ years. He has chaired and supervised IRBs, managed institutional research portfolios, and participated in ethics committees and HIPAA taskforces.


  • J. Bruce Smith, MD, CIP, Section Co-Director, Associate Vice President, Research, Director, Office of Human Research, and Director, Division of Human Subjects Protection, at TJU: He is certified by CCIP, was Chair or a voting member of a TJU IRB for 9 years and has been a voting member and Director for the 4 current TJU IRBs since 2005. He trains clinical investigators, research coordinators, and IRB members about federal regulations, IRB policies, HIPAA, and ethics of human subjects research. He participates in HIPAA and HIPAA security task forces and is a member of the ARENA.


  • Matthew Carabasi, MD, Department of Medical Oncology, Associate Director for Clinical Investigations at TJU's Kimmel Cancer Center (KCC): Earlier, he was IRB Vice-Chair at University of Southern California. That board oversaw research for Los Angeles County Hospital and the Norris Cancer Center, an NCI-designated Comprehensive Cancer Center. He also chaired the Norris Hospital ethics committee. He now supervises clinical research conduct for the KCC and Jefferson's KCC network, covering hospitals in 3 states and >12,000 new cancer patients a year.


  • Paul E. Garfinkel, MSH, CIP, Director, Office of Human Subjects Protection at Nemours/AIDHC: He has been a member of or co-chaired multiple IRBs. His >30 years in health administration includes being Director of Corporate Compliance, HIPAA Privacy Officer, and Director, Human Research Protection Program. He sits on the Nemours/AIDHC Ethics Committee, co-chairs the Nemours/AIDHC Ethics Education subcommittee, and is a Certified IRB Professional.


  • Elizabeth Peloso, MSE, MBA, Director, Research Compliance at UD: A voting IRB member, she is the IRB Administrator, running the day-to-day operations of UD's IRB. She serves on the University Biosafety Committee and the Institutional Animal Care and Use Committee (IACUC), and is responsible for developing and providing training in areas related to the responsible conduct of research. She has many years of research experience in both animal and human subjects programs.


  • Mark Greene, PhD, Assistant Professor, Department of Philosophy at UD: A published bioethicist, he was a Greenwall Fellow in Bioethics and Policy at Johns Hopkins and was Visiting Assistant Professor at University of Pennsylvania Center for Bioethics before moving to UD. He serves on a UD IRB.


  • Jerry Castellano, PharmD, CIP, has >20 years experience in clinical medicine, medical research, and IRBs. He is a Certified IRB Professional, and oversees human research subject protection for >700 active protocols at CCHS. He has served on the boards of the Applied Research Ethics National Association (ARENA) and Public Responsibility in Medicine & Research (PRIM&R), two national human research subject protection organizations. He is a past member of the Executive Committee of the Council of IRB Professionals (CCIP) and a member of the State of Delaware Ethics Committee.


  • Karen Novielli, MD, Professor of Family and Community Medicine and Senior Associate Dean for Faculty Affairs and Professional Development at Jefferson Medical College: In the Dean's Office, she has primary responsibility for implementing faculty development programs and for oversight of the appointment, promotion and tenure systems. A recipient of the Thomas Hale Ham Award for New Investigators in Medical Education Research, she chairs the Group on Faculty Affairs (GFA) for the Association of American Medical Colleges (AAMC).


  • Steven E. McKenzie, MD, PhD, Vice President for Research, TJU: He oversees research administration, research integrity and policy throughout TJU. He oversees the Office of Human Research, including the Divisions of Research Biosafety, Clinical Trials Support, and Human Subjects Protection, as well as the Office of Technology Transfer, Office of Research Administration, and the Office of Animal Resources.


  • William Ullman, PhD, Professor of Marine and Geological Sciences in the College of Earth, Ocean, and Environment at UD: He sits on UDEL's Committee on Responsible Conduct of Research and advises new faculty in UD's mentoring program. For many years, he has given workshops to both undergraduate and graduate audiences at the College of Marine and Earth Studies concerning the need for integrity and honor in scientific practice and in career planning. These workshops cover proper conduct of research, and, most recently, ownership and authorship of scientific data and results. He is a co-PI of the UD RAISE (Responsibility and Integrity in Science and Engineering) Program.


  • Thomas M. Powers, PhD, Assistant Professor of Philosophy at UD and Faculty Research Fellow and Director, Science, Ethics, and Public Policy (SEPP) Program at Delaware Biotechnology Institute: He researches ethics and emerging technologies and the responsible conduct of scientific research. He publishes on ethics and policy of nanotechnology, biomedical ethics, and computer ethics, and studies ethics in biofuel and neuroimaging research. He is PI of NSF-RAISE, research ethics program for graduate students, as well as RAISE-2, a UD Graduate Program Improvement and Innovation project in the same area.


  • Stephen Weinstein, PhD, Director, Division of Substance Abuse Programs, at TJU. He has been an IRB member since 1992, and Chair since 1997. He has been Ombudsman for the entire Jefferson Medical College faculty and for the post-doctoral trainees since 2003. In July 2009, he became Ombudsman for the University faculty. He is a member of the ARENA.


  • Sandra Hassink, Chair of Nemours/AIDHC's Hospital Ethics Committee, and is on their IRB: She is a clinical ethics consultant and teaches ethics to medical students, research students, residents and house staff. She co-chairs Delaware's State Ethics Committee, which advises the Governor. She is Assistant Professor of Pediatrics at TJU and holds an MS in Pastoral Care and Counselling.