The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project s ee the NIH Grants Policy Statement.
Grantee Meetings: Upon initiation of the program, the NHLBI together with the Data Coordinating Center will arrange for up to three meetings in the first year and up to two meetings in years to establish and consolidate networking among the investigators who participate in this program. At these meetings awardees will be expected to share their results, coordinate joint projects and to help evaluate the progress of the overall program and the individual centers.
Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. The Data Coordinating Center should also include funds to pay for up to one meeting a year each , in Bethesda , Maryland , of an outside scientific advisory committee that would review and foll o w the program and review collaborative protocols and of an Observational Study Monitoring Board OSMB that would review and follow protocols conducted at the clinical sites.
In addition, any projects that include new science will require prior approval of an outside peer review group scientific advisory committee indicating that the science is important and meritorious before funds are released by the DCC. Both the TB Systems Biology Centers staff and the DCC staff must have appropriate training and experience for working safely with biologically hazardous specimens that may contain M. They must indicate what steps they will take to safely acquire, process, ship, store, and distribute biologically hazardous specimens that contain M.
This is a multidisciplinary, highly collaborative program. The DCC will be expected to provide assistance to the TB Systems Biology Centers in maintaining quality control, facilitating data sharing, and program coordination.
Applicants are encouraged to establish links and utilize existing resources including those listed below, but other resources not mentioned here may also be appropriate:.
Applicants for the centralized Data Coordinating Center DCC should present a description of plans to: 1 provide data management, including quality control and development of forms; 2 develop needed databases and implement a web-based system to coordinate program activities; 3 provide statistical support 4 provide support in designing and conduct i ng joint protocols; 5 provide leadership in identifying the common elements, standardizing definitions and harmonizing data ; 6 provide support for preparing and submitting joint presentations and joint publications; and 7 provide coordination of meetings and reports as needed 8 provide administrative support services for an Observational Study Monitoring Board OSMB for all the clinical R01s estimate up to 4 grants.
The DCC staff should have appropriate expertise and experience in project management, biostatistics, informatics , systems biology, and expertise in web-based data management. Prior experience in complex collaborative studies is desired.
The DCC Principal Investigator and other key staff should have knowledge of t uberculosis and pulmonary clinical studies and repositories. Applications for the DCC may be submitted by individuals located at the same institution as an applicant for a clinical site grant submitted under this FOA, but an individual may not be the Principal Investigator of a research grant and the DCC.
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process. NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.
A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits e. Application Review Information. Only the review criteria described below will be considered in the review process. Review and Selection Process. As part of the scientific peer review, all applications will:. The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.
As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. Overall Impact. Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.
An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
To what degree extent will the DCC be able to provide services described in. Section I O bjectives: Scope of Activities? Investigator s. If established, have they demonstrated an ongoing record of accomplishments that have advanced their field s?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Will the DCC develop appropriate and innovative interfaces to facilitate the interaction of multi-disciplinary systems biology research?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Does the applicant present a reasonable description of plans for data management, quality control of forms, coordination of activities, support for harmonizing data, developing joint protocols and integrated models, provision of statistical support, support for interacting with other programs that are not part of the F O A, working with biospecimens, , publication support, meeting coordination and administrative support?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?
Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1 risk to subjects, 2 adequacy of protection against risks, 3 potential benefits to the subjects and others,.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1 the justification for the exemption, 2 human subjects involvement and characteristics, and 3 sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. Vertebrate Animals. Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1 the Select Agent s to be used in the proposed research, 2 the registration status of all entities where Select Agent s will be used, 3 the procedures that will be used to monitor possession use and transfer of Select Agent s , and 4 plans for appropriate biosafety, biocontainment, and security of the Select Agent s.
Resource Sharing Plans. Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications submitted in response to this FOA will compete for available funds with all other recommended application s submitted in response to this FOA. T he following will be considered in making funding decisions:. Award Administration Information. If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization.
The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official. Selection of an application for award is not an authorization to begin performance.
Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated. Section VII. Agency Contacts.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Hannah H. Peavy, M. Sandra Colombini Hatch, M. Section VIII. Other Information. Molecular epidemiology is gaining importance in tracking strains and addressing key public health challenges to prevent and control communicable diseases in Ethiopia, including tuberculosis TB.
Ethiopian pastoralist populations have been neglected despite their vulnerability to various infectious diseases. Surveillance of TB in these areas is also minimal. As pastoralists rely on livestock products, a significant, largely unexplored challenge is the potentially high level of transmission of tuberculosis between livestock and people. There is currently no effective vaccine protecting humans against TB. The Bacillus Calmette Guerin BCG vaccine consisting of attenuated Mycobacterium bovis preparations is the only approved vaccine against TB, but no longer provides protective immunity in some populations.
Another challenge is the need of prolonged antibiotic treatment which, if not properly completed, accelerates the development of Mtb multi-drug resistance. Major problems in high TB disease burden countries are human and environmental factors that contribute to a weakened immune system and can increase susceptibility to Mtb infection, recurrence of latent infection and high morbidity and mortality.
Modern genomics tools will considerably impact the knowledge of transmission dynamics, the extent of strain diversity and molecular interactions of TB with its host environments. Second, it is also hard to predict which patients with latent disease will go on to develop an active infection, posing risks not only for individual patients but also for those around them. Compounding these clinical challenges are equally significant challenges in the laboratory. TB is among the top 15 causes of death worldwide, killing some 1.
An estimated one-third of the global population carries the culprit microbe, Mycobacterium tuberculosis Mtb , which is spread through the air. Without proper treatment, about 45 percent of HIV-negative people with active infection—and nearly all HIV-positive people who harbor the TB bacterium—will die.
But as an undergraduate at Yale University, she got a taste of biological research while working in a laboratory focused on the developing brain. Soon after, she witnessed the devastation wrought by TB up close. The devastation of those twin outbreaks was on par with what is often now seen in parts of the developing world. One destroys the vestibular system in the ear that helps the body maintain balance. Another can trigger psychosis. Put simply, advances on the clinical side of TB have not kept up with the toll.
Her guiding scientific question: What makes the TB bacterium such a hardy survivor? One key insight is that, as a group, Mtb cells are not homogeneous. Fortune believes these rare, specialized cells account for why TB treatments are so protracted—a six-month course of antibiotics is needed to contain the disease—and also why developing an effective TB vaccine has proven so elusive. Biologically speaking, there are a few possibilities.
The cells could vary genetically, through changes to their DNA. They could also differ as a result of variations in their epigenome, a chemical code embedded within DNA that determines when and where certain genes get switched on or off. Or they could be programmed through molecular differences set in motion by a key group of regulators called transcription factors. This concept of bacterial individuality signals a stark departure from the picture of Mtb as a monolithic foe, an idea commonly held as recently as a decade ago.
Fortune and her team have since shown that these presumed do-nothing microbes are in fact highly sophisticated. Unlike most cohabiting bacteria, which each perform the same functions for individual gain, Mtb adopt distinct roles in service of the entire group, making them more like a colony of bees than a colony of bacteria.
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