Clinical research subject recruitment: the Volunteer for Vanderbilt Research Program www.volunteer.mc.vanderbilt.edu

Abstract

This article provides information concerning a novel research subject recruitment registry developed at Vanderbilt University. Project goals were (1) to provide a mechanism for lay individuals to self-enter information conveying interest in volunteering for clinical research and (2) provide tools for researchers to select and contact potential volunteers based on study-specific inclusion criteria. The registry was built and offered as an institutional resource to all university scientists conducting institutional review board-approved research. The authors present (1) a model for redesigning workflow associated with subject registration, volunteer retrieval, and subject contact; (2) details of a Web-based software application used as a focal point in designing workflow for our system; (3) descriptive statistics for volunteer and researcher use of the system during the first 32 months of operation; (4) cost estimates for the project; and (5) a set of recommendations for other medical centers wishing to adopt similar methodology.

Figure 1.

Registration process diagram using central software application.

Figure 2.

(A) Registry population versus time. Note the initial Vanderbilt Medical Center and campus e-mailing resulted in approximately 800 registrants. Since this time, the registry has averaged approximately 65 entries per month based largely on passive Web site advertisement. (B) Monthly data viewing frequency versus time. Viewing information was reported for each event in which an individual researcher was presented contact information for an individual subject registrant. Although cyclical, the general trend shows progressive use of the registry by researchers actively recruiting subjects for clinical studies.

Figure 3.

Histogram representation of (A) age and (B) body mass index (BMI) data collected from subject response data. Age and BMI data are slightly skewed, indicating a potential for selection bias toward young, healthy volunteers.

Figure 4.

Disease of interest. Of 2,907 respondents, 918 (32%) individuals volunteered no disease of interest, whereas 1,989 (68%) individuals indicated at least one disease of interest. Of those individuals who volunteered disease(s) of interest, each individual may have chosen up to three categories of interest. Disease categories are shown in order of frequency of selection.