Steinberg, Mindy J. MPH; Rubin, Elaine R. PhD
Ms. Steinberg is policy and program analyst, Association of Academic Health Centers, Washington, DC.
Dr. Rubin is vice president for policy and program, Association of Academic Health Centers, Washington, DC.
Correspondence should be addressed to Ms. Steinberg, Association of Academic Health Centers, 1400 16th Street, NW, Suite 720, Washington, DC 20036; telephone: (202) 265-9600; fax: (202) 265-7514; e-mail: firstname.lastname@example.org.
Increasing regulatory mandates, heightened concerns about compliance, accountability, and liability, as well as a movement toward organizational integration are prompting assessment and transformation in education and training programs at academic health centers, particularly with regard to clinical research compliance. Whereas education and training have become a major link between all research and compliance functions, the infrastructure to support and sustain these activities has not been examined in any systematic, comprehensive fashion, leaving many critical interrelated issues unaddressed. Through a series of informal interviews in late 2008 with chief compliance officers and other senior leadership at 10 academic health centers, the authors studied the organization, management, and administration of clinical research compliance education and training programs. The interviews revealed that while clinical research compliance education and training are undergoing growth and expansion to accommodate a rapidly changing regulatory environment and research paradigm, there are no strategies or models for development. The decentralization of education and training is having serious consequences for leadership, resources, and effectiveness. The authors recommend that leaders of academic health centers conduct a comprehensive analysis of clinical research compliance education and training as clinical trials administration undergoes change, focusing on strategic planning, communication, collaboration across the institution, and program evaluation.
Compliance education and training programs have long been integral to research at academic health centers. Increasing regulatory mandates and heightened concerns about compliance, accountability, and liability, as well as a movement toward organizational integration within academic health centers, are prompting assessment and transformation in education and training programs, particularly with regard to clinical research compliance. The educational programming necessary to train clinical research personnel on compliance is changing rapidly to keep pace with a constantly expanding regulatory environment. Administrative infrastructures have been developed to manage a complex web of policies, procedures, and regulations—and associated education needs—that affect thousands of personnel conducting clinical research within academic health centers nationwide.
Traditionally, compliance education programs for researchers focused on the ethical conduct of research; today, they include a broad range of issues from the basics of protocol and study design to budgeting and billing compliance. Education and training programs have expanded to include technical and operational issues and state and federal regulations that apply to clinical research.
Whereas education and training have become a major link between all research and compliance functions, the infrastructure to support and sustain these activities within academic health centers has not been examined in any systematic, comprehensive fashion, leaving many critical interrelated issues unaddressed. As part of an ongoing analysis by the Association of Academic Health Centers of clinical trials administration,1–3 we conducted informal interviews in late 2008 with chief compliance officers at 10 academic health centers to analyze the organization and structure of research compliance education and training activities and the nature and scope of current offerings.4 Although the institutions varied significantly in size and structure, the issues institutions confronted related to education and training were quite similar.
Common Themes Emerge
Profiles of the various institutions revealed a pattern of administrative decentralization for clinical research compliance education and training. The diffused nature of research compliance education shows* diminished visibility and weakened effectiveness of the function within the institution. In many cases, one office serves as a clearinghouse for information about the various training opportunities available throughout the institution, but it is rare for any one office to have complete responsibility for and authority over all of the training at the institution. The decentralization of clinical research education and training has resulted in significant variation in standards, content, and delivery methods, often hampering the institution's ability to strategically address the education and training function.
Our findings show that subject matter drives program development and the administration of education and training, with training divided among different departments and schools on the basis of the topics being covered. Course offerings are found under the auspices of the institutional review board, the office of research administration, the compliance office, the office of human subject protection, the grants and contracts office, various hospital departments, and/or the various billing departments throughout the institution. Spread across the institution, and with no one person or office with direct responsibility for all education and training activities, the infrastructure provides no framework for strategic planning or the development of new processes and procedures related to education and training. Ultimately, the curriculum suffers. The development of new training offerings, therefore, becomes focused around the buzz of the moment rather than the needs of the institution and the changing realities of the research enterprise.
Although training is offered to a broad range of stakeholders in the research enterprise, participation is frequently voluntary. Mandatory training for the various research constituencies varies significantly within and among institutions. Compliance officers voiced interest in expanding the number of mandatory offerings as well as linking mandatory training to job performance evaluation. However, the expansion of mandatory offerings is hampered by the variability in job titles and job descriptions as well as a high turnover in research staff. Without standard job titles and descriptions, a systems approach to monitoring and enforcing training completion will be difficult. Without such a system in place, institutions are reluctant to begin linking education and training to job performance for fear of uneven application across the institution.
The design and delivery methods used in education and training vary widely. Almost all of the profiled institutions have—or will soon have—a significant portion of their education and training in a Web-based format. Often, the courses most in demand or those that are mandatory are offered via the Internet in an effort to accommodate the schedules of a greater number of faculty and staff.
Barriers to Success and Factors to Address Them
What we learned from the interviews with chief compliance officers made clearer than ever that research compliance education suffers from a lack of visibility within the academic health center, resulting in low prestige and limited decision-making power. A lack of consolidation of education and training may result in faculty and staff perceiving the function to be of limited importance. Time constraints of faculty and staff further complicate the problems caused by decentralization of the function. Principal investigators often perceive training as an unnecessary distraction from their research and report that training covers topics they are already familiar with. The multiple competing demands on faculty and staff time are symptoms of larger regulatory problems and administrative burdens that cannot be addressed solely through the education and training function.4
Leadership is critical to the success of clinical research compliance education and training. Compliance officers described direct involvement of senior academic health center leaders in developing or supporting education and training as a key factor in facilitating consolidation across the institution and in ensuring the adequate allocation of resources to education within the larger research enterprise.
Strategic thinking on communications with respect to education and training is rare. Only one profiled institution has a strategic plan for communications. When asked about the existence of a strategic communications plan, interviewees often pointed to the means of communication or tasks to accomplish. Institutions will need to approach communications as a strategic issue requiring systematic planning to establish a framework for information flow and image development. If institutions would approach communications from a strategic vantage point, they would be more able to address perceptions and concerns of target audiences, including the view that compliance offices only deal with enforcement.
Difficulties in engaging some important research constituencies in the full scope of education and training may also reflect how the lack of strategic communications planning has had a detrimental impact on the function's image and significance within the academic health center. A perception that education is low in the hierarchy of importance can also risk reallocation of needed resources to other areas of the institution, thus limiting even further the education function. Strategic communications planning would permit educators to work with all stakeholders to identify and implement viable communication options.
A variety of factors, particularly the decentralized nature of the education and training function, create reason for concern about the ability of academic health centers not only to adequately monitor and evaluate training offerings but also to address compliance readinesss for the future. Assessment of program elements or educational tasks seems to be the norm within academic health centers rather than a broad examination of the goals, relevance, practicality, and effectiveness of education and training as a whole. Through a comprehensive evaluation, compliance officers would be able to gain needed feedback on participants' perceptions of the quality of training, assess the usefulness of the information provided, and determine how that information is being applied in the research context.
The inability to conduct such evaluations may be having unintended consequences. For example, many institutions are attempting to strike the balance between education and training and time constraints of faculty and staff by transitioning to more online training that is less time-intensive and more flexible to researchers' schedules. With a one-dimensional assessment that takes account of faculty time only, institutions may be compromising the quality of the education, which would have the effect of diminishing both the importance of the information in the eyes of researchers and also comprehension and information retention in the course. The overall perception of the researchers may be one of lowered standards for training rather than enhanced programming focusing on increased innovation and research productivity.
Our examination of the education and training function at academic health centers highlights many critical, interrelated issues that require attention as clinical trials administration undergoes change. With public and economic exigencies increasingly threatening the research enterprise, academic health center leaders and research administrators must address one of the fundamental pillars of the enterprise—clinical research compliance education and training. To ensure that the research enterprise remains viable in the future, academic health center leaders should
* engage key stakeholders to develop and implement a comprehensive, institution-wide, strategic plan for education and training that addresses (1) infrastructure and the opportunities for consolidating all institutional programs within one office or under one senior administrator, and (2) leadership requirements to ensure that the individual managing education and training is knowledgeable about the clinical research enterprise, regulatory compliance, and adult learning;
* ensure that a communications plan is part of the strategic plan and that it addresses the needs of all research constituencies;
* address human resource policies that create barriers to education and training, and develop plans to standardize job titles and descriptions;explore creative solutions, including, but not limited to, technologies to expand faculty and staff engagement while increasing effectiveness;
* develop and implement a comprehensive evaluation plan to actively monitor the success of training offerings, delivery methods, and educational techniques; and
* establish mechanisms to collaborate across the academic health center and share innovative ideas with all academic health centers.
As institutions have decreased resources to respond to the changing research environment and expanding regulatory mandates, a comprehensive analysis of the education and training function is needed to ensure current quality and effectiveness along with future creativity and innovation.
1Rubin ER, Lazar D, Gaich N, Haray D. The Clinical Trials Landscape: Limitations, Strengths, and Promise. Washington, DC: Association of Academic Health Centers; 2007.
2Association of Academic Health Centers. Investing in Clinical Trial Compliance. Washington, DC: Association of Academic Health Centers; 2007.
3Rubin ER, Lazar D, Gaich N, Haray D. The Clinical Trials Functional Process Map: A Guide to a High-Performing Research Enterprise. Washington, DC: Association of Academic Health Centers; 2008.
4Steinberg MJ, Rubin ER. Research Compliance Education and Training Programs: Responding to a New Regulatory World. Washington, DC: Association of Academic Health Centers; 2009.
* We have used the present tense to report our findings from the informal interviews to highlight our conviction that little has changed since those interviews. Cited Here...