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Science Policy |
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| Small Business Research Programs up for Reauthorization |
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Thanks to an amendment sponsored by Representative Vernon Ehlers (R-MI) and the strong support of Representative David Obey (D-WI), the House reauthorization of two small business innovation programs did not include a proposal to increase the set-asides from research agencies including the NIH. The Small Business Innovation Research (SBIR) program was established in 1982 through the Small Business Innovation Development Act. The purpose of the program is to stimulate technological innovation, increase private sector commercialization of innovation, use small businesses to meet federal research and development needs, and encourage the participation of minority and underrepresented persons in technological innovation. SBIR programs are administered by all federal agencies that distribute more than $100 million per year in extramural research funds. These agencies are required to set aside 2.5% of their extramural budgets to make research grants to small businesses. Eleven federal agencies currently meet these criteria, including the National Science Foundation (NSF), NASA and the National Institutes of Health (NIH). A second program was established in 1992 to fund Small Business Technology Transfer (STTR), a program designed to foster collaborations between small businesses and the academic research community. Funded in a manner similar to SBIR, the STTR program set aside is currently 0.3%. It is important to note that the percentage set aside for these programs represents a minimum spending level, and that agencies have the flexibility to spend more than the set aside amount, but not less. Like many federal programs, SBIR and STTR require periodic reauthorization through legislation passed by Congress. The programs were last reauthorized in 2000 (SBIR) and 2001 (STTR) and this year Congress has been considering legislation that would reauthorize both programs through September 30, 2010. The House of Representatives passed a bill on April 23, 2008 entitled the SBIR/STTR Reauthorization Act (H.R. 5819). Of significant concern in the original version of the bill was a provision that would increase the percentage set aside for SBIR and STTR programs from 2.5 to 3.0% and from 0.3 to 0.6% respectively. At a time when research budgets at most agencies have failed to keep pace with inflation, any increase in small business programs would come at the direct expense of investigator-initiated research project grants. According to an analysis by the Office of Management and Budget, the increased set aside would result in the diversion of approximately $100 million over the current amount at the NIH, for a total of nearly $700 million. At the NSF an additional $18 million would go to small business programs, which would total nearly $110 million. Moreover, demand for these programs does not seem to indicate an urgent need for an increase in the funding level. As noted in testimony given before the House Subcommittee on Technology and Innovation on April 26, 2007 by Dr. Norka Ruiz Bravo, NIH Deputy Director for Extramural Research, the number of applications for SBIR grants at NIH actually declined in 2005 (down 11.9% from 2004) and 2006 (down 14.9% from 2005). This comes at a time when research project grant applications at the NIH have risen sharply, causing success rates to fall as a result of flat funding. It was in recognition of the danger that the increased set-aside represented to research that Rep. Ehlers proposed his amendment to strike the increases from the bill, keeping the set-aside percentages the same. Rep. Ehlers is a physicist and long time champion of research in Congress. Rep. David Obey, chairman of the Appropriations committee, made strong statements in support of research funding during the debate on the bill, discouraging the proposed increases for small business programs. While the threat was avoided in the House bill, similar proposals to increase the SBIR and STTR programs have been included in Senate version of the legislation. The APS will continue to work with organizations such as the Federation of American Societies for Experimental Biology (FASEB), Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) who have all sent letters to Congress expressing concerns about the proposed increase in the SBIR set aside. |
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Over the course of the last year, the National Institutes of Health (NIH) has been evaluating and overhauling the peer review process. While NIH’s peer review system is regarded as the gold standard for funding the best science, a flattened NIH budget and rising numbers of applications have caused success rates to fall to a projected low of 18% in FY 2009. As a result, morale among reviewers and applicants has fallen significantly and the process has begun to show signs of the strain. The overhaul of the peer review system is intended to optimize the efficiency and effectiveness of the system, with the goal of identifying and funding the best research with the least amount of administrative burden. In the first phase of this project, the NIH consulted with stakeholders in the intramural and extramural communities. A working group of the advisory committee to the director was established and chaired by Lawrence Tabak, DDS, PhD, Director of the National Institute of Dental and Craniofacial Research, and Keith Yamamoto, PhD, Univ. of California, San Francisco. A series of meetings was held in Washington, DC, Chicago, San Francisco and New York City. The APS was represented by members of the Public Affairs Committee and APS staff at the meetings in Washington, DC and Chicago. In addition, last summer the APS Public Affairs Committee prepared a formal response to the NIH’s request for information on peer review and the final draft report. After collecting input from the scientific community, the NIH prepared a final draft report which was issued on February 29, 2008. In this report, NIH outlines seven major challenges to the peer review system (below), as well as goals and recommendations to address each challenge. The report was 88 pages and contained dozens of recommended actions. The entire report can be accessed from the NIH website (http://enhancing-peer-review.nih.gov/). Drs. Yamamoto and Tabak presented a summary of the report at the EB 2008 meeting in San Diego, which gave members a chance to ask specific questions and offer comments on the report’s recommendations. Challenges Outlined in Final Draft Report Challenge 1: Reducing Administrative Burden on Applicants, Reviewers, and NIH Staff Challenge 2: Enhancing the Rating System Challenge 3: Enhancing Review and Reviewer Quality Challenge 4: Optimizing Support for Different Career Stages and Types Challenge 5: Optimizing Support for Different Types and Approaches of Science Challenge 6: Reducing the Stress on the Support System of Science Challenge 7: Meeting the Need for Continuous Review of Peer Review The NIH had a brief comment period ending on March 17, 2008. Excerpts from APS comments on the report appear below. To read the entire APS comment letter, go to http://www.the-aps.org/pa. Because of the brief comment window, the Society chose to focus on the issues of greatest concern, rather than addressing every aspect of the 88 page report. The next steps in the process will be determined by the NIH Director and the Steering Committee Peer Review Implementation Group, which will issue a final report and announce new initiatives based on the report’s recommendations. The APS Public Affairs Committee will continue to track these issues as recommended actions are implemented. From the APS response (Please note that the recommended actions listed below in bold are the recommendations contained in the report, NOT the recommendations of the APS.): “We appreciate the working group’s thorough review of the peer review process, and the attention paid to maintaining the core values that make this system successful. While we agreed with many of the report’s recommendations, there are areas that are of concern to APS members, and the comments below focus on those recommended actions. “Recommended Action: Provide unambiguous feedback to all applicants. In our original comments submitted in response to NOT-07-074, APS proposed eliminating the practice of not scoring each application and we are pleased to see that the report makes this recommendation. By providing comments and a score for each application, and using the full range of scores (1.0 to 5.0) we feel that the implementation of a Not Recommended for Resubmission (NRR) designation will become unnecessary. In other words, a score of 4.5 should reasonably be interpreted as not recommended for resubmission. In order for this to be effective, reviewers would need to be aware of their obligation to use the full range of scores, and applicants would need to understand the implications of receiving a poor score. Program officers could be involved in counseling applicants about the advisability of resubmitting grant applications that scored poorly. “Recommended Action: Eliminate the “special status” of amended applications. While we recognize the troubling trend towards not funding applications until the second resubmission, the recommendation to treat all applications as new is of great concern to the Society’s members. Many NIH funded scientists find tremendous value in the process of revising grants in response to reviewer comments, and feel that this practice should not be discontinued. Because applications would still be resubmitted, we are concerned that there will be an increase in administrative burden on the new reviewers who will not be able to benefit from seeing the prior reviewers’ comments and insights, and that applicants will essentially be trying to hit a “moving target” as they revise their grant applications. In addition, not providing the previous reviews diminishes the value of the original reviewers’ efforts. The APS recommends that the NIH not move forward with this idea. “Recommended Action: Pilot the use of short, bi-directional ‘prebuttals’ (for applicants and/or reviewers) to correct factual errors or explain factual items in review. We feel that the use of “prebuttals” has the possibility of being useful for reviewers and applicants, but that it may ultimately increase the burden on reviewers by requiring them to complete and post reviews in a shorter time frame. In addition, it may be difficult to define “factual errors” and separate them from what are more often errors of judgment in grant reviews. “Recommended Action: Rank applications considered by the study section. Our members are concerned that explicitly ranking all of the applications at the end of the meeting, removed in time from a discussion of the pros and cons of an application, will lead to an undesirable degree of arbitrariness in the final scores. The process of ranking also suggests that the success of an application will be directly affected by the quality of the other applications that happened to be at a particular meeting. Instead, we suggest that the applications be briefly discussed at the end of the meeting and the opportunity given to rescore all of the applications. “Recommended Action: Link potential study-section service to the most prestigious NIH awards. We agree that linking study section service to receipt of NIH awards is a necessary step towards increasing the pool of expert reviewers and ensuring that study sections have experienced scientists contributing to the review process. “Recommended Actions regarding early career investigators For early career investigators, we agree that continuing to fund more R01s is an important part of securing the success of the next generation of scientists. We also agree with taking into account the applicant’s institutional commitment when evaluating the environment rating criteria. Rather than having early career investigators reviewed by generalists, we feel that evaluating early career investigators in regular study sections and comparing them to each other instead of the general applicant pool is an idea worth pursuing. “Recommended Action: Use the NIH Director’s Pioneer, NIH Director’s New Innovator and the EUREKA award programs as starting points to develop a path to invite, identify and support transformative research, expanding the number of awards to a minimum of 1 percent of all R01-like awards. Regarding the expansion of award mechanisms such as the Director’s Pioneer, new Innovator and EUREKA awards, we feel that it is important to have some measure of the success of these relatively new award programs before expanding them to a significant fraction of R01-like awards. “Recommended Action: Determine the underlying causes of submission patterns and results in CSR and IC panels and consider corrective actions if needed. The report notes that concerns about inadequate human subjects protections can cause applications to be scored poorly. We are concerned that reviewers may not have adequate training and experience to proficiently evaluate the appropriateness of human subjects protections in grants. The “just in time” rule that allows grants to be submitted prior to IRB approval may be adversely affecting the scoring of clinical research grants, and we suggest having a review for human subjects research concerns by experts who are familiar with the OHRP rules that is separate from the review of the merit of the application. “Recommended Action: Require, in general, a minimum percent effort on research project grants. We agree with the recommendation for grants to require a minimum percent effort for Principal Investigators, which would limit the number of grants that one researcher could hold. However, we feel that it is important that there be a process for requesting exemptions from the rule when necessary. There may be cases where requiring a minimum 20 percent effort on a grant causes problems in terms of level of salary support for senior investigators submitting modular grant applications. “Recommended Actions: Mandate a periodic, data-driven, NIH-wide assessment of the peer review process. Capture appropriate current baseline data and develop new metrics to track key elements of the peer review system. With all of the suggested changes under consideration, we are in favor of continuous review of the peer review system. We feel that it is necessary to pilot as many of the recommendations as possible, and follow up with a transparent evaluation process. Because the peer review system depends on the participation of scientists, it is of the utmost importance that scientists have confidence in the functioning of the system.”
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March 28 marked the launch of Speaking of Research (http://www.speakingofresearch.org), a new animal research advocacy group focused on rallying the support of university faculty and students. Speaking of Research founder, Tom Holder was a leader in the Oxford grassroots group Pro-test (http://www.pro-test.org.uk), which confronts animal rights extremism in the UK. Holder played an integral role in founding of Pro-Test and in the remarkable success of its first event—a march attended by an estimated 1,000 people supporting the construction of an animal research lab in Oxford, the construction of which was long delayed by vandalism and harassment. Thanks in large part to the role played by this student-lead group, the animal research dialogue in the UK is far less dominated by the shouts of extremists. Speaking of Research debuts at a time of escalating extremism in the US. On top of what has become a norm of threats and harassment, the last six months have seen the firebombing of one researcher’s home and an attempt to invade the home of another during her child’s birthday party. “Students played a major part in changing public attitudes toward animal research in the UK,” Holder noted in a statement, adding that he “believe[s] that American students can do the same.” He exhorts Americans: “It’s time to stand up for science, reason and the belief that a small and sometimes violent minority should not be allowed to dictate the future of medical research.” Jacquie Calnan, president of Americans for Medical Progress (http://www.amprogress.org) , hailed the new group: “For far too long our college campuses have been prime recruitment turf for animal rights groups seeking to misrepresent scientists’ need for animals in biomedical research.” Calnan explains, “[a]nimal rights disinformation campaigns have dissuaded some students from pursuing careers in the life sciences, and others to actively oppose the ongoing search for medical progress.” Speaking of Research provides information on its website (http://www.speakingofresearch.org) to empower people to respond to animal rights arguments. Its online outreach efforts also include an RSS feed as well as groups on a Facebook [http://www.facebook.com/group.php?gid=9224245414] and MySpace [http://groups.myspace.com/speakingofresearch] . In addition to these resources, Speaking of Research provides speakers for talks or debates on animal research. To request a speaker to visit your university or organization, call 703-395-0646 or go to http://speakingofresearch.wordpress.com/contact-us/request-a-speaker/. |
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