Human Subjects Research Enhancement Program at Columbia

Columbia Univ New York Morningside, New York NY

Investigators

Abstract

This proposal has two specific aims which are designed to complement Columbia University's current efforts to enhance our education of human subject participants and our internal IRB administrative work,flow and systems : (1) The development of an audiovisual/multimedia program which would be available to potential human research participants and the general local community which would explain, in common terms, what research is; what is the role of human participants; what "informed consent" means; what should be considered prior to participation; and what the rights of participants are. (2) The enhancement of Columbia's web-based Research Administration (RASCAL) system's IRB module to allow it to be utilized by affiliated institutions and other institutions involved in our human subject research. Aim 1 is an educational initiative aimed at all shareholders in clinical research - participants, investigators, administrators, and IRB members. Not only will the end product be invaluable in enhancing the informed consent process, but the process of its development and distribution will lead all parties to a greater understanding of the underlying fundamentals of the informed consent process and the ethical conduct of clinical research. Aim 2 will enable Columbia to provide our affiliated institutions and other entities with access to the web-based, secure, comprehensive, state-of-the-art research administration system that is being develed; in particular, the IRB module which contains an Informed Consent Builder, an IRB Protocol Builder, and administrative workflow and record-keeping system. This programming enhancement will lead to improved monitoring and coordinating of adverse event report between multiple sites, increase coordination of inter-institutional IRBs and the approval of multisite consent forms, strengthen continuing review, facilitate the role of DSMBs, and serve to enhance the overall protection of human research subjects at Columbia and at national and international institutions which participate with Columbia in research involving human participants.