GHUCCTS

GHUCCTS Programs & Resources

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Participant and Clinical Interactions

Learn more about Participant and Clinical Interactions.

  • What's It All About
    Participant and Clinical Interactions (PCI) is the component of the GHUCCTS which provides facilities and resources to enable investigators to successfully conduct their clinical research. We are committed to using our capabilities in order to foster collaborative research efforts in the Washington, DC region. We seek to reduce barriers to clinical research for both investigators and participants to best serve the entire research community, with emphasis on the underserved. 

    The cornerstone of the activities of the PCI is our Clinical Research Units, our Scientific Evaluation and Prioritization Committee (SEPCOM), and our collaboration with the GHUCCTS IRB. The SEPCOM protocol review process is designed to be both rigorous and constructive, in order to stimulate high quality research and encourage new investigators. The joint GHUCCTS IRB ensures efficient approval of protocols at multiple GHUCCTS sites.

    Clinical Research Units (CRUs) based at Georgetown University and Howard University provide specialized in-patient and out-patient resources which allow clinical and translational investigators to observe and study human physiology as well as study and treat disease with innovative approaches. Similarly, the Washington DC Veterans Affairs Medical Center (VAMC) has a CRU that supports clinical investigators throughout the DC VAMC. 

    The objective of the CRUs is to make available to clinical scientists the resources that are necessary for the conduct of clinical research. The CRUs do not fund specific research projects. Infrastructure and support in the form of inpatient beds, outpatient services, staff and core equipment necessary to conduct studies are available as a fee-based service. Federally funded studies may receive some no cost or reduced cost services based on scientific priority and availability of resources. The CRUs can also be used to support other hypothesis-based research. GU-CRU and HU-GRU have different and complementary facilities and space and operate in collaboration with the clinical sites at other GHUCCTS institutions, including MedStar Health Research Institute (MHRI) and the DC VAMC and investigators are encouraged to utilize resources from all sites. All investigators, including MedStar investigators at all locations, are encouraged to inquire about services available to them at all three CRUs.

    View a list of CRU leadership and additional staff and resources at each institution.
  • Who is Responsible

    Director of the DCVA-CRU : Marc Blackman, MD

    Associate Chief of Staff for Research & Development, Washington, DC VAMC
    Assistant Dean for VA Research and Professor of Medicine and Rehabilitation Medicine, GUMC

    Dr. Blackman is an active clinician, teacher, researcher and administrator. While at Johns Hopkins, he employed clinical, translational and laboratory-based investigations to evaluate the effects of age-associated alterations in the growth hormone, gonadal and adrenal steroid axes on body composition, and endocrine-metabolic, cardiovascular, immunologic, musculoskeletal, and psychobehavioral functions in healthy and frail older persons. Dr. Blackman served as Chief, Endocrine Section, NCCAM, NIH, from April, 2001, until June, 2007.

    During this time, he conducted research, and research training, related to the influences of diverse CAM modalities that might allay or attenuate the life “stressors” of musculoskeletal frailty, chronic pain, and cancer, particularly as they affect the elderly, including those who are underserved.

    Dr. Blackman joined the Washington DC VAMC as the Associate Chief of Staff for Research and Development in June, 2007, where he 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 further develops his own research programs. He is a member of numerous medical and scientific societies, and has served as a scientific consultant for various government, academic, industrial, and private organizations, including the National Advisory Committee for Endocrinology and Aging in the NIA’s Biology of Aging Program, and the Executive Committee of the GCRC’s National Program Directors Association. Dr. Blackman served (2010-2014) as a member of the NIH/NIA’s Aging Systems and Geriatrics Study Section, is a frequent national and international lecturer and consultant on neuroendocrinology and aging, has received numerous teaching and academic awards, and has published more than 400 journal articles, editorials, books, chapters, and abstracts.

    Headshot of Dr. Charles HowellCo-Director of PCI Programs, Program Director HU-CRU : Charles Howell, MD
    Charles Howell, MD (co-PL) is a tenured professor and Director of the Viral Hepatitis Center in the Department of Medicine at the Howard University College of Medicine. In addition, Dr. Howell is a co-director of the GHUCCTS KL2 program and IDP advisor. He received the Doctor of Medicine degree from Howard University with many honors including induction into Alpha Omega Alpha Honor Medical Society. He completed an Internal Medicine residency at the Baylor College of Medicine Affiliated Hospitals in Houston, TX (1982-85) and a Gastroenterology and Hepatology fellowship at the University of Colorado Health Sciences Center (UCHSC) in Denver, CO (1985-88). He is board certified in Internal Medicine and Gastroenterology. Dr. Howell has had a long-standing research interest in racial disparities in liver diseases, with a focus on chronic hepatitis C virus (HCV) infection and primary liver cancer. Under his leadership, the Viral Hepatitis Center strives to reduce the burden of hepatitis in the Washington metropolitan area through high-quality patient care, education, research, and community service. His research activity has been funded by the National Institutes of Health, private foundations, and private corporations. From 2000-2007, Howell chaired the Steering Committee for the study of viral resistance to antiviral therapy for chronic hepatitis C (VIRAHEP-C). He was one of eight principal investigators for this NIH-sponsored, multicenter study, which investigated the basis for the lower efficacy of interferon and ribavirin therapy for hepatitis C in African Americans compared to White Americans. He has been a site PI for many clinical trials, and has successful in recruiting racial and ethnic minority participants. From 2011-2013, he co-chaired the National Medical Association’s Task Force on Hepatitis C in African Americans.

    Dr. Howell has published more than 70 journal articles, book chapters and reviews, and is recognized nationally for his medical expertise and research accomplishments. In addition, he has been a frequent lecturer at national meetings. Furthermore, he has mentored more than 40 students, residents, fellows and junior faculty members during his career. This includes 8 years of service on the University of Maryland Baltimore’s (UMB) Multidisciplinary Clinical Research Development (K12) Advisory Committee and 9 years as Leader of the Clinical and Translational Science Track of the Gastrointestinal Research Training (T32) Program. As Department of Medicine chair from 2014-2018, Dr. Howell oversaw career development for many junior faculty members. He is a fellow of American Gastroenterological Association (AGA), the American Association for the Study of Liver Diseases (AASLD), and American College of Physicians, and is a member of the Association for Academic Minority Physicians. Dr. Howell has served on many medical society committees, and previously chaired the AGA Committee on Under-represented Minorities, the AASLD Public Policy Committee and the AASLD Diversity Committee. He has served on numerous National Institutes of Health study sections and several editorial boards.

    Headshot of Dr. Jonklaas standing in a library wearing a dark shirt with light flowersCo-Director of PCI Programs, Program Director GU-CRU : Jacqueline Jonklaas, MD, PhD

    Dr. Jonklaas is currently a professor in the endocrinology division at Georgetown University. Dr. Jonklaas obtained her MD, residency, and fellowship training at Georgetown University. Her area of interest, both with respect to research and patient care, is the management of thyroid cancer and hypothyroidism. 

    Dr. Jonklaas has published research regarding treatment and outcomes in patients with thyroid cancer and therapy for hypothyroidism. She is involved in translational research, particularly regarding biomarkers of thyroid hormone action and TSH bioactivity. Dr. Jonklaas is involved in teaching at both a national and local level. She teaches endocrinology to residents and fellows in both the inpatient and outpatient setting. She also co-directs the endocrinology course for Georgetown Medical School’s first year medical students. She is a member of the American Thyroid Association and serves on their Guidelines and Statements Committee. She was the lead author for the American Thyroid Association’s Guidelines for the Treatment of Hypothyroidism that were published in 2014. She is also a member of the Endocrine Society and serves on the editorial board of the Journal of Clinical Endocrinology and Metabolism and as a member of the Endocrine Society Self Assessment Committee.

    Additional Team Members

    Our nurse managers are responsible for the administration, management and direction of the operational, personnel and financial activities of the CRUs. They coordinate inter-institutional collaboration between GU HU, MHRI and the VAMC as part of the GHUCCTS and assist investigators in implementation of their protocols.

    • Kathryn Turner serves as the Nurse Manager for the GU-CRU. In 2012, she completed her Bachelor of Science in Community Health from the University of Maryland, College Park and in 2015, completed her Bachelor of Science in Nursing from the University of Maryland, Baltimore. Kathryn began her nursing career specializing in pediatrics at Children's National Medical Center and became a Certified Pediatric Nurse in January 2017. Here, she was also chair/ co-chair of multiple unit and hospital wide committees. Kathryn began working part-time as a Clinical Research Nurse at GU in March of 2017 and started in the Nurse Manager role as of November 2018. Kathryn is passionate about growing her knowledge and expertise in the realms of clinical research and nursing leadership. She also hopes to pursue a Family Nurse Practitioner degree while continuing to develop in her current role.
    • Alice Ukaegbu: serves as nurse manager for HU-CRU. She has a Doctor of Nursing Practice and is a Family Nurse Practitioner, with over 27 years of nursing experience, including 11 years in clinical research. Dr. Ukaegbu has conducted research into the use of text message reminders to influence positive compliance in adults with type 1 diabetes and has expertise in culturally competent strategies for recruitment and retention of African American populations into clinical trials.

    View CRU Leadership and Staff

  • Tell Me More

    PCI Provides the following resources:

    Clinical Research Units

    The CRUs provide infrastructure and support in the form of inpatient beds, outpatient services, staff and core equipment necessary to conduct studies. They can be used to support hypothesis-based research and are available for industry-sponsored research. We provide a multitude of resources and services at a reasonable cost. CRU service costs should be written into your study budgets and grant proposals whether industry-funded, federally-funded, or otherwise. CRU administrative staff can assist your study team to create CRU service estimates for proposed projects. Federal awards are provided a reduced or prorated cost. Check with the CRU administration to see if your study qualifies for reduced rates. We encourage you to work with us when preparing grants to ensure that we can help you meet your budgetary needs.

    View Directory for CRU Leadership & Staff

    Study Coordinator Effort

    Some study coordinator effort is available to new and junior investigators at GU-CRU. Our study coordinators offer regulatory support for pilot and phase I-III clinical trials, including: preparation of IRB submission, SEPCOM application submission, assistance in protocol and consent form writing, participant scheduling, and payment.

    Acknowledging Support from CRUs

    List of Available Facilities and Equipment


    To apply for PCI resources:

    SEPCOM

    The cornerstone of activities within PCI is our Scientific Evaluation and Prioritization Committee (SEPCOM) and Clinical Research Units. Clinical Research Units (CRUs), located at Georgetown University and Howard University are supported by GHUCCTS and provide specialized institutional resources which allow clinical investigators to observe and study human physiology as well as study and treat disease with innovative approaches. An independent CRU is also available at the VAMC. Clinical protocols can be activated on the GU and HU CRUs after they have been approved by both the IRB of record and SEPCOM, which is the governing committee of the CRUs. Committee members are recommended by the CRU Program Directors of respective institutions within GHUCCTS and appointed by the Principal Investigators of the CTSA grant, Joseph Verbalis, MD and Thomas Mellman, MD.

    Protocol Approval

    We strongly encourage submission to GHUCCTS IRB. This multi-institutional IRB allows for efficient study implementation at any or all of the GHUCCTS CRUs. The DC VAMC’s IRB and GHUCCTS IRB coordinate their review processes for GHUCCTS protocols involving participation of investigators and patients from the VA and other GHUCCTS clinical institutions. We also recommend that studies are submitted to both the IRB and SEPCOM simultaneously, although it is not required. Many studies utilizing the GHUCCTS IRB must receive their SEPCOM review prior to their GHUCCTS IRB review. SEPCOM meets on a monthly basis and a protocol must generally be received 3 weeks before the monthly meeting in order to be reviewed at the next meeting. (Please refer to the 'How Do I Apply' tab for more details)

    Additional GHUCCTS Resources

    ResearchMatch

    ResearchMatch is a participant recruitment and feasibility analysis tool that is currently available to Georgetown University, Howard University, and MedStar Health Research Institute researchers. ResearchMatch is a national volunteer research registry that brings together researchers and willing volunteers who wish to get involved in research studies. It provides a secure, web-based approach to recruiting research participants and thus addresses a key barrier to advancing research. It was developed by institutions affiliated with the Clinical and Translational Science Awards (CTSA). 
    More information | Download ResearchMatch Presentation

    Nursing Resources of Interest

    The International Association of Clinical Research Nurses (IACRN) was founded in 2008 by five Nurse Managers of predominantly GCRC and CTSA Clinical Research Units. Shaunagh Browning RN, FNP-BC, the Nurse Manager at Georgetown, was one of the key founding members of the association and remains active in its mission. IACRN's mission states: "The International Association of Clinical Research Nurses is a professional nursing organization. Its purpose is to define, validate and advance clinical research nursing as a specialty practice and to support the professional development of registered nurses who directly or indirectly impact the care of clinical research participants across all clinical specialties." IACRN is working internationally to support that mission. There are many resources both, on-line and at educational events from IACRN.

  • How To Apply

    SEPCOM Information

    SEPCOM Meeting Dates and Submission Deadlines

    • Complete a Scientific Evaluation and Prioritization Committee (SEPCOM) application. | REDCap Application
    • Studies that are GHUCCTS-funded and/or will be utilizing more than one GHUCCTS' institution, please submit your IRB application to GHUCCTS IRB. Please use this SEPCOM - GHUCCTS IRB review summary as a guide to this streamlined review process. Note that the SEPCOM review must occur prior to the GHUCCTS IRB review.

    • Once the complete study application is submitted, it will go to the SEPCOM for review. The source of study funding, as well as the study's prior level of review, determines the type of review the Committee will carry out. Please see this reference grid for details.

    • You may contact ghucctscruadmin@georgetown.edu or your institution's respective Program Coordinator, if you have any questions about the process.

    • CRU Nurse Managers can assist you if you have questions about clinical support services available from the CRU.

    • If there are any concerns about the study, you will receive a contingency letter asking you to address the concerns prior to final approval.

    • Once the study has received both IRB and SEPCOM approval, you are ready to start accessing CRU resources.

    • You must schedule an initiation meeting with the CRU(s) you intend to utilize. The initiation meeting is held to train the CRU staff on protocol procedures. You will be provided a copy of the CRU initiation meeting notes and staff sign-in sheet for your records. Your study will be assigned a CRU primary clinical liaison if initiated on the GU-CRU. This CRU staff member will be your primary contact for your study. S/he will complete flow sheet development, which will be used to document the procedures conducted on the CRU, and the protocol orders.
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