Background:

In the summer of 1959, the U.S. Senate Committee on Appropriations recognized the need to expand federal support of clinical studies in health and human disease. The committee recommended that special centers for clinical research be established throughout the country to address the deficit in clinical investigation.

Two years later, a nationwide clinical research program was developed by the National Institutes of Health (NIH). Funds were released in May 1960 for the establish- ment of "General Clinical Research Centers". Three months following the announcement, nineteen medical schools responded with requests to form centers.

The University of Virginia General Clinical Research Center (GCRC) opened in April 1968. This is an NIH-supported multi-disciplinary research facility located on the 8th Floor of the University Hospital of the University of Virginia Health System. The GCRC provides investigators with the specialized resources necessary to conduct advanced clinical research. The facility includes ten inpatient beds, skilled research nurses, a core assay laboratory, a metabolic kitchen, outpatient facilities, computing and statistical consultants and facilities, and sleep and exercise physiology laboratories. 

What type of studies are done here?

More than 250 research protocols have been, and are being, pursued on the GCRC.  Selected themes are illustrated below:

- Regulation of growth hormone secretion in children, young adults, and the elderly in health and disease.
- Hormonal changes in the menopause with or without estrogen replacement. 
- Anatomic and physiologic basis for, and consequences of, the sleep apnea syndrome. 
- Metabolic responses to exercise in obese subjects, athletes, and the aged. 
- Mechanisms of rennin, prorenin, and aldosterone regulation. 
- Relevance of air and body-borne allergies to asthmatic disease. 
- Therapeutic effects of anticonvulsant and antihypertensive drugs. 
- Impact of renal transplantation on pancreatic beta-cell function. 
- Impact of pancreatic transplantation in diabetes mellitus. 
- Effects of steroid hormones on pituitary function and body composition. 
- Pathophysiology of gastrointestinal motility disorders. 
- Neuroendocrine physiology of puberty in boys and girls. 
- Metabolic markers and consequences of diabetes mellitus.

Resources of the GCRC:

Ten semi-private inpatient beds
Outpatient facilities for clinical research studies
Protocol Development Office
Metabolic Kitchen staffed by nutritionist and dietary aides trained in research
Experienced and Skilled Research Nurses present 24 hrs/day
Core Laboratory facilities including the capability to develop new research assays
Access to state-of-the art computing and software programs custom-designed to store, protect and analyze clinical research data
Computer and graphics consultants for basic and complex projects
Statistical, Biomathematical , and study design consultation
Exercise Physiology Laboratory
Sleep Research Laboratory
Research Subject Advocates 
Access to all hospital services, including radiology, electrocardiography, physical and occupational therapies, chaplains, pharmacy and social work

Human Investigation Committee:

All clinical research plans are submitted to thoughtful, complete, unhurried, and committee-wide review by a panel of physicians, scientists, ethics, religious and community representatives. The Human Investigation Committee must grant prior approval before any clinical research study is initiated. All studies are voluntary, and carried out only after written informed consent is provided by the volunteer.  A subject may decline initial or continuing participation in any study for any reason at any time.

The GCRC Research Advisory Committee:

All clinical experiments must also be reviewed and approved for scientific merit, validity, significance, relevance, and feasibility by the GCRC Research Advisory Committee. This advisory board is chaired by the Dean of the Medical School. Voting members are MD and PhD scientists with diverse research experience and statistical expertise to offer critical advice and constructive guidance.

Training of Physicians and Scientists:

An integral activity of the GCRC is the stimulation, direction, training, and preparation of physicians and scientists at various stages of their careers for significant clinical research accomplishments. Training is by mentorship, formal coursework, weekly clinical rounds, and an annual clinical research day with external scholars in attendance. These avenues offer a significant impetus to physicians at multiple stages in their clinical research training, beginning in medical school and extending through internship, specialty residency training, post-doctoral subspecialty fellowship, and academic faculty-level investigator-ship. The Clinical Associate Physician (CAP) award is offered by the NIH as a competitive GCRC supplement to outstanding subspecialty research fellows who are devoted to clinical and basic medical investigation. This award allows junior faculty appointments with the aim of motivating a life-long commitment to clinical research.

The Multidisciplinary Training Program in Clinical Investigation or MTPCI was created to foster the development of physicians and scientists into successful, independent clinical investigators.  The program is supported by the School of Medicine and the General Clinical Research Center

Who pays for the services?

Most costs are borne by our NIH GCRC grant. For example, room charges, nursing care, basic laboratory studies, meals, and the cost of computer usage are paid by the GCRC grant. Investigators with clinical study protocols approved by the Human Investigation Committee and supported by peer-reviewed intra- or extramural funds receive these services at no cost. If an investigator is carrying out an industry-initiated study, fees are charged based on proportionate utilization of resources.