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Regulatory, Ethics, Knowledge and Support

  1. What's it All About?
  2. Who is Responsible?
  3. Tell Me More
  4. Resources

The mission and goals of the Regulatory Ethics Knowledge and Support (REKS) component of GHUCCTS are to:

  • Advance the application of ethical principles to the design and implementation of translational research;
  • Promote and support ethical and compliant research through personal and electronic support systems;
  • Encourage and assist institutional collaborations;
  • Promote the protection of human and animal subjects; and
  • Facilitate translational research.

The REKS component emphasizes promoting and preserving the integrity of the research, the researcher and the research enterprise, preserving the trust between the public and the research enterprise, and the public trust in the fruits of the research process.


Sheila Zimmet, BSN, JDREKS Director

Sheila Cohen Zimmet is the Georgetown University Senior Associate Vice President for Regulatory Affairs and also serves as the research integrity officer and conflicts officer for the Georgetown University Medical Center. Ms. Zimmet previously served as Associate Dean for Research Integrity for Weill Cornell Medical College, until returning to Georgetown in her current role in which she has oversight responsibility for an array of research ethics and compliance matters.

She is a former neonatal intensive care nurse, Senior Associate Counsel to the Georgetown University Medical Center, and the University’s first Director of Research Assurance and Compliance. Ms. Zimmet has been appointed to a three-year term on the advisory council of the Eunice Kenndy Shriver National Institute of Child Health and Human Development (NICHD). She also sits on the elected Steering Committee for the AAMC Forum on Conflict of Interest in Academe. She is a former two-term member of the National Center for Research Resources (NCRR) Advisory Council (1996-2000 and 2004-2008). Ms. Zimmet frequently speaks on issues related to research compliance matters at local, national and international professional meetings.

Jane Otado, PhD
, REKS Associate Director

Dr. Jane Otado holds a doctorate in Medical Sociology/Social Demography and a Masters in International Development and Health. She also completed a post-doctoral fellowship at the Centers for Disease Control and Prevention (CDC).  

Prior to joining the faculty of Howard University's Department of Family Medicine and Community Health, Dr. Otado served as the Manager of Comprehensive Cancer Prevention Program for the District of Columbia Department of Health, and also as Senior Research Associate in Geriatrics in the Howard University Department of Medicine. Dr. Otado has extensive experience working with clinical trials and as a research participant advocate.  She has presented workshops on health services research relative to issues on minority aging; presentations on informed consent process and research ethics. Her research interests include minority population and issues of availability of and accessibility to health care services, maternal and child health, and recruitment of minorities into clinical trials. She designed a post-consent survey to assess the participants understanding of the informed consent process and presented findings at a PRIMR conference. She has also conducted a follow-up participant survey to evaluate participant experiences with the research process at Howard University Clinical Research Unit (CRU). 

Kevin T. FitzGerald, SJ, PhD
, Director, REKS Ethics Subcomponent

Dr. Kevin T. FitzGerald is the David Lauler Chair of Catholic Health Care Ethics in the Center for Clinical Bioethics at Georgetown University. He is also a Research Associate Professor in the Division of Biochemistry and Pharmacology of the Department of Oncology at the Georgetown University Medical Center.

He serves as a member of the Center for Clinical Bioethics, the Advisory Board for the Center for Infectious Disease (CID), and the Angiogenesis, Invasion, Metastasis Program at the Lombardi Cancer Center. Dr. FitzGerald holds doctorates in molecular genetics and in bioethics from Georgetown University and a Master of Divinity degree from the Jesuit School of Theology in Berkeley. His research efforts have focused on the investigation of abnormal gene expression in cancer, and on ethical issues in biomedical research. He has published both scientific and ethical articles in peer-reviewed journals, books, and in the popular press.

Assya Pascalev, PhD, Co-Director, REKS Ethics Subcomponent

Dr. Assya Pascalev is an Associate Professor of Philosophy and Director of the interdisciplinary program in Health Care Ethics at Howard University College of Medicine. Dr. Pascalev holds a Ph.D. in applied philosophy, and has held academic appointments in the department of philosophy at Howard University and the department of philosophy at the University of North Florida, where she was the Associate Director of the Center for Ethics, Public Policy and the Professions.

Dr. Pascalev is a member of the Task Force on Social Media at the Board of Medicine, D.C. Department of Health. She is also a member of the European Platform on Ethical, Legal and Psychosocial Aspects of Organ Transplantation, and a member of the Editorial Board of the Ethics Journal. Her professional interests are in the areas of medical ethics, research ethics, applied and professional ethics, and social and political philosophy. She has published and presented on end-of-life ethics, the ethics of organ transplantation, the ethics of biotechnology and food ethics.