This proposal is based on the need to fully implement a comprehensive human subjects protection program for the University of Medicine and Dentistry of New Jersey (UMDNJ), its affiliates where appropriate and develop the infrastructure support to assure its effectiveness. In the fall of 2000 UMDNJ approved the conceptual design of such a program. This success of this program is imperative to protect the research participants that volunteer for research studies at UMDNJ, but most important a program such as the one described herein is important to begin rebuilding the public trust which has been damaged by the recent discoveries of inappropriate conduct by investigators resulting in unacceptable risk to research participants. The Public Health Research Institute is now located on UMDNJ's Campus in Newark as part of the International Intitute for Public Health and is a new partner in our human subjects protection program. This program as proposed is a tiertary model of education/training, Institutional Review Board oversight during initial and as an ongoing process for continuing review, and a monitoring and obervation program for ongoing research. The building of an infrastrucure for this function is imperative to its success as a model. Upon completion of program development, the UMDNJ Human Subjects Protection Program is expected to be a state-wide resource for all of our affiliates. Many programs have suffered from a lack of understanding of the structure and vast resources needed to fulfill responsibilities for the protection of human subjects. While UMDNJ has been a leader in developing human subject protection models and its Executive Director has participated with OHRP in oversight reviews, the additional resources that this grant will provide to strengthen and continue building our support base is urgently needed for the ongoing success of developing and strengthening our program.
