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Science Policy |
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Federal
Research Grants and Administrative Burden |
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Federally funded biomedical researchers are
subject to an increasingly complex set of regulations that govern everything
from the protection of human and animal subjects to the handling of
potentially hazardous materials to conflict of interest. A recent survey
conducted by the Federal Demonstration Partnership (FDP) explores the amount
of administrative burden experienced by faculty who receive federal research
grants. The FDP is a cooperative initiative between ten federal agencies (including the NIH, NSF and NASA) and approximately one hundred institutions that receive federal funds. The FDP was established in 1988, and its purpose is to streamline the administration of federally sponsored research. The faculty administrative burden survey was carried out by the Faculty Standing Committee of the FDP and was led by Robert Decker, Ph.D. Results are summarized below and the report can be read in its entirety on the FDP website (http://thefdp.org/Faculty%20burden%20survey%20report.pdf). Responses were received from 6081 PIs or co-PIs from 73 institutions that receive federal research grants, in areas of research including the physical, biological, computer, agricultural, health and social sciences. A majority of respondents were tenured faculty with a rank of associate or full professor. The goals of the survey were to determine the amount of time spent on activities that support and enable research associated with federal research projects, and to estimate how much more time would be available for research if these burdens were reduced. Time spent writing and submitting grant applications, service on study sections, service on institutional compliance committees, and attendance of mandatory training was excluded from the survey. The survey results indicate that of the time that was spent by faculty on federal research project activities, only 58% was devoted to active research. The remaining 42% of the time was taken up by pre- and post-award research administration. No single overriding burden emerged, but the top tasks identified were writing and submitting grant progress reports, hiring personnel, managing project revenue, equipment and supply purchases, IRB protocol approvals and training, training personnel and students, and personnel evaluations. Most respondents (95%) reported that they would be able to spend more time on research if support was available for research-related administrative tasks. Based on the findings in the survey, the report suggests several ways in which the level of faculty burden could be reduced. One obvious solution is an increase in the amount of administrative support available to PIs. Another way to alleviate some of the burden is to implement best practices, which may be identified by taking a closer look at institutional practices and the reported levels of administrative burden. Finally, working with federal agencies to harmonize requirements may reduce some of the burden on researchers. As this is an ongoing topic of concern for federally supported researchers, the APS Public Affairs Committee plans to address this topic at the next Experimental Biology meeting with a session on regulatory burden. |
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On June 6, 2008 the National Institutes of
Health (NIH) announced a series of changes intended to enhance the peer
review system that will be implemented in the coming months. The initiatives
are the culmination of a year-long effort on the part of NIH to update a
system that is struggling to deal with flat budgets as the number of
applications soars. A task force led by Drs. Lawrence Tabak and Keith Yamamoto released an 88-page report in February. The NIH evaluated it internally and asked for feedback from the scientific community. As a result, some of the more controversial proposals were dropped including establishing a “not recommended for resubmission” designation, treating all applications as new, and instituting a minimum percent effort requirement. The changes are organized around four main priorities: engaging the best reviewers, improving the quality and transparency of reviews, ensuring fair and balanced reviews across scientific fields and career stages, and developing a permanent process for continuous review of peer review. The changes associated with each of the four priorities are summarized below. Some of the major modifications include shortening R01 grant applications to 12 pages, providing administrative supplements for reviewers who serve 18 full study section meetings as chartered members, and scoring applications on a 7 point scale. Priority 1. Engage the best reviewers In order to attract and retain the best reviewers, the NIH plans to increase the flexibility of reviewer service by allowing the 12 session reviewer commitment to be spread over 4-6 years. There will also be an expansion of flexible submission deadlines for reviewers and pilots for new forms of electronic review. Certain awards including Merit/Javits and Pioneer awards will now include a “service expectation.” PIs with three or more R01 equivalents or type 2 renewals that exceed $500,000 in direct costs will now be expected to serve as peer reviewers. To compensate the time and effort spent on review, reviewers who serve a minimum of 18 full study section meetings as chartered members will be eligible to apply for an administrative supplement of up to $250,000. Those individuals may also request consideration for Merit/Javits awards on a competitive basis. Finally, training and mentoring will be provided to all study section chairs, reviewers and SROs using an NIH-wide curriculum based on best practices, augmented by IC and study section specific additions. Priority 2. Improve the quality and transparency of reviews The rating system will be modified to focus on specific review criteria, placing less emphasis on methodology, and more on scientific impact. Individual scores will be given for each of five review criteria and assigned on a scale of 1-7, instead of the current 41 point scale. The five criteria that will be scored are impact, innovation/originality, investigator, project plan/feasibility, and environment. Following the initial scoring, applications will be grouped and ranked within relevant categories. Any applications that are streamlined will be given the averaged scores on all five criteria. To go along with the revisions in the scoring system, the summary statement will be structured to align with the review criteria. An optional field for “mentoring advice” will be provided and could include a recommendation not to resubmit the application unless fundamentally revised as a new proposal. NIH plans to develop appropriate tools, guidance, and training for reviewers in order to establish best practices for generating summary statements. Under the new system, the length of R01 applications will be reduced to 12 pages, with other mechanisms scaled appropriately. Appendices will be allowed for specific information such as elements of a clinical trial. Priority 3. Ensure balanced and fair reviews across scientific fields and career stages One of NIH’s goals is to continue to support and develop policies to fund a minimum number of early stage investigators (ESIs) and new investigators. To that end, there are plans to cluster review, discussion, scoring and ranking of ESIs within study sections, and pilot percentiling ESIs across all study sections. In an effort to make sure that experienced reviewers get fair evaluations, there will be equal emphasis on retrospective assessment of accomplishments and a prospective assessment of what is being proposed. Clinical research applications will also be clustered for review, discussion, scoring and ranking within a study section. To encourage risk taking by applicants, the review process that was initiated for the Pioneer, EUREKA and New Innovator awards will be expanded, and the Transformative Research portfolio will be grown to reach ~1% of R01-like awards. Finally, based on analysis of success rates as a function of initial scores, NIH will work to reduce the need for resubmissions by carefully rebalancing success rates among A0, A1 and A2 submissions. Priority 4. Develop a permanent process for continuous review of peer review Recognizing the need to carry out ongoing review of the peer review system, NIH will continue to pilot and evaluate new models of review (i.e. editorial board models, use of prebuttals), pilot and evaluate difference methods for ranking relative merit of applications, pilot and evaluate high bandwidth electronic review and develop metrics for monitoring performance of peer review. The next step in this process will be the formation of an ad hoc peer review task force that will develop plans and oversee implementation. To learn more about the implementation process and the changes under consideration, go to http://enhancing-peer-review.nih.gov. |
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The Humane Society of the U.S. (HSUS) has
unveiled a new strategy in its 10 year-old campaign to eliminate pain and
distress in laboratory animals. The latest phase consists of asking colleges
and universities to sign a pledge “to ensure that no laboratory animals in
[their] care experience severe and unrelieved pain and/or distress.” A copy
of this request can be found at
http://www.nabr.org/pdf/HSUSP&Dmailing.pdf. According to The Chronicle of Higher Education [http://chronicle.com/daily/2008/06/3407n.htm], HSUS sent letters in early March of this year to 301 “teaching oriented” colleges and universities, but by mid June, only 13 institutions had signed the pledge. In an article published online June 17, 2008, the Chronicle reported that 18 other institutions had promised to get back to HSUS with a response, while 8 had refused to sign. Officials at some of the 13 campuses told the Chronicle that “signing the pledge was easy…because no such research went on there.” At one institution, the only research projects were behavioral studies. At another institution the only procedures involving surgery on anesthetized animals were performed. The pledge is an outgrowth of a campaign HSUS launched in 1998 with the announced goal of eliminating pain and distress in laboratory animals by the year 2020. In a May 29, 1998 letter, HSUS Senior Vice President for Research, Education, and International Issues Andrew Rowan wrote to IACUC chairs at U.S. research institutions, urging them to join with HSUS in pursuing this objective. “Like most scientists, The Humane Society of the United States (HSUS) would like to see the day when animals are no longer used in harmful research and testing,” Rowan wrote. “However, The HSUS recognizes that the goal of completely replacing animal use in harmful research is not likely to be reached in the next few decades.” In the face of that reality, HSUS called upon IACUC Chairs to focus instead on the elimination of painful experiments. Since then, HSUS has sought to launch a variety of collaborative efforts as part of this campaign. Few have garnered much success because the approaches it recommended were often at odds with the professional judgment of scientists and veterinarians on how best to recognize and manage animal pain and distress. As University of California at San Francisco senior veterinarian Lawrence Carbone explained to the Chronicle, “detecting pain on the basis of animals’ behavior is often more of an art than a science.” In the most recent letter, HSUS President and CEO Wayne Pacelle refers to the more modest goal of “prevent[ing] severe pain and distress in research animals” (emphasis added). Nevertheless, the limited response to date reflects the difficulties of trying to address subtle issues with broad pronouncements. In an appendix to Pacelle’s letter, HSUS provided more detail about what signing the pledge entails. Institutions will be asked to take into account “what the animals actually experience, regardless of steps taken to prevent or mitigate pain and distress” (emphasis in original). The pledge would apply to all vertebrate animals and compliance would require virtually continuous monitoring of each animal at risk for anything above minimal pain or distress. This monitoring would cover the period from the animals’ arrival at the research institution until their death or transfer elsewhere at the conclusion of the study. Moreover, HSUS is asking institutions to consider both the intensity and the duration of pain and/or distress. Unless the institution was certain that animals would experience only low levels of pain or distress before, during, and after the study, constant monitoring and immediate action would be required to ensure that no animal experienced moderate pain or distress for more than an hour or a high level for more than a minute. Among the procedures that HSUS says “typically cause severe and unalleviated pain or distress” are the use of paralytics without anesthesia; recovery from major surgery without analgesics; restraint “lasting more than minutes”; noxious electric shock that is “repetitive and/or not immediately escapable”; and inducing startle through the “repetitive application of a noxious stimulus such as loud noise over an extended period of time.” Other examples of unacceptable research include disease models involving severe arthritis, advanced inflammatory conditions, advanced infectious diseases, advanced metastatic cancer, severe burns, “marked” social deprivation, and the LD50 toxicity test. However, according to UCSF’s Carbone, “some studies using a procedure discouraged under the pledge would not, in fact, cause animals unrelieved pain or distress.” Some of the institutions that signed the pledge downplayed its significance to the Chronicle reporter. An official at one university described the pledge as not legally binding and said that it would not be an impediment to “one day expanding the scope of [the institution’s] research.” Kathleen M. Conlee, the HSUS director of program management for animal research issues told the Chronicle that HSUS “will, over time, go up the ladder to those institutions in a different category.” The effort to recruit institutions that do not conduct much research is simply “a place to start.” |
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During the past year Congress rebuffed two
moves to restrict researchers’ access to non-purpose bred dogs and cats.
Instead, Congress requested two independent studies to document the
scientific need for these animals and to determine the effectiveness of
current federal pet protection regulations. These studies are expected to be
undertaken during the next year. The use of dogs and cats in medical research has long been a source of contention. The 1966 Laboratory Animal Welfare Act was intended to ensure that dogs and cats were acquired legally and treated humanely. Although the total number of animals from these species needed for research has declined significantly since the USDA first began collecting statistics, and an increasing proportion of the animals are purpose-bred, some research critics still claim that pet theft for research is a thriving industry. In the spring of 2007, the Humane Society of the United States sought to attach a rider to the NIH appropriations bill that would have prohibited the use of funds to purchase non-purpose bred dogs or cats from USDA-licensed Class B dealers. HSUS, which the Washington Post has called “the largest and richest animal advocacy organization in the world,” suggested to Members of Congress that these animals are inappropriate as research subjects because they lack uniformity in genetic background and health status. HSUS also asserted that existing pet protection laws are ineffectual and that the only solution is to eliminate Class B dealer sales of dogs and cats. Research advocates countered that non-purpose bred dogs and cats are excellent models for certain kinds of biomedical research precisely because of their diverse genetic backgrounds, and that existing laws are sufficient to ensure pet safety as long as they are appropriately enforced. Confronted with this profound difference of opinion, the Senate Appropriations Committee opted to ask NIH to commission an independent study to “determine how frequently such animals [supplied by Class B dealers] are used in NIH research and the need for these animals in research.” NIH was expected to sign a contract with the National Academy of Sciences by early summer June, 2008 to conduct this study. The same issue was brought to Congress again a few weeks later in the context of the farm bill, a massive package of legislation that sets agricultural policy including price supports. Since the USDA is also the agency charged with enforcing the Animal Welfare Act (AWA), and the farm bill is considered “must pass” legislation, it has often served as a vehicle for AWA amendments. That is what occurred on July 26, 2007 when the farm bill was brought to the House floor, and two AWA amendments were added by voice vote without discussion or debate. One amendment would have banned Class B dealer sales of dogs and cats for medical and veterinary research, teaching, and testing. The other would have prohibited live or recorded sales demonstrations of medical devices using animals. In early December, it was the Senate’s turn to debate the farm bill. Just before final passage on December 14, 2007, a collection of amendments were added by unanimous consent, including a Class B dealer ban. Although the Senate language differed slightly from the House language, because the two sets of language were so similar, there was grave concern among some researchers that Congress would eliminate Class B dealers even before the NIH-commissioned study could be carried out. It was therefore both surprising and gratifying a few months later when the final farm bill was announced, and it turned out that the conferees dropped both the prohibition on sales demonstrations of medical devices and the Class B ban. The conferees included one important AWA amendment in the final version of the bill: an increase in the maximum penalty for violations from $2,500 to $10,000. The $290 billion farm bill was sent to the President on May 15, but its tortuous course continued until mid June. President Bush vetoed the bill on May 21, as was expected, and both the House and Senate overrode the veto the same day. However, due to a printing error, two major sections of the bill had never been sent to the White House. To avoid a legal challenge to the legislation, the House and Senate passed the legislation again a few weeks later. President Bush then vetoed it again, and on June 18, both houses of Congress overrode the veto for a second time. In an explanatory statement, the conferees acknowledged the controversy over Class B dealers and indicated that the Agriculture Committees wanted to review the findings of the NIH-commissioned report on the scientific need for non-purpose bred dogs and cats. In addition, the Committees announced plans to ask the Government Accountability Office (GAO) to “review APHIS regulations to ensure that they are sufficiently assuring the source of random source animals.” |