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Regulatory, Ethics, Knowledge and Support

Learn more about Regulatory, Ethics, Knowledge and Support (REKS).

  • What's It All About

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

    • Provide expert guidance and assistance in promoting safety and protection of research participants; and to develop and promote innovative training and educational resources for investigators (with an emphasis on diverse, under-represented populations).

    • Provide ethical consultation to GHUCCTS investigators in the design and implementation of clinical and translational research.

    • To facilitate and assist with the regulatory management of GHUCCTS intra- and inter-institutional CTSA 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.

  • Who is Responsible

    Jane Otado, MD HeadshotREKS Interim Director : Jane Otado, PhD

    Dr. Otado is the Howard University (HU), REKS personnel. Her responsibilities involve providing regulatory assistance and coordination. This entails assisting investigators to meet regulatory and ethical obligations regarding human research protection via consultations with investigators, research ethicists, and regulatory personnel at GHUCCTS institutions, at HU, thereby reducing the regulatory burden on investigators and facilitating the conduct of research in an ethical, efficient and compliant manner. Dr. Jane Otado holds a doctorate in Medical Sociology/Social Demography and a master’s in international development and Health. She 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. Prior to joining the DC Dept. of Health, served as a Senior Research Associate in Geriatrics section, Howard University Department of Medicine and as a Senior Associate with Institute of College Research Development & Support, Silver Spring, MD. Dr. Otado has extensive experience working with clinical trials and as a research participant advocate for more than 10 years.  She has presented workshops on health services research relative to issues on minority aging; informed consent process, recruitment strategies; and research ethics. Her research interests include minority population relative to issues of availability of and accessibility to health care services to include maternal and child health issues; prenatal care utilization; and adolescent health. Currently, her research interests have focused on recruitment strategies and retention of minorities into clinical trials; satisfaction and perceptions of research participants in clinical trials; and understanding of informed consent among African Americans; and Knowledge, attitude and behavioral aspects of genetic research among African Americans.

    James Giordano, MD headshotDirector, REKS Ethics Subcomponent : James Giordano, PhD

    Dr. James Giordano is a Professor in the Departments of Neurology and Biochemistry, and Chief of the Neuroethics Studies Program of the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC. He has served as a Research Fellow of the European Union Human Brain Project; a consultant to the Organization for Economic Cooperation and Development (OECD), an appointed member of the US Department of Health and Human Services Secretary’s Advisory Council for Human Research Protection; as an appointed member of the Neuroethics, Legal and Social Issues Advisory Panel of the Defense Advanced Research Projects Agency (DARPA), and as Senior Science Advisory Fellow of the Strategic Multilayer Assessment Group of the Joint Staff, Pentagon.   

    The author of over 275 publications, 7 books, and 15 governmental whitepapers, he is an Overseas Fellow of the Royal Society of Medicine (UK); was elected to the European Academy of Science and Arts (EC) and the Dana Alliance of Brain Initiatives (DABI), and named as a Distinguished Lecturer of both the Institute for Electrical and Electronics Engineers (IEEE), and Sigma Xi – The National Scientific Honor Society in recognition of his achievements.

    REKS Leadership : Marc R. Blackman, MD

    Marc R. Blackman, M.D. serves as a Senior Physician Scientist and Chief, Laboratory of Geriatric Endocrinology and Metabolism, and formerly served as Associate Chief of Staff for Research and Development, at the Washington DC VA Medical Center; the Assistant Dean for VA Research and Professor of Medicine and Rehabilitation Medicine at Georgetown University; a member of the Executive and Steering Committees, and co-Director of the Patient Clinical Interaction Module, of the Georgetown-Howard Universities Center for Clinical and Translational Science; Clinical Professor of Medicine and Biochemistry and Molecular Medicine at the George Washington University School of Medicine; and Professor of Medicine (Part-time) at the Johns Hopkins University Schools of Medicine.

    Dr. Blackman facilitates and expands the varied clinical, translational and laboratory based research and research training programs within the DC VAMC, and with the VA’s academic partners, and pursues his own funded research programs in neuroendocrinology, reproductive endocrinology, and gerontology/geriatrics. 

    Dr. Blackman is a member of multiple medical and scientific societies, and has served as a scientific consultant for various government, academic, industrial, and private organizations.  He was a member of the National Advisory Committee for Endocrinology and Aging in the NIA’s Biology of Aging Program, and of the Executive Committee of the GCRC’s National Program Directors Association.  Dr. Blackman served as a member of the NIH/NIA’s Aging Systems and Geriatrics Study Section. He is a frequent national and international lecturer, and consultant on various aspects of neuroendocrinology and aging.  Dr. Blackman has received numerous teaching and academic awards, and has published more than 475 scientific journal articles, editorials, books, chapters, and abstracts.

    Sheila Zimmet, BSN, JD headshotREKS Consultant : Sheila Zimmet, BSN, JD

    Sheila Cohen Zimmet was the Georgetown University Medical Center Senior Associate Vice President for Regulatory Affairs and Conflict of Interest Officer, the Georgetown University Research Integrity Officer. and until recently, the REKS Director.    Ms. Zimmet previously served as Associate Dean for Research Integrity for Weill Cornell Medical College, until returning to Georgetown in these roles, in which she had oversight responsibility for an array of research ethics and compliance matters. She currently maintains her faculty position as an Adjunct Associate Professor at the Georgetown University Medical Center.

    Ms. Zimmet 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 completed a four-year term on the Advisory Council of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). She also served on the 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 ethics and compliance matters at local, national and international professional meetings.

    Assya Pascalev, PhD headshotREKS Ethics Subcomponent Member : Assya Pascalev, PhD

    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.

    Sarah B. Vittone DBe, MSN, RN headshotREKS Ethics and Research Participant Advocate : Sarah B. Vittone DBe, MSN, RN

    Dr. Vittone is an Assistant Professor, Georgetown University and Clinical Ethics Consultant with the Pellegrino Center for Clinical Bioethics at the Georgetown University Medical Center, Washington DC.  She holds a Doctor of Bioethics and has twenty years’ experience in clinical and research ethics.  She is a member of the GHUCCTS Scientific and Prioritization Committee for Safety and Human Protection Reviews with cross over responsibilities on the GHUCCTS IRB-E. She serves on the Adverse Event/ DSMB Committee of the GHUCCTS IRB-E.  Dr. Vittone provides consultation to Investigators and Research Teams on specific issues in human protection and safety.  She provides research ethics training in collaboration with GHUCCTS REKS members. Dr. Vittone has research interests in decision making for others and research ethics. She is a frequent regional and national speaker on these topics.  Dr. Vittone serves as the Georgetown Research Participant Advocate supporting CTSA research participants.

    For Investigators

    Kristen Katopol is the Director of the Human Subject Protection Program at Georgetown University, providing chief administrative and programmatic support for Georgetown’s Institutional Review Boards (IRBs), assuming responsibility for the oversight of all biomedical, social and behavioral research involving human subjects. Ms. Katopol supervises the ethical and technical review of proposals requiring IRB review and she provides consultation, assistance and information regarding the review process to the research community, as well as to staff and students on all campuses. Ms. Katopol possesses nearly 20 years of experience in the field of protecting human subjects in research. Prior to her position at Georgetown University, she served as site manager and Human Subjects Protection Scientist at Ft. Detrick, where she managed a large Department of Defense research portfolio, supervised a team of Human Subject Protection Scientists and worked to solve complex issues surrounding human subject protocols and regulations. Prior to her work with the DOD, Ms. Katopol was the IRB administrator for the St. Joseph Mercy Health System in Ann Arbor, Michigan.

    Kristen R. Katopol, MS, CIM, Regulatory Support Coordinator
    Georgetown University
    Phone: 202-687-0328
    Email: krk63@georgetown.edu

     Institutional Review Boards


    For Research Participants


    Research (RPA) Program

    The Research Participant Advocacy (RPA) Program is a program that assists current and potential research subjects/participants with their participation in research/clinical trials. If you need help with reaching and/or communicating with a member of the research team, the RPAs can help you by facilitating communication with the study investigators and/or other members of the research team. The RPAs are also available for general inquiries about participation in research or to discuss questions/concerns about participation in research.

    You can leave a message for the Research Participant Advocates (RPAs) at any time by calling the 24-Hour Phone Number at (202) 681-2872 or by sending an email to wecare@ghuccts.org.

  • Tell Me More

    What We Do | The regulatory team are a resource for study coordinators and investigators and other key personnel on engagement, protection and consenting of study participants.  The Research participants specialists help investigators and study coordinators comply with the ethical guidelines and regulatory requirements related to the engagement and protection of study participants. Areas of assistance include: informed consent development; data and safety monitoring (DSMP); and informed consent process.

    REKS are active participants in planning, designing, and conducting training in ethical and regulatory issues related to the conduct of research. For instance, Research Participants specialists conduct face-to-face, a biannual GCP training offered to study coordinators and investigators. They also provide needed inputs in any other training on responsible conduct of research as it pertains to the engagement, protection, and safety of study participants.

    We provide assistance to:

    • Investigators/Researchers
    • Current Research Subjects/Participant
    • Potential Research Subjects/Participants
    • Research Administrators
    • Healthcare Consumer and Provider Members of the Community

    What type of assistance do we provide?

    • For investigators/researchers and research administrators
      • Assistance in designing clinical translational research
      • Assistance in preparing an application for IRB and other applicable regulatory review
      • Review data safety
      • Assistance in conducting clinical translational research in compliance with applicable regulations
      • Assistance in compliance with applicable reporting procedures while conducting clinical translational research
      • Assistance in ensuring that the clinical translational research promotes both the safety and welfare of research subjects and benefits the public health
      • Assist with ethical considerations for conducting clinical translational research
    • For current research subjects/participants
      • Provide access to general information about research and participation in research
      • Facilitate communication between subjects/participants and all members of the research team
      • Discuss questions or concerns with subjects/participants about participation in research/clinical trials
    • For potential research subjects/participants
      • Provide access to general information about research and participation in research
      • Discuss questions or concerns with subjects/participants about participation in research/clinical trials
    • For Healthcare Consumer and Provider Members of the Community
      • Provide access to information about ongoing research studies/clinical trials
      • Provide access to information on participating in research/clinical trials as a study site

     What are our goals?

    • To provide regulatory and ethics support for investigators
    • To promote an integrated program of regulatory support, ethics, and responsible conduct of research
    • To establish and promote continuing education programs
    • To promote ethics and responsible conduct of research training for investigators
    • To promote ethics research and scholarship
    • To implement a program of participant advocacy that focuses on protecting the health, welfare, and rights of research participants

    REKS Publications

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    REKS Presentations 

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    GHUCCTS Training/Courses:

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  • Resources

    For Investigators:

    For application forms for IRB Review, please go to your sponsor institution's IRB site.

    We also do provide assistance with study design and ethical consultations. Please contact the program director for more information. For application forms for IRB Review, please go to your sponsor institution IRB site.

    The Georgetown Clinical Research Network (CRN) Seminar Series is co-sponsored by GHUCCTS and the Clinical Trials Office, and is open to all individuals interested in clinical research at Georgetown University. Seminars take place on the 4th Thursday of each month at 12:30PM in the Warwick Evans Conference Room in Building D.  View seminar schedule.

    The Research Team Training series is designed for new research professionals who, manage and oversee one or more aspects of research studies involving human subjects. This is in addition to any CITI research training requirements your organization has. Target audience that may benefit from the workshop include Clinical Research Coordinators, Clinical Research Nurses, Clinical Research Staff and Research Investigators as well as Research Administrators and Assistants.


    GHUCCTS Resources & Training

    Good Clinical Practice (GCP)

    As you are aware, as of January 1, 2017, NIH requires all PIs and clinical research team members who are supported in whole or in part by NIH funds, to complete GCP training. Investigators and others are expected to refresh their training every three years. The resources linked below are available to the Georgetown research community to satisfy these requirements.  When the courses are completed, each researcher should print and maintain the certificate of completion that is provided. You will be required to produce proof of completion to the IRB in order to obtain IRB approval of clinical research!

    For biomedical researchers: CITI training module instructions and access
    For social and behavioral researchers: Society of Behavioral Medicine GCP eLearning Course 

    Training materials were developed by the Clinical and Translational Science Awards Program, funded by the NIH National Center for Advancing Translational Science. SBM is hosting the training at the request of the NIH Office of Behavioral and Social Sciences Research.

    Good Laboratory Practices (GLP) 

    GLP training modules also are now available for faculty, students, and staff as part of the Georgetown University suite of training modules from CITI.

    Annual Spring Regulatory and Hot Topics in Clinical Research Conference

    Co-sponsored by GHUCCTS and the Clinical and Translational Science Institute at Children's National (CTSI-CN) at George Washington University (GWU), this free conference explores the latest and greatest in the world of regulatory research and ethics. Download PDF | 2019 Meeting Agenda

    Georgetown-MedStar New e-IRB System: Huron Click

    Huron Click will eliminate existing challenges with the previous e-IRB system, such as over-customization, which made it difficult to fix problems as they arose. The newly implemented e-IRB system is a complete management system for the IRB. It is capable of administratively managing studies for which the GHUCCTS IRB is the IRB of record for other institutions, such as multi-site studies, and studies that deferred to another IRB of record.  The new e-IRB system will also be used to assess researcher satisfaction with the use of a single IRB and to conduct quantitative assessment of clinical trial performance.  REKS will work with GHUCCTS leadership to standardize GHUCCTS policies where possible (e.g., methods of recruitment, review of security data); and to help research teams meet their compliance goals (e.g., clinicaltrials.gov reporting obligations). | Read More

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    Clinical Trial Registration and Results Reporting

    ClinicalTrials.gov Background 
    ClinicalTrials.gov Results Database


    Food and Drug Administration (FDA)

    Dietary Supplements - FDA

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    The NIH single IRB [sIRB] requirement for multi-site research is effective as of January 25, 2018. 

    Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

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    Research Ethics

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    Regulations, Policies and Guidance

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    Working with Special Populations

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    Rigor and Reproducibility

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    Responsible Conduct of Research

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    Additional Useful Information

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