Dominick P. Purpura - US grants

biomedical equipment resource;

biomedical equipment purchase; image processing; electronic recording system;

biomedical equipment purchase;

A tradition of scientific excellence and open collaboration among the faculty will foster the establishment of a new GCRC program at the Albert Einstein College of Medicine-Montefiore Medical Center. The Einstein- Montefiore GCRC will serve a population in the Bronx and Westchester Counties of New York State totaling some 1.9 million people, half from minority racial and ethnic groups. The strong commitment of the two institutions to the GCRC initiative has provided new space and facilitated access to resources for patient-oriented research. The enthusiasm for the GCRC program is demonstrated by the participation of 44 investigators from a total of II departments--both clinical and basic science--who will be involved in the projects described in this application, bringing to bear over $14 million in federally-funded research support. These investigator- initiated projects involve a diverse range of human diseases such as diabetes, tuberculosis, Wilson's disease, liver disease, sickle cell anemia, polycystic kidney disease, systemic lupus erythematosus, infectious diarrhea, obesity, cardiovascular disease, impotence, cervical cancer, and dementia. The projects bring together interdisciplinary research which is principally NIH-funded but which lack adequate resources for clinical studies. The GCRC facilities are located on a single campus in the Bronx; the GCRC administrative, outpatient, sample processing laboratory, and biostatistical components will be located at the College of Medicine and the inpatient per diem admissions and special procedures units at the contiguous University Hospital. A large number of Centers and Shared Scientific Facilities will provide support to GCRC investigators. The Einstein GCRC will provide an environment to conduct human studies and to facilitate data acquisition, management, and analysis, and will encourage collaborations between basic and clinical scientists. Finally, the GCRC will serve as the centerpiece of the Institution's commitment to the training of young physician scientists. The Center's administration will include executive staff from the College of Medicine and Hospital, and the Center will be directed by an experienced group of investigators with previous GCRC experience, basic science expertise and strong independent scientific programs.

The protection of human subjects is of high priority to all clinical investigators and institutions. The Albert Einstein College of Medicine, Montefiore Medical Center, Ferkauf Graduate School of Psychology, and Wurzweiler School of Social Work maintain a strong commitment to the safe and ethical treatment of human subjects. Two Institutional Review Boards (IRBs) located at the Albert Einstein College of Medicine (Einstein) and Montefiore Medical Center (MMC) oversee all of the human research protocols at these four institutions. The IRBs function under the auspices of a federally-approved Cooperative Agreement which ensures institutional oversight and adherence to federal regulations. While one IRB serves as the Primary Reviewer, the other is kept informed via an Ad Hoc mechanism. The two IRBs meet regularly in a Joint Conference Committee to review policies, procedures and mutual concerns. Our aim is to extend the implementation of the Einstein/MMC web-based Protocol Application and Tracking System (PATS) to the Ferkauf Graduate School of Psychology and Wurzweiler School of Social Work. The addition of PATS to Ferkauf and Wurzweiler will enhance the monitoring and coordination of behavioral and social research, reduce submission errors, track all required paperwork (including amendments, progress reports, adverse events, etc), and enhance the quality assurance program. In addition, we propose to customize the human subjects educational component at Ferkauf and Wurzweiler by dealing specifically with issues related to behavioral and social research. Tailored seminars will be offered on all campuses to make it easier for faculty and students to attend. These customizations will require infrastructure, technology and educational materials development. Resources are requested for the continuing development and alterations to the multiplatform web-based application as well as the educational component. This will ensure high quality monitoring and coordination of the behavioral and social research protocols conducted at each institution.