Freedom of Information Act Office
IC Directors' Meeting Highlights
February 13, 2002
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights— January 31, 2002|
I. Visit by and Comments from Terrell Halaska
Dr. Kirschstein introduced and welcomed Ms. Terrell Halaska, Deputy Chief of Staff for the Department. Ms. Halaska said she hopes to visit NIH about once a month to talk about the Secretary and the President's agenda and to hear what we would like her to take back to the Secretary.
II. Clinical Research
This item followed up the brief discussion of the upcoming Clinical Research Forum by Dr. Katz at the January 17 IC Directors' meeting. Dr. Kirschstein called the group's attention to several articles on clinical research in the January 31, 2002, New England Journal of Medicine. The article by Ley and Rosenberg discussed the issue of whether the NIH loan repayment program should be primarily for clinical research or basic science research. Dr. Katz noted that FASEB believes the loan repayment program should be extended to all physician-scientists; this would require new legislation. Dr. Collins raised the issue of whether the definition of clinical research is adequate, and the group concluded that the language of the bill includes the words "or colleague" and therefore is broader than it should be to attain its goal. Dr. Fauci noted that if we broaden the definition, it would be at odds with the original intent of the bill, which was to attract physicians into clinical research. Dr. Tabak asked the group to expand the discussion to include all clinician-scientists, because in his mission area, dentistry, there is a great need for those who do both basic and clinical research. The group was supportive of the special need for dentists in both areas, basic and clinical research. (They are already included in the language of the Clinical Research Enhancement Act.) Dr. Kirschstein asked Dr. Tabak and Mr. Smolonsky to work on this issue with the appropriate organizations. There was general agreement that the program should not include Ph.D. scientists, given NIH's limited resources, although the announcement specified that Ph.D. scientists are eligible. Dr. von Eschenbach noted that the forces against attracting physicians into clinical research are not solely financial; they are psychological and cultural as well, although these cannot be addressed in a loan repayment program. Dr. Kirschstein decided to retain our more restrictive position for the first year of the program (after which the decision can be re-examined) and to use the definition that was published in the loan repayment program announcement. Dr. Lenfant is heading a group that will recommend what the second year of the program should include. The announcement of the loan repayment program, as published in the NIH Guide, follows:
"The Public Health Improvement Act of November 2000 (Public Law
106-505), also known as the Clinical Research Enhancement Act, added
to Section 487F (42 USC 288-5a) of the Public Health Service Act. This
Act authorizes the establishment of a program of educational loan repayment
to promote participation in clinical research by qualified health professionals.
Clinical research is patient-oriented research that is conducted with
human subjects, or research on the causes and consequences of disease
in human populations involving material of human origin for which an
investigator or colleague directly interacts with human subjects in an
outpatient or inpatient setting to clarify a problem in human physiology,
pathophysiology or disease, or epidemiologic or behavioral studies, outcomes
research or health services research, or
developing new technologies, therapeutic interventions, or clinical trials. Qualified health professionals who contractually agree to conduct clinical research for a two-year consecutive period are eligible to apply for this program. Participants in this program can receive educational loan repayment of up to $35,000 annually, depending on total educational loan debt (click here to see the graduated repayment schedule), plus a Federal tax liability offset."
The group also agreed that the definition of clinical research must be interpreted consistently across ICs. Mr. Horowitz and his office will receive all the loan repayment applications and will assign each to the appropriate IC. Each IC is then responsible for reviewing the applications it receives. Dr. Spiegel suggested that we should collect statistics on how many applications we receive, how many are eligible, etc. Mr. Horowitz should have that data by late March or early April. Dr. Kirschstein suggested the group discuss the issue again before ICs make final funding decisions.
III. Information Items
Dr. Cassman invited the group to a workshop on June 9-11 on the Basic Biology of Mammalian Stem Cells. Dr. Cassman then announced he will leave NIH by mid-May to become Director of a new institute on quantitative biomedical research, QB3, which is located in San Francisco.
Dr. von Eschenbach commented on the PDQ panel's conclusion last week that there is insufficient evidence to prove that mammograms prevent breast cancer deaths. This controversial conclusion, as well as the Danish research on which it was based generated a good deal of press attention. NCI believes that further deliberations are appropriate to determine the level of proof for the benefit of mammography but at present the evidence is sufficient to maintain current NCI recommendations for mammography screening.
Dr. Gallin noted that the CC patient census for the first quarter of FY02 shows a 9.4 percent decrease, which he attributed to the impact of September 11. He asked IC Directors to talk to their intramural clinicians to see if there is anything else the CC can do to bring the census back to pre-September 11 levels. He said the census appears to be coming back somewhat, but it is still low for both inpatients and outpatients.
Dr. Gallin also reported that another Introduction to Clinical Research course began this week with over 150 participants from all over the nation. For the first time those who are off-campus will be able to participate using interactive television, thanks to CIT.
Mr. Smolonsky mentioned an article in today's Wall Street Journal about establishing an intramural program for NIBIB in Mississippi. The group expressed concern about Senator Cochran's statement that peer review is not needed in Mississippi. The group discussed the history of other off-campus sites, including NIEHS, Framingham, Phoenix, and the Rocky Mountain Lab in Montana.
Dr. Skirboll said OS has given NIH a very quick turnaround on an NPRM for the Privacy Rule, which will be published in the Federal Register for public comment shortly. The NPRM proposes changes in the Rule that are related to research and the Rule's implementation by researchers. Once the NPRM is released, she will discuss it with the IC Directors at a future meeting.
Karen Pelham O'Steen
cc: OD Staff