AAMC REPORT ON FINANCIAL CONFLICTS OF INTEREST IN CLINICAL RESEARCH. The Association of American Medical Colleges (AAMC) report proposes that institutions adopt high standards for the reporting, review, and disclosure of researchers' financial interests in all human subjects research, regardless of funding source. The report further recommends that academic institutions presume that any individual holding a significant financial interest in human subject research may not conduct that research, unless the researcher can demonstrate to a reviewing body that the circumstances are compelling. The report also recognizes that each potential conflict of interest case must be closely examined on its merits. Jeff Kahn, director of the University of Minnesota Center for Bioethics, was a member of the task force that wrote the report. For more information, see http://www.aamc.org/coitf.
 

FDA GUIDANCE ON DATA MONITORING COMMITTEES FOR CLINICAL TRIALS. The FDA is accepting comments until 22 January 2002 on a draft document entitled “Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees.” The FDA document will assist sponsors of clinical trials to determine when a DMC is needed and how such a committee should operate. The draft guidance addresses the roles, responsibilities, and operating procedures of DMCs, and describes certain reporting and record keeping responsibilities including: standard operating procedures (SOPs); interim reports by a sponsor to a DMC and DMC reports of meeting minutes to the sponsor; and meeting records. See http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-28962-filed.pdf for details
 

HOLIDAY WISHES. The RSO wishes you and your families good health and good cheer during this holiday season. We'll look forward to working with you in 2002.