This proposal is a continuation of funding 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. This program is into the third year and growing in stature, not only as a regulatory necessity, but also as a resource to the faculty, students and community. The 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. Over the past months we have reached out to our affiliates and neighboring institutions to include them in our educational initiatives and are building relationships with new partners 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 observation 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 infrastructure and resources needed to fulfill the 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 in educational initiatives in this regard, 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.
