Infrastructure issues can hamper program effectiveness within academic health centers

The infrastructure required to support and sustain compliance education and training programs is often decentralized and under-resourced which can hamper program effectiveness within academic health centers, according to Mindy Steinberg, MPH, and Elaine R. Rubin, Ph.D., of the Association of Academic Health Centers (AAHC), in this month's issue of Academic Medicine.

In their commentary, Compliance Education and Training: A Need for New Responses in Clinical Research, the authors note that while clinical research compliance education and training programs are undergoing growth and expansion to accommodate a rapidly changing regulatory and research environment, there are no strategies or models for developing administrative infrastructure.

Based on a series of informal interviews with chief compliance officers and other senior leadership at academic health centers, the authors found that the diffused nature of research compliance education shows diminished visibility and weakened effectiveness of the function within the institution.

The interviews revealed significant infrastructure issues that hamper effectiveness, including highly decentralized program development, dispersed leadership, variability in implementation and enforcement, limited standardization of the training mechanisms, and a lack of strategic planning.

To strengthen and sustain research compliance education and training, the authors recommend:

• Engaging key stakeholders to develop and implement a comprehensive, institution-wide strategic plan;
• Ensuring that an effective communications plan is part of the strategic plan;
• Addressing human resource policies that create barriers;
• Exploring creative solutions, including technology, to expand faculty and staff engagement and interest;
• Developing a comprehensive evaluation plan to monitor success and effectiveness; and
• Establishing mechanisms to collaborate and share innovative ideas institution-wide and with other academic health centers.