Participant and Clinical Interactions

  1. What's It All About?
  2. Who is Responsible?
  3. Tell Me More.
  4. How Do I Apply?

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.

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. More information.

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. You can learn more about IACRN at http://iacrn.org/aboutus or talking to Shaunagh Browning.