GHUCCTS Programs & Resources

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 skills 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 (GU) and Howard University (HU) 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 an outpatient CRU that supports clinical investigators throughout the DC VAMC. These CRUs are complemented by two Practice-based Research Networks, DC PrimCare and CAPRICORN.

The objective of the CRUs is to make available to clinical scientists the resources that are necessary for the conduct of clinical research. The 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.

A Primary Care Practice-Based Research Network (PBRN) is a sustained collaboration between primary care clinicians, their patients, and academicians, dedicated to developing and answering relevant questions about primary health care. This synergy provides the opportunity to learn from each other and gain the skill set necessary to appreciate the clinical content, patient significance, and methodological approaches to conducting translational research. 

DC PrimCare is the HU-led DC primary care PBRN that conducts research that addresses health care needs of the poor and underserved. DC PrimCare has strong ties with the GU-led PBRN, CAPRICORN, and these two PBRNs serve an extensive DMV (District of Columbia, Maryland, Virginia) catchment area. Both DC PrimCare and CAPRICORN are registered PBRNs with the Agency for Healthcare Research and Quality (AHRQ) and have over a decade-long relationship with GHUCCTS. Together, the two PBRNs work with 150 providers in the community to promote active research studies and to facilitate and conduct community-based participatory research that engages underserved regions in DC. 

The District of Columbia Primary Care (DC PrmCare) PBRN is a research component of the Department of Community and Family Medicine at Howard University College of Medicine. DC PrimCare sites are primarily Family Medicine private group and solo practices, and hospital based clinics.  DC PrimCare's mission is to improve the understanding of health disparities in urban minorities and to develop practical strategies to promote prevention and enhance treatment of diseases common in minorities, particularly those of African Ancestry. The goal of DC PrimCare PBRN is to facilitate and provide resources for community-based primary care clinicians to address relevant issues regarding underserved populations and translate research into practice. 

The Capital Area Primary Care Research Network (CAPRICORN) is a research component of the Georgetown University Department of Family Medicine at Georgetown University School of Medicine. CAPRICORN is a practice-based research network of University and community health centers with a mission to engage in practice-based primary care research that will lead to improved understanding and delivery of primary care. CAPRICORN consists of providers from the Washington, DC metropolitan area who have a wide variety of patient populations. Sites include primary care or urgent care offices led by general pediatricians, family physicians, general internists, or nurse practitioners. 

Director of the DCVA-CRU : Marc Blackman, MD

Dr. Blackman serves as a Sr. Physician Scientist, and previously served as Associate Chief of Staff for R&D, at the Washington DC VA Medical Center. He is ABIM Certified in Internal Medicine and Endocrinology, Diabetes and Metabolism; and has extensive grant, publication, and practical experience in T1-T4 research, research mentoring and research administration. He is a Professor of Medicine and Rehabilitation Medicine at Georgetown University; VA representative to the GHUCCTS Executive Committee, member of the Steering Committee, co-chair of the Scientific Evaluation and Prioritization Committee; Clinical Professor of Medicine, Biochemistry and Molecular Medicine at George Washington University, Professor of Medicine (Part-time) at The Johns Hopkins University, Chief Editor, Endotext (Section on Endocrinology of Aging); Specialty Chief Editor, Frontiers In Endocrinology (Aging Section) and Associate Editor of the textbook “Endocrinology of Aging, Clinical Aspects in Diagrams and Images”, (Elsevier S&T Books, English language  (September, 2020) and Spanish language (July, 2023) editions).

Co-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. 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. She also studies side effects of thyroid cancer therapies. She  serves leadership roles within the American Thyroid Association. She was the lead author for the American Thyroid Association’s Guidelines for the Treatment of Hypothyroidism that were published in 2014 and is a member of the task force that is currently updating these guidelines.

Co-Director of PCI Programs, Program Director HU-CRU: Thomas A. Mellman, MD

Dr. Mellman is Professor of Psychiatry and Director of the Center for Clinical and Translational Research and Stress/Sleep Studies Program at Howard University College of Medicine. He received training at the NIMH Division of Intramural Research Programs and has previously held faculty appointments and achieved the rank of Professor at the University of Miami and Dartmouth.

Dr. Mellman has had continuous funding as PI on federal research grants since 1991 including a VA Merit award, and R01, R21, and K24 awards from NIMH, NHLBI, and NIMHHD. His primary research interest over the years has been the role of sleep in posttraumatic stress disorder (PTSD) and the early aftermath of trauma. He recently completed an RO1 grant to investigate the relationship of PTSD to nocturnal blood pressure in young adult African Americans and R21 grants to investigate the role of sleep in processing traumatic memory, and sleep adaptations to stressful environments. His additional research interests with resulting publications include other aspects of the psychobiology and treatment of PTSD, evidence-based practices in psychopharmacology, and the role of stress in health disparities. He has a consistent track record of mentoring junior investigators and interdisciplinary collaboration. He was a member of the NIH study section for Mechanisms of Emotion Stress and Health, was previously a member of NIMH IRGs for Violence and Traumatic Stress and Interventions and has served on several review committees for the NIH Roadmap and Department of Defense research programs. Dr. Mellman was a member of the original ISTSS committee for developing treatment guidelines for PTSD, APA committee for text revision of the DSM-IV, and the Institute of Medicine Committee for review of the evidence regarding the treatment of PTSD.

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.

• Marie Therese (Terry) Jeffs serves as the Nurse Manager on the CRU in addition to her role as a Clinical Research Nurse. She graduated from George Mason University with a BSN. She is a professional member of the International Association of Clinical Research Nurses (IACRN) and Sigma Theta Tau. Over the years, Terry has held various leadership positions within IACRN, demonstrating her passionate commitment to advancing the specialty field of Clinical Research Nursing and clinical research. Before joining the CRU in 2003, Terry worked on a specialty surgical unit at Georgetown University Hospital where she cared for adults including liver and kidney transplant patients from the then newly launched Transplant program as well as neurology, urology, orthopedic, ophthalmology and reconstructive plastic surgery patients.

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 at 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 the CRUs can help you meet your budgetary needs.

View Directory for CRU Leadership & Staff
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 Marjorie Gondre-Lewis, MD.
SEPCOM Application

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. 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

• Biostatisticians
• Health Informatics
• Pilot Projects
• Community Engagement
• Regulation and Ethics
• Hub Liaison Team

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

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, a former 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.

SEPCOM Information

Complete a Scientific Evaluation and Prioritization Committee (SEPCOM) application. | REDCap Application

• Please include the following supplemental documentation with your submission: | Checklist for 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 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 flowsheet development, which will be used to document the procedures conducted on the CRU, and the protocol orders.