Department of Health and Human Services
Public Health Service
National Diabetes and Digestive and Kidney Diseases
May 31-June 1, 2000
I. Call to Order
Dr. Spiegel called to order the 153rd National Diabetes and Digestive and Kidney Diseases Advisory Council meeting on May 31, 2000, at 8:35 a.m.A. Attendance
Council Members Present (See Attachment A)
Dr. Edward J. Benz, Jr.
Dr. D. Montgomery Bissell, Jr.
Dr. Judith Bond
Dr. Jeffrey I. Gordon
Hon. Levan Gordon
Ms. Ruby R. Haughton
Dr. Edward W. Holmes
Ms. Genevieve R. Jackson
Dr. C. Ronald Kahn
Dr. Saulo Klahr (Ad-hoc)
Dr. John McConnell
Dr. Kristen McNutt
Dr. Daniel Podolsky
Dr. Daniel Porte (Ex Officio)
Dr. Sandra Puczynski
Dr. Joseph Szurszewski (Ad-hoc)
Dr. Ming-Jer Tsai
Dr. Dana Weaver-Osterholz
Dr. Robert W. Schrier
Dr. Rena R. Wing
Council Members Absent:
Dr. Eric G. Neilson
Dr. Joseph T. Spence (Ex Officio)
B. Staff and Guests
In addition to Council members, others in attendance at the meeting included NIDDK staff members, representatives of the NIH Office of the Director (OD), Center for Scientific Review (CSR), Scientific Review Administrators, and other NIH staff members. Guests were present during the open parts of the meeting. Attendees included the following:
|David Badman, NIDDK |
Jeff Ball, NIDDK
Michelle Barnard, NIDDK
Pamela Belton, NIDDK
Johnny Bladen, NIDDK
Josephine Briggs, NIDDK
Ben Burton, NIDDK
Francisco Calvo, NIDDK
Syd Carter, NIDDK
Catherine Cowie, NIDDK
Leslie Curtis, NIDDK
Charlenia Daniels, NIDDK
Florence Danshes, NIDDK
Jane DeMouy, NIDDK
Nancy Dixon, NIDDK
Jackie Dobson, NIDDK
Linda Edgeman, NIDDK
Jay Everhart, NIDDK
Richard Farishian, NIDDK
Teresa Farris, NIDDK
Ned Feder, NIDDK
Carol Feld, NIDDK
Bill Foster, NIDDK
Judith Fradkin, NIDDK
Joanne Gallivan, NIDDK
Sandy Garfield, NIDDK
John Garthune, NIDDK
Janet Gregory, NIDDK
Colleen Guay-Broder, NIDDK
Lauren Hafer, The Blue Sheet
Ann Hagan, NIDDK
Frank Hamilton, NIDDK
Joan Harmon, NIDDK
Mary Harris, NIDDK
Maureen Harris, NIDDK
Barbara Harrison, NIDDK
Jay Hoofnagle, NIDDK
Van S. Hubbard, NIDDK
Donna Huggins, NIDDK
Desiree Johnson, NIDDK
Camille Jones, NIDDK
Mary Beth Kester, NIDDK
M. A. Khan, CSR
Krish Krishman, CSR
John Kusek, NIDDK
|Maren Laughlin, NIDDK|
L. Earl Laurence, NIDDK
Kim M. Law, NIDDK
Todd Le, NIDDK
Monica Liebert, NIDDK
Barbara Linder, NIDDK
Billie Mackey, NIDDK
Denise Manouelian, NIDDK
Ronald Margolis, NIDDK
Winnie Martinez, NIDDK
Dan E. Matsumoto, NIDDK
Ken May, NIDDK
Barbara Merchant, NIDDK
Carolyn Miles, NIDDK
Barbara Minor, NIDDK
Neal Musto, NIDDK
Beth Paterson, NIDDK
Denise Payne, NIDDK
Aretina Perry-Jones, NIDDK
Judith Podskalny, NIDDK
Rose Pruitt, NIDDK
Alice Robinson, NIDDK
Charles Rodgers, NIDDK
Mary Kay Rosenberg, NIDDK
Lakshmanan Sankaran, NIDDK
Sheryl Sato, NIDDK
Bill Schmidt, Juvenile Diabetes Foundation
Jose Serrano, NIDDK
M. James Sherbenske, NIDDK
Elizabeth Singer, NIDDK
Ron Sleyo, NIDDK
Philip F. Smith, NIDDK
Gloria Snowden, NIDDK
Jane Spencer, NIDDK
Robert Star, NIDDK
Joan Starr, NIDDK
Walter Stolz, NIDDK
Tommie Sue Tralka, NIDDK
George Tucker, NIDDK
Susan Yanovski, NIDDK
Rita Yeager, NIDDK
Charles Zellers, NIDDK
Troy Zimmerman, National Kidney Foundation
Leonard Zon, The Children's Hospital, Boston
C. Conflict of Interest Statement (See Attachment B)
Dr. Spiegel 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. Spiegel announced that the Council meeting would be open to the public in accordance with the provisions of Public Law 92-463 on Wednesday, May 31, 2000, from 8:30 a.m. to 12:30 p.m., closed from 1:30 p.m. until 5:30 p.m., closed on Thursday, June 1, 2000, from 8:00 a.m. until 11:00 a.m. for review, discussion, and evaluation of grant applications, and open from 11:00 a.m. to 12 noon.
II. Consideration of the Summary Minutes of the Previous Meeting
The Council members present accepted the NDDK Advisory Council Summary Minutes of the last Council meeting unanimously.
III. Future Meeting Dates
Dr. Spiegel asked for consideration of the following dates for future NDDK Advisory Council meetings:
- September 20-21, 2000
- February 7-8, 2001
- May 30-31, 2001
- September 20-21, 2001
- February 13-14, 2002
- May 30-31, 2002
- September 18-19, 2002
IV. Director's Report
Dr. Spiegel introduced two ex-Council members who were attending in an ad hoc capacity, Drs. Saulo Klahr and Joseph Szurszewski. He introduced new NIDDK staff members, Dr. Monica Liebert in the Kidney, Urologic, and Hematologic Division, Dr. Michele Barnard, in the Division of Extramural Activities, and Dr. Pamela Starke-Reed, Deputy Director in the Division of Nutrition Coordination. He reported that Dr. Ruth Kirschstein would continue as Acting Director of the NIH until after the 2000 Presidential election when it is anticipated that a new director will be named.
Dr. Spiegel discussed ethical issues in clinical trials and some of the problems that had surfaced recently. He focused on changes in how clinical trials were reviewed and the additional oversight that would be required over the life of a trial. He pointed out that some of the problems in the oversight of trials had been with communication between the FDA and the NIH, and that these problems were being addressed. He said that the Congress wanted research moved to the bedside as quickly as possible while the NIH, at the same time, was asked to provide evidence that patient risks were minimized. He reported that Institutional Review Board (IRB) reviews of clinical trial protocols would not be required prior to the clinical trial applications being reviewed by NIH study sections, but would be required prior to funding. He described some of the changes in the methods for monitoring clinical trials as well as the issue of conflict of interest. Finally, he reported that the Office for Protection from Research Risks (OPRR) would be moved from the NIH to the DHHS.
Dr. Spiegel discussed the implications for the NIH of the Human Genome Project. He pointed out that the Congress's investment in fundamental research was underpinning the biotechnology industry. Also, he said that the NIH should not relinquish its role of ensuring open access to facets of the human genome as well as ensuring that no single private entity could monopolize the technology in some way. He reported that the mouse genome was important and was being sequenced. Also, he said that the Sanger Centre with funding from the Welcome Trust was considering sequencing of the zebrafish genome.
He reported that stem cell research was at a pivotal stage in terms of the state of the research and potential application to human disease. He pointed out that the NIH had draft guidelines for investigators who want to work with embryonic stem cells and that these guidelines, when released, would permit this research to go forward supported by Federal funds. He pointed out the importance of the guidelines and said that the public would be well served with federally funded researchers investigating these problems.
Dr. Spiegel gave a brief overview of the NIH's budget and said that the President's budget for FY 2001 called for a 6 percent (or about a $1 billion) increase over FY 2000. He said while the House also called for a $1 billion increase, the Senate called for a $2.7 billion increase. He described some of the programs mentioned in the bills, in particular a congressional effort to distribute more NIH funds to States that currently receive relatively few grants. He said the House and Senate bills addressed this issue by increasing funding for the Institutional Development (IDeA) Program in the National Center for Research Resources with up to $60 million.
Dr. Spiegel discussed the MERIT (Method to Extend Research in Time) Award process and reviewed the criteria for the selection of MERIT Awardees. He pointed out that the MERIT Award should be reserved for the very best research even if there were years when no award would be given. He pointed out that it would be a major problem if a MERIT Award were given and the extension had to be denied because of lack of productivity of the awardees. He said that MERIT candidates were favored who had not previously held a MERIT award. He asked the Council members to discuss the criteria and to give suggestions for any changes they would recommend.
Council members said they were pleased with some of the changes relating to the support and monitoring of clinical trials, especially the new mechanisms for help with the infrastructure costs. They pointed out that some of the costs for certification and credentialing required by the Government agencies need to be addressed since these costs were no longer being borne by drug companies. Also, they said that the multiple agencies with oversight responsibility were confusing to investigators, and there should be a common set of rules so investigators would know their obligations. They expressed concern about the system for auditing the clinical trials. Dr. Spiegel responded that there were guidelines that were being developed and that there would be more information later. He pointed out that it was important to assure the highest integrity in the way clinical trials were conducted so as to maintain the confidence of the public and the Congress.
Council members asked about data to show trends of whether the "have not" States were receiving fewer funds and whether the research dollars were being concentrated in fewer and fewer places. They said the distribution of NIH funds across regions of the country was a serious issue and pointed out that to appropriate funds to States without understanding the underlying dynamics of the system was not a good use of funds. They recommended finding out why some States received few NIH funds. Dr. Spiegel responded that an article that tracked NIH funding at major medical centers indicated that the spread of the funding was becoming slightly more concentrated in a few institutions, but only marginally so. He pointed out that some States were using money they received from tobacco for State universities and for biomedical research. Also, he said that the NIH was concerned about how the funds were to be distributed. He said that one idea was to use the funds for planning grants.
Council members pointed out that the changing health care environment had made the maintenance of a vigorous research and training enterprise more difficult to develop and maintain. Dr. Spiegel said that emphasizing partnering of some of the academic medical centers that lack the fundamental research base in the "have not" States with multi-center networks with strong clinical research components would be a way to address this problem. Council members pointed out that some clinicians liked taking care of patients and were not interested in doing clinical research or entering their patients in clinical trials. They pointed out that care should be taken not to exploit patients, and that there must be the necessary staff and infrastructure in place to do clinical research. Dr. Spiegel said that some had made the point that it required a strong basic research component to do good clinical research. He said planning grants, training courses, and an appropriate investment in the infrastructure needed for successful clinical research may be an appropriate use of NIH money. A Council member suggested that NIH invest in interactive video conferencing as a way to pull in small focus groups in the weaker research universities to interact with the larger groups and consortia to address this problem. Dr. Spiegel responded that higher technology would be an adjunct and would facilitate communication.
V. Annual Review of the Division of Intramural Research
Dr. Spiegel gave the report of the Division of Intramural Research, describing the Division's budget, staffing, the laboratories and branches, the research conducted, and how the Division's research was peer-reviewed. He gave some of the personnel changes and announced some of the awards won by Division personnel. He reported on the status of the search for a new Intramural Division Director.
A Council member asked if there was a diversity plan as part of the search for a new Division Director. Dr. Spiegel responded that outreach for diversity had been vigorously pursued.
VI. The NIDDK Planning Process
Dr. Spiegel pointed out that it was necessary to do both short-term and long-term strategic planning. He said that three ad hoc trans-NIDDK planning groups were to be organized to develop and review initiatives in which at least two divisions shared an interest. He said that these planning groups were to give advice on trans-institute program initiatives in three crosscutting areas of research: (1) Genetics, Genomics, and Bioinformatics, (2) Stem Cells and Developmental Biology, and (3) Disease Prevention and Management. He then defined the areas to be covered by each group. He asked Council members to serve on one or more of these groups, and he said there would be NIDDK program staff and outside experts serving as well.
Mr. Earl Laurence reported on discussions that had occurred at the NIH Director's meeting. He said there was extensive discussion about States that receive relatively few grants from NIH, and that the Congress may direct the NIH to allocate $100 million to support biomedical and behavioral research in these States. He said it was important to structure a program that would be competitive and effective in increasing the research infrastructure in these States over the long term.
Dr. Josephine Briggs reported on the Institute's efforts to develop a set of policies and procedures to fund a limited number of applications beyond the usual payline by defining "special emphasis" areas of science. She said that the divisions had been asked to review their grant lists for applications that were not within the payline but were candidates for the special emphasis grant funds that had been set aside. She gave the criteria for these special emphasis grants as areas of high program relevance for the division and areas that were under-represented in the portfolio. Also, the divisions were asked to look for grants in enabling technology or special tools. She pointed out that this process had been designed to be responsive to areas of congressional interests. She said priority had been given to exceptional grants, to young investigators, and minority investigators, especially if they worked on minority health problems.
Ms. Barbara Harrison gave the report on the Study of Health Outcomes of Weight-Loss (SHOW) Trial. She said that this multi-center clinical trial, to be conducted under a cooperative agreement over 7 years, excluding the design and analysis phases, was designed to assess the benefits and risks associated with interventions to produce sustained weight-loss in obese individuals with diabetes. She described the initial design of the trial, including the numbers of patients to be recruited (6,000) among 16 centers and the three treatments arms: (1) the usual treatment for obesity by the primary physician, (2) the usual treatment plus intensive life style intervention, and (3) the usual treatment plus intensive life style intervention and possibly anti-obesity medication. She said it had been proposed that the principal outcome measure would be an assessment of atherosclerosis using ultrasound to determine the carotid wall thickness. She said that, after extensive discussions, a number of basic design changes had been adopted by the SHOW trial investigators including (1) to use cardiovascular events as a primary end point, (2) to change the treatment arms from three to two [(a) the usual treatment for obesity by the primary physician, (b) the usual treatment plus intensive life style intervention, and possibly anti-obesity medication], and (3) to increase the power of the study by extending it to 11.5 years. Another recommendation was to assess physical fitness whether weight-loss occurred or not.
Dr. Robert Starr gave a report on the progress of two programs to support the incorporation of gene profiling technology into research programs supported by NIDDK. He said $4 million had been allocated for biotechnology centers to be funded at $500,000 each for 3 years, and he said that out of 35 applications received, it is expected that 8 will be funded. He reported that, in a complementary program, administrative supplements of $35,000 each were proposed for people with NIDDK grants to perform limited gene profiling experiments. He said the NIDDK had received 121 applications for supplements and that they expected to fund at least 20. Dr. Spiegel pointed out that this clearly showed a demand for these supplements to existing R01 grants, and that it had been decided to allocate an additional $500,000 to fund more supplements.
Dr. Susan Yanovski reported on the current state of research in the area of the genetics of obesity. She said that four human genome scans had been published in the obesity area, another four presented, and about a dozen were in progress. She said that the investment was not being used efficiently because people were measuring different things and using different statistical techniques and different phenotyping procedures. She said that the Institute planned to form a consortium to adopt common definitions and procedures and to pool data and resources. A meeting was to be held July 14 to determine what material, financial resources, and methodology would be needed to go forward. Dr. Spiegel pointed out that the consortium was a top priority as there were huge barriers, and that the conventional approach to complex genetic diseases even with a large expenditure of resources had not worked.
Council member Dr. C. Ronald Kahn reported on plans for a "Diabetes Genome Anatomy Project" (DGAP). The Diabetes Research Working Group (DRWG) originally proposed this concept. He said the DRWG proposed a national consortium for the genetics of diabetes that included genes expressed in the beta cell that might be involved in diabetes, the genes related to obesity, genome-wide screening for type 2 diabetes. He said DGAP's goals were to create a complete data set of the genes and gene products that were involved in insulin action and insulin resistance found in type 2 diabetes and other diseases such as obesity and hypertension. He said it was planned to use the information to develop an integrated map of genetic and insulin-signaling alterations in type 2 diabetes and to make the data and reagents collected available to all diabetes investigators. Dr. Kahn then described how a diabetes genome project steering committee would organize the data and samples collected and distribute them through core resources. He said ultimately the goal was to create something for all investigators to use. Dr. Spiegel said prevention and treatment of diabetes would be changed by the flow of information from this technology and would be customized for each patient. He said that this could have a major public health impact. He indicated that it could lead to targeting specific drugs and to rational drug design.
Council members said that some of the initiatives they discussed were trans-NIH and involved DNA and cell repositories that raised informed consent, regulatory, ethical, and legal issues, and they asked if the NIH had an NIH-wide policy that would address them. Dr. Spiegel replied that this would be an issue the planning groups should take on for discussion. He said that large institutes such as NCI had major repositories. He said that informed consent in clinical trials was a difficult issue and described some of the problems in a genetics clinical trial. He said there would be a meeting on informed consent in September to discuss these issues and a planning group would be looking into the problems.
Council members expressed concerns about the separation of the planning groups and recommended that there be interaction and cross talk among them. They recommended that each group designate one Council member to participate in a troika to communicate with one another about the discussions in each group. Dr. Spiegel described examples of interaction among the planning groups.
Dr. Spiegel described the Biomedical Information Science and Technology Initiative (BISTI) Consortium as an example of cooperation and interaction of many NIH components and other government agencies with interests in information science and technology as applied to biomedicine. He said that the Consortium coordinated research grant programs, training opportunities, development of associated research and training resources, and scientific symposia associated with biomedical computing. Council members were interested in whether there was a training component in the BISTI. They said there was interest in going in this direction with other types of training grants. Dr. Spiegel responded that training grants were planned and that planning grants had been recommended preliminary to setting up research centers. He described how the decision for planning grants had evolved. Council members said that informatics was important and that competition with industry was a problem. They asked if the SBIR grant program could be used for this. Dr. Spiegel said it was an area that could be pursued.
Council members expressed concern about funding applications designated as "special emphasis" at the expense of other applications with better percentiles. Some Council members said that they thought this was a dangerous trend and that the reasons why these grants were being funded should be very clear. Council members indicated that the special emphasis program should be evaluated to see if it was actually funding productive research. Dr. Spiegel said that the grants being funded out of funding line were selected for a purpose. He said that measuring the outcome of funding these grants was not impossible, but it would be difficult. He pointed out that the special emphasis grants that were funded would need a control group for an evaluation to be done and that a step in that direction needed to be taken. Council members expressed concern that there were not more guidelines for the special emphasis grant category. They wanted to know the impact on long-range planning. They pointed out that without guidelines there was the risk of inflation, which they described as a problem if one division funded all of the recommended grants and then the next Council round another division might feel they had to fund all of their recommended grants in order not to lose any funds for their division. Council members said that they wanted more people recommended in this category so they would have more of a selection. They also wanted to see more clinical investigations. Dr. Spiegel replied that it was possible to provide more candidates for the special emphasis grants, and also, he would put the onus back onto the Council members to scan through the Council listings to select applications they would like to have discussed. He also pointed out that if they did not find sufficient applications in their division to select for special emphasis, there were other projects such as trans-NIH projects where the funds could be used. He said it was important to track the fate of special emphasis grants so the Institute would know what it was doing with this program, although it might be 4 to 5 years before anything would be known such as productivity, the impact of these investigators, and the ability of these investigators to renew. He said a control group would be needed.
VII. NIDDK Strategic Plan on Minority Health Disparities
Dr. Lawrence Agodoa reported on the NIDDK strategic plan on minority health disparities, and he said the purpose was to identify initiatives or areas of focus that would positively impact on the health of minorities and to formulate a plan to help reduce and eliminate the disparities in health among population groups. He said that this was a trans-NIH effort and that a trans-NIH working group was steering the development of the plan. He said the plan was to define the areas of focus, identify research goals, formulate initiatives, identify infrastructural and crosscutting issues unique to the disease areas, and develop specific public information and outreach strategies for each area. He reported that for the public information outreach, the goal was to establish a communication network with African-American and Hispanic or Latino-American and American Indian health professional organizations and community organizations to improve the numbers participating in biomedical research.
Council members were concerned about what was not included in the diseases for minorities such as cardiovascular disease that included stroke, heart attacks, and hypertension. Dr. Agodoa responded that hypertension was a primary interest of the National Heart, Lung, and Blood Institute and that the focus for NIDDK was diseases covered by this Institute. Dr. Spiegel said that AIDS was a primary interest of the National Institute of Allergy and Infectious Diseases, but that the NIDDK had a very narrow interest in AIDS semen transmission and that there would be coordination between the institutes on the overlapping interests.
VIII. Continuation of Discussion of Training, Career Development, and New Investigators
Dr. Walter Stolz reported on career tracking of new investigators. Dr. Stolz gave a definition of a new investigator as one who had not previously received an R01-type grant, either from NIH or from a comparable funding source. He said it was sometimes difficult to determine whether nonacademic investigators should be classified as "new." Dr. Stolz then presented some data developed by Dr. Maren Laughlin comparing new investigators who had been identified by the study sections as new investigators with those identified by the DEM staff. He pointed out that the data were similar except the DEM staff identified more new investigators than the study sections. He reported additional data from Dr. Laughlin's analyses showing that the success rate of all new R01s was 34 percent but that the success rate of new R01s submitted by new investigators was 41 percent. This showed that new investigators had a higher probability of being funded than did experienced investigators proposing new projects.
Dr. Stolz gave an updated report on the new career mechanisms, the K23, K24, and K25, and he also reported on the status of the K08 program. He said that in FY 1998, the K08 was the principal career development award offered by the Institute, and there were 81 applications reviewed with 42 applications funded. He said that in FY 1999, additional funds were added to the K08 award to make it more attractive, and the two new awards, the K23 and K24, were added to the program. As a result, the numbers of applications submitted doubled to 162 and the number of awards rose to 79. He pointed out that the K25 was a new type of career award in FY 2000. He said it was a mentored award that was designed to bring physical scientists, mathematicians, and engineers into the NIH biomedical research area. He reported there were two being reviewed at this Council meeting and there would be three at the September 2000 Council meeting.
Dr. Stolz proposed to track graduates of the career awards using as a main outcome subsequent NIH grants applied for and received. He said there would also be a measure of publications that had not been defined yet.
Council members said that the success rate data of new investigators was information they needed, and they asked how many new investigators that received awards also received a second round of funding. They pointed out that the data collected on the R29 awards showed a lack of success in second rounds of funding.
Council members asked about the expertise on the committees that reviewed the career development award applications. They were interested in the data on the percentage of K awards that were funded. Dr. Stolz responded that they were the same NIDDK review committees that reviewed all NIDDK training grants and that the committees were composed of senior investigators with broad scientific expertise and significant experience in training new investigators. Dr. Spiegel said that the K23 and K24 awards were targeted for clinical research and that the numbers of additional applications were coming in at a high enough percentile score to warrant additional funds for these awards.
Council members wanted a study to answer the question of whether there would be enough scientists for the next generation in the areas of the Institute's scientific focus. They pointed out that if the NIH budget went up 15 percent per year for the next few years, additional scientists would be needed to use these resources well. They said there was a need to replace or increase the numbers of qualified investigators by some percentage, and information was needed on manpower in the Institute's programs similar to what had been published on the NIH. They expressed concern that while the numbers of scientists in other areas might be growing, such as in neuroscience, it was not clear if the pool of investigators in the areas of NIDDK responsibility was growing. Dr. Spiegel said that growth in manpower in neuroscience and AIDS was evident, and he agreed that this information was needed for the Institute's programs as well. He asked Dr. Stolz to take on this task.
IX. Scientific Presentation: Zebrafish, a Model for Development and Disease
Dr. Leonard Zon reported on his research using the zebrafish. He said that he focused on the zebrafish to understand how organs developed and functioned in order ultimately to help his patients. He said the zebrafish was an excellent model because the embryos were completely transparent, all the organs could be seen, and development was very rapid (24 hours of embryonic development for the zebrafish was comparable to 7.5 days for a mouse and 19 days for a human). Of most importance, he said the zebrafish could live in a small area and each mother fish produced 300 eggs weekly, thus there were many siblings available for genetic studies. He described how mutations were produced in the zebrafish that affected every organ. He pointed out that this was a forward genetic system because a mutation was produced and then the gene was isolated. He reported that there were 50 known mutants that affected hematopoiesis and five that could not produce hemoglobin. He described how comparing zebrafish genes and zebrafish mutants with human genes and human diseases gave a method of verifying which genes were involved in which diseases. He described how the mutants were produced and how the genes were isolated.
X. Division Directors' Reports
A. Division of Extramural Activities
Dr. Stolz gave the division report and began by describing the Council operating procedures for second-level review of grant applications and for delegations of authority. He described the kinds of actions in second-level review as (1) deferral of applications for re-review, (2) budget and project length recommendations, (3) high program priority and special emphasis, (4) MERIT nominations and extensions, and (5) any other kinds of special issues relating to second-level peer review of applications. He described the procedures followed in each of these situations. He pointed out that the use of Council worksheets in the closed plenary session of Council meetings was designed to preserve the Council members' time, but that it was not designed to cut off Council discussion.
He said the procedures were a framework that was designed to give consistency among the Subcouncils. Dr. Stolz asked Council members for their recommendations for any changes they wanted.
Council members discussed the amount of time spent on discussing initiatives vs. special emphasis applications in their Subcouncils, and they pointed out that these were competing pools of funds and that the time spent on each should be balanced. They pointed out that if more time were spent reviewing candidate applications for Special Emphasis, there would be less time for considering other issues. Dr. Spiegel recommended that a longer list be provided to the Council members, that it be prioritized, and that the Council members review the lists and the Council books in advance.
Council members commented on the MERIT Awards as enabling investigators to embark on more ambitious and innovative programs that could create new paradigms of thought. They pointed out that the MERIT Awardees were people who had distinguished themselves. They said that the NIH was in the unique position of rapidly evolving science to catalyze very bold use of concepts and tools that were available now. Thus, they said, ambitious programs addressing important biological questions required significant time to develop. They said that identifying outstanding individuals to do particularly innovative types of projects for MERIT Awards was important. Dr. Spiegel pointed out that the MERIT Awards began as a way of streamlining the review process and unexpectedly had taken on an honorific connotation. He said that the extensions of the MERIT Awards had been kept to 3 years to avoid adversely impacting on the average grant lengths of the portfolio.
Dr. Jay Hoofnagle raised the question of whether MERIT extensions should be 3 or 5 years in length. Council members discussed the option of awarding the renewal of a MERIT Award for 5. They said that since the number of MERIT Awards was a relatively small subset of grants, it would not impact on the average grant length or budget adversely.
B. Division of Diabetes, Endocrinology, and Metabolic Diseases
Dr. Judith Fradkin gave an overview for the allocation of funds in the Division. She described the Balanced Budget Act of 1997 that provided $30 million per year for 5 years for research on type 1 diabetes and that $3 million per year went to the CDC for a national diabetes laboratory. She described how the $27 million that came to the NIH had been spent. She described how the funds for FY 2001 would be spent.
Council members expressed interest in psychosocial research and pointed out that the Institute supported relatively little psychosocial and behavioral research in diabetes. They asked what could be done to increase the behavioral aspects of clinical research in the Institute. They recommended bringing in NIH expertise when reviewing novel ideas in patient-oriented research. Dr. Spiegel pointed out that he had gone to all the institutes asking for projects but none came forward in behavioral research. He also pointed out that a workshop had been held on behavioral aspects of diabetes. He said that there was the plan to use the ongoing clinical trials to allow other types of interventions to be done.
C. Division of Digestive Diseases and Nutrition
Dr. Jay Hoofnagle gave the Division report and discussed several initiatives, including those dealing with obesity, prevention of obesity, and hepatitis C. He described an RFA for ancillary studies on the SHOW trial and a shadow trial that would use the SHOW trial cohort. He described a contract for a clinical trial in hepatitis C (HALT-C) and a clinical trial in African Americans on prevalence and character of the disease. He pointed out the huge number of diseases for which the Division was responsible.
Council members asked about inflammatory bowel disease (IBD) and the autoimmune mechanisms that might underlie both diabetes and IBD. They said this seemed to be an area that was under-researched. Dr. Spiegel responded that there was an autoimmunity committee working on this problem NIH-wide, both in the human and the mouse model.
D. Division of Kidney, Urologic, and Hematologic Diseases
Dr. Josephine Briggs gave the Division report and focused on efforts to prevent kidney disease. She reported that an important aspect of preventing kidney disease was changing physicians' behavior.
She described the Division's role in the zebrafish project. She also described some of the trans-NIH projects of the Division.
Council members commented that one of the major issues relating to work with animal models was the inability of many investigators to adequately assess whole organism metabolism. They said there was a need for technology for monitoring key physiological functions in genetically defined model systems. Dr. Spiegel said that the NIMH was heavily involved in this area.
XI. Consideration of Review of Grant Applications
Summary Table 1
|Applications Taken to Council by Budget Category|
|Budget Category ||Scored ||NRFC ||Deferred ||No Action ||Total|
|Regular Research * ||830 ||- ||- ||- ||830|
|Other Research ||149 ||- ||- ||- ||149|
|Centers ||10 ||- ||- ||- ||10|
|Training ||39 ||- ||- ||- ||39|
|MBS ||- ||- ||- ||- ||-|
|Totals ||1028 ||- ||- ||- ||1028|
Summary Table 2
|Applications Taken to Council by Support Mechanism|
|Support Mechanism ||Scored ||NRFC ||Deferred ||No Action ||Totals|
|Program Projects (P01) ||14 ||- ||- ||- ||14|
|Research (R01) ||631 ||- ||- ||- ||631|
|MERIT (R37) ||6 ||- ||- ||- ||6|
|STTR (R41) ||9 ||- ||- ||- ||9|
|(R42) ||2 ||- ||- ||- ||2|
|SBIR (R43) ||82 ||- ||- ||- ||82|
|(R44) ||17 ||- ||- ||- ||17|
|Coop Agreements (U01) ||31 ||- ||- ||- ||31|
|Coop Agreements (U19) ||11 ||- ||- ||- ||11|
|Conferences (R13) ||43 ||- ||- ||- ||43|
|Small Grants (R03) ||23 ||- ||- ||- ||23|
|AREA (R15) ||10 ||- ||- ||- ||10|
|Explor/Develop (R21) ||27 ||- ||- ||- ||27|
|Education (R25) ||1 ||- ||- ||- ||1|
|Career Awards (K01) ||24 ||- ||- ||- ||24|
|(K02) ||1 ||- ||- ||- ||1|
|(K08) ||29 ||- ||- ||- ||29|
|(K23) ||14 ||- ||- ||- ||14|
|(K24) ||2 ||- ||- ||- ||2|
|(K25) ||2 ||- ||- ||- ||2|
|Core Centers (P30) ||9 ||- ||- ||- ||9|
|Special Centers (P50) ||1 ||- ||- ||- ||1|
|Training (T32) ||39 ||- ||- ||- ||39|
|MBS (S06, DK Secondary) ||- ||- ||- ||- ||-|
|Total ||1028 ||- ||- ||- ||1028|
Summary Table 3
|Applications Not Taken to Council |
|Applications by Support ||Bottom Tier ||NRFC ||Excluded by Institute Staff ||Non-Competitive ||Total|
|Traditional Research (R01) ||7 ||1 ||- ||427 ||435|
|Cooperative Agreement (U01) ||- ||1 ||- ||- ||1|
|STTR (R41) ||- ||- ||- ||7 ||7|
|(R42) ||- ||- ||- ||1 ||1|
|SBIR (R43) ||- ||- ||- ||76 ||76|
|SBIR (R44) ||- ||- ||- ||8 ||8|
|Conferences (R13) ||1 ||- ||- ||- ||1|
|Small Grants (R03) ||- ||1 ||- ||1 ||2|
|AREA (R15) ||- ||- ||- ||8 ||8|
|Explor/Develop (R21) ||- ||- ||- ||16 ||16|
|Career (K02) ||- ||1 ||- ||- ||1|
|(K08) ||- ||1 ||- ||- ||1|
|Total ||8 ||5 ||- ||544 ||557|
Dr. Spiegel thanked the Council members for their attendance and advice. There being no other business, Dr. Spiegel adjourned the 153rd meeting of the NDDK Advisory Council on June 1, 2000, 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.
Allen Spiegel, M.D. Director, National Institute of Diabetes
Digestive and Kidney Diseases and Chairman, National Diabetes and Digestive and Kidney Diseases Advisory Council