Eighth Annual Grant Winners 2007-2008
David Thomas, M.D. - HPD-OST
Josephine Shallo-Hoffman, Ph.D. - HPD-OPT
Anthony Silvagni, Dean - HPD-OST
Title: Quality Enhancement Program for the NSU Institutional Review Board
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.