Human Subjects Research Enhancements Programs

St. Luke'S-Roosevelt Inst For Hlth Scis, New York NY

Investigators

Abstract

The Institutional Review Board at St. Luke's-Roosevelt Hospital Center (SLRHC) is responsible for the protection of human subjects in clinical research. Its activities must be responsive to federal, state and local hospital regulations as well as to the judgments of both its professional and community members. In response to increased public and governmental scrutiny of research on humans, further regulations have been added and old regulations have been more specifically defined and enforced. In several well-publicized examples, all research at a number of large institutions was closed down pending corrective action. There has been little or no increase in funds to support these activities. In addition, the government has increased the care with which it ensures the integrity of IRB decisions. New mandates have been established and old ones expanded. There are new educational requirements dealing with the protection of human subjects and a real understanding of conflict of interest. SLRHC has put in place activities supporting both of these important mandates, as well as systems to monitor compliance. The government, the main source of these new unfunded mandates, has stated that, for federally supported studies, all money for support of the IRBs is included in the overhead for that particular institution. However, planning for most ongoing investigations did not foresee the increase in costs consequent to these new mandates and have had to find additional sources of funds with which to support these important activities. We propose to strengthen the oversight of research on human subjects by instituting mechanisms to improve the accuracy, speed and effectiveness of the IRB and to provide on-going education in the protection of human subjects for both IRB members and the research community. We will: (1) Create a web site containing up-to-date guidelines, forms and regulations. The site will expedite IRB applications with technology designed to minimize errors and omissions and thus result in more efficient and rapid process; (2) Enhance the existing IRB database and link it to the web site so that it is automatically updated when an application is completed. The database also will be upgraded to make it more searchable and to permit a greater variety of reports to be generated; (3) Provide on-line education for both members of the IRB and researchers. Monthly review of new policies and/or clarification of old policies will be posted. Readers will be engaged with quizzes on current pertinent issues and ethical case histories. All such monthly reviews and quizzes will be archived for review. All of the above activities will be designed to be continued after the completion of the initial year of support.