HHS ISSUES FINAL GUIDELINES ON CONFLICT OF INTEREST . The Department of Health and Human Services has issued final guidelines to institutions for dealing with financial conflicts of interest that may affect human subjects research. Rather than setting specific, binding rules (with dollar limits for financial interests), the document suggests the issues that academic institutions and their IRBs should consider before undertaking human subjects research. These final guidelines evolved from an initial document published one year ago. Critics of the final guidelines believe that specific rules are needed, whereas supporters are pleased that HHS has not issued inflexible rules that might not fit every situation. The guidance is available on the website of the Office of Human Research Protections (OHRP) <http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf > or in the May 12 edition of the Federal Register (69 CFR 26393).

ACADEMIC COLLABORATION IN DRUG DEVELOPMENT. The FDA has issued a "Critical Path" document, which aims to identify the key obstacles in pharmaceutical development < http://www.fda.gov/oc/initiatives/criticalpath >. The FDA seeks input into ways in which academic basic scientists and clinical investigators could become involved in analyzing and improving the drug development process.

CONGRATULATIONS. Judith Parker , CCRC, an RSO Research Process Manager, is one of only two recipients of the ACRP Meritorious Service Award for 2004 from the Association of Clinical Research Professionals for her “time, work, and dedication given in support of the ongoing growth of the clinical research profession.” The RSO is proud to have one of our original staff members receive this prestigious national award. And also to the Research Subjects Protection Program for receiving accreditation from AAHRP, the Association for the Accreditation of Human Research Protection Programs. This major accomplishment has been attained by only nine organizations thus far.

MAY CLINICAL RESEARCH COORDINATOR MEETING. The subject of the May CRC meeting is Establishing Research Accounts with Fairview and UMP. Speakers will address establishing Research Institutional Accounts (Sharon Goudge), creating Lab Research Pool accounts (Kathy Hansen), connecting with UMP services (Kathy Clark), working with Investigational Drug Services (Darlette Luke) and the subcontracting process (Adrienne Baranauskas). The meeting will be held Tuesday, May 25, 2004 from 7:30 to 9:00 am in 2-520 Moos Tower.