Academic Medicine

Skip Navigation LinksHome > September 2012 - Volume 87 - Issue 9 > Research Subject Advocacy: Program Implementation and Evalu...
Academic Medicine:
doi: 10.1097/ACM.0b013e3182628afa
Research Issues

Research Subject Advocacy: Program Implementation and Evaluation at Clinical and Translational Science Award Centers

Kost, Rhonda G. MD; Reider, Carson PhD; Stephens, Julie; Schuff, Kathryn G. MD; on behalf of the Clinical and Translational Science Award Research Subject Advocacy Survey Taskforce

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Abstract

Purpose: In 2000, the National Center for Research Resources mandated that general research centers create a research subject advocate (RSA) position. In 2008, the Clinical and Translational Science Award (CTSA) consortium endorsed a new advocacy model based on four RSA Best Practice Functions. The authors surveyed CTSA centers to learn about their implementation of programs to fulfill the RSA functions.

Method: In 2010, the RSA taskforce developed a two-part online survey to examine leadership, organizational structure, governance, scope, collaboration and integration, and funding and evaluation of RSA activities implemented at CTSA centers.

Results: Respondents from 45 RSA programs at 43 CTSA centers completed the survey. Senior university or CTSA officials led all programs. Ninety-six percent (43/45) of programs were funded by a CTSA core. Eighty percent (36/45) designated an individual “RSA.” Ninety-eight percent (44/45) provided diverse services either in collaboration with or complementary to other departments, including development of data and safety monitoring plans (16/45; 36%), informed consent observation (10/45; 22%), training responsive to audit findings (12/45; 27%), and direct advocacy services to participants (11/45; 24%). Eighty-six percent (24/28) reported qualitative evaluation methods for these activities.

Conclusions: RSA programs conduct both collaborative and unique research protection activities. This survey, an initial step in developing a more robust mechanism for evaluating RSA programs, collected valuable feedback. The authors recommend defining and developing outcome-based evaluation measures that take the heterogeneity of the individual RSA programs into account while advancing their value and effectiveness in protecting human research subject participants.

© 2012 by the Association of American Medical Colleges

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