IC Directors' Meeting Highlights

Discussion Items

I. on Amendments to the Freedom of Information Act (FOIA), Ms. Susan Cornell, Freedom of Information Officer and Chief FOIA Liaison, NIH

Ms. Cornell presented the key provisions of the Open Government Act of 2007, which was signed on December 31, 2007. She explained that the law does not change the government's basic obligation under FOIA. Some of the key provisions of the Act include:

• Codifies the definition of news media requester;
• Codifies the applicability of FOIA to records maintained for the government by contractors;
• Modifies when certain fees can be assessed;
• Modifies provisions regarding the recovery of attorney fees in the event of FOIA litigation.

Ms. Cornell noted other miscellaneous provisions:

• Establish telephone or internet service for requesters to check the status of pending requests;
• Additional reporting requirements for the FOIA Annual Report;
• Codifies the Chief FOIA Officer and FOIA Public Liaison positions;
• Office of Personnel Management (OPM) to report on personnel practices that could be made to improve FOIA administration.

II. Clinical Research Center Retreat Update, Dr. Stephen Katz, Director, NIAMS

Dr. Katz updated IC Directors on the projects and goals identified and defined at the July 12, 2007 IC Directors' Retreat on the Mark O. Hatfield Clinical Research Center (CRC). The CRC houses inpatient units, day hospitals and research labs and connects to the Warren Grant Magnuson Clinical Center, together forming the NIH Clinical Center. Dr. Katz presented the following developments and progress of the CRC:

1. Center for Human Immunology (CHI).
The CHI is a trans-NIH initiative. Its mission is to improve treatment and prevention of human diseases resulting from chronic inflammation and immune dysfunction by integrating diverse subspecialties and uniting basic and clinical research. Goals of the CHI are to: connect basic immunological science to multiple medical subspecialties to achieve real benefits in patient outcomes; increase interaction and innovation; and become the leading institution in human immunological research.

Progress to Date:

• Space identified in Bldg 10 (7th floor, A Wing);
• Retreat planned for spring 2008 to discuss specific programs;
• Charter created incorporating organization and governance;
• $1.5 million (FY07 funds) committed for additional equipment;
• $3 million annually being sought for next three years for operating expenses and personnel;
• Requests for voluntary contributions (funding or in-kind) from participating ICs are forthcoming.

2. Clinical and Translational Science Award (CTSA) Structure. Potential linkages and opportunities are being explored; however, the CTSA program is still in its initial stages. Dr. John Gallin, Director of the NIH Clinical Center, is engaged in many of the CTSA committee discussions.

3. Extramural Collaborations. The Advisory Board for Clinical Research (ABCR) is charged to identify models that have worked, seek and break down bureaucratic barriers to financing collaborations, and encourage more bench to bedside initiatives (extramural/intramural).

4. Rare and Difficult Diseases. The concept is for the CRC to serve patients with rare, undiagnosed diseases.

The effort is being led by Dr. William Gahl (NHGRI) with support from the Office of Rare Diseases (ORD). The program will triage to existing clinics, plus use clinic time and space assigned by the Clinical Center. Highly qualified senior clinical consultants have agreed to participate. The following is planned:

• Physician referral required;
• Nurse practitioner/fellow, with the guidance of a senior consultant, collects and reviews medical records;
• Case presented to a board of specialists to determine eligibility;
• Cases triaged to existing clinics;
• Patients spend approximately one week at the Clinical Center;
• Follow-up admissions are at the discretion of the attending NIH physician;
• Selected cases will be presented at a regular Problem Conference.

5. "Manhattan-like" projects involving many ICs. Two initiatives have been embraced:

• Streamline clinical protocol generation and approvals by identifying regulatory and other burdens involved in launching clinical studies, and improve the process to decrease time to 1st patient enrollment. This effort is being led by Dr. Clifford Lane (NIAID).
• Establish an NIH Bone Marrow Stromal Cell Transplantation Center for the treatment of skeletal and non-skeletal disorders. This effort is being led by Dr. Pamela Robey (NIDCR).

6. Recruitment and Retention. Goals are to increase recruitment and retention of clinical investigators and foster and reward team science through several initiatives and programs. Recent progress includes the establishment of the position of Assistant Clinical Investigator (3 year appointment with two one year renewals).

Dr. Katz noted longer range issues include identifying infrastructure issues at the CRC that inhibit rapid translation of observations into clinical care for patients, and implementing informatics systems that will capture all aspects of patient encounters. He requested IC Directors to approve these initiatives, help identify funding to facilitate the activities, and determine leaders for further implementation. IC Directors offered their full support of the CRC initiatives and progress.

III. NIH World AIDS Day Awardees, Dr. Jack Whitescarver, Director, Office of AIDS Research

Dr. Whitescarver explained that the NIH World AIDS Day Award is to acknowledge the tremendous progress in understanding, preventing and treating HIV/AIDS, as a result of 25 years of AIDS research at NIH. The Office of AIDS Research (OAR) and the National Institute of Allergy and Infectious Diseases (NIAID) initiated this annual employee recognition award. The award includes a $5,000 prize and recognizes NIH scientists and managers who have made exceptional contributions to the AIDS research efforts at NIH—either for original scientific research or for programmatic support for research. Dr. Whitescarver announced the individuals selected for the 2007 honor:

• Daniel Douek, M.D., Ph.D. and Richard Koup, M.D., of the Dale and Betty Bumpers Vaccine Research Center of the NIAID—a joint award for their original scientific research that significantly contributed to determining the mechanisms that control HIV pathogenesis and immune reconstitution. Their landmark findings have led the field in understanding the role of HIV-specific T cells in the control of HIV infection and helped to establish the immunological basis for the future development of an AIDS vaccine.
• Kenneth Bridbord, M.D., M.P.H., of the Fogarty International Center—for his efforts to develop innovative programs to build a cadre of international research scientists and clinicians trained to join the global fight against the AIDS pandemic. These programs have played a significant role in building research infrastructure and capacity for the conduct of basic and clinical biomedical and behavioral AIDS research in more than 100 nations around the world.

Each of the World AIDS Day awardees made a presentation to the IC Directors on their research findings. Dr. Zerhouni commended the awardees as demonstrating the NIH commitment to supporting a multifaceted research effort in HIV/AIDS, and the research and development of new medical tools to prevent the devastating effects of the disease around the world. Dr. Zerhouni presented plaques to the World AIDS Day awardees, and the IC Directors warmly congratulated them on their achievements.

Kerry Brink
Cc: OD Small Staff