Deans

Anthony Silvagni – College of Osteopathic Medicine

Award Date

1-1-2008

Abstract

Institutional Review Boards are an outgrowth of past abuses in the research system and exist in law for the protection of human subjects participating in research protocols. It is incumbent upon conscientious IRBs and their parent institutions to constantly seek to improve the quality of the review process. Continuous Quality Enhancement is essential for the operation of a sophisticated University Institutional Review Board. To that end this research is of paramount importance to the University for the protection of its human subjects, its image in the community, the quality of the research product, and compliance with the regulatory schema which gets ever more burdensome. This proposal attempts to establish the data necessary and the protocols required to implement a continuous quality enhancement plan for the NSU-IRB. This research is of both a qualitative and quantitative nature. The measurable objectives include: An internal analysis of the operation of our IRB An external analysis of the operation of our IRB An internal analysis of the policies of the OHRP as interpreted by the current membership of that body (see above- turnover of the regulators and varying interpretations). An evaluation of IRBís identified by various sources (including information gleaned from OHRP itself) as doing high quality reviews and protection of their human subjects while still fostering the research needs of their parent institution. An evaluation of IRBís which have had (according to public records of the OHRP) problems in protecting their human subjects during research and why they had the problems, what led to the problems and how (if) they have addressed the problems. Developing NSUís IRB into a model IRB of high quality protection of human subjects while embracing the research needs of the University.

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