Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
Advisory Council
February 12-13, 1997
I. Call to Order
Dr. Gorden called to order the 143rd National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on February 8, 1996, at 8:05 a.m.
A. Attendance Council Members Present
Dr. Irwin M. Arias
Dr. Judith Bond
Dr. Richard J. Boxer
Dr. Jack E. Dixon
Dr. David M. Harlan (Ex Officio)
Ms. Ruby R. Haughton
Dr. Barbara E. Hayes
Dr. Saulo Klahr
Dr. Robert S. Levine
Dr. Eric G. Neilson
Dr. Don W. Powell
Dr. Jerrold M. Olefsky (Ex Officio)
Dr. Barbara J. Rolls
Mrs. Suzanne Rosenthal
Dr. James Rothman
Dr. Joseph T. Spence (Ex Officio)
Dr. George Stamatoyannopoulos
Dr. Joseph H. Szurszewski
Dr. Richard D. Williams
Council Members Absent
Dr. James R. Gavin, III
B. Staff and Guests
In addition to Council members, others in attendance at the meeting included NIDDK staff members, NIH Office of the Director (OD), Division of Research Grants (DRG), Scientific Review Administrators, and other NIH staff members. Guests were present during the open parts of the meeting. Attendees included the following:
Syed Amir, DRG, David Badman, NIDDK
Ralph Bain, NIDDK
Peter Ballard, The Blue Sheet
G. Becker, DRG
Sharon Bourque, NIDDK
Josephine Briggs, NIDDK
Colleen Broder, NIDDK
Francisco Calvo, NIDDK
Dolph Chiancheano, National Kidney Foundation
Paul Coates, NIDDK
Florence Cohen, NIDDK
Catherine Cowie, NIDDK
C.R. Creveling, NIDDK
Leslie Curtis, NIDDK
Charlenia Daniels, NIDDK
Cerise Day, NIDDK
Jane DeMouy, NIDDK
Nancy Dixon, NIDDK
Richard Eastman, NIDDK
Linda Edgeman, NIDDK
Michael Edwards, NIDDK
Elvira Ehrenfeld, DRG
Donald Ellis, NIDDK
Bill Elzinga, NIDDK
Jay Everhart, NIDDK
Ned Feder, NIDDK
Carol Feld, NIDDK
Bill Foster, NIDDK
Judith Fradkin, NIDDK
C. Ganguly, DRG
Usha Ganti, NIDDK
John Garthune, NIDDK
Sandy Garfield, NIDDK
Rashi Gopal, NEI
Phillip Gorden, NIDDK
Roberta Haber, NIDDK
Ann Hagan, NIDDK
Frank Hamilton, NIDDK
Joan Harmon, NIDDK
Mary Harris, NIDDK
Barbara Harrison, NIDDK
Shirley Hilden, DRG
Trudy Hillard, NIDDK
Gladys Hirschman, NIDDK
Terri Holmes, NIDDK
Jay Hoofnagle, NIDDK
Van S. Hubbard, NIDDK
Donna Huggins, NIDDKJohn James, DRG
Desiree Johnson, NIDDK
Camille Jones, NIDDK | M.A. Khan, DRG
Sooja Kim, DRG
Kathy Kranzfelder, NIDDK
Tom Kresina, NIDDK
Krish Krishman, DRG
John Kusek, NIDDK
L. Earl Laurence, NIDDK
Kim M. Law, NIDDK
Alec S. Liacouras, DRG
Helen Ling, NIDDK
Mimi Lising, NIDDK
Billie Mackey, NIDDK
Donita Marconi, NIDDK
Ronald Margolis, NIDDK
Dan E. Matsumoto, NIDDK
Ken May, NIDDK
Nicholas Mazarella, DRG
Ludlow McKay, NIDDK
Catherine McKeon, NIDDK
Clifford Moss, NIDDK
Diana Nguyen, NIDDK
Beth Paterson, NIDDK
Denise Payne, NIDDK
Sharee Pepper, NIDDK
Aretina Perry, NIDDK
Larry Pinkus, DRG
Judith Podskalny, NIDDK
Rose Pruitt, NIDDK
Linda Quick-Cameron, NIDDK
Sharon Ricks, NIDDK
Alice Robinson, NIDDK
Carmen Robinson, NIDDK
Charles Rodgers, NIDDK
Lakshmanan Sankaran, NIDDK
M. James Scherbenske, NIDDK
D. Schneider, DRG
Eric Schutt, JDF
Elizabeth Singer, NIDDK
Philip F. Smith, NIDDK
Gloria Snowden, NIDDK
Walter Stolz, NIDDK
Tommie S. Tralka, NIDDK
George Tucker, NIDDK
Karen Vagley, National Kidney Foundation
Charles A. Wells, NIDDK
Nola Whitfield, NIDDK
Danita Woodley, NIDDK
Susan Yanovski, NIDDK
Rita Yeager, NIDDK
Charles Zellers, NIDDK |
C. Conflict of Interest Statement
Dr. Gorden called to the attention of the Council the Confidentiality and Conflict of Interest Statements. After discussing the scope of confidentiality and conflict of interest, he requested that Council members comply with the requirements. He reminded Council members to avoid a conflict of interest by leaving the room when the Council discussed individual applications in which an actual or perceived conflict of interest might occur. Members were asked to sign a statement to this effect. This did not apply to en bloc actions.
Dr. Gorden announced that the Council meeting would be open to the public in accordance with the provisions of Public Law 92-463 on Wednesday, February12, 1997, from 8:40 a.m. to noon, closed from 1 p.m. until 5 p.m., closed on Thursday, February 13, 1997 from 8:30 a.m. to 10 a.m. for review, Discussion, and evaluation of grant applications, and open from 10:30 a.m. to noon.
II. Consideration of the Summary Minutes of the Previous Meeting
Dr. Gorden asked for acceptance of the NDDK Advisory Council Summary Minutes of the last Council meeting. The minutes were unanimously accepted.
III. Future Meeting Dates
Dr. Gorden asked for consideration of meeting dates for future NDDK Advisory Council meetings, and the following meeting dates were proposed and accepted:
- May 28-29, 1997
- September 17-18, 1997
- February 4-5, 1998
- May 27-28, 1998
- September 14-15, 1998
- February 17-18, 1999 (new)
- June 16-17, 1999 (new)
- September 8-9, 1999 (new)
IV. Director's Report
Dr. Gorden began his report by welcoming back Dr. Richard Boxer and by introducing the new members of Council, Drs. Judith Bond, Barbara Hayes, Robert Levine, Eric Neilson, Jerrold Olefsky (Ex Officio), James Rothman, and George Stamatoyannopoulos, and Ms. Ruby Haughton. He announced several appointments in the Department of Health and Human Services: Dr. Shalala has agreed to remain as Secretary; Kevin Thurm is now Deputy Secretary; and Philip Lee, previously the Assistant Secretary of Health, has resigned. Dr. Gorden said that in NIDDK, John Garthune has the new position of Special Assistant for Grants Analysis and Control. He also announced that Bill Eaton and James Hofrichter, NIDDK Intramural staff members, have received the Hillibrand Award presented by the local chapter of the American Chemical Society.
Dr. Gorden gave a brief overview of some of the important congressional events that affect the NIDDK. He pointed out that the 105th Congress had convened and that the NIH would be defending its Budget in the spring. He reported that reauthorization of the NIH by the subcommittee chaired by Senator William Frist (a surgeon) and Representative Michael Bilirakis, was scheduled for this year.
He reminded the Council members that they would be asked to review the Institute's planning documents at this meeting and stressed that the Council members' recommendations were needed.
Dr. Gorden reported that the NIDDK in fiscal year 1996 awarded 508 competing and1,673 noncompeting research project grants. He indicated that for fiscal year 1997, NIDDK was projected to receive $816 million which will enable the Institute to fund approximately 600 competing grants.
Budget
Mr. Zellers, NIDDK Budget officer, gave an overview of the NIDDK Budget by describing the numbers and dollar amounts of grants funded in FY 1996, the amounts projected for FY 1997, and the President's Budget request for FY 1998. He noted that there was an increase of 5.9 percent for NIDDK for FY 1997. He reported that the total increase for the NIH was 6.9 percent, which included significant amounts for construction of the new Clinical Center and for the human genome project. He said that there were changes in the financial management plan for FY 1997, which included a reduction in the inflation rate that had been set by the NIH at 4 percent. He said that ongoing grants would continue to receive a 4 percent cost-of-living increase, but that competing grants funded in FY 1997 would only receive an increase of 3 percent in each of their noncompeting years; and in FY 1998, the Pressident's Budget requests that it be a 2 percent increase. He noted that this would be reexamined if the appropriation were increased for FY 1998.
He reported that the multi-year funding proposal described at the previous Council was not implemented, so it was not shown as part of the FY 1997 and FY 1998 Budget projections.
He pointed out that Dr. Varmus had designated special emphasis areas and that the NIDDK's programs fit well into some of these such as new approaches to pathogenesis, new preventive strategies against diseases, and genetic medicine. He described a new NIH-wide instrumentation initiative designed to provide additional funds for equipment to research project grants. Also, he reported that in FY 1997 the set-aside for funding Small Business Innovation Research awards had risen from 2 percent to 2.5 percent of the NIH extramural Budget.
Discussion
A Council member asked how the Budget increase for NIDDK compared with other institutes' increases. Mr. Zellers responded that the average increase for other institutes was 6.3 percent, slightly higher than the NIDDK increase. Council members expressed concern that the NIDDK was not doing as well as the average NIH institute in the funds being allocated, and they asked what could be done to provide a larger increase for the NIDDK. They expressed concern that as the NIH Budget increased, the NIDDK would fall further and further behind. Dr. Gorden described some of the Budget processes and how the recommended Budget made its way from the NIH through the DHHS to OMB and from the initial development to the final allocations.
V. Reports and Discussions
A. NIDDK Support for New Investigators
Dr. Foster gave a report of the status of new investigators over the past 10 years and pointed out that the decrease in new investigators was a NIH-wide problem and not just a NIDDK problem. He said that he would limit his presentation to the ratio of those new investigators without any previous grant awards compared to the total research project grant awards. He reported that, in general, the NIDDK had done better in supporting new investigators than most of the institutes until this past year when the NIDDK dropped significantly. He said that after peaking in FY 1989 with new investigators making up 30 percent of the competing research project grants, the percentage was now at 21.9 percent which meant that it had fallen at a rate of more than 1 percent per year. He reported that, until recently, 50 percent of the new investigators who did not succeed on their first attempts at NIH funding were eventually successful in receiving an award. He said that this number had also been dropping such that now it was below 25 percent. He reported that physicians received awards as frequently as those with other degrees, and that the percentage of newly funded investigators under the age of 36 had fallen from 44 percent in FY 1989 to less than 22 percent currently.
He described a variety of measures that the NIH and the NIDDK had taken to nurture new investigators such as: creation of the R29 grant, preferential advantage given to the R29, and the current efforts by the NIDDK to raise the amount of the R29 award.
Finally, he indicated that a broader study of the problem of new and young investigators trying to enter the grants system would be mailed to Council members within a few weeks.
B. Continuation of September Discussions on FIRST Awards
Dr. Stolz reported that in response to the Council members' request at the September 1996 Council meeting, he looked into ways to increase the R29 award from $70,000 per year to $100,000 per year, direct costs. This recommendation was discussed with Drs. Varmus and Baldwin who approved the following general strategy: Each R29 application and its summary statement would be reviewed by Council members to determine an appropriate Budget between $70,000 to $100,000 per year for 5 years. Grants made for more than $70,000, direct costs, would be funded as R01s. Dr. Stolz said that this plan would cost the Institute between $1.5 and $2 million per year. Dr. Stolz also addressed the issue of funding R29s to a substantially higher payline than other research project grants.
He said that if R29 grants were funded to 10 percentile points higher than the payline for other grants, there would be another 20 R29 grants within this 10 percentile range that could be funded per year. He said that this would raise the number of competing R29 grants to 75 per year that could be funded and would cost the Institute about $2.8 million.
Discussion
Council members asked about the effect on scoring of R29 applications in the first level of review when it became known that this was the procedure NIDDK planned to use. Dr. Stolz responded that because each grant would be considered on its own merits by the Council, study sections would not be able to predict whether or not a Budget might be increased and by how much. Therefore, he believed that there was not likely to be significant impact on the scoring for the R29 applications by the study sections.
Council members expressed concern that R29 investigators applying for subsequent R01s tended to have a relatively low success rate. The Council members pointed out that these data showed that the number of new investigators entering the fields supported by the NIDDK was declining even with the actions taken to encourage young investigators. As an example, Council members said that among the new investigators, in 1994 there were 85 new investigator R01s and 59 R29s; in 1995, there were 80 new investigator R01s and 60 R29s; while in 1996, there were 66 new investigator R01s and 45 R29s.
Council members recommended that more data be acquired on the applicants for the R29 awards. Council members pointed out that there were two types of applicants, some who were applying for the R29 were using the award to prolong their stay in the same institution as their postdoctoral award, and some who moved to a new setting such that the R29 was actually their first independent grant. It was pointed out that the applicants had to show independence in their research to obtain the R29 award. However, Council members asked for these data to be collected, and the two groups with R29 awards compared for their success rate in applying for subsequent R01s.
Council members pointed out that when the young investigator applied for an R01, if he or she had had an R29, then they were limited in the increase that would be allowed such that someone holding an R29 would be penalized when receiving an R01. Dr. Gorden pointed out that the Institute knew which new investigators applying for R01 grants had had an R29 grant previously. He said that these applications could be called to the Council members' attention for their recommendation.
Council members expressed concern that the study sections were not giving the R29 applications, and those R01s from new investigators, the consideration they were supposed to give them. It was pointed out that this varied from study section to study section. Council members recommended that the review process of the R29 be assessed and steps taken to enhance the reviews of the R29 applications. It was agreed that Dr. Ehrenfeld, director of DRG, would be asked about the DRG plans to review and to standardize the review of the R29 applications among study sections.
The Council members did not think that the steps being taken currently were enough to increase the opportunities for young investigators. Council members pointed out that the current Budget for the R29 was not sufficient for a beginning laboratory, so the R29 awardee was not as competitive when the applicant applied for an R01 grant. Council members made other suggestions to try to increase the amount of funding for the R29 such as decreasing the amount of effort of the investigator on the R29. Council members recommended raising the stipend for the R29 award.
Council members pointed out that changes within institutions and academic health centers were making it harder to support young investigators. As an example, it was pointed out that funds coming into the clinical research center and used for clinical research were disappearing, resulting in a decreased ability of the institution to cost-share. Also, the institutions were reorganizing and eliminating all subspecialty fellowship training in clinical departments. It was pointed out that if this occurred and the discretionary funds from clinical income disappeared, then institutions would have a decreased ability to fund young investigators with their own funds.
Council members were in agreement that new investigators with new ideas must constantly be brought into the system to maintain its vitality. However, they pointed out that with a steady state of funds and an increase in the numbers of new investigators, fewer established investigators would be funded and that there would be fewer dollars to fund new investigators at the end of their R29 awards. It was suggested that ideas about what it would take to support these investigators after the completion of their R29s needed to be developed.
Council members were in agreement that the institutions were more likely to fund more established investigators than young investigators, and that for each established investigator, three young investigators could be funded with R29 awards. Council members were in agreement that new investigators needed support.
Council members recommended that the R29 maximum be raised to $100,000 per year with the Council members reviewing and making recommendations on all R29 grants. They proposed that this be done as an experiment and reviewed each year. They recommended that R29 investigators and new R01 investigators be tracked to see whether they were able to continue to compete successfully for support at the completion of their first grant.
C. Report of the December 1996 Meeting of the Advisory Committee to the Director, NIH
Council member Dr. Don Powell had attended the December 1996 meeting of the Advisory Committee to the Director, NIH, as the representative from the NDDK Advisory Council, and he gave a report of the meeting. He said that the issues discussed included the NIH strategic planning process and the new clinical center being built. He reported that a governing board of 17 members, of which 9 would be from outside of the NIH, would oversee the clinical center. He said that the new center would be smaller than the current building and have fewer beds, 250 inpatient beds and 100 day-care outpatient beds.
He reported that a panel, convened by Dr. Varmus and chaired by Dr. David Nathans of Harvard Medical School, had been asked to determine how much clinical research is carried out and funded by the NIH and to make recommendations about how the NIH could facilitate clinical research. He said that an interim report had been prepared and that the final report would be due at the end of the year. He pointed out that there was a difference in the way the definition of clinical research was applied by the panel in comparison to the way the definition had been applied in studies by the Institute of Medicine. In the NIH method, if one component of an R01 or a P01 had clinical research then the whole grant was counted as clinical research. The Institute of Medicine, with its more strict criteria, attempted to estimate the percentage of clinical research within each grant. The Institute of Medicine reported that about 10 percent of research was clinical, while the NIH, using its definition, reported about 26 percent of P01 and R01 research grants had some clinical content, and that 31 percent of career awards contained clinical research.
He reported that the panel had met with industry and foundations for their ideas of how much research they would be willing to fund. He said that although they had expressed an interest in increasing their support of clinical research, it could be difficult given the press of other priorities. He reported that other recommendations for improving clinical research included supplying expertise on clinical trial design, research, and analysis, and ensuring fair and effective review by having people familiar with clinical research serve on review panels. Other recommendations were to collaborate with the private sector in initiating a medical student program and to foster a student debt reduction program.
D. Report of the Meeting of Representatives of the Institute Advisory Councils and Boards
Dr. Powell reported that draft reports had been produced from the several subcommittees that were addressing different issues. One subcommittee covered advocacy and what could be done to increase the visibility of the NIH as a supporter of biomedical research. Another subcommittee reviewed the evaluation of NIH scientific directors, and the subcommittee recommended that at least one member of an advisory council or board be a member of the ad hoc committee for evaluation of a scientific director. A third subcommittee addressed strategic planning and concluded that Council members should be more involved in strategic planning, in determining the contents of the portfolios of the institutes, in deciding how funds were to be distributed, and in guiding both the intramural and extramural programs. He pointed out that this would need a lot of Discussion so that Council members did not overstep their advisory role. A fourth subcommittee was a grant review working group that was assessing how the review process impacted on whether funding was based on scientific merit and how the scores were used to develop a presumptive payline. This subcommittee was looking at the roles of the advisory councils and their behavior in recommending special consideration as well as program relevance issues. It was suggested that a certain percentage of the Budget in each institute be set aside for program relevance.
E. The Role of the NDDK Advisory Council in NIDDK's Extramural Program: A Report of the Williams Subcommittee and Continuation of Discussions Begun at the September Meeting
Dr. Gorden introduced Council member Dr. Richard Williams by describing how the Williams Subcommittee of the NDDK Council was formed, who served on the Subcommittee, and the purpose of the Subcommittee.
Dr. Williams said that the Subcommittee was established to discuss how the members of the Council could be more involved in Institute business and how more use could be made of Council members' expertise in their advisory role to the NIDDK. He described some of the issues the Subcommittee had identified, which included program planning and the identification of scientific initiatives. The Subcommittee recommended that the Council members be more involved at the formative stage of the initiatives by identifying scientific initiatives and some of the hot areas of research. Dr. Williams described a number of ways the Council members could help with the formulation of these initiatives. He pointed out that concerns were expressed about what happened to the RFAs and PAs proposed by the Institute and whether they resulted in R01 grant applications being submitted.
Dr. Williams said that strategic planning was a concern and pointed out the difficulty in developing long range plans such as 5-year or 10-year plans. He said that what was hot this year when the strategic plan was developed might not be hot in the future. Dr. Williams reported that another area of concern was the funding of grants that were just missing the payline. He said that the Subcommittee was in favor of bridge funding of grants, and he described other recommendations from the Subcommittee for finding funds to pay more of the grants at the payline margin. Dr. Williams said that the Subcommittee recommended finding a way to fund grants before the Council met that were obviously going to be funded later.
He said that the Subcommittee expressed concern about the decrease in numbers of new grantees, and he described some of the recommendations of the Subcommittee. He pointed out that it would be helpful for the Council members to be familiar with the entire NIDDK portfolio of grants as well as those in their own areas of expertise. He described some of the concerns the Subcommittee expressed about the first level review of the grants.
Discussion
Council members discussed scientific initiatives and why it was important for Council members to identify high priority, new, and gap areas of research. Council members voiced their concerns about being involved in the identification of initiatives late in the process and recommended that they be involved very early so that they could ask their societies and lay organizations for their opinions as well. Council members pointed out that the initiatives could be used as a template in the planning process. They said that most strategic plans were too specific and should be broad. They said that since most research was investigator initiated, they recommended some middle ground as a compromise. They also said that they needed information on which grants were in the broad areas identified by Dr. Varmus as high priority research areas.
Council members discussed what they could do with the applications at the margin of the funding line. It was pointed out that there were small numbers of applications in this range and that it would not be a burden for them to consider this pool of grants. They decided that it would be helpful to have more information about the portfolio and which areas had large amounts of funding and which areas had little funding. They pointed out that this information was critical for making decisions about funding grants in this marginal group.
Council members were concerned about continuity of funding for continuing grants that were within this marginal group. It was pointed out that to restart a laboratory after it had been shutdown was very costly in both time and funds, and they recommended that bridge funding of these grants should be a high priority item. Dr. Gorden pointed out that each time one grant was funded out of line, it replaced a grant with a better score. He said it was hard to answer a researcher's concerns when his grant was not paid even though it was in the funding range. Council members recommended approaching the universities about partnering with the NIH to do more bridge funding. There were some problems with this because the universities were strapped for funds.
Council members suggested that some applications having very high scores that were sure to be funded could be funded by the Institute and reported to the Council members at the next Council meeting. They pointed out that this would give these grantees a 2-month lead time and would even out the work load for the Institute staff.
Council members indicated that the scientific presentations during Council meetings were useful, and they recommended that research successes should be presented as well.
VI. Special Discussions: Peer Review
Dr. Gorden introduced Dr. Elvira Ehrenfeld, the newly appointed head of the Division of Research Grants (DRG). Dr. Ehrenfeld gave an overview of how the DRG was reorganizing after assuming responsibility for many of the reviews traditionally performed by the National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and National Institute of Mental Health. She pointed out that some of the hottest areas of science were all going to a few study sections while some study sections were reviewing grant applications in scientific areas that were not so active, resulting in a sort of entitlement for these areas. She said that some grant applications in newly emerging fields of science were put into study sections that might not be appropriate for them. She described how the restructuring of the study sections would address these problems. She discussed the problems with attracting good reviewers, and she said that there were some communities that did not think they were well served by DRG. She pointed out that DRG could not address these issues in isolation, but had to be responsive to the communities and the institutes. She described some of the steps being taken in the process of restructuring the study sections.
Dr. Ehrenfeld went over questions that had been given to her by Council members. She said that the DRG was reevaluating the criteria for reviewing the R01 grant applications and that the review of fellowships had been reevaluated.
Discussion
Council members asked questions about the review of the R29 grant applications, and how to determine why there appears to be a relatively low rate of success when R29 holders attempt to renew their grants as R01s. Dr. Ehrenfeld responded that the best qualified researchers may be applying for R01 grants instead of the R29, and that those who applied for the R29 might not be the best qualified applicants.
Council members pointed out that there were no performance evaluations for the reviewers or the study sections, and that the age of the reviewers made a difference in how they reviewed the grants. Dr. Ehrenfeld pointed out that the reviewers were individuals and were dependent on the skills of the scientific review administrators that ran the study sections. She agreed that the reviewers needed to know about successes of the applications that were reviewed. She described some changes that were being discussed in order to attract good reviewers.
A Council member asked about program directors' roles in monitoring the study sections. Dr. Ehrenfeld described the logistics involved for the program directors to attend study section meetings and some of the ways that the study sections tried to accommodate the program directors.
Dr. Ehrenfeld said that there were several pilot projects to address some of the issues that the Council members had raised. She added that the scientific review administrators had a difficult job to do, that they had to be competent, and that a stimulating environment had to be provided for them.
VII. Participation of Women and Minority Populations in NIDDK-Sponsored Clinical Research
Dr. Stolz described a report developed by the Office of Research on Women's Health about the inclusion of women and minorities as subjects in clinical research. He said that the Council was required by law to certify that the Institute was in compliance with the law in ensuring that appropriate numbers of subjects were enrolled in clinical research representing each gender and each minority group. He pointed out that the initial review groups were responsible for assessing compliance by the universities doing clinical research as to whether they were in compliance with the law. If an initial review group found that an application was not in compliance, it could not be funded until further information was supplied or the design of the study was modified. All clinical research studies were being tracked by having the data entered annually as the principal investigators submitted enrollment information broken down by minority group and gender in their noncompeting applications. The NIH and NIDDK compliance was about 95 percent. Dr. Stolz asked the Council members to approve the report, and it was moved and seconded to accept the report.
Discussion
Council members asked about large grants with many projects and how these were counted. Dr. Stolz responded that protocols were counted rather than grants such that one protocol might be used by many grants and, conversely, one grant might have several protocols.
VIII. Demonstration of Viewing Summary Statements Using the Internet
Dr. Ann Hagan, chief of the Review Branch, NIDDK, gave a demonstration of how Council members would be able to retrieve and view summary statements prior to future Council meetings. She said that only NIDDK summary statements that were going to Council would be accessible to the Council members. She said that since the summary statements were confidential, the Council members would be issued passwords for each Council that could only be used for a few weeks prior to Council and then for a brief period after Council. She described several types of information that could be retrieved.
IX. Discussion of the NIDDK Proposed Financial Operating Plan
Dr. Gorden described some proposed adjustments to the Institute's financial operating plan that would accommodate to the FY 1997 Budget. He proposed several priorities for the use of the FY 1997 funds. He recommended, as a first priority, bridge funding of grants just missing the payline; as a second priority, he recommended raising R29 maximum 5-year Budgets from $350,000 to $500,000 on a case-by-case basis; as the third and fourth priorities, he recommended easing the restrictions in the growth of both new and continuing competing grants; and as a fifth priority, he recommended raising the payline for competing applications by 2 percentage points.
Discussion
Council members pointed out that some of the recommendations would cost the Institute very little, such as the recommendation on bridge funding of grants, and others would use large amounts of Institute funds such as increasing the growth of all competing awards.
In response to Council members' questions on the amount of Institute funds that would be involved, Dr. Gorden pointed out that the Institute would not know precisely how many grants or funds would be involved until later in the year. He pointed out that in the past, every effort had been made to fund more grants; however, now he was proposing to ease the constraints on the average grant size and allow some growth in the grants before raising the payline.
Council members were concerned that none of the priorities addressed funding additional program initiatives from the Institute's Annual Research Plan. They recommended that the Institute put some funds into new initiatives that connected with the public.
Some Council members said that raising the payline was more important than increasing the average grant size, and they said that changing the payline made a major difference in the scientific community's outlook on the future. They said that the goodwill generated by a raised payline would be extensive. Council members also pointed out that by funding more grants some of the new initiatives could be addressed. Other Council members pointed out that if a grantee did not have sufficient funds to do the research then that money would be wasted. These Council members were in favor of increasing the average grant size.
X. Division Director's Report
A. Division of Diabetes, Endocrinology, and Metabolic Diseases Report
Dr. Eastman gave the Division report and described the growth in the Division's Budget over a span of years between 1988 and 1997.
B. Division of Digestive Diseases and Nutrition Report
Dr. Hoofnagle gave the Division report and described plans for a Consensus Development Conference on the Management of Hepatitis C to be held on March 24-26, 1997, at the NIH. He said that hepatitis C (HCV) was one of six viruses that accounted for the majority of cases of viral hepatitis. He pointed out that these viruses were the most common cause of liver disease and thus liver transplantation. He reported that population-based surveys have shown an estimated 4 million Americans are infected with Hepatitis C. He said that the conference would focus on appropriate approaches to diagnosis and monitoring of patients, effective therapies, which patients should be treated and recommendations to prevent transmission of hepatitis.
C. Division of Kidney, Urologic, and Hematologic Diseases Report
Dr. Leroy Nyberg, acting director of the Division, gave the report and announced that Josephine P. Briggs, M.D., would become the new director of the Division, and he said that Dr. Gorden would introduce her officially at the next Council meeting. Dr. Nyberg reported on a media campaign about urinary incontinence to encourage women to seek treatment for this condition. He reported that the Institute had the media campaign under way to publicize this problem which affects 11 million women of the 13 million Americans with urinary incontinence.
XI. Consideration of Review of Grant Applications
Summary Table 1
| Applications Taken to Council |
All Applications by
Budget Category | Scored | NRFC | Deferred | No Action | Total |
Regular Research *
(P01, R01, R29,
R37, R41, R42,
R43, R44, U01) | 630 | 21 | - | - | 651 |
Other Research *
(R03, R13, R15,
K02, K08) | 146 | - | - | 4 | 150 |
| Centers (P30, P50) | 22 | - | - | - | 22 |
Training *
(T32) | 12 | - | - | - | 12 |
* Includes both DK primary and secondary.
Of these applications, three were received from institutions outside the U.S.A.
Summary Table 2
| Applications Taken to Council |
Applications by
Support Mechanism | Scored | NRFC | Deferred | No Action | Total |
| Program Projects (P01) | 7 | - | - | - | 7 |
| Research (R01) | 459 | 1 | - | - | 460 |
| FIRST (R29) | 69 | - | - | - | 69 |
| MERIT (R37) | 8 | - | - | - | 8 |
STTR (R41)
(R42) | 10
- | 3
2 | -
- | -
- | 13
2 |
SBIR (R43)
(R44) | 61
13 | 15
2 | -
- | -
- | 76
15 |
Cooperative
Agreements (U01) | 1 | - | - | - | 1 |
| Small Grants (R03) | 21 | - | - | - | 21 |
| Conferences (R13) | 37 | - | - | 4 | 41 |
| AREA (R15) | 65 | - | - | - | 65 |
Careers (K02)
(K08) | 3
20 | -
- | -
- | -
- | 3
20 |
| Core Centers (P30) | 5 | - | - | - | 5 |
| Special Centers (P50) | 17 | - | - | - | 17 |
| Training (T32) | 12 | - | - | - | 12 |
| All Applications | 810 | 21 | - | 4 | 835 |
Council did not concur with Initial Review Group recommendations on three applications.
Summary Table 3
| Applications Not Taken to Council |
Categories by
Support Applications | Unscored
Applications | NRFC
Applications | Excluded by
Institute Staff | Total
Applications |
| Traditional Research (R01) | 288 | 2 | - | 290 |
| FIRST Awards (R29) | 46 | - | - | 46 |
| STTR Phase I
(R41) | - | 5 | - | 5 |
| SBIR Phase I
(R43) | - | 35 | - | 35 |
| SBIR Phase II
(R44) | - | 5 | - | 5 |
| Conferences
(R13) | - | 3 | - | 3 |
| AREA Grants
(R15) | - | 11 | - | 11 |
| Careers CIA (K08) | 1 | - | - | 1 |
| Special Centers (P50) | 9 | - | - | 9 |
| Totals | 344 | 61 | - | 405 |
XII. Adjournment
Dr. Gorden thanked the Council members for their attendance and advice. There being no other business, Dr. Gorden adjourned the 143rd meeting of the NDDK Advisory Council on February 13, 1997, at 12:05 p.m.
I hereby certify that, to the best of my knowledge, the foregoing summary minutes and attachments are accurate and complete.
Phillip Gorden, M.D.
Director, National Institute of Diabetes and Digestive and Kidney Diseases
and
Chairman, National Diabetes an Digestive and Kidney Diseases Advisory Council
