VA Puget Sound Health Care System Clinical Research Unit

VA CRUThe Clinical Research Unit (CRU) was established in 2000 to provide VA and UW researchers with a well-equipped, controlled, and safe inpatient and outpatient setting for investigators and staff to conduct clinical research trials. Its mission is to provide skilled nursing and technical assistance in performing a wide range of clinical research.

The VA Puget Sound Health Care System has one of the nation’s most competitive and comprehensive research programs, including diabetes and endocrinology, Alzheimer’s disease, multiple sclerosis, spinal cord injuries, mental health, addiction treatment, PTSD and vaccine trials. The CRU provides research services to both Veteran and non-Veteran research subjects.

The Clinical Research Unit has an advisory board composed of investigator members and representatives from VA R&D and the Seattle Institute for Biomedical and Clinical Research (SIBCR) who meet once a month to discuss the issues and expanding needs of the CRU.

Nursing staff

The CRU nurse manager oversees the functioning of the CRU to provide professional, effective and efficient research subject care and study support. The manager is responsible for assuring that PI’s and coordinators adhere to research guidelines and protocols, and that everyone follows JCAHO and Good Clinical Practice (GCP) guidelines.

Services

VA CRUWe provide clinical monitoring and care to research subjects. The CRU is able to provide a variety of fee-for-service procedures, including:

  • Assistance with study procedures, clinical monitoring, completion of IRB and Research & Development (R&D) applications, and regulatory follow-up
  • DEXA (bone density, whole body, spine and/or hip; body composition)
  • Obtaining specimens, processing, aliquoting (including PK studies) and shipping
  • EKG’s
  • Vital signs and measurements
  • IV placement and blood sampling via angiocath access
  • Pulse oximetry
  • Glucose testing
  • Administration of investigational drugs or vaccines
  • Patient assessments, physicals
  • Assistance with lumbar punctures
  • Consenting and questionnaires
  • Resource consulting

Safe patient and research subject care is the primary concern of the CRU. All studies need to be IRB and R&D Committee approved, and each subject must have a current signed consent and HIPAA form in order to conduct the research. 

Facilities

Well equipped and spacious, the CRU has 7 beds. There are three 2-bed rooms, a one-bed exam room, conference room, and a small room for interviewing and consenting. There is an on-site room which has two centrifuges and a -80 freezer for processing and storing specimens. The CRU is located in Building 1 on 6 West at the VA, and is open from 7 am to 4 pm Monday-Friday, with weekends and/or overnight capabilities also available.  Directions to VAMC.

How researchers use this resource or service

VA CRUWe provide assistance for a full range of funded projects, including NIH, DOD, VA Merit Review, pharmaceutical industry, VHO’s and career development awards. We also collaborate with the Seattle ERIC (Epidemiologic Research and Information Center) and HS R&D (Health Services Research and Development Service). The Seattle Institute for Biomedical and Clinical Research (SIBCR) serves to facilitate the research and education endeavors of the investigators and staff. All funds expended by the Institute directly or indirectly support the research and education mission, and they also assist with budget review and finalization.

Below are some examples of how the VA CRU has been used by researchers:

  • Testosterone Replacement and Dutasteride Effectiveness (TRADE) -Determine whether correction of hypogonadism using a combination of testosterone and Dutasteride spares subjects from progressive symptoms of BPH associated with the use of Testosterone alone. Since the prostate is an androgen responsive organ, and the correlation of circulating androgens and the development of prostate cancer is controversial, intraprostatic hormonal milieu and the genetic program within the prostate it self, is examined to understand in vivo effects of androgen supplementation. This study will help guide clinic providers in the development of hormonal replacement protocols that will treat hypogonadal symptoms such as low libido, energy and initiative levels, cognition , and bone changes in the presence of obstructive prostate symptoms.
  • Mild TBI and Biomarkers of Neurodegeneration - The goals of this study are to gather data to be used to complete brain imaging, clinical neurologic and cognitive evaluation, and genetic and biomarker assessment obtained through lumbar puncture in a large cohort of blast exposed and control OIF veteran subjects to identify persons with mild traumatic brain injury at risk for degeneration of brain cells and progression to dementia.
  • Body composition in veterans with spinal cord injury and disorders - This is a cross-sectional study designed to define obesity and its comorbid effects on medical conditions, function and quality of life in veterans with spinal cord injury (SCI). The overall objective of this study is to provide health care providers who care for veterans with SCI a simple and accurate diagnostic tool for identifying and managing obesity. This study will address a significant problem found not only in SCI individuals but also in the general veteran population. Findings from this project will impact the way obesity is assessed among veterans with SCI. It will help bridge a major knowledge gap regarding the screening and diagnosis of obesity in a clinical setting.
  • Macronutrient Effects on Alzheimer’s Disease (MEAL) - will examine the effects of a high saturated fat / high glycemic index (HSF/HGI) diet and low saturated fat/low glycemic index diet (LSF/LGI) on memory and other cognitive functions, as well as on blood and/or CSF levels of insulin, IDE, FFA, AB40 and 42, and inflammatory markers in healthy older adults and patients with MCI/AD using a randomized, controlled design. There is a paucity of information regarding the effects of diet on insulin function in older humans at this time. The study will provide a well-controlled test of dietary effects on insulin levels, insulin action, AD biomarkers and inflammatory agents in healthy older adults and in adults with either Mild Cognitive Impairment (MCI) or Alzheimer’s Disease (AD).

Fees

The CRU provides a variety of fee-for-service procedures described on the request for clinical research unit services form.

Getting started

All investigators who plan on using the CRU must submit a request form to Susan Bigda. It can be accessed at www.sibcr.org via the clinical studies link.

Last modified: March 3, 2009