RSO Newsletter November 2005

STANDARDS FOR CONDUCTING AND REPORTING CLINICAL TRIALS AT ACADEMIC INSTITUTIONS.  The Association of American Medical Colleges (AAMC) has adopted a set of principles to preserve integrity in the conducting and reporting of clinical trials. The principles prevent academic institutions from accepting restrictions by trial sponsors that would exclude members of academic research teams from full intellectual participation in those trials or prevent those investigators from being held responsible and accountable for the results. The principles are intended to be applied to all clinical trials conducted in academic medical institutions, regardless of the funding source. The consensus report can be obtained at http://www.aamc.org/research/clinicaltrialsreporting/start.htm.

POSSIBLE SOLUTION TO CONFLICTING RULES FOR REPORTING ADVERSE EVENTS.  The Office for Human Research Protections (OHRP) is requesting public comment on the draft guidance it will provide to institutional review boards, investigators, research institutions and others on the reporting and reviewing of adverse events in research. Entitled "Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others," the document seeks to clarify when to report adverse events and unanticipated problems to appropriate institutional and federal officials. Comments must be submitted by Jan. 13, 2006. Information is available at http://www.hhs.gov/ohrp/requests/com101105.html.

RSO STAFF GAIN ACRP CERTIFICATION. Congratulations to RSO research coordinators Kathy Duderstadt and Carmina Suter who completed the Association of Clinical Research Professionals (ACRP) certification process and exam and are now Certified Clinical Research Coordinators (CCRC).