RSO VITAL STATISTICS AND THIRD ANNUAL REPORT. The RSO is currently participating in 73 active studies (20 involve complete start-up plus research coordinator services); an additional 27 studies are in the final stages of approval. This reflects a 33% increase in start-up services provided by the RSO. These projects have an estimated contract value of $ 9.3 million.
     Twenty-five clinical trials were completed last year. In 2000, the RSO worked with more than 50 different faculty members on their research projects. These faculty belong to 12 different departments in the medical school, and to the dental school and college of pharmacy. This large volume of clinical trials work was accomplished by 3 research process managers, 4 clinical research coordinators, 1 administrative assistant, and 1 secretary.
     If you would like a copy of the RSO Annual Report, please contact us at rso@umn.edu and request either an electronic or print version.
 

HUMAN SUBJECTS EDUCATION. In response to the NIH requirement for training in human subjects research by all key clinical research participants, a number of self-guided, web-based tutorials have been developed. The University of Minnesota tutorial is excellent (http://www.research.umn.edu/consent/). The National Cancer Institute has now made its tutorial available (http://cme.nci.nih.gov/). Both include a self-testing mechanism and provide documentation of having taken a self-test module. The NCI site also provides CME credit for physicians. Both sites contain similar instructional material and include case studies. The NCI site has built-in links to the Code of Federal Regulations and other original sources. The University’s graphics are better and its questions are more challenging. Try both and see for yourself!
 

CLINICAL RESEARCH OVERSEAS. The Office for Human Research Protections will establish an Office of International Activities to address ethical and procedural concerns about clinical trials performed by public and private U.S. organizations outside of the U.S. Many of these concerns were highlighted in a recent Washington Post series provocatively titled “The Body Hunters” (http://www.washingtonpost.com/wpsrv/photo/onassignment/theBodyHunters/index.htm).