INSTITUTE OF MEDICINE REPORT ON HUMAN SUBJECTS PROTECTION.  The Institute of Medicine of the National Academies of Science has released a report “Responsible Research: A Systems Approach to Protecting Research Participants.” See <http://www.nap.edu/books/0309084881/html/index.html> for the complete 276 page report or <http://www.iom.edu/iom/iomhome.nsf/WFiles/ResponsibleResearchFINAL2/$file/ResponsibleResearchFINAL2.pdf> for an eight-page summary The report recommends a three-part strategy that includes refocusing the mission of the IRB on ethical review and oversight; recognizing research participant contributions and integrating them into the system; and maintaining high standards for continuing review of human research participant protection program performance. With regards to IRBs, the report goes so far as to recommend renaming IRBs “Research Ethics Review Boards” to signify a reduced scope of responsibility. Other institutional panels would be responsible for scientific review and for financial conflict of interest review. Emphasis should be placed on the consent process as an ongoing activity, rather than on signing a piece of paper, whose major function is to protect the institution instead of the individual. The report even suggests renaming the informed consent form the consent form, something we’ve already done at the U of Minnesota, to signal that informed consent cannot be obtained through a one-time signing of a document. Finally, the report reiterates the need for well-defined safety monitoring and internal audit processes. These are all laudable goals. Congressional action is required to address the deficiencies in the current system. The challenge will be to avoid imposition of additional burdensome administrative procedures in an attempt to provide a quick fix for the clinical research system.
 

COMPLAINTS ABOUT COST MANAGEMENT OF STUDIES BY CORPORATE SPONSORS.  A recent article in CenterWatch (Sept 2002) summarized financial problems many sites encounter when performing industry-sponsored research. Initial budgets are often unrealistically low and negotiating a reasonable budget is time consuming. Many companies are slow to pay causing cash flow problems. Up-front or start-up payments are difficult to secure. The director of a Florida research center complained, “the site can do a massive amount of work and can make large payments [experience large expenses] up front in order to get the study rolling. But if the study is canceled, the sponsor backs out of it, it’s late or an IRB puts a hold on it, you won’t be paid for any of the time or dollars that you have put in.” Sponsors also often withhold 15 to 20 % of the budget until the data is locked, which sometimes does not occur for a year or more after the study has been completed. Nevertheless, in a survey of 111 investigative sites the operating margin was 12% so many investigators will continue to perform industry-sponsored research, particularly when important therapeutic issues are being addressed. Although the RSO certainly encounters these same difficulties, its mission is to ease the administrative and logistical burdens of research projects for researchers, permitting them to devote their energies to creative, scholarly purposes. If you would like advice on preparing and negotiating budgets and payment schedules, contact the RSO (contact information below).
 

PRODUCING DRUGS OR OTHER MATERIALS FOR CLINICAL TRIALS.  When drug development reaches the stage at which product is produced for clinical trials, compliance with the FDA’s Good Manufacturing Practice (GMP) regulations is required. The drug product must be produced in an appropriate facility and use processes that have been confirmed to be valid. There must also be written procedures and instructions for the equipment used to manufacture the drug product. The FDA has issued a guidance document addressing this titled “Guideline on the Preparation of Investigational New Drug Products (Human and Animal).” It is on the FDA web site at http://www.fda.gov/cder/guidance/old042fn.pdf. AHC policy requires that biologics produced at the University for clinical trials are produced at the Molecular and Cellular Therapy Facility (www.ahc.umn.edu/mmct).