Development and progression of a model: prospective research compliance monitoring.

Author:Fedor, Carol
 
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Introduction

More than a decade ago, Weijer (Weijer et al., 1995) called for institutional research compliance monitoring programs for several purposes: education of researchers; prevention of problems; and avoidance of financial loss due to fraudulent research. In 2001, the FDA monitoring program revealed that 70% of human subject protection deficiencies are the result of investigator noncompliance (Wolfe & O'Rourke, 2002). Following the 1999 death of a healthy volunteer, the University of Pennsylvania developed the Office for Human Research (OHR) to assume internal compliance monitoring responsibilities. The focus of OHR was on investigator-initiated studies and moderate- to high-risk research whose mission was "not only to discover possible noncompliance but also to provide the education, tools, and resources to correct noncompliance" (Sherwin & Fromell, 2002). The UHCMC CCRT implemented a comparable approach, emphasizing post-IRB approval monitoring in unison with research education to promote research integrity.

Prior to the development of a prospective compliance monitoring program, investigation of allegations of noncompliance was a burdensome task requiring extensive resources by the UHCMC IRB office. Rather than compromising the effectiveness of the IRB and compliance program by exhausting shared personnel, the CCRT recognized that separate staff with compliance expertise would ensure efficiency of the monitoring program. The CCRT's prior experience also demonstrated that directed monitoring, or monitoring required by the IRB in response to a noncompliance issue, was not an effective or proactive means by which to manage noncompliance. As a result, the Office of Research Compliance (ORC) was created under the quality improvement initiatives for the Human Research Protection Program (HRPP), and was introduced to the research community as research-support services. The ORC applied the Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements as the foundation for the ORC's Standard Operating Procedures (SOPs). The initial SOP manual summarized the monitoring process, including the categories listed in Table 1.

The following factors are considered when identifying priorities for monitoring of clinical research protocols: risk level; study population; whether the study involves treatment or intervention; and whether the study is investigator-initiated, industry or foundation originated, or federally funded. These categories represent factors to classify research conduct that poses greater than minimal risk to participants and may have a lesser amount of oversight by external regulatory monitors.

Congruently, with the development of the prospective compliance monitoring program, research education resources were being dedicated to establish a consistent offering of individualized and interactive education sessions. Beginning in September 2000, institutional programs were developed in preparation for the NIH mandate for investigator certification requirements in Human Subject Protections. Along with the initial core training utilizing the text "Protecting Human Subjects in Research" (Dunn & Chadwick, 1999) and subsequent adoption of the Collaborative Institutional Training Initiative (CITI) core curriculum, institutional seminar series, panel discussions, and workshops were developed, marketed and conducted monthly. The following categories of individuals from the research community were targeted for the research education and training (Table 2).

These extensive efforts have successfully culminated in improving the conduct and oversight of research and establishing a program that transformed compliance monitoring into research integrity through principles of research conduct.

Background

The diverse roles of research administrators have become progressively more comprehensive as this discipline moves toward continued professionalization and the conceptualization of research expands to an all-encompassing Human Research Protection Program (HRPP) (Cola, Fedor, & Haffke, 2005). Research administrators are responsible for the legal, fiscal, ethical, and scientific and compliance reviews of protocols from their initiation through completion. In the past, research administrators were regarded primarily as grant or IRB administrators (Cola, Fedor, & Haffke, 2005). In response to recent trends in clinical research and growth of regulatory oversight requirements, the profession has become more encompassing, and research administrators have assumed the roles of grant writers, clinical research coordinators, human subject protection and compliance specialists, and research billing professionals. This professional evolution has lead to increased awareness and understanding of the vital roles that research administrators serve in the conduct of both basic science and clinical research.

A distinct area that has recently gained considerable momentum has been the role of the clinical research compliance monitor. Similar to other academic or business specialties, the process of conducting clinical research is closely monitored. Historically, this monitoring has been performed by external sources (i.e., the sponsor, contract research organization(s), or federal agencies). During the past decade, given the remarkable growth in clinical research, it has become evident that relying solely on external...

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