The Public Health Institute (PHI) proposes to provide additional resources during a one year period to strengthen the oversight of human subjects research by its hqstitutionat Review Board (IRB). The IRa currently conducts its 1RE}activities in conformity with federal regulations, but the institution also recognizes that the education of its investigators and tRB members could be enhanced with additional tools, and that the overall administration and recordkeeping requirements could be streamlined and improved. One goal for this next year will be to research and identify resources particularly appropriate to PHI's mix of research projects and to make those resources readily available to our researchers on a secure website available to all PHI staff. A second goal will be to research, purchase and install software designed for IRa use, to track projects submitted to the IRa from first submission through final closeout. PHt's mix of research projects includes some whose Principal Investigators (PIs) are PHI employees. PHI also acts as a grantee agency for some projects conducted by PIs who are employees of the State of California. We propose to enter into discussion with California's Committee for the Protection of Human Subjects to explore whether or not our two institutions could negotiate some sort of inter-institutional or cooperative agreement on the review of these types of projects. Some of the research carded out by State agencies is mandated by State statutes. Some other activities might be considered research, or might be considered surveillance. We plan to spend some time researching the issues to see if we can arrive at a set of guidelines that will assist us in determining more easily just which projects really qualify as research involving human participants, and therefore require 1RB review, and which do not. We hope that this effort will result in progress towards designing diagrams or other tools similar to those used by OHRP in its Human Subjects Regulations Decision Charts. Finally, our research projects are located at sites away from our administrative offices. While we know from IRB review of protocols that projects are taking appropriate actions to assure confidentiality and security of information collected, both during and after a project period, we plan to work towards the development of a uniform organization-wide standard for research data retention and security.
