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
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