The SRA Symposium - College of Medicine

There are two main accrediting bodies, “The National Committee for Quality Assurance” (NCQA)
and the “Association for the Accreditation of Human Research Protection Programs, Inc. (AAH-
RPP). In 2003, The NCQA and the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) joined forces to develop the “Partnership for Human Research Protection”
(PHRP), an independent accreditation organization to broaden the NCQA’s former range from
Veterans Affairs Medical Centers to public and private hospitals, AMCs, and research facilities
(National Committee on Quality Assurance [NCQA], 2003).
AAHRPP was incorporated in 2001 as an amalgamation of several renowned biomedical and
academic research organizations, including but not limited to, the Association of the American
Medical Colleges (AAMC), the Association of American Universities, the National Health Council,
and Public Responsibility in Medicine and Research (PRIM&R). The guiding premise behind
AAHRPP’s accreditation program is that the protection of human research participants should be
a responsibility shared amongst institutional review boards, investigators, and organizations with
the oversight of an accrediting body (Speers & Cooper, 2003).
Efforts aimed at improving HRPPs would be remiss if comprehensive education was not an
integral component of the approach. As Shalala (2000) notes, “The never-ending challenge for
academic institutions and other organizations participating in research is to make sure that researchers
and other personnel have up-to-date training and a thorough knowledge of their responsibilities.
Those responsibilities include communicating with IRBs, ensuring that procedures
for informed consent are followed, monitoring compliance with protocols, and reporting on safety
issues.” Comprehensive education efforts for the entire research program at AMCs should be
focused on not only facilitating the understanding of Federal regulations and institutional policies
and procedures, but also on the results of their own compliance activities. Through compliance
activities, AMCs are able to scrutinize the clinical research conducted at their institution, monitor
for common non-compliance trends, and identify areas of needed continuing research education.
Furthermore, improved educational efforts and compliance activities in conjunction with all components
of research administration serve to improve the overall quality of the research, increase
the quality of human subject protections, and enhance the efficiency of the IRB (Sugarman, 2000).
This paper aims to describe the development, implementation and evaluation of a prospective
approach to research compliance monitoring at an Academic Medical Center. The information
described and presented will allow research administrators and investigators from other institutions
to gain knowledge and ultimately share best practice experiences in this area while maintaining
a focus on the role of research administration functions in the responsible conduct of clinical
research.
Methods:
Papers
The various types of research administration activities aforementioned were developed to supplement
the grant and IRB administrative functions at UHC beginning in 1999. With the development
of education and compliance monitoring programs the institution needed to create policies
and procedures for collecting internal outcome data and to be able to respond appropriately to the
data it was collecting.
2005 Symposium Proceedings Book 69