Regulatory Compliance Office by smx43008


									                                     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

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

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