Minutes of the National Advisory General Medical Sciences Council -- January 25-26, 1996

The National Advisory General Medical Sciences (NAGMS) Council was convened in closed session for its one-hundred and first meeting at 8:30 a.m. on Thursday, January 25, 1996, in Conference Rooms E1/E2, Natcher Conference Center, Building 45. Dr. Marvin Cassman, Acting Director of the National Institute of General Medical Sciences (NIGMS), presided as acting chairman. The meeting was open to the public on January 25 from 11:00 a.m. to 5:15 p.m., followed by the closed session for consideration of grant applications.

Members Present:

Paul Anderson, Ph.D.
Elvera Ehrenfeld, Ph.D.
Alfred Gilman, M.D., Ph.D.
Carlos G. Gutierrez, Ph.D.
Leland H. Hartwell, Ph.D.
Susan Henry, Ph.D.
Freeman Hrabowski, Ph.D.
Henry Lewis III, Pharm.D.
Alvin Manalaysay, M.D., Ph.D.
Thomas Pollard, M.D.
Franklyn Prendergast, M.D., Ph.D.
Mary Wiley, J.D.
Franklin J. Zieve, M.D., Ph.D.

Members Absent:

None

Special Consultants Present:

Timothy Buchman, M.D., Ph.D.
Professor of Surgery, Anesthesiology and Medicine
Washington University School of Medicine
St. Louis, MO 63110-1093

Perry Frey, Ph.D.
Professor
Department of Biochemistry
Co-Director
Institute of Enzyme Research
University of Wisconsin
Madison, WI 53705-4098

Wayne Hendrickson, Ph.D.
Professor
Department of Biochemistry and Biophysics
Columbia University
New York, NY 10032

Dieter Soll, Ph.D.
Professor
Department of Molecular Biophysics
Yale University
New Haven, CT 06520-8114

(For the record, it is noted that to avoid a conflict of interest, Council members absent themselves from the meeting when the Council discusses applications from their respective institutions or in which a conflict of interest may occur. Members are asked to sign a statement to this effect. This does not apply to "en bloc" actions.)

Council roster (available from NIGMS).

Members of the Public Present:

Dr. Philip Harriman, National Science Foundation
Mr. Laresh Jayasanker, The Blue Sheet
Dr. Karl A. Koehler, National Science Foundation
Dr. Elizabeth Marincola, American Society for Cell Biology
Dr. Georgia Persinos, Washington Insight
Ms. Linda Raber, Chemical & Engineering News

Federal Employees Present:

National Institute of General Medical Sciences Employees:

Please see the attached sign-in sheet (available from NIGMS).

Other Federal Employees:

Please see the attached sign-in sheet (available from NIGMS).

Open Portion of the Meeting

I. Call to Order and Opening Remarks

Dr. Marvin Cassman, Acting Chair, called the meeting to order and welcomed the members and guests present and the four special consultants.

Dr. Cassman introduced and welcomed four ad hoc members of Council: Dr. Timothy Buchman, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Dr. Perry Frey, Department of Biochemistry, University of Wisconsin, Madison, WI; Dr. Wayne Hendrickson, Department of Biochemistry and Biophysics, Columbia University, New York, NY; and Dr. Dieter Soll, Department of Molecular Biophysics and Biochemistry, Yale University, New Haven, CT.

Dr. Cassman thanked Drs. Lee Hartwell, Paul Anderson, and Alfred Gilman for agreeing to stay on Council for one more round, even though their terms have officially expired.

Dr. Ciriaco Gonzales, long-time director of the Minority Biomedical Research Support Program, has left the Division of Minority Opportunities in Research to take a position as the Director, Division of Disadvantaged Assistance, HRSA.

Dr. Cassman congratulated Dr. Paul Anderson on his new position as President-elect of the American Chemical Society.

II. Consideration of Minutes

The minutes of the September 18-19, 1995 meeting of the National Advisory General Medical Sciences Council were approved as submitted.

III. Future Meeting Dates

The following dates for future Council meetings were confirmed:

May 16-17, 1996	Thursday-Friday
September 19-20, 1996	Thursday-Friday
January 30-31, 1997	Thursday-Friday
May 15-16, 1997	Thursday-Friday
September 15-16, 1997	Monday-Tuesday

Dr. Cassman reminded the members of their responsibility and commitment, and asked that they not schedule any other meetings, etc., for the dates that they had just confirmed, and to inform their secretaries of these dates so that other commitments would not be made for them.

IV. Report from the Deputy Director, NIH

Dr. Ruth Kirschstein, Deputy Director, NIH, reported on the Congressional activities of the past few months that affected NIH, particularly the status of the FY 1996 budget for NIH, which had just been set at a 5.7% increase. Dr. Kirschstein also described the consequences of the furlough and the subsequent interruptions due to the blizzard. She concluded by noting that with all the difficulties, the business of NIH was progressing, albeit with some delays.

V. Current Funding Policy and Actions

Dr. Cassman described the Institute's actions since the beginning of the fiscal year in funding applications. The applications funded in December, our normal first start date, were all non-competing continuations and some competing continuations. Following the furlough, the first priority will be to fund the new (Type 1) and competing (Type 2) applications to insure that investigators and institutions know who will be funded. Some non-competing grants will be delayed in funding, but will get the full costs for the year.

The non-competing grants will be awarded with a 4 percent increase. The earlier awards, which were not given any increase, will be amended to reflect the new policy. Competing awards will be given an average increase of 4 percent as well.

VI. DRG Reorganization

Dr. Donald Luecke, the Acting Director of the Division of Research Grants (DRG), gave a summary of the changes in the organization of DRG. He described the consequences of the effort to group study sections into a larger unit, termed an Initial Review Group (IRG). These are organized by a common scientific focus, and are coordinated by a scientific review administrator who has oversight of the whole grouping. One intent is to provide increased flexibility in the use of reviewers.

These are all pilot programs, and the utility of this approach is still being evaluated. It is anticipated that the broader approach to science provided by an expanded membership will be a benefit in the peer review process. It should also help in the management of an organization as large and complex as DRG.

The Council was generally supportive of the direction that DRG was moving, but expressed some concern that many of the review groups were still identified with traditional disciplines. Given the necessity to move to interdisciplinary structures in the academic environment, there was some feeling that the current organization represented a link with an outmoded past that should be changed.

VII. Report on a Study of the Minority Access to Research Careers Program

Results of the NIGMS study of the Minority Access to Research Careers (MARC) Program were presented by the Chief of the Office of Program Analysis and Evaluation (OPAE), Dr. James Onken. Data were presented on the number of institutions and students who have received support under the program, the educational outcomes of former trainees, and the capacity of MARC institutions to produce students who obtain Ph.D.'s in the biomedical sciences.

The results show that MARC students have pursued and obtained graduate degrees at greater rates than minority bachelor's degree recipients in biology and chemistry who did not participate in the MARC Program, and that a substantial number of former students have already obtained research doctorates. A greater percentage of former MARC students receive the Ph.D. than do other minority and majority baccalaureates in biology and chemistry.

The percentage of MARC students entering graduate school who eventually receive a doctorate is slightly higher than the percentage among all minority students entering graduate school. However, both are substantially below the percentage of majority graduate students who receive a doctorate. Although there are many former MARC students who have been successful, few instances were found of major increases in the numbers of students from MARC institutions who go on to receive Ph.D.'s or M.D.'s.

In the subsequent Council discussion, it was noted that the MARC Program has contributed to the education of a select group of students whose educational attainments have exceeded those of their counterparts, both minority and majority. Examples were provided of cases in which the MARC Program has had a beneficial effect on the institutions it supports. Discussion also focused on the problems in using Ph.D. production rate as a measure of success for an undergraduate honors program, and the difficulty of establishing a cause-effect relationship in a study of any training program in which trainees are selected from among the best students.

VIII. Discussion of MORE Programs

The Director of the Minority Opportunities in Research (MORE) Division, Dr. Clifton Poodry, presented a group of RFA's designed to provide opportunities for MBRS and MARC grantees to strengthen their programs. The new guidelines of the revised MARC Program, which has the title MARC U*STAR rather than MARC HURT, were briefly discussed. Dr. Poodry explained that the changes were responsive to what had been learned from the MARC evaluation and were intended to encourage and support broader thinking on the part of the grantees.

Dr. Poodry asked for Council approval to modify the policy under the S06 mechanism that had limited the dollar amount per award and the minimum number of subprojects that could constitute an MBRS award. Dr. Cassman felt that a formal vote was not needed but accepted that the sense of Council was concurrence with the request to remove the restrictions.

Dr. Poodry informed Council that the rethinking of programs is ongoing and that a new plan for the organization of the MBRS Program would be prepared for the May Council meeting.

IX. Interim Funding Policy

Dr. Cassman reminded the Council of the discussion on this issue that had taken place at the previous Council meeting. At that time, several options were presented to attempt to provide more stability to investigators in a steady-state environment. The conclusion at that time was that the most feasible approach would be to provide interim funding to a selected group of investigators. The suggestion was to provide $50,000 in direct costs, with limited indirect costs, to support applications that fell within 10 percentile units of the payline. This would be paid for by assessing 0.5% of each grant. There would be some discretion on how these funds would be awarded. For example, a small grant would not necessarily get the full amount, and an investigator with substantial other support might not get anything. After further discussion, a motion was passed to initiate this program, pending approval of a lower indirect cost rate.

X. NIH Interactions with Howard Hughes Medical Institute (HHMI) Scientists

Dr. Shafer summarized the report. The charge to the Committee was to examine the interaction of NIH- and HHMI-funded investigators at all stages of the grant application, review, funding, and award management process. The mission was broadened to include NIH interactions with all well-funded investigators. The Committee identified the following problems: 1) the NIH philosophy of support focuses on the research project, while HHMI research support focuses on the individual;2) peer reviewers have been taking factors other than scientific merit into account in the scoring of some applications; 3) NIH currently has no guidelines for award decisions which take into account an investigator's total level of support; 4) due to NIH policy, HHMI investigators must leave the room when another HHMI investigator is being reviewed; and 5) NIH currently has no guidance for program and grants management staff regarding what actions to take when an investigator receives substantial research support from another source after the NIH award is made.

The Committee made the following recommendations: 1) return to the concept under which NIH previously operated, which acknowledged that NIH does not fully support any research project, but provides a grant that aids the institution and other sources in supporting the research; 2) refocus the initial peer review on scientific merit; 3) change the NIH conflict of interest policies so that HHMI investigators can review other HHMI investigators when they are not otherwise in conflict; 4) develop guidance for applicants, reviewers, Council members, and staff regarding investigators with substantial other research support. The guidance should address both the pre-award and post-award periods; and 5) develop a Memorandum of Understanding with HHMI and certain other organizations regarding interactions with NIH in supporting biomedical research.

Council discussion focused on the following issues:

1) HHMI does not provide for direct support of graduate students. Could NIH co-fund projects just to support the graduate students' activities?

2) Partial awards to HHMI investigators may be a better solution than either full funding or no award at all.

3) NIH should consider some level of support that would act as a trigger for closer scrutiny before award. While NIGMS has used $500,000 direct cost as a trigger, research in other fields may require different amounts.

XI. Funding of New Investigators

Dr. Cassman presented some data bearing on the support of new investigators between 1980 and 1993. The key observations were that the number of new applicants has gone up significantly, the success rate for new applicants has gone down, and the entry rate (the number of new investigators funded divided by the total number of investigators funded) has also gone down over the time period examined. The major issue is the decrease in the entry rate, which appears to be primarily due to competition for available slots from existing funded investigators. After extensive discussion, it was agreed that this topic would be revisited at the May 1996 Council meeting, when some additional information regarding the funding of new investigators will be provided.

Closed Portion of the Meeting

XII. Procedure for Conduct of Meeting

Dr. Cassman brought to the attention of the Council members the procedures for the conduct of the meeting. Council members were reminded that all of the review materials furnished are privileged information. Although most conflicts of interest involving institutional affiliation already had been identified, members were asked to absent themselves during discussion of any application in which there was a personal conflict that was not readily apparent.

XIII. Review of Applications

Dr. Shafer called Council's attention to tables found under Tab V of the agenda book. These show the numbers and funds requested by applications reviewed for the January 1996 Council.

Council reviewed the following applications with primary NIGMS assignment: 695 applications that included new research grants, competing continuation grants, and supplemental grants; and 45 institutional training grant applications. In addition, Council considered 159 applications on which NIGMS had received secondary assignment. A summary of applications reviewed by Council is attached (available from NIGMS).

Appendix I: Research grant applications
Appendix II: SBIR applications
Appendix III: Institutional fellowship applications
Appendix IV: Minorities in biomedical research applications

These appendices are available upon request from Ms. Haney (301-594-2172).

Adjournement

The meeting adjourned at 11:30 a.m. on Friday, January 26, 1996.

Certification

I hereby certify that the foregoing minutes are accurate and complete to my knowledge.

Marvin Cassman, Ph.D. Acting Chairman National Advisory General Medical Sciences Council

W. Sue Shafer, Ph.D. Executive Secretary National Advisory General Medical Sciences Council

Attachments:

Council Roster
List of Federal Employees Present
Summary of Applications

Attachments are not included with this mailing, but are available upon request.