Regulatory Compliance Office FY98 Program Review The Regulatory Compliance Office exists to administer federally mandated regulatory procedures on campus having to do with animal care and use, human research, biosafety, radiation safety, controlled substances, and misconduct in science. The RCO Director also reviews Material Transfer Agreements for biological materials or chemical compounds for VPRIT signature. CSU's procedures and policies are in keeping with other institutions of similar types, and meet federal mandates. Workload is heavy and continues to increase, especially in the area of Material Transfer Agreements. A subjective sense, supported by a faculty committee convened two years ago by Dr. Barry Beaty, has long been that turn-around time is too long. The budget is adequate to accomplish RCO objectives. The Vice President for Research and Informational Technology has authorized a 2-year emphasis on campus training about human research and Misconduct in Science, to concentrate on the underlying principles and campus procedures and be conducted primarily among faculty and graduate students. Training in ACUC, HRC, and IBC matters is essential to building a commitment to the responsible conduct of research. It promotes more efficient use of faculty and staff time, and thus may afford additional staff time to cope with the increased protocol volume. Training should speak to our researchers and our graduate students, as well as regulatory committee members. Significant effort must be invested in developing data bases, eventually integrated, for the various types of protocols. All systems should interact with Sponsored Program's 5-3 data base to share approval status for award management purposes. As security difficulties are resolved, data would also be made available to faculty on-line to help them better and more easily manage their protocols. We anticipate a radical improvement to RCO services once the data base(s) are operational. The web affords a convenient and reliable way of conveying current application forms and information to the campus; of collecting information from applicants, and of provided training information. Considerable web development will need to be in RCO plans for the coming years. Review via computer will be considered in the future plans, but because of some federal regulations, differing technological levels of some of the community committee members, security, and alterations to the caliber of protocol reviews, it is difficult to assess the promise it offers. Because of the documented history of animal rights involvement, terrorist access to infectious agents, and "hacking" of commercial proprietary information, the regulatory area is especially sensitive to security concerns associated with increased computerization. No significant organizational changes are anticipated for the RCO in the near future, although some occasional help would ease back-logs. If the Director and Coordinator become involved in more campus training or significant computer conversion, additional professional assistance will be needed. Likewise, if volume trends continue for more than 1-2 more years, additional professional staff will need to be hired.
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