Research subject advocacy: program implementation and evaluation at clinical and translational science award centers.

In 2000, the National Institutes of Health (NIH) National Center for Research Resources (NCRR) introduced the requirement for institutions to create a Research Subject Advocate (RSA) position at NCRR-funded General Clinical Research Centers (GCRCs) to enhance human research subject protections. The primary function of RSAs would be to ensure that human research studies were “designed and conducted safely and ethically with protection of human subjects accorded the highest priority.”1 The RSA program was initially deployed in 78 NCRR-funded GCRCs; each center was responsible for defining the specific activities of its RSA,2,3 maximizing the flexibility of the position and preserving local discretion in filling institutional and center-specific needs according to the general guidelines.1 While some members of the Clinical and Translational Science Award (CTSA) RSA Taskforce4 and of the national Society of Research Subject Advocates5 have broad experience with the roles fulfilled by RSAs in the GCRCs, no one has compiled a systematic inventory of how GCRCs incorporated the position. Historically, only a few RSA programs have published evidence about their RSA activities.6–11 The implementation of the CTSA program presented an opportunity for the NCRR to extend the platform for research subject advocacy, while preserving local control of the funding, design, and scope of RSA roles and responsibilities. Without specific guidance, some CTSA institutions dismantled their RSA programs, either distributing research subject advocacy-specific functions across other institutional entities or abolishing them entirely. Other CTSA centers expanded their RSA programs, adding responsibilities, complementary oversight, and resources. In 2007, to clarify the role of RSAs at CTSA centers, the Consortium Executive Committee (CEC) asked the Regulatory Knowledge and Support (RKS) Key Function Committee (KFC) to convene a taskforce to recommend best practice functions for RSA programs. Through a collaborative, iterative process, the taskforce proposed and the executive committee endorsed four RSA Best Practice Functions in January 2008 (see List 1).4 List 1 Research Subject Advocacy (RSA) Best Practice Functions within the Clinical and Translational Science Award Consortium, 20084 The RSA functions should include a reporting pathway to institutional officials of appropriate authority and should be free of conflict of interest. The RSA functions should be complementary to and integrative with existing entities at the institution to promote and facilitate safe and ethical conduct of human research. The RSA functions should have, or have direct access to, an authority that can temporarily suspend a research activity based on ethical and safety concerns so that problems can be explored or resolved through proper procedures. This capacity enables preliminary intervention into problems that might not necessarily invoke an institutional review board suspension. The RSA functions should be a resource to the research community and to participants; have a voice in policy regarding research ethics, participants rights, and research safety; and play a role in the protection of human subjects and responsible conduct of research educational programs of the institution. Subsequently, the CEC asked the RSA taskforce to explore models of RSA Best Practice Function implementation and to make recommendations for the evaluation of these models. Currently, there are no CTSA-endorsed evaluation metrics for assessing the implementation of the RSA Best Practice Functions.12 Anecdotes of RSA program heterogeneity, and the absence of standards or a recent inventory of RSA program implementation strategies, led the taskforce to develop a multi-step initiative to: (1) describe the models of RSA program organization, associated activities, and current modes of evaluation; (2) define meaningful outcome measures for those activities; and (3) develop the methods to assess these outcomes. In this report, we describe the method and results of a survey designed to address the first step of this initiative. Based on the results, we then present recommendations for the next step of the process--defining outcome measures to enable CTSA centers to evaluate whether they have fulfilled the RSA Best Practice Functions.