IC Directors' Meeting Highlights |
February 22, 2005
Dr. Zerhouni introduced and welcomed the new OER Deputy Director, Dr. Sally Rockey. Discussion Items I. Clinical Research Policy Analysis and Coordination: A Status Report on Harmonization Dr. Patterson provided a status report to the group on the activities of the Clinical Research Policy Analysis and Coordination (CRpac) program. The aim of this newly established program is to promote clear, effective, and coordinated policies and regulations for the conduct and oversight of clinical research. CRpac currently has seven main priority issues including: adverse event reporting, clinical trial data and safety monitoring, models of IRB review, and variable interpretation of human subjects regulations. Dr. Skirboll and Dr. Patterson stressed the importance of these issues and the support needed from IC Directors as this program continues to move forward. OSP will shortly be asking IC Directors to name high level senior staff having the appropriate expertise and ability to serve as representatives on two committees: the Trans-NIH Bioethics Committee (tNBC) and a new Trans-NIH Adverse Event Steering Committee. Dr. Zerhouni thanked Dr. Patterson for providing clarity to this issue and reminded all that it is strategically imperative to move towards greater streamlining, coordination, and harmonization of policies that govern the conduct and oversight of clinical research. II. II. Update on Activities of the Advisory Board for Clinical Research Dr. Gottesman updated the group on activities of the newly formed Advisory Board for Clinical Research (ABCR). The ABCR’s replaces the CC Board of Governors and the CC Research Steering Committee and its purpose is to provide advice and guidance to integrate the vision, planning, and operations of the NIH intramural clinical research programs. It was created due to a key recommendation from the NIH Director’s Blue Ribbon Panel on Intramural Clinical Research. This recommendation was to revise the NIH intramural clinical research oversight structure by creating a single high-level oversight committee to replace all existing governing bodies that have oversight responsibilities for intramural clinical research. It includes four main working groups: Research Opportunities; Operations and Planning; Finance; and Careers in Clinical Research. III. Scientific Review and Evaluation Award (SREA) Program Ms. Barros reported on the changes to the SREA program. The SREA funds are used to reimburse travel, lodging, per diem, and honoraria for Initial Review Group (IRG) members. The Office of Management Assessment was asked by the Office of Financial Management (OFM) to determine whether the program complies with existing policies and regulations, has adequate internal controls, and operates effectively and efficiently. The Management and Budget Working Group and Steering Committee endorsed the following proposed recommendations:
IV. Informational Items
Ann Brewer |
This page was last reviewed on September 21, 2006 . |
National Institutes of Health (NIH) |