The AAHC’s Forum on Regulation ELG continues to be active addressing new issues that impact academic health centers and the portfolio of chief compliance officers. Forum meetings and member exchanges have produced a variety of products and initiatives including:
Clinical Research Compliance Education and Training
After collaborating with the AAHC to produce its Clinical Trials Administration Toolkit, the Forum identified the need to focus attention on clinical research compliance education and training. Based on in-depth profiles of several member institutions, the AAHC issued a report, Research Compliance Education and Training Programs: Responding to a New Regulatory World. A follow-up commentary authored by AAHC staff, Compliance Education and Training: A Need for New Responses in Clinical Research, was published in Academic Medicine in March 2010. In both the issue brief and commentary article, AAHC identified several areas for improvement in clinical research compliance education and training. Working with members of the Forum, the AAHC developed a new Clinical Research Compliance Tool on Education and Training assisting academic health center leadership to assess the current state of their education and training programs, evaluate existing processes, identify areas for improvement, and develop a strategic plan for the future.
Clinical Trial Policy and CMS
The Forum on Regulation continues to identify and take a leadership role in advocating for more standardized implementation of the Centers for Medicare & Medicaid Services (CMS) clinical trial policy. With language in place in the newly-enacted health reform law requiring private insurance companies to cover routine care in clinical trials, the Forum is engaging with CMS to advocate for a more standardized enforcement of coverage for routine care services provided to Medicare and Medicaid beneficiaries enrolled in clinical trials. As CMS undergoes a significant restructuring under the Obama administration, the Forum’s Workgroup on Education and External Affairs anticipates developing a stronger relationship with new CMS leadership to address existing and upcoming policies and regulations that impact academic health centers.
The Use of Cadavers and Other Identifiable Body Parts in Research and Education
After a dynamic discussion at its May 2009 meeting, the Forum established a new workgroup to address policies and procedures governing the use of cadavers and other identifiable body parts in research and education. Based on an AAHC survey of 34 Association of Academic Health Centers 2010 Annual Report Forum members, the workgroup determined: 1) there is a need for improved processes governing the use of human specimens for research and education; 2) many academic health centers should consider developing policies and procedures on an institutional level; and 3) many of the institutions that reported having already put new policies in place had done so in the wake of a challenging experience. The workgroup created a best practices document on how to assess the institutional landscape and begin the process of developing and instituting new policies and procedures.