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Public Affairs
APS Offers “Roadmap” Ideas
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| APS Offers “Roadmap” Ideas |
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With the first round of projects funded under
the NIH Roadmap for Medical Research coming to an end, the agency put out a
call for input from the community for the next set of initiatives. On
November 17, 2006 the APS submitted a proposal for “Systems and Integrative
Biology: A Collaborative Approach to Translational Research.” The following
are excerpts from the APS submission. “Research into the fundamental molecular components of life has provided the raw materials for understanding the functions of cells, tissues, organ systems, whole organisms and even populations. However, despite tremendous gains in biomedical research there remains a need to apply the findings of molecular biology to organisms in all of their physiological complexity. Doing so will lead to a better understanding of human health and disease, and facilitate the development of new treatments and prevention strategies. To bridge this knowledge gap, we propose a Systems and Integrative Biology (SIB) plan that involves broad coordination of research and training efforts between scientists working at various levels of biological complexity. “Bringing together reductionist approaches to biological processes with research into whole organism functioning will transform biomedical research and enable strides in translational research. Infrastructure building, investigator-initiated research and training will all be necessary investments for the enterprise in the long-term. “Animal models are a critical step when moving from basic, in vitro or in silico experiments to human disease research. Any SIB initiative should support the development of animal models of disease, as well as building infrastructure such as animal housing and new technologies such as live animal imaging. We propose a series of National Research Centers that will support research and training for work with animal models, both small and large. While work with mouse models has generated substantial gains, there is still a need to train investigators to make physiological measurements in such models. Further, mice do not faithfully mimic all aspects of human disease and thus capacity to use larger animal models must be sustained. “The current NIH structure favors proposals that fall neatly under the mission of single institutes. Integrative proposals may be difficult to categorize, leading to lower success rates. In addition, the complexity of the research often mandates a longer period of time to generate definitive results as compared to other experimental systems. A Roadmap initiative would address these challenges by supporting investigator-initiated SIB research. Resources should be provided for collaborations among physiology, pharmacology, molecular biology, and bioinformatics, among others. By supporting the uniquely collaborative field of integrative biology, a Roadmap initiative will allow researchers to advance their careers and train others, thereby further establishing their presence in the scientific community. When the initiative phases out, the progress made should have established the promise and validity of the research, encouraging more scientists to pursue this area. “Currently researchers are trained to approach biological problems at a reductionist level, but in order to confirm insights and apply findings from less complex systems (i.e., in vitro models) to whole organisms, researchers need to develop a set of skills that combines knowledge of molecular biology with in vivo systems. The key to bridging this knowledge gap lies in providing training programs and opportunities in SIB. Education should focus on bringing together scientists with diverse skills and expertise to exchange knowledge, i.e. scientists who focus on the description of molecular events would benefit from working with researchers who define mechanisms in animal models and vice versa. The next generation of researchers will need diverse skills to carry out translational research, bridging basic and clinical science. Training should be offered at all levels, from undergraduate to continuing professional education. “A successful SIB initiative will enhance the research enterprise by facilitating collaboration between disciplines and moving translational research forward. One of the overarching goals in biomedical research is to use basic research findings to improve human health. By incorporating studies of biological functioning at the molecular level into the larger context of organ systems, whole animals, and even human subjects translational research will be advanced dramatically. The outcomes of the proposed initiative will benefit the missions of all NIH institutes and centers by creating a generation of researchers with diverse skills and collaborative research programs. Because the proposed initiative depends on researchers, both basic and clinical, from diverse fields working together, it would be difficult for any one institute or center to fund making it an appropriate and ideal candidate for a Roadmap initiative.” |
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One of the last actions of the 109th Congress
was to approve the first NIH reauthorization bill since 1993. The
legislation, HR 6164, had been one of the highest priorities for House
Energy and Commerce Committee Chairman Joe Barton (R-TX). The bill passed
the House on September 26, 2006 by voice vote. A modified version was
cleared the Senate on December 8 and got final approval from the House in
the early hours of December 9, 2006. The National Institutes of Health
Reform Act of 2006 recommends funding levels for the next three years,
establishes a Common Fund to support trans-NIH research initiatives, and
revises the agency’s reporting requirements. All expenditures by government agencies must be authorized by Congress. However, because the NIH also operates under the permanent authority of the Public Health Service Act, the agency can function without separate legislation. That has been the case since 1993 as a series of attempts to generate authorizing legislation got bogged down due to controversial provisions, such as human embryonic stem cell research and a host of disease specific initiatives. During the same period, Congressional appropriators filled the gap by giving the agency direction in the report language that accompanies funding legislation. This was where things stood when Rep. Barton assumed the role of Energy and Commerce Committee Chair in 2004. Barton generated the momentum behind the NIH Reform Act of 2006 as he sought to ensure that all agencies within his new committee’s purview were operating under appropriate legislative authority. Chairman Barton cited the doubling of the agency’s budget and recent troubles with conflict of interest as important reasons for reauthorization, and he and his staff worked intensively with the scientific community to win passage of the legislation. Even after the Republicans lost control of the House and the Senate in the mid-term elections, Chairman Barton worked hard to keep the legislation free of disease specific initiatives despite efforts in both chambers to add such provisions. FASEB and the APS supported H.R. 6164 because of Barton’s commitment to support higher funding levels and the addition of reporting requirements to increase transparency in terms of how the budget is being utilized. FASEB was heavily involved in the discussions that produced the legislation and sought to maintain an emphasis on investigator initiated research and the peer review process. The rationale for supporting the NIH Reform Act was to produce legislation that would show strong Congressional support for the NIH while demonstrating to Congress that the agency can be managed in a more efficient and transparent manner. Key provisions of the final legislation are outlined below. Funding levels The NIH Reform Act of 2006 authorizes NIH funding at $30.3 billion for fiscal year 2007 (a 6% increase over ‘06), $32.8 billion for FY 2008 (an 8% increase over the proposed ‘07 level) and “such sums as necessary” for FY 2009. The term “such sums as necessary” allows appropriators to decide at a later time how much money to allocate. It is important to note that appropriators are not obligated to provide the level of funding specified in an authorization bill. Nevertheless, the recommended increases represent a strong Congressional endorsement of the NIH and its programs. The “Common Fund” HR 6164 authorizes the creation of a Common Fund to support research initiatives involving more than one institute or center. Early versions of the bill would have required that 50% of all new funds allocated to the agency go to the Common Fund. When the bill reached the Senate, this provision was removed in the face of pressure from appropriators who did not want to be forced to allocate half of all new monies to the Common Fund. The final version of the bill does not include a specific amount for the Common Fund, but does require that the amount allocated to the fund will not decrease from year to year as a percentage of total appropriations. If the Common Fund reaches 5% of the total NIH budget, the agency will be required to submit an evaluation report to Congress. Decisions about how the money in the Common Fund will be spent will made by the Council of Councils, a new advisory board in the office of the Director. Restructuring The NIH Reform Act creates a Scientific Management Review Board to review the organization of NIH as a whole and recommend structural changes if needed. There must be a formal review at least every seven years, and the board’s reports must be made available to the public. Changes to the structure of the NIH as a whole will be subject to Congressional approval and a public consultation process. The bill also caps the total number of institutes and centers (ICs) at 27, which is the current number. Reorganization within the Office of the Director will be at the discretion of the NIH director, subject to approval by the Secretary of Health and Human Services. Individual IC directors will have authority to make changes within their own ICs, with the consent of the NIH Director. Reporting Requirements The NIH Reform Act of 2006 requires the NIH Director to make a biennial report to Congress on NIH activities and the state of biomedical research. The report must also include a strategic plan and recommendations for future research. A number of “categorical” reports are also required on topics such as cancer, neuroscience, autoimmune disease, genomics, infectious disease and minority health and health disparities. The bill requires a report on NIH-funded graduate student education programs and the establishment of a new system to electronically code grants. In addition to the above requirements, each institute and center must submit a yearly report on the percent of its budget that was devoted to trans-NIH activities. The NIH director can waive this requirement if this is deemed inappropriate in light of the IC’s mission. However, ICs that fail to comply without receiving a waiver could become ineligible to receive a budget increase the following year. |
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November 27, 2006, President Bush signed the
Animal Enterprise Terrorism Act (AETA) (http://www.the-aps.org/pa/resources/archives/highlights/AETA.htm)
into law, ensuring stronger protection for the nation’s biomedical
researchers. The Senate passed the AETA by unanimous consent September 30,
2006 just before Congress went into recess for the election. The measure
then went to the House, which passed it by voice vote on November 13, 2006
the first day of the post-election lame duck session. National Association
for Biomedical Research (NABR) President Frankie Trull hailed the measure as
a “momentous step” and described the legislation as “a key milestone on the
path to protecting researchers and their families from intimidation and
harassment by extremists.” The passage of the AETA comes at a time when escalations in extremist attacks have placed biomedical researchers in considerable danger. In recent years, anti-research extremists have grown more violent and have expanded their targets beyond animal facilities themselves. In some cases they have targeted not only researchers and other employees but also family members and even businesses that are marginally associated with animal facilities. The AETA enables federal law enforcement to prosecute violence and threats against persons due to their association with research or other activities involving animals. Opponents claimed that the AETA would have a chilling effect on legitimate protest. House Judiciary Committee Chairman James Sensenbrenner (R-WI) countered this argument on the House floor by pointing out that the language of the bill had been revised to address these concerns. He read the section of the bill that specifically exempts First Amendment protected activities and went on to note that the ACLU had withdrawn its earlier opposition. Senator Patrick Leahy of Vermont, who had originally opposed the act, said that with the revised language “peaceful conduct is not chilled by the threat of federal prosecution.” |
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The Humane Society of the United States (HSUS)
brought in $119.9 million in revenue in FY2006, according to the latest
edition of the independent publication Animal People. Animal People’s “Who Gets the Money?” feature, released each December, advises animal-cause donors on which animal-focused organizations are making good use of their funds. Some of the HSUS increase in income derives from its recent mergers with the Doris Day Animal League, as well as Fund for Animals. The latter group was originally formed after a split with HSUS. Some $20 million of the HSUS receipts are estimated to be from special contributions for animals affected by Hurricanes Katrina and Rita. Five years ago, the combined total budgets of the twelve most prominent activist groups involved in biomedical research issues was $97.6 million. This year the budget of the HSUS alone is $86 million, a sum not matched by the combined total budgets of the next ten groups. On November 7, 2006, the Wall Street Journal published a front-page article describing the political influence of HSUS. The Journal reported that HSUS, with more than twice the membership of the NRA, was putting its political strength to work by trying to elect sympathetic candidates from both parties. According to HumaneUSA.org, the HSUS Political Action Committee endorsed 343 national candidates. Of them, only 34 were defeated. With an average of 23,000 members in each House District, an HSUS endorsement could have played a significant role in some close races. HSUS CEO Wayne Pacelle told the Wall Street Journal that his organization spent money in the closest races where he believed “he can swing about 5% of the vote.” All told, HSUS spent $3.4 million in national campaigns and ballot initiatives and contributed $150,000 to congressional candidates. The Journal noted that HSUS spent more on campaigns than Exxon Mobil and gave more contributions than Halliburton Co. Pacelle said of HSUS, “We can be an incredibly influential political organization, as powerful as the Chamber of Commerce.” |
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On August 30, 2006, the National Institutes of
Health (NIH) issued a request for information on a proposed data sharing
policy for NIH-funded genome wide association studies (GWAS). The proposed
policy would require NIH-funded investigators conducting GWAS to deposit
resulting data in a central repository where it would be available for use
by other scientists. Individual patient’s genotype and phenotype data would
be de-identified by the submitting investigators before being placed in the
repository and access to the data would be controlled by a data access
committee (DAC) at the NIH. Investigators who submit data would have a nine
month period of publication exclusivity. During this period, other
researchers could access and analyze the information, but would be
prohibited from publishing their findings. Scientists who utilize data from
the repository would also be required to acknowledge the submitting
investigators in their publications. The NIH held a town hall meeting in December 2006 to hear concerns from the stakeholder community and expects to issue a final policy in the spring of 2007. There remain significant outstanding concerns about informed consent, protection of patient privacy as well as the ability of NIH to enforce rules for those who access the data, but are not funded by the NIH. The following are excerpts from the APS response to the RFI that was submitted on November 29, 2006. “Providing access to data generated from government supported research is important to advancing medical science, which is a central part of the NIH mission. The creation of a central repository will facilitate data submission and maintenance, and will also provide a uniform mechanism for ensuring the protection of research participants. While such an endeavor may be costly, providing access through a standardized database platform in the proposed manner is an effective way to access data from multiple research studies and will result in significant benefits to researchers, making it an appropriate use of NIH resources. Currently, data is gathered by reviewing individual published articles and extracting the data from either the article itself or from any available supplemental materials. Developing a centralized database will be much more efficient than mining data from individual studies. “There are many possible benefits for scientists who choose to participate in this effort and deposit data in the GWAS repository, including wider recognition of their research and contribution to the knowledge base of the field. However, there are also risks that should be minimized through careful control of access to the repository. The most obvious threat is that other scientists may be able to gain access to the deposited data before the contributing investigator has a chance to publish their findings. Contributing investigators must be allowed ample time to analyze and publish based on the data they generate before it is released for general access. Another risk is that users may fail to acknowledge the original data contributors when they publish their work. The APS urges the NIH to consider ways to prevent and reduce these risks. “The benefits to those who access the data are clear – researchers will have access to patient data that they otherwise might not be able to collect and analyze. However, because the data will be generated from multiple sources it will be a challenge to ensure the quality, accuracy and reproducibility of the results. Standardization and quality control of data submission will be essential to minimizing that risk. In addition, because researchers wishing to access data will require the approval of their institution’s internal review board (IRB), the NIH should be sure to provide adequate training and resources to help institutional IRBs as they deal with this new area. “For research subjects and patients who choose to participate in GWAS where data will be deposited for wider use, informed consent and privacy protection are critical areas that must be fully addressed. It is important that the informed consent address the many possible end uses of the data generated from submission to the repository. Patients should be made fully aware that their genetic and phenotypic data will be deposited for public use by researchers, and that the data may be used in research that is outside the scope of the current project they have agreed to participate in. “Allowing access to a patient’s genetic information, even after removal of identifying information, creates risk that can only be minimized within the limits of currently available technology. Despite de-identification of the data, publication of marker data at multiple informative loci constitutes identification of individuals. Recent high profile breaches of sensitive data by government agencies highlight the need to minimize this threat through a careful evaluation of security measures. In addition to ensuring that computer systems and coding protect patient identities, the possibility of experiencing discrimination based on genetic information would be minimized through the passage of genetic non-discrimination legislation. While the APS realizes that this decision rests with the United States Congress and not with the NIH, we take this opportunity to emphasize the importance of this legislation.” |
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A National Institute of Health expert
committee has determined that the current edition of the Guide for the Care
and Use of Laboratory Animals (Guide) “continue[s] to be relevant and
support[s] the Public Health Service commitment to animal welfare.” The
Guide was originally published in 1963 and has been revised six times, most
recently in 1996. The NIH-convened committee of 12 scientists and
veterinarians reviewed comments provided in response to a November 9, 2005
Request for Information. After a year-long review process, during which the
committee evaluated 132 reference items submitted by 39 respondents, it
concluded unanimously that there was “no scientific evidence that would
warrant revising the associated performance standards of the 1996 Guide.”
Nevertheless, the committee did make a number of recommendations as far as updating reference materials. It proposed that the Guide become a “living,” web-based document, to enhance the ease with which its appendices may be updated. The committee further recommended that Appendix A be periodically revised using a critical peer-review process so that it will include an updated bibliography of best-practices. The committee also recommended the inclusion of reviews and guidelines of societies such as of the American Veterinary Medical Association (AVMA) and the Ornithological Council and called for an improved dialogue between such societies and ILAR to “help ensure consistency.” It also recommended that, as the body of peer-reviewed literature on new topics accrues that specialized documents be developed, similar to the ILAR Guidelines for the Care and Use of Mammals on Neuroscience and Behavior. By doing so, these reference documents could fill gaps in Appendix A of the Guide. |
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