Autism Centers of Excellence (R01).
The NIH currently supports a vast array of projects in autism research. Centers such as the STAART (Studies to Advance Autism Research and Treatment) and CPEA (Collaborative Programs of Excellence in Autism) programs support some of these investigations. The CPEA program, an international program begun in 1997, now includes nine centers. These Centers focus research on the possible causes of autism, including genetic, immunological, and environmental factors. The CPEA program resulted from a congressionally mandated conference on the State of the Science in Autism. The attendees identified gaps in the knowledge of autism and directions for future research. Both NICHD and NIDCD sponsor the current CPEA program. As a result of the efforts of researchers affiliated with the CPEA, data now exist on the genetics and outward characteristics of the largest group of well-diagnosed persons with autism in the world. After the establishment of the CPEA Centers program, Congress enacted the Children's Health Act of 2000. This legislation mandated the establishment of a new autism research program. In response, the five Institutes of the NIH Autism Coordinating Committee (NIH-ACC; represented by NICHD, NIDCD, NIEHS, NIMH, and NINDS) implemented the STAART program. Each of the eight currently funded STAART Centers contributes to the autism research base in the areas of causes, diagnosis, early detection, prevention, and treatment. Collaborations among the STAART centers include a multisite psychopharmacological clinical trial. The CPEA and the STAART programs interact extensively through a shared data coordination center.
Consolidation of funding from the CPEA and STAART programs is now needed to maximize coordination and cohesion of NIH-sponsored efforts in autism research. The new autism centers and networks will be called the Autism Centers of Excellence or ACE.
The focus of the ACE must be on the causes and best treatment of autism (as listed in the autism research matrix hrtp://www.nimh.nih.gov/autismiacc/researchmatrix.pdf). In February 2003, Congress requested that the Department of Health and Human Services (DHHS) develop a set of autism research goals and activities for the next several years (House Report 10910). Input into this activity included a meeting of autism investigators with a range of scientific expertise as well as input from community members. Preparation for specifying this matrix involved a two-day meeting of an expert panel of scientists; public presentation and discussion of a draft matrix at the Autism Summit Conference in Washington DC on 20 November 2003; and adoption of the matrix by the Federal Interagency Autism Coordinating Committee (IACC).
Research projects should focus on finding causes and preventive intervention for autism as well as improved treatment. Applications should incorporate the latest techniques and propose studies to advance key goals related to causes and best treatment on the autism research matrix. Examples include, but are not limited to 1) identification of individual characteristics that predict response to behavioral, pharmacologic, and other treatments; 2) identification of environmental factors (e.g., viruses, medication, lifestyle factors, environmental chemicals) that contribute to the development of autism and their associated developmental windows; 3) identification of the biologic and/or behavioral markers to develop indices of risk for the development of autism in infants; 4) intervention methods for infants and toddlers developed to lower the age for which there are efficacious interventions; 5) multisite randomized clinical trials to identify moderators and effective ingredients (e.g., dose, intensity, mode of delivery, age of onset) of early intervention treatments; 6) multisite longitudinal study of subsequent pregnancies and infant siblings of children with autism to identify risk factors, broader phenotype, and early characterization of autism; 7) innovative and newly developed intervention strategies to improve outcomes in school and community settings throughout the lifespan (e.g., academic functioning, social and adaptive behavior, family functioning, employment), including transitions; 8) development of efficacious drug treatments that target core symptoms of autism; 9) characterization of the neuropathology of autism to identify impaired brain structures and functions; 10) identification of susceptibility genes and animal models of autism for further study of phenotypic characteristics of autism.
NIH will consider centers as well as networks in response to the ACE initiative. This funding opportunity solicits applications for ACE Networks supported by the R01 mechanism. A companion RFA (RFA-HD-06-016) solicits applications for ACE Centers supported by the P50 mechanism.
This funding opportunity solicits applications for ACE Networks. A network will consist of multiple sites focusing on a specific topic of research for R01 support through this funding opportunity. Each network will submit one R01 application that includes subcontracts to the collaborating sites. An ACE Network application must include one or more collaborative projects that require multiple sites for optimal design and conduct of studies. For example, an interrelated series of clinical trials of pharmacologic, behavioral interventions, or a combination of these, could be an example of the focus of such a network. Other examples include, but are not limited to, a multisite network that could conduct one or more neuroimaging protocols and collect data using common standards and a multisite epidemiology study of risk factors (e.g., genetic, environmental) for ASD. Special populations requiring large numbers of participants for each protocol may also be studied best under a network because of enhanced recruitment and other benefits of multisite subject accrual.
A companion RFA solicits applications for ACE Centers (RFA-HD-06-016). Centers bring together expertise, infrastructure, and resources focused on major questions about autism. Centers should involve collaborations of basic and clinical scientists optimally suited to address the research questions posed. NIH expects Centers to provide an environment and core resources to bring together biomedical, behavioral, and clinical science investigators to study autism. Collaborations involving more than one institution are strongly encouraged to provide optimal resources and expertise. The centers should provide investigators with well-characterized patients and control subjects, family information, and other scientific resources that facilitate research projects. Applications for centers must include a minimum of three but no more than six research projects. The addition of core support is optional and will depend on specific needs.
An ACE Center must support major multidisciplinary research programs, consisting of interdependent and interrelated subprojects. Meaningful and committed interactions among the disciplines must be evident. Subprojects may share materials, results, data, patient populations, or methodologies. Results of one subproject may well affect the understanding and interpretation of data from another project and thereby influence the nature of the research performed in one or more of the other subprojects. In addition, each subproject must have goals and objectives that focus on the common unifying theme that interrelates the subprojects.
NIH is developing a National Database for Autism Research (NDAR) to facilitate data sharing. NDAR (http://ndar.nih.gov) is both a database and a set of tools for autism researchers--a national resource for collaboration in autism research and clinical practice.
All ACE Centers and Networks will be required to contribute data to NDAR. Data sharing is required and NDAR will be involved to facilitate sharing activities. NDAR will function as a data repository for all ACE projects. Central clinical coordination and local data management for data cleaning and entry and biostatistical consulting will be the responsibility of the ACE Center or Network. Depending on the number and size of the multsite projects, NDAR may provide Data Coordinating Center (DCC) functions for large ACE multisite projects to increase efficiencies. This funding opportunity will use the Traditional Research Project Grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the nonmodular budget formats (see http://grants.nih.gov/grants/ funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for nonmodular research grant applications.
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/ phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, 301-435-0714 (telecommunications for the hearing impaired: TTY 301-451-0088) or by e-mail: GrantsInfo@nih.gov.
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling 866-705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The letter of intent receipt date for this RFA is July 11, 2006, with the application receipt date August 11, 2006. The complete version of the RFA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-06-004.html.
Contact: Alice Kau, Mental Retardation and Developmental Disabilities Branch, Center for Developmental Biology and Perinatal Medicine, National Institute of Child Health and Human Development, 6100 Executive Boulevard, Room 4B09F, MSC 7510, Bethesda, MD 20892-7510 USA, Rockville, MD 20852 USA (for express/courier service; non-USPS service), 301-496-1383, fax: 301-496-3791, e-mail: firstname.lastname@example.org. Reference RFA-HD-06-004