Advisory Council Minutes, January 30-31, 1997

The National Advisory General Medical Sciences (NAGMS) Council was convened in closed session for its one-hundred and fourth meeting at 8:30 a.m. on Thursday, January 30, 1997, in Conference Rooms E1/E2, Natcher Conference Center, Building 45. Dr. Marvin Cassman, director of the National Institute of General Medical Sciences (NIGMS), presided as chairman. The meeting was open to the public on January 30 from 11:16 a.m. to 4:40 p.m., followed by the closed session for consideration of grant applications.

Members Present:

David A. Clayton, Ph.D.
Sarah C.R. Elgin, Ph.D.
Slayton A. Evans, Ph.D.
Carlos G. Gutierrez, Ph.D.
Wayne A. Hendrickson, Ph.D.
Susan A. Henry, Ph.D.
Freeman A. Hrabowski, III, Ph.D.
Alvin Manalaysay, M.D., Ph.D.
Neil S. Mandel, Ph.D.
Steven M. Paul, M.D.
Thomas D. Pollard, M.D.
Franklyn Prendergast, M.D., Ph.D.
Christopher T. Walsh, Ph.D.
Mary Wiley, J.D.

Members Absent:

None

Special Consultant Present:

Peter A. Ward, M.D.
Professor and Chairman
Department of Pathology
University of Michigan Medical School
Ann Arbor, MI 48109-0602

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:

Mr. Nielsen Hobbs, The Blue Sheet
Dr. John Holmfield, DANA
Dr. Douglas Kelly, Association of American Medical Colleges
Dr. Georgia Persinos, Washington Insight
Dr. Maria Persinos, Washington Insight
Mr. Christopher Shafer, American Chemical Society

Federal Employees Present:

National Institute of General Medical Sciences Employees:

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

Other Federal Employees:

Dr. Philip Harriman, National Science Foundation
Dr. Delill Nasser, National Science Foundation
Dr. Dagmar Ringe, National Science Foundation

OPEN PORTION OF THE MEETING

I. Call to Order and Opening Remarks

Dr. Cassman introduced and welcomed the two new members of Council: Dr. Wayne Hendrickson, professor, Department of Biochemistry and Molecular Biophysics, Columbia University; and Dr. Slayton Evans, professor, Department of Chemistry, University of North Carolina, Chapel Hill. Dr. Cassman also introduced Dr. Neil Mandel, the Council's new ex officio member from the VA Medical Center in Milwaukee, and professor at the Medical College of Wisconsin. Dr. Cassman welcomed Dr. Peter Ward, professor and chairman, Department of Pathology, University of Michigan.

Dr. Cassman congratulated Dr. Carlos Gutierrez on receiving one of the first annual Presidential Awards for Excellence in Science, Mathematics, and Engineering Mentoring. He also congratulated Dr. Freeman Hrabowski, who received the same award for his institution, the University of Maryland, Baltimore County.

II. Consideration of Minutes

The minutes of the September 19-20, 1996 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 15-16, 1997
September 11-12, 1997
January 29-30, 1998
May 14-15, 1998
September 10-11, 1998
Thursday-Friday
Thursday-Friday
Thursday-Friday
Thursday-Friday
Thursday-Friday
Dr. Cassman reminded the members of their responsibility and commitment, and asked that they not schedule any other meetings, etc., for the dates they had just confirmed, and that they inform their secretaries of these dates so that other commitments would not be made for them.

IV. Report from the Director, NIGMS: Status of Appropriations

Dr. Cassman described the Administration's budget for NIH and NIGMS for FY 1998. He then discussed the status of funding at this mid-point in FY 1997, pointing out that most of the increase provided went to the Research Project Grant budget category. Of this amount, over 90 percent was allocated to noncompeting grants. Part of this came from the 4 percent inflationary increases we have normally given to noncompeting grants. The remainder is due to an increase in the number of noncompeting awards from 2,445 in FY 1996 to 2,541 in FY 1997. This is a consequence of the cyclical nature of the way the grant portfolio turns over. Nevertheless, the increase allowed real growth in the total number of grants awarded, which increased from 3,301 in FY 1996 to a projected 3,358 in FY 1997. This is predicated on the assumption of an increase in the average cost of competing grants of no more than the BRDPI (the Biomedical Research and Development Price Index). However, an unexpected development has been a large increase in the average recommended cost of new (Type 1) applications in FY 1996 and particularly in FY 1997 thus far. The recommended levels for competing renewal (Type 2) applications have stayed close to the BRDPI. As a consequence, uniform reductions to arrive at a level consistent with an overall inflationary increase would affect competing renewals disproportionately, in some cases resulting in reductions below the previous year's award. Dr. Cassman pointed out that it would be necessary to reduce the new awards significantly below their recommended levels in order to prevent such an outcome, and the Council agreed.

V. Briefing on Electronic Research Administration (ERA)

Mr. Geoff Grant of the NIH Office of Extramural Research described the recent history of research grant administration at NIH, beginning with the development in 1995 of an invention reporting system, named Edison, which is currently being used by about 85 institutions around the country. Edison has been used as a prototype for other NIH ERA systems. NIH is working with other Federal agencies that support research to develop and agree on the standards for electronic data interchange. Shortly, the Department of Commerce and other Federal agencies will announce their intent to adopt Edison for use as their invention reporting system.

Mr. Grant described the process of using electronic media at all stages of the chronology of the grant process, from application receipt and referral through payment of awards and post-award administration. He envisions not only specific transactions such as applications, notifications, and awards, but also access by both applicant institutions and NIH staff to commonly held data, i.e., institutional profiles or abstracts of supported projects. Goals are to facilitate information transmittal and sharing, while at the same time NIH changes, simplifies, and streamlines our business. The Streamlined Noncompeting Application Process that NIH implemented this year simplifies noncompeting awards for both NIH and awardee institutions. A module for direct processing and approval at the institution followed by direct electronic submission is being piloted.

Another module, for electronic receipt of actual applications--the basic administrative and budget pages, abstracts, and specific aims for competing applications--from a test group of nine institutions will start soon. After the pilot testing, the next phase will involve institutions in the Federal Demonstration Partnership. NIH hopes to have several ERA modules moving through this process over the next few years.

VI. Summary of Program Activities on Career Counseling

Dr. John Norvell presented the Council with a summary of activities being undertaken by the NIGMS predoctoral training grant recipients to provide their graduate students with employment and career counseling. This issue has received attention at the national level--a report by the National Research Council, a Congressional hearing, and in the national press. At its meeting 1 year ago, the Council discussed this issue at some length. The Council agreed that this was a crucial issue and asked staff to obtain further information on program activities in this area. The staff sent letters to all 237 NIGMS predoctoral training grant program directors and received 95 responses. Almost all of these indicated that efforts were under way to provide trainees with employment and career information and counseling. Most programs are using seminars or workshops to provide their students with information about scientific careers, with speakers from a wide spectrum of scientific fields.

The Council discussed various aspects of this topic, especially the need to prepare biomedical scientists for productive research careers and the broader societal requirements for scientific expertise in many employment settings. Some Council members pointed out the need to broaden graduate education to include communication and other skills, especially given the current employment market. On the other hand, it was also pointed out that research training is the primary mission of the training programs and that the long pipeline of graduate education makes it difficult to forecast future job markets.

The staff was asked to disseminate the results of this informal survey and to prepare an information packet on scientific employment opportunities for interested students. The Council thought the staff letter had produced its desired effect and agreed that the language in the NIGMS training announcement was appropriate (i.e., encouraging research training grant programs to provide students with career counseling).

VII. Report on the National Foundation for Biomedical Research

Dr. Michael Gottesman, Deputy Director for Intramural Research, NIH, briefly related the history of the National Foundation for Biomedical Research (NFBR), a private nonprofit foundation established by Congress in 1993 to support the research and training mission of the NIH and its goal to improve public health. While the scope of the Foundation's interests was originally envisioned as limited to intramural NIH, now the Foundation is defining its scope more broadly, to address the needs of the extramural functions of NIH. The Foundation offers the private sector an opportunity to donate funds to help NIH pursue specific activities that might be of interest to the donors, such as supporting training in certain disciplines. The Foundation has been operational about a year. The Board of Directors has begun to solicit funds as well as ideas for how to spend donated funds. Among the suggestions they are considering is one to help support the NIGMS Pharmacology Research Associate Training Program. It was noted that since one-third of the graduates of the PRAT Program have pursued careers in industry, pharmaceutical firms might be interested in supporting this program. The Board is concentrating initially on training programs, including one to help integrate some aspects of the new NIH Clinical Research Training Program with the Howard Hughes Medical Institute-supported program at NIH for M.D.s interested in learning to perform basic research. Another program the Foundation is considering is one to bring junior scientists to NIH for a short period to perform independent research, followed by a year or two in academia in preparation for applying for grant support.

Dr. Gottesman then asked Council members for their ideas and answered a number of questions.

VIII. Collaborative Studies of Protein Structures

Over the last year, the Council has discussed several aspects of the review and support of crystallographic research projects. At this meeting, Council members focused on the best mechanism for providing grant support. There was broad agreement that protein crystallization is often the most difficult aspect of a structural project and that the lag time between successful crystallization and the start date of an award is too long. Competitive supplements also have a long delay and do not ease this situation. The Council considered a two-stage award, with a small initial award for crystallization work and a larger budget for projects that obtain diffraction-quality crystals. The Council believed such applications would be difficult to review and concluded that administrative supplements would be better.

Administrative supplements for crystallographic projects would be limited to $50,000 for 1 year and would be on a fast track for review and award. The Council envisioned brief applications and informal reviews by outside reviewers. These supplemental awards are intended for active grants, where the biology has already been assessed and the principal investigator has been able to crystallize the macromolecule and has found a crystallographic collaborator. The awards are intended for new investigators with little or no other research grant support. The program is envisioned as a pilot program with a predetermined number of awards. The NIGMS staff was asked to prepare a draft announcement.

IX. Recent Events at DRG

As the newly appointed Director of the Division of Research Grants, Dr. Elvera Ehrenfeld described her priority as providing top-quality and fair review for all applications to enable NIH institutes and centers to advance their programs most effectively. To do this she intends to develop new ways to engage the extramural scientific community through a variety of means, including professional societies and Councils. The intent is to get feedback on what needs to be done and how. She also plans to establish better networking and communications with the institutes and centers at NIH. Questions she is seeking feedback on include:

  • Are our study sections organized correctly?
  • Is the best science going to too small a subset of study sections?
  • Do we have some entitlements in study sections where the research areas may not be quite so productive today?
  • Do we have the right balance of scientific breadth and depth on the study sections?
  • Are we tracking newly emerging fields in science?

A good evaluation of study section organization and boundaries is needed. She intends to use some of the lessons gained in integrating the review groups from the former ADAMHA institutes into DRG as part of a model for how to think about this problem.

Subsequent discussion explored the role and interactions of the DRG Advisory Committee and the Peer Review Oversight Committee in dealing with review matters, comparability of scoring between study sections, creating an environment at DRG that will let staff perform to their highest level, and building or rebuilding confidence in the fairness of the peer review system.

X. Report on the Advisory Committee to the NIH Director

Dr. Franklyn Prendergast, the NAGMSC representative to the Advisory Committee to the NIH Director, reported on the most recent meeting. He noted that there were two principal topics.The first dealt with extramural support of clinical research by NIH. A report on this topic was given by Dr. David Nathans, the chair of the task force that has been examining this issue. This report was still in draft form. The second topic dealt with a single grant request to examine the effect of needle distribution among drug addicts on the spread of AIDS. Some ethical issues were raised about the structuring of the study. However, the conclusion of an external advisory body was that the study should go forward.

Dr. Prendergast also reported on a meeting of members of NIH advisory councils that was held the day following the Advisory Committee to the Director meeting. This group is considering the functions and operations of institute advisory councils. A report is in preparation.

XI. Report on Implementation of the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

Dr. Alison Cole reported on this subject. She noted that investigators who perform clinical research and use human subjects must report on the inclusion of women and minorities. The NIH has instituted a tracking system that allows the Institutes to input this information into a database. NIGMS has developed procedures to comply with this requirement, although the Institute has only about 400 grants that can be classified as any kind of clinical research, and only a small fraction of these involve human subjects in any way. After describing the procedures, the Council moved to approve them.

XII. Council-Initiated Discussion

CLOSED PORTION OF THE MEETING

XIII. 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.

XIV. Review of Applications

Council reviewed the following applications with primary NIGMS assignment: 597 applications that included new research grants, competing continuation grants, and supplemental grants; and 59 institutional training grant applications. In addition, Council considered 166 applications on which NIGMS had received secondary assignment. A summary of applications reviewed by Council is 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.

ADJOURNMENT

The meeting adjourned at 12:50 p.m. on Friday, January 31, 1997.

CERTIFICATION

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

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


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