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IC Directors' Meeting Highlights

August 3, 2001
To: IC Directors
From: Director, Executive Secretariat
Subject: IC Directors' Meeting Highlights — July 12, 2001

I. Visit by Representatives of Foundations Interested in Enhancing the Supply of Clinical Investigators

The goal of this presentation was to summarize the response of the community of private foundations to the 1997 report from the NIH Director's Panel on Clinical Research and to seek information from IC Directors on NIH plans for the career development of clinical investigators.

Dr. Queta Bond, President of the Burroughs Wellcome Fund, summarized the interactions of the foundations and NIH to date. She noted that approximately $2 billion flows to medical research from the private sector. The foundations are seeking opportunities in which they can serve as catalysts or can fund things that NIH cannot. Dr. Robert Goldstein, Chief Scientific Officer of the Juvenile Diabetes Foundation International, added that there is real strength in having the foundations all working together with NIH on common issues.

Dr. Nancy Sung, Program Officer of the Burroughs Wellcome Fund, summarized the foundations' collective investment in clinical research, which has doubled since 1997. She noted that mentors are critically important; the foundations currently support them with about $20 million per year. Remaining critical needs are debt repayment, recruitment of minority scientists, and training in translational research for Ph.D.s. Ms. Lorraine Egan, Executive Director of the Cancer Research Fund of the Damon Runyon-Walter Winchell Foundation, shared her foundation's experiences in loan repayment. She said that 81 percent of the students who graduated from medical school in 2000 had debt; the average individual debt was nearly $100,000. She said programs are needed to pay for medical school so students can avoid debt in addition to programs to repay existing student loans. She noted that foundation boards are often reluctant to institute loan repayment programs because they are not targeted enough. The foundations believe NIH loan repayment programs are key, and they want to help. Dr. Elaine Gallin, Program Director for Medical Research of the Doris Duke Charitable Foundation, described her foundation's medical student fellowship programs. Dr. Peter Bruns, Vice President for Grants and Special Programs at the Howard Hughes Medical Institute, said he hopes this is the first in a series of discussions so that the foundations can develop programs that complement NIH's efforts.

In response to a question, Dr. Donella Wilson, Scientific Program Director of the American Cancer Society, acknowledged that the amount of money required to attract minority scientists is greater than that required to recruit non-minority scientists. Minority physicians are faced with debts and a loss of future earning power if they choose a research career. She also noted the need for minority mentors.

Dr. Kirschstein explained that recent legislation allows NIH to repay student loans for extramural clinical researchers, and Dr. Lenfant gave a brief update on the status of the implementation. He clarified that while debt avoidance would be preferable to loan repayment, Federal agencies cannot pursue this path under current laws. Dr. Gallin described an NIH intramural "Bench to Bedside" award program in which clinical research teams integrate Ph.D. basic scientists with clinical investigators. Investigators from different Institutes or different laboratories in the same Institute are encouraged to establish partnerships. These awards are low budget but very popular. He suggested that a similar program could be created among different schools within a university. Dr. Kirschstein suggested that the foundations work with specific ICs and then come back to an IC Directors' meeting for another discussion.

II. Placebo Initiatives

Dr. Straus said this initiative began to gel nearly two years ago. A trans-agency workshop organized by NCCAM and NIDDK with 17 other ICs and Offices took place in November 2000. The workshop participants produced recommendations for research in three broad areas, based on a scholarly assessment of the science: elucidating underlying mechanisms, applying placebo effects in clinical practice, and using placebos in clinical trials. Based on these recommendations, NCCAM and NIDDK have developed a trio of what they hope will be trans-NIH initiatives: an integrative approach to the elucidation of the underlying mechanisms of placebo effect; the placebo effect in clinical practice; and ancillary studies of the biological, behavioral, ethical, and statistical aspects of the use of placebo in randomized clinical trials. The timeline calls for FY02 funding, if possible. NCCAM hopes to issue the RFAs in August or September. NCCAM will contribute about $2.3 million per year; NIDDK will await applications in response to its PA. NCCAM and NIDDK are looking for additional partners and hope to accrue about $5 million per year for the three initiatives combined.

III. New Guidance on Secretarial Correspondence

Dr. Kirschstein told the group that the increased emphasis on the Secretary's correspondence is his own personal initiative. He wants to sign most responses within 13 days of receiving a letter. He wants to sign all responses, even those involving complex issues and requiring major rewriting, within a maximum of 15 days. In addition, the Secretary wants to respond to letters thoroughly, substantively, and in plain English. The new guidance is already in effect, and the Secretary is holding Agency Heads personally accountable for meeting the new requirements. She asked IC Directors and members of the OD Senior Staff to personally ensure that correspondence prepared for the Secretary's signature is high quality and meets the new deadlines.Ms. O'Steen reviewed the specific requirements and reminded the group that the new guidance affects only letters for the Secretary or Deputy Secretary's signature and memos to OS. Since Secretary Thompson's swearing-in, NIH has received about 20 documents for his signature each month. The only way to meet the new deadlines is by transmitting these documents electronically. All but two ICs are operating in Workflow, NIH's electronic document management system, so we are in relatively good shape. Ms. O'Steen distributed a timeline showing the deadlines ICs will need to meet. Preparing offices will have three days in which to write a response; clearance offices will usually have less than one day in which to clear. OS will assume concurrence if a response is not received by the deadline, so the NIH Executive Secretariat will have to follow the same policy.

Ms. O'Steen stressed the importance of having IC Directors and OD Senior Staff members designate an alternate who can sign off on correspondence in the Director's absence and having top quality staff who are proficient in the electronic systems for document transmission, skilled in analysis and review of documents, and able to move quickly. The NIH Executive Secretariat is holding meetings with all NIH correspondence contacts on July 19 and August 2 to discuss this new guidance. Attendance at one of these meetings is mandatory for every NIH correspondence contact. Ms. O'Steen also briefly reviewed the new information alert and information advisory documents for the Secretary. Information alerts should be used to inform the Secretary about an especially urgent, timely matter, while information advisories are for less urgent matters. Summary statements are especially important. The Secretary wants them to provide complete, concise information about a document — to explain, for example, why a response doesn't address a particular issue or why an apparent option isn't offered in a decision memo.

Karen Pelham O'Steen
cc: OD Staff

This page was last reviewed on March 13, 2007 .

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