and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute for Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
Title: Autism Centers of Excellence (R01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-HD-06-004
Catalog of Federal Domestic Assistance Number(s)
93.865, 93.242, 93.853, 93.173, 93.113
Key Dates
Release Date: January 20, 2006
Letters of Intent Receipt Date(s): July 11, 2006
Application Receipt Dates(s): August 11, 2006
Peer Review Date(s): October/November 2006
Council Review Date(s): January 2007
Earliest Anticipated Start Date: April 1, 2007
Additional Information to Be Available Date (Url Activation Date): Not Applicable
Expiration Date: August 12, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
1. Research Objectives
Background
Autism spectrum disorders (ASD) are complex neurodevelopmental disorders with early childhood onset. ASD prevalence may be increasing and ASD is more common than previously thought. These disorders, for which there is presently no cure and only limited treatments, generally have lifelong effects.
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 multi-site 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 in order 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.
Research Scope
The focus of the ACE must be on the causes and best treatment of autism (as listed in the Autism research Matrix http://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 109-10). 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 November 20, 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:
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.
Networks
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 multi-site network that could conduct one or more neuroimaging protocols and collect data using common standards and a multi-site 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 multi-site subject accrual
Centers
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 6 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.
National Database for Autism Research (NDAR)
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 bio-statistical consulting will be the responsibility of the ACE Center or Network. Depending on the number and size of the multi-site projects, NDAR may provide Data Coordinating Center (DCC) functions for large ACE multi-site projects to increase efficiencies.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the Traditional Research Project Grant (R01) award mechanism(s). 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 non-modular 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 non-modular research grant applications.
2. Funds Available
NIH (NICHD, NIDCD, NIEHS, NIMH, and NINDS) intends to commit up to $24 million per year for this funding opportunity and its companion RFA for ACE Centers. Funding will begin in FY 2007 and FY 2008 for the first year of funding. Approximately 10 to 15 ACE awards are anticipated in response to both RFAs. An applicant may request a project period of up to five years and a budget for direct costs up to $2 million for networks.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
While the applicant institution must be domestic, foreign institutions may be involved as a consortium. For example, a project within an ACE Network may be located at a foreign institution and supported through a subcontract. Funding requests for foreign subcontracts must be made in U.S. dollars. Facilities and administrative costs on foreign consortia will be awarded at 8 percent of the total direct costs less equipment.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.
2. Cost Sharing or Matching
Cost sharing is not required.
3. Other-Special Eligibility Criteria
Each principal investigator may submit only one application for either an ACE Center or an ACE Network. This does not exclude multiple applications from a single institution, provided each application is submitted by a different principal investigator.
1. Address to Request Application Information
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, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
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 title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Specific Instructions for Preparing a Network Application
Applications are to be submitted on Form PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html). All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by the specific instructions described below.
In lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily.
The Table of Contents should contain the information described below. It should be divided into the following sections: Section I - General Information, Section II - Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents are underlined.
Section I Networks General Information
A. Networks Face Page
Complete all items on the application's face page. This is Form Page 1 of the application; number succeeding pages consecutively.
On line 2, enter the appropriate Request for Applications (RFA) number and title, and mark the YES box.
B. Networks Description and Personnel
On Form Page 2, describe briefly the research program, and the purpose and structure of the Network including a Data Coordinating Center (DCC). The DCC should be functionally independent of the data collection sites.
List key scientific and technical personnel participating in the ACE. Use continuation pages as necessary, numbering consecutively. Network Principal Investigators and the DCC principal investigators must contribute 20% effort to the ACE Network.
C. Networks Table of Contents
Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions.
D. Networks Budget Estimates
Prepare a series of composite Budget Tables for the ACE Network as requested below.
1. Networks Composite Budget
a. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present the total direct cost budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each research project. Include total costs (direct and F&A) associated with "CONSORTIUM/CONTRACTUAL COSTS". Costs for purchased services should be itemized under "OTHER EXPENSES."
b. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS
398 to prepare a budget, by category, that provides direct cost totals for each year of requested support.
2. If there is more than one study or project proposed, prepare individual budgets for each
a. First year (use Form Page 4 of PHS 398 for each)
b. Total project period (use Form Page 5 of PHS 398 for each)
3. Prepare a detailed and separate budget for the DCC. The budget for the DCC should be counted towards the direct cost limits. Include provision for availability of scientific expertise in biostatistics and personnel to carry out the interface with the National Database for Autism Research (NDAR) describe above.
a. First year (use Form Page 4 of PHS 398)
b. Total project period (use Form Page 5 of PHS 398)
Consortium Budgets (if applicable) should be presented as described in Item 1(Composite Budget), including a budget for the entire proposed project period. Total Direct and F & A costs of sub-awardees are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" and a detailed consortium budget is to be prepared.
Budget Justifications: Describe the specific functions of key scientific and technical personnel, consultants, collaborators, and support staff. Clearly specify and justify the needs for the DCC staff and functions. If NIH chooses to enhance the NDAR’s function prior to the time of award, specific components of the applicants DCC budget may be modified. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For future years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts.
E. Networks Biographical Sketch
Biographical sketches are required for all key scientific and technical personnel as listed on
Form Page 2.
Beginning with the ACE Network Director, and following in alphabetical order, submit biographical sketches as described in the "Instructions for Form PHS-398," using Form Page 6.
G. Networks Resources
Complete the "RESOURCES" section on Form Page 8 of the PHS 398 for the overall ACE. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Use continuation pages as needed.
SECTION II Networks Research Plan
Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify research project (s) by title, and assign each research project a number that reflects the order in which the research projects are presented in the application research plan. For each research project, provide the name of the Principal Investigator and biographical sketches for personnel not identified previously.
A. Networks Introductory Overview (20-page limit)
Provide an overview of the entire proposed ACE Network describing the central theme and goals. Describe how the overall ACE can achieve its major objectives. Explain the proposed contribution of each of the studies proposed in achieving the objectives of the network. Furthermore, the administrative arrangements and support necessary to affect the research should be carefully described in the application. Shared resources should be described. In addition, provide detailed information on collaborations, recruitment, facilities and resources. Provide documented evidence of recruitment capability specific to each study proposed.
1. Purpose and Objectives of the ACE Network. Discuss the philosophy and objectives of the ACE network and general plans for the proposed grant period. Describe relevant history leading up to the ACE network application.
2. Administration, Organization, and Operation of the ACE Network. Include information on the support and commitment of the institution serving as clinical co-coordinating center for the ACE network, the authority of the ACE network Director, and the use of advisory committees. Describe organizational framework and provide an organizational chart. Identify any investigators new to the field of autism (junior and/or established investigators) that will be involved directly in Network activities. Describe any additional efforts that will be made to recruit and/or train new investigators over the course of the award.
3. Applications must have a clearly defined Data Coordinating Center (DCC) section in the research plan that describes the DCC’s functions in detail and explains how it will operate independently from data collection sites. The data management plan should take into account the interface with the National Database for Autism Research (NDAR) described above.
4. Assurances and Collaborative Agreements. Arrangements for collaborations or subcontracting should be highlighted. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate research project.
B. Networks Preliminary Data (five-page limit)
This section should be used to present, in condensed form, previously published and/or preliminary data that are relevant to proposed ACE network activities and research projects. List relevant publications published or accepted for publication during the past five-years. The list of publications does not count against the page limit.
C. Networks Research Project Description
If the network application has more than one project, identify each project by a Roman numeral (I, II, III ) and a title.
For each component research project, a full description is to be provided following the format presented in Form PHS 398. Begin the presentation of each component research project on a separate cover page. For each project, include the following information:
1. Network Introductory Information
a. Indicate:
Project Title
Project Principal Investigator, title, location
Other investigators, consultants, and collaborators, titles (Associate Professor, Postdoctoral Fellow, student).
b. Description of Research Plan (use Form Page 2 of PHS 398)
2. Network Research Project Plan (Do not exceed 25 pages for Sections a-d):
Discuss the purpose and nature of the project and its relevance to the application's overall theme. Address the following:
a. Specific Aims
b. Background and Significance
c. Preliminary Studies
d. Research Design and Methods. In addition to usual contents of this section, describe the plan for recruitment and retention of subjects.
e. Human Subjects. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements.
E. Networks Checklist - As required in Form PHS 398
Section III Networks Appendix
Include materials as appropriate (see PHS 398).
Other Support information should be provided in the format shown in sample Tables I at http://www.nichd.nih.gov/funding/dsr_p50_guide.htm#table1.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A).
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: July 11, 2006
Application Receipt Date(s): August 11, 2006
Peer Review Date: October/November 2006
Council Review Date: January 2007
Earliest Anticipated Start Date: April 1, 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be received by the date listed at the beginning of this document.
The letter of intent should be sent to:
Alice Kau, Ph.D.
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
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1383
FAX: (301) 496-3791
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496 1485
FAX: (301) 402 4104
Email:
[email protected]
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NICHD, in collaboration with the other sponsoring Institutes. Incomplete and non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks. All ACE applications will initially be assigned to NICHD. Once the review is completed, meritorious applications will be assigned to appropriate Institutes for funding purposes.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
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. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
All Networks applications must include collection of data using the following measures or a justification of why the measures are not appropriate.
Differences in imaging protocols across projects make it difficult for investigators to combine information for integrated morphometric, genetic and brain-behavior analyses. Therefore, NIH is encouraging the use of standard imaging protocols in the ACE programs. Because imaging data on an epidemiologically-ascertained sample of typically developing children are available through the NIH MRI Study of Normal Brain Development, imaging studies shall use the protocols for structural MRI adopted for use in this initiative (http://www.bic.mni.mcgill.ca/nihpd_info/) unless compelling reasons for the use of a modified protocol are provided. This will enhance the ability to discern deviations from normal development associated with autistic disorders. Investigators are encouraged to consider using existing and developing protocols for diffusion tensor imaging that are part of the MRI Study of Normal Brain Development.
Network applications also must include travel funds for key investigators to attend annual two-day ACE meetings in Bethesda, Maryland. Network principal investigators, project principal investigators, and DCC principal investigators should plan to attend the annual meeting to share findings, research approaches, and information about core instrumentation.
Network application should include a steering committee consisting of the Principal Investigators from each participating institution. A Data Safety and Monitoring Board (DSMB), established by the responsible NIH Institute, may be required to advise the NIH and the ACE network on research design issues, data quality and analysis, and ethical and human subject issues. It will also monitor the safety of any ongoing clinical research.
Plan for Sharing Research Data
Principal investigators of ACE funded projects will be required to contribute data to the National Database for Autism Research (NDAR), which is currently under development. Data from this database will be made available to other researchers, under the guidelines to be established by this entity, adhering to HIPAA and Human Subjects research codes.
The NIH data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All ACE applicantions must include a plan for sharing research data. The precise content of each data-sharing plan will vary, depending on the data being collected and the expected schedule for data sharing. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Genetics Data Sharing in the ACE Program
The dissemination of data and biomaterials via individual laboratories and Web sites is not sufficient, as it would force interested investigators to have to search several different data collections to make use of the results of this initiative. In addition, differences in protocols across projects for creating databases may make it impossible for researchers to combine information for integrated genetic analyses. It is preferable that data and biomaterials from subjects analyzed in grants funded under this RFA should be placed in common, public cell repositories and databases that are widely accessible by investigators in the international scientific community. An NIMH-supported data management facility and cell repository the NIMH Center for Collaborative Genetic Studies on Mental Disorders (http://nimhgenetics.org) - is such a community resource. Information regarding access procedures and policies utilized in the NIMH Human Genetics Initiative can be found at http://nimhgenetics.org.
It is expected that the investigator’s data sharing plan will specify the following elements: (1) the creation of comprehensive and verified databases that contain all clinical, diagnostic, and genotypic information; (2) if possible, the availability of high-quality cell lines, from which DNA will be extracted and stored; (3) mechanisms by which all databases and any biomaterials (DNA samples and cell lines, if applicable) are widely distributed to qualified investigators in the scientific community; (4) a protocol for wide dissemination of these data and applicable biomaterials; (5) a timetable for distribution; and (6) an assurance that data and applicable biomaterials are disseminated in a manner comparable to pre-existing protocols and procedures for distributing such data and biomaterials in the NIMH Human Genetics Initiative (see http://nimhgenetics.org).
After extensive discussion with mental health and human genetics researchers and advocacy members, the Genetics Workgroup of the National Advisory Mental Health Council (NAMHC) recommended that NIMH should draft a policy that provides for the sharing of genetic materials after a 12- to 18-month proprietary period. Adherence with the time frame recommended by the NAMHC’s Genetics Workgroup is highly desirable. This is expected to result in all data being released to the scientific community no later than the end of the award period, even if a competing renewal application is submitted. More rapid sharing is strongly encouraged. Requests for exemptions or extensions will require compelling justification and will be fully evaluated through peer review and by program staff.
NIMH, in consultation with NIH’s Office of the General Counsel, the National Human Genome Research Institute's Ethical, Legal, and Social Implications Research Program and the Department of Health and Human Services' Office for Human Research Protections, has developed a model consent form for use in human genetic research at http://zork.wustl.edu/nimh/NIMH_initiative/NIMH_initiative_link.html. This may then serve as a template that is subject to modification and/or approval by local institutional review boards. It is expected that the applicant’s approved consent form address the following:
1. Criteria
Only the review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Network Research Projects
Significance: Does this project address an important problem? If the aims of the project are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the network allow studies that would not otherwise be possible in individual sites or small groups of collaborating sites? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there evidence of a collaborative track record of the investigators?
Additional Review Criteria Specific to ACE Networks Program
How will the Network attract both established and junior investigators to autism research?
What is the potential for impact of the ACE network on the progress of autism research locally and nationally?
Does the network as a whole serve a purpose greater than the sum of the individual components? What is the likelihood that the proposed network will advance research in the autism research matrix (http://www.nimh.nih.gov/autismiacc/researchmatrix.pdf)?
Data Coordinating Centers
Evidence of Successful Past Performance: What level of experience does the DCC principal investigator have in the design, conduct, data analysis, and data management of major collaborative clinical research projects? Is there evidence of successful performance as a DCC for multi-site studies?
Appropriate Staff Expertise and Capability: Do the DCC Principal Investigator and other staff have appropriate expertise and capability in biostatistics, developmental study design, development and support, data management, data analysis, and project management? If the network involves clinical trials, is there appropriate clinical expertise for medical monitoring and consultation regarding clinical data management (e.g., adverse events reporting, safety and protocol deviation monitoring)?
Capacity and Ability to Manage Data and Communications: Does the DCC applicant provide evidence of data management and program support capabilities by describing standard operating procedures that include assisting in the design of protocols, data collection forms, manuals of operations, data collection/distribution systems, quality assurance (edit/query procedures) and monitoring systems, reliability assessment and generating reports? Does the applicant provide evidence of the ability to organize and conduct on-site monitoring?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.
1. Award Notices
After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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. See Also Section IV.5. Funding Restrictions.
All ACE applications will initially be assigned to NICHD for review purposes. Once the review is completed, meritorious applications will be assigned to appropriate Institutes for grant and program management. Consideration may be given to converting an application to a cooperative agreement prior to funding, if deemed appropriate by the funding institution.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
We strongly encourage your inquiries as early as possible concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Alice Kau, Ph.D.
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
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1383
FAX: (301) 496-3791
Email: [email protected]
2. Peer Review Contacts:
Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]
3. Financial or Grants Management Contacts:
Chris Robey
Grants Management Team Leader
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17E, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 402 4165
Fax: 301-451-5510
E-Mail: [email protected]
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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