RSO PRESENTATION AT ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP) ANNUAL MEETING. Three RSO staff members, Debra Dykhuis, Stephanie Zumbolo, and Lisa Hostetler, will be presenting an abstract titled “Estimating Site Personnel Costs for Industry-sponsored Clinical Trials: An Academic Health Center Experience.” This presentation will address how the RSO estimates the time it will take to perform all aspects of a clinical trial, which can be a useful tool in budget negotiation. Some items to take into account when estimating personnel time are: the complexity of the case report forms, the number of institutional committees that need to review and approve the research, the availability of subjects and associated recruitment efforts, and time to submit all IND safety reports. The average amount of time to perform pre-study activities is 102 hours, whereas the average amount of time required to perform post-initiation activities is 221 hours (see “Clinical Trials are Time Intensive” in last month’s newsletter for additional details). For more information, contact any of the studies’ authors (http://www.ahc.umn.edu/rso/rso_staff.html).
 

NATIONAL CONFERENCE ON HUMAN SUBJECT PROTECTION ISSUES. The University of Minnesota will be hosting a conference titled “Innovation, Inclusiveness, and Informed Consent: Current Challenges for Institutional Review Boards and Researchers” on May 13-14, 2002 at the Hubert H. Humphrey Center. The symposium is jointly sponsored by the University of Minnesota, U.S. Department of Health and Human Services, Office for Human Research Protection (OHRP), Food and Drug Administration (FDA), and Office of Research Compliance Administration (ORCA) of the Department of Veterans Affairs. This two day workshop is designed for researchers, IRB members, IRB administrators and research staff, and will continue the dialogue with federal regulators on the issues of informed consent and the inclusion of diverse populations in research, two problematic areas for researchers and IRB members. Conference information and registration information can be viewed at http://www.research.umn.edu/subjects/conference/.
 

RSO STAFF CHANGES. Congratulations to Stephanie Zumbolo who has been appointed director of the psychiatry clinical trials office at Regions Medical Center. Unfortunately, the RSO will lose Stephanie’s talents. A search for another Research Process Manager to take her place is underway.