WHEN DOES HUMAN SUBJECT RESEARCH REQUIRE IRB APPROVAL? The Office for Human Research Protections (OHRP) has updated the Human Subject Regulations Decision Charts, an extremely useful set of decision trees to assist investigators to decide if an activity must be reviewed by an IRB (under the requirements of the HHS regulations 45 CFR part 46). Specifically, the charts address 1) whether an activity is research that must be reviewed by an IRB, 2) whether the review may be performed by expedited procedures, and 3) whether informed consent or its documentation may be waived. The decision charts can be obtained at < http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm .

FDA GUIDANCE DOCUMENT ON COMPUTERIZED SYSTEMS USED IN CLINICALTRIALS. A new FDA document recommends nine general principles that should be followed when one creates, modifies, maintains, archives, retrieves, or transmits clinical data. Among these are design of the system to preclude errors, security to include access restriction, and integrity of electronic records. The guidance recommends that SOPs pertinent to the use of the computerized system be available and that research staff training be documented. The guidance document can be viewed at http://www.fda.gov/cder/guidance/6032dft.htm .

NIH APPLICATIONS TO USE NEW FORM . NIH has revised PHS 398, the form used for all DHHS Public Health Service Grant Applications. Details are available at < http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-006.html >. The new form will be accepted for submission/receipt dates on or after December 1, 2004 and must be used for all applications received on or after May 10, 2005.

NEW LOCATION FOR THE AHC OFFICE OF RESEARCH. The AHC Office of Research has moved to R694 Children's Rehabilitation Center . Please drop off clinical trial packets for review and approval at the new location. The phone number of 612-625-1109 and email address of ahcoor@umn.edu remain unchanged.