Freedom of Information Act Office
IC Directors' Meeting Highlights
February 22, 2005
|From:||Deputy Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—January 27, 2005|
Dr. Zerhouni introduced and welcomed the new OER Deputy Director, Dr. Sally Rockey.
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. 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:
- The travel should be paid directly from Government account
- Centralize program administration in CSR
- Explore a flat-rate payment system to reimburse reviewers
- Issue electronic payments through OFM
- Beginning in FY 2006, fund program through RMS funds to retain eligibility for Government travel rates
- Transfer funds from grants to RMS in FY 2006 budget
- Update and integrate the data systems that support the program
- Establish a policy for periodic internal review of the SREA program
- Consider pros and cons of contracting out the activity
IV. Informational Items
- Dr. Katz is organizing an executive retreat on March 1, 2005. The retreat will concentrate on strategies for managing during challenging budget times.
- Dr. Battey provided an update on the Varki article on hESCs grown in animal feeders.
- Dr. Straus advised the group that the IOM has issued a report on broad issues of alternative drugs – dietary supplements. He offered to review the report with the group at an upcoming IC Directors meeting.
- Dr. Zerhouni reported that Dr. Nabel’s appointment as the NHLBI Director has been announced. He thanked Dr. Alving, and she in turn thanked all for their support.
cc: OD Senior Staff