The second major achievement was just announced in the past few weeks. This was the determination of the structure of the HIV RNase H, a component of a viral protein that is essential for replication of the AIDS virus. Knowledge of this structure will also allow a rational approach to drug design, targeting a different portion of the AIDS virus. It is essential that a diverse set of antiviral agents be developed to combat this dread disease.

RPG'S AVERAGE COST INCREASE

Mr. Early. What is the average increase for noncompeting research project grants under the budget proposal? For new and competing grants?

Dr. Kirschstein. The FY 1992 budget request provides a 7 percent increase for noncompeting research project grants and an 8.6 percent increase for new and competing grants. This proposal provides approximately 3 percent growth, after adjusting for inflation, using the 1992 Biomedical Research and Development Price Index of 5.8 percent.

Mr. Early. What was the downward negotiation rate for competing grants in FY 89 and FY 90?

Dr. Kirschstein.

In FY 1989 and FY 1990, the downward negotiations for competing research project grants were 10.6 percent and 13.9 percent, respectively.

Mr. Early. What are you projecting for FY 91?

In

Dr. Kirschstein. Our FY 1991 funding strategy is to determine appropriate funding levels using FY 1990 levels as a baseline upon which to build. Thus, in order to establish the appropriate support level for all competing and noncompeting grants, the Institute staff is examining each research project award on an individual basis. doing this and in making prudent budget adjustments, we are guided by principles that were recommended by our National Advisory Council as well as by the principles outlined in the NIH cost-management plan.

For new competing awards, we are carefully analyzing the budget levels recommended after review by the study sections and Council. Using such analyses, we establish grant budgets so that the average cost of these awards will be equal to an increase of approximately six percent over the average cost of such awards in FY 1990. This is appropriate based on the increase in the Biomedical Research and Development Price Index.

We are sensitive to special needs, however. For example, many awards to first-time investigators are being made without adjustment, in order to give these new scientists a good start on their first independent research projects. These investigators are supported by special FIRST awards, which are limited to approximately $70,000 direct costs per year.

For competing continuations, grants are awarded at a level of ten percent over the amount awarded in FY 1990 plus additional funds

for equipment as needed. Renewals of grants to new investigators with no other research support are being allowed a somewhat larger increase commensurate with the appropriate expansion of such research projects at this stage in their career development.

Mr. Early. What about noncompeting grants?

Dr. Kirschstein. For noncompeting continuations, appropriate increases averaging four percent are being allowed. For all awards, the budgets in subsequent years are being escalated by four percent with some accommodation for additional equipment and personnel, if needed. This results in firm and realistic commitment levels for all future years and assures investigators of predictable levels of support, thus allowing them to plan their research projects.

Mr. Early. Doctor, doesn't this institutionalize the large downward negotiations the Institute has had to make in competing grants these past few years?

Dr. Kirschstein. At the end of this fiscal year, NIGMS will have established commitments which we intend to meet fully in the coming fiscal years. We view this as an important first step in renewing funding predictability and stability which will allow investigators to carry out their research projects most efficiently. In this year of transition, the only realistic approach to establishing future commitment levels which the Institute can meet, while funding as many superb competing applications as possible, is to base FY 1991 awards for competing grants on previously awarded levels that had been established through downward negotiations in past years.

Mr. Early. Will the Institute be able to fund noncompeting research project grants at commitment levels and new and competing research grants at peer reviewed levels?

Dr. Kirschstein. Yes, in FY 1992, the President's Budget provides funding which will allow the Institute to fund noncompeting research project grants at the commitment levels established in FY 1991. Budget requests for new and competing research grants will be carefully examined by initial peer review groups, the National Advisory General Medical Sciences Council, and the Institute staff. The awards made will reflect both the principles of the cost management plan and the advice of the Council for determining the appropriate levels of support for the initial year as well as for future committed years.

RESEARCH PROJECT GRANTS

Mr. Early. What percentage of new and competing grants will the Institute fund under the FY 92 budget request, and how does this compare to FY 91 and FY 90?

Dr. Kirschstein. An estimated 26 percent of approved applications would be funded in FY 1992. This compares to 27 percent in FY 1991 and 23 percent in FY 1990.

Mr. Early. How does this compare to the award rate of five years ago? Ten years ago?

Dr. Kirschstein. The award rates in 1987 and 1982, five years and ten years ago respectively, were both 39 percent.

Mr. Early. What is the projected "success rate" and how does this compare to FY 91 and FY 90? Five years ago? Ten years ago?

Dr. Kirschstein. The estimated success rates for FY 1991 and FY 1992 are 27 percent and 26 percent, respectively, while in FY 1990 the success rate was 22 percent. The success rate in 1987 was 38 percent, compared to 37 percent in FY 1982.

Mr. Early.

What success rate would you like to see in order to fund an appropriate number of exciting and most promising research proposals coming out of your Institute?

Dr. Kirschstein. In order to fund a significant number of the most exciting and most promising research applications received by the Institute, a success rate of 35-40 percent would be optimal. This would still leave a number of meritorious proposals unfunded.

Mr. Early. How would you characterize the quality of research applications the Institute is receiving today? What kinds of comparisons would you make to prior years?

Dr. Kirschstein. The current group of applications is outstanding, with perhaps an even greater depth of quality than in previous years. I would say that the quality of applications remains extremely high through at least the top 40 percent of those received.

Mr. Early.

To what payline percentile will the Institute be able to fund under the budget request and how does this compare to FY 91 and FY 90?

Dr. Kirschstein. The estimated percentile payline for both FY 1991 and FY 1992 is 21 percent, while in FY 1990 it was 16 percent.

RESEARCH CENTERS

Mr. Early. What is the average increase in a center grant under the budget request?

Dr. Kirschstein. The FY 1992 budget request will provide an average increase of 2.5 percent for research center grants.

Mr. Early. How was the size of this increase determined?

Dr. Kirschstein. In allocating the FY 1992 budget request, NIH concentrated heavily on providing substantial increases for individual investigator-initiated research grants. Other mechanisms, though important, received more modest increases. Research centers were given a 2.5 percent increase.

Mr. Early. What was the level of downward negotiations in the centers' program in FY 89 and FY 90? And what is the estimate for FY 91?

Dr. Kirschstein. The downward negotiations for research center grants in FY 1989 and FY 1990 were 8.5 percent and 10 percent, respectively. In FY 1991, noncompeting research center grant budgets will be increased by approximately 6 percent over the average cost of such awards in FY 1990. This is the level of the Biomedical Research and Development Price Index.

Mr. Early. Doctor, will NIGMS be able to fund noncompeting centers at commitment levels under the budget request? Competing centers at the peer reviewed levels?

Dr. Kirschstein. During FY 1991, NIGMS will have established commitments for research center grants that we intend to meet fully in FY 1992. The Study Sections will recommend the appropriate budget level for each competing center grant application, and the Institute's Council and staff will also be examining these on an individual basis in light of the cost management principles.

FINANCIAL MANAGEMENT PLAN

Mr. Early. Doctor, how does your Institute plan to administer the financial management plan with respect to research project grants? How do you plan to stay within the parameters that have been set?

Dr. Kirschstein. In FY 1992 the Institute will fund noncom peting grants at the levels shown as future commitments on the FY 1991 awards, and we will continue to use the approaches developed in FY 1991 to establish the appropriate award levels for competing awards. Except for FIRST awards and MERIT awards, which will be awarded for five years, other competing awards will be awarded for four or three years, to achieve an average length of four years.

Mr. Early. Does the NIGMS plan to make greater use of "outof-order" funding to achieve a lower cost per award?

Dr. Kirschstein. The NIGMS has not needed to employ "out-oforder" funding to achieve a lower cost per award, since our approach of establishing the appropriate level of support for each competing award is achieving this goal. With the advice of our National Advisory Council, however, the Institute has always made some use of "out-of-order” funding as a means of promoting the broadest possible diversity of ideas and approaches to the scientific research it supports. In FY 1990 and FY 1991, because of fiscal constraints, the Institute made greater use of this approach. Thus NIGMS has reached for "out-of-order" to fund excellent investigators, at the margin, who have no other source of research support.

Mr. Early. What has been the reaction of your Institute's study sections to the financial management plan, and limiting the overall average increase in the cost of a grant?

Dr. Kirschstein. It is a little too soon to tell what the reaction might be. Although the scientific community has been widely consulted in the development of the financial management plan, the final version, reflecting the comments of the Department and of the new Director of NIH, Dr. Healy, has not yet been released to the public. Members of our study sections, like others in the scientific community, have indicated that they welcome the renewed predictability and stability which will result from establishing firm commitments for future years of support for each grant awarded. However, they are also acutely aware of the funds needed to support the many excellent research ideas described in individual applications and of the fact that, in limiting the size of the grants we award, the goals of each research project may take longer to achieve.

Mr. Early. What impact will limiting the average increase in the cost per award have for your Institute? What's your professional judgment on this?

Dr. Kirschstein. Investigators who are supported by NIGMS are doing superb research on fundamental biomedical questions and the knowledge so gained will continue to have an enormous impact on our ability to prevent, diagnose, treat, and cure the many diseases for which there are no totally satisfactory strategies yet available. By limiting the average increase in the cost per award, it may take each such investigator a longer time to achieve the goals that he or she has outlined in the research proposal as originally submitted. Thus, real scientific progress may be slowed, in many cases, significantly.

In my professional judgment, while such limits will allow us to make a larger number of awards, this slowdown in real scientific progress is very unfortunate since important discoveries will be delayed and this inevitably lengthens the period of time before the American people benefit from the clinical applications of cuttingedge research.

Mr. Early. Doctor, the NIGMS research portfolio emphasizes research project grants. In general, what do you see as the downside of shortening the length of a grant? What impact will shortening the average length of a grant to 4 years have on your Institute's programs?

Dr. Kirschstein. By shortening the period of a grant to 4 years the percentage of an investigator's time spent writing grant applications, rather than doing research, is increased. Since it now takes about six months for most investigators to write a grant application, plus 9-12 months after submission before it can be funded, investigators must begin writing a grant renewal application about two and one-half years after they receive an award. This also means that not much time is available to produce results. Thus many investigators may choose more routine and safe projects rather than the speculative but risky studies that could ultimately be of more value. Additionally, young investigators might be particularly affected, since, with no track record, there is even more pressure on them to produce and publish scientific papers.