Janet McGill, M.D., talks to a possible clinical trial volunteer at Washington University's Volunteer for Health offices.

An innovative program at the Washington University School of Medicine has the twin goals of improving public knowledge about clinical trials and advancing the school's research. Volunteer for Health (VFH), which has received nearly 20,000 inquiries on clinical research from patients in its few years of existence, has enlisted thousands of volunteers for more than 100 trials.

The program is a boon for both volunteers and researchers, say VFH staff. It results in volunteers who are better informed and suited for the clinical trials they participate in. On the other hand, VFH's services, including its extensive database of potential volunteers, allow investigators to focus on research rather than recruitment.

"Volunteer for Health augments what the principal investigator and study coordinator are already doing," says Janet McGill, M.D., associate professor of medicine at Washington University and VFH director. The program was started in 1994 to increase diabetes patients' awareness of clinical programs at the university and was expanded university wide in 1998. Since then, VFH has handled nearly 19,000 calls, amassed a database of 8,500 individuals, and recruited for 135 studies.

VFH prescreens individuals and refers only those who are likely to qualify for a study. In addition, the program forwards to study coordinators volunteers' self-reported medical history information, expediting the referral generation process. VFH can handle the volunteer volume because of its dedicated phone systems, Web site, and staff - resources that are often out of reach for a single study coordinator. In addition, the program's offices are located on the main floor of the Barnes-Jewish Hospital, providing valuable access and visibility to hospital visitors and staff. Walk-ins are encouraged to inquire about current studies.

"We try to be sensitive to the needs and concerns of patients and their families as well as the needs of researchers," Dr. McGill says. She emphasizes that people are interested in their health and in supporting research that might advance knowledge about diseases and their treatment. "VFH has identified patients willing to participate as research subjects on all levels. We can match volunteers to appropriate studies since we have firsthand knowledge of many ongoing studies at the university."

Through its Web site, materials, and interpersonal interactions, VFH educates prospective volunteers both on clinical research's basic tenets and potential benefits and on specific trials. In this sense, VFH has acted as a vehicle for well-informed consent, says Carmen Gaebler, R.N., VFH program coordinator.

As its name implies, VFH stresses to prospective volunteers the public health benefits of participating in clinical research. The program appeals to volunteers' altruistic sides by utilizing slogans such as "Do something extraordinary by helping WU develop tomorrow's medicine today." Gaebler says this approach is especially effective with retirees, who have more time and want to contribute to research about disorders that affect them or someone close to them.

In the office or on the Web, people interested in volunteering can complete a health questionnaire that determines their eligibility for studies. Although a volunteer may not meet the requirements for one study, he or she can choose to be contacted for other current and future trials. Also, local practitioners, who may refer their patients to VFH, can receive free information about current clinical studies.

VFH works very closely with the medical school's institutional review board (IRB) and applies each year for IRB approval. The IRB reviews all VFH publications and materials. Therefore, as the program grows and IRB requirements change, VFH ensures that it strictly adheres to all policies and regulations, especially those concerning advertising studies and information collecting.

For a nominal fee, VFH services are available to every IRB-approved study at WU, and the IRB's applications now include a checkbox that principal investigators can mark if they're interested in using VFH. Gaebler says that VFH actively services 45 to 60 studies at any one time. As more studies register with the program, she expects a growing number of volunteers to contact VFH. "This increases the database and, ultimately, helps us to enhance the assistance we provide to Washington University's clinical studies."

- Jennifer Proctor

Information: Janet McGill, M.D., Program director for Volunteer for Health, (314) 362-8688, or Media Relations, (315) 464-4828