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 on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Title: Case Ascertainment to Estimate the U.S. Prevalence of Fetal Alcohol Spectrum Disorders in Young Children (U01)
Announcement Type
New
Related Notices
Request For Applications (RFA) Number: RFA-AA-10-005
Catalog of Federal Domestic Assistance Number(s)
93.273
Key Dates
Release Date: October 23, 2009
Letters of Intent Receipt Date: November 22, 2009
Application Receipt Date: December 22, 2009
Peer Review Date: March-April 2010
Council Review Date: May 2010.
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: December 23, 2009
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
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, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
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. Resource Sharing Plan(s)
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. Dispute Resolution 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
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
Fetal alcohol spectrum disorders (FASD) comprise a distinctive set of anthropometric and central nervous system abnormalities following prenatal alcohol exposure which manifest across a continuum of severity, ranging from mild to moderate cognitive and growth deficiencies to severe mental retardation. The purpose of this FOA is to establish reasonable, reproducible and generalizable estimates of the prevalence of FASD, including fetal alcohol syndrome (FAS), partial FAS (pFAS) and alcohol-related neurodevelopmental disorders across a range of fetal alcohol exposures and risk groups. This research effort will be accomplished through the cooperative development and use of a diagnostic system that will be used specifically to evaluate characteristics of FASD among affected children across representative geographic areas (such as counties or cities/metropolitan areas) in the United States. This effort also will require the development and/or use of standardized research approaches for valid indicators of prenatal alcohol exposure, and the use of standardized criteria for FASD diagnosis in order to establish a reasonable prevalence of FASD in young children. Research approaches should include development of culturally appropriate measurement tools and establishment of clear thresholds for diagnostic criteria to reliably classify children affected by prenatal alcohol exposure.
Background
Fetal alcohol spectrum disorders (FASD) comprise a distinctive set of anthropometric and central nervous system abnormalities following prenatal alcohol exposure which manifest across a continuum of severity ranging from mild to moderate cognitive and growth deficiencies to severe mental retardation. The estimated lifetime cost (e.g., lost productivity, housing, medical services) for one individual diagnosed with FAS, the most severe disorder, is $2 million; and 1998 cumulative costs of care for all FAS-affected individuals has been estimated at $4 billion annually. Often primary care physicians lack knowledge or awareness of the clinical features of FASD, resulting in the failure of referral of FASD-affected individuals to appropriate evaluation and treatment, and likely underreporting of the disorder. The magnitude of potential cost of FAS to affected individuals and families substantiates the critical public health significance of FASD. Thus, greater precision in ascertaining a more accurate prevalence of FASD is warranted in order to reduce economic and medical burden and ultimately improve health outcomes.
Fetal alcohol spectrum disorders were first characterized in the early 1970s as a pattern of birth defects in children born to alcoholic women. Diagnosis is based on clinical evidence of prenatal and/or postnatal growth retardation, distinct facial structural abnormalities, and evidence of central nervous system dysfunction. These clinical features have been included in diagnostic guidelines recommended by the Institute of Medicine and the Centers for Disease Control and Prevention (see Fetal Alcohol Syndrome: Diagnosis, Epidemiology, Prevention, and Treatment, Institute of Medicine, National Academy Press, 1996; and Bertrand J, Floyd RL, Weber MK, O Connor M, Riley EP, Johnson KA, Cohen DE, National Task Force on FAS/FAE. Fetal Alcohol Syndrome: Guidelines for Referral and Diagnosis. Atlanta, GA: Centers for Disease Control and Prevention; 2004.). Full fetal alcohol syndrome, at the most severe end of the FASD continuum, is characterized as one of the leading causes of mental deficiency and/or neurobehavioral impairment and diagnosis encompasses deficits in at least three domains: pre- and/or post natal growth, neurocognitive dysfunction, and recognition of specific set of dysmorphic (primarily facial) features. Partial FAS and other conditions comprising FASD, including alcohol-related neurodevelopmental disorder (ARND), may or may not be associated with less severe neurobehavioral outcomes and manifest some but not all other attributes of FAS. Those individuals with ARND typically do not have the FAS facial characteristics.
Multiple studies designed to examine the risk factors for and effects of FASD have estimated the overall prevalence of FAS in the U.S. to range from 0.1-3.0 cases per 1000 births. Estimated rates between 2 and 9 per 1000 births have been reported in some select U.S. communities that are at high risk for heavy drinking among pregnant women. In addition to rates reported in the U.S., rates above 70 per 1000 births have been reported for some high-risk communities in South Africa. The primary focus of many of these studies specifically was to gain an understanding of FASD risk factors and to implement prevention and treatment in communities of known high rates of maternal drinking. While prevalence estimates for FASD via active case ascertainment have been obtained in the U.S. among selected populations, there is a need to determine the FASD prevalence among other broader U.S. population groups and communities.
As a wide variety of studies has shown, prevalence can vary greatly, depending on the size and risk status of the population under study, inconsistencies in case definitions and diagnostic criteria used, lack of training in methods of ascertainment and surveillance, and possibly even the presence of environmental or genetic protective factors. Although the risk for drinking while pregnant among U.S. women may vary by age, socioeconomic and education levels, results of these studies suggest disparities due to relatively high rates of FASD in selected racial/ethnic groups. Thus the high rates of FASD reported among high-risk individuals in these communities do not precisely reflect FASD prevalence in the broader communities where high-risk individuals reside. Consequently, there is a substantial need to determine a more accurate prevalence of FASD in order to provide necessary prevention and treatment for affected individuals and their families. Preference will be given for the determination of FASD, via active case ascertainment, of FASD prevalence in multi-ethnic communities, for example representative samples from one or more mid-sized U.S. cities or counties.
Fetal alcohol exposure occurs when a woman consumes ethanol during pregnancy. Whereas most cases of FAS have been diagnosed among children of heavily drinking mothers, the precise quantity and frequency of alcohol consumption and timing of gestational exposure required to produce abnormalities is unknown. Published reports from a national survey (Behavioral Risk Factor Survey, BRFSS 1991-2005) on the prevalence of alcohol consumption by women of childbearing age (age 18-44) included women who acknowledged being pregnant during the interview (4 percent). The reported rates of drinking among women of childbearing age far exceed the Healthy People 2010 goals and objectives regarding targets for abstinence from alcohol use and binge drinking. Since drinking during pregnancy is considered 100 percent preventable, FAS has been reported to be the most preventable cause of mental retardation. Given that most women are unaware of the exact timing of conception, especially in unplanned pregnancies, the risk for maternal alcohol consumption is not inconsequential. A number of maternal risk factors have been identified to place offspring at risk for FASD, including, moderate to maternal heavy alcohol consumption prior to, during and after pregnancy, poor prenatal care and nutrition, maternal age, multiple pregnancies, and low socioeconomic status. In addition, many mothers of FASD children were found to have multiple risk factors. Thus in addition to ascertainment of clinical features of FASD, assessment of prenatal alcohol consumption from birth mothers is important in discerning diagnosis.
In addition to the variable levels of risk, and type and severity of clinical features involved in the diagnosis of FAS, reported rates of FASD also may vary by gender and racial/ethnic category of cases, criteria for case definitions, diagnostic surveillance and referral methods, population size, and normative drinking patterns. Predominate approaches used for FAS diagnosis include studies based on direct clinical examination (including but not exclusively active case ascertainment), and population-based passive surveillance derived from referral of clinical data to a central repository (e.g., birth registries) from cases known for or suspected of prenatal alcohol exposure. To arrive at a diagnosis, active case ascertainment involves comprehensive identification and recruitment of possible cases of FAS, and clinical and neurocognitive assessments of cases, in addition to maternal interviews by a team of professionals. By contrast, passive surveillance systems have provided a less costly means of estimating FASD prevalence, based on systematic coding of multiple sources of archival data (e.g., hospital discharge data) from clinical examinations entered into central birth defects registries.
FASD researchers have used various systems of classification for development and utilization of case definition criteria and diagnostic clinical features for diagnosis of FAS, partial FAS and other less severe outcomes of prenatal alcohol exposure (i.e., ARND and Alcohol-Related Birth Defects). Since all methods are based on subjective clinical assessments of physical structural anomalies, they are contingent on some level of subjective bias in diagnostic evaluations. Active case ascertainment alone can yield the highest number of cases and prevalence rates for a specific high-risk population. However, this method could be subject to population selection bias resulting in prevalence rates that may not be generalizable. Reported limitations of passive systems used by some investigators include use of incident data from clinician assessments without the necessary requirement of standardized training and inter-rater reliability. In addition, the data from birth defect registries often include assessments made at birth or within a few months after birth. Thus, important clinical features, that are not apparent until later in childhood, could be missed by untrained primary care clinicians, thereby increasing the opportunity for false negative results. Conversely, most studies using active clinical case ascertainment have incorporated rigorous training and measures of inter-rater reliability in an attempt to standardize assessments and reduce bias. Thus, this solicitation will require collaborative establishment of consensus on standardized FASD diagnostic criteria based on the presence of multiple clinical features as well as varying complementary neurological and neurocognitive abnormalities.
Research Approaches
As indicated previously in this solicitation, a significant challenge in FASD research is the variable timing and severity of the expression of clinical features across the lifespan due to changes in facial anomalies well after birth, and from pubertal development into adulthood. Therefore, for the purposes of this solicitation, proposed assessments should be limited to establishing prevalence among samples of children ranging in age between 3 and 12 years of age. In addition, to maximize the capability of research teams to accurately identify and diagnose FASD, applications considered responsive to this solicitation will propose active case ascertainment techniques in establishing FASD prevalence. Classification systems based on assignment of codes to clinical assessments are permitted, provided that standardized case definitions and criteria are utilized. The challenge of case recognition varies across the continuum with FAS and pFAS posing less difficulty than recognition of ARND. The ability to recognize cases of ARND will be dependent upon such factors as the extent of neurodevelopmental impairment and accuracy of maternal drinking history. The diagnostic approach used should be able to provide, in addition to reasonable prevalences of FAS and pFAS, an estimate of the prevalence of ARND for at least the more severe end of the ARND spectrum, and thereby permit an overall FASD prevalence estimate. For the purposes of this solicitation, the use of the term FASD will encompass the study of these three diagnostic categories.
As necessary, funds from the award may be used for the refinement of research instruments used to determine the prevalence of FAS, pFAS or ARND. Several standardized diagnostic approaches for FAS(D) case recognition have been published, e.g., the modified IOM diagnostic criteria (see: Hoyme, H.E. et al. A practical clinical approach to diagnosis of fetal alcohol spectrum disorders: Clarification of the 1996 Institute of Medicine criteria. Pediatrics 115, pp. 39-47, 2005) and the 4-digit code (see: Astley, S.J., and Sterling, K.L. Diagnosing the full spectrum of fetal alcohol-exposed individuals: Introducing the 4-digit diagnostic code. Alcohol & Alcoholism, 5 (4), pp.400-410, 2000). Should awardees chose to use different diagnostic systems the data from each performance site should be collected in a manner to permit consistent diagnoses and data compatibility with both systems.
Research approaches should include the use of culturally appropriate measurement tools. Researchers should be aware that mothers of FASD children may exhibit low endorsement of drinking during pregnancy due to perceived stigma. Such stigma may be associated not only with alcohol use during pregnancy, but also may reflect culturally-specific prohibitions such as cultural sanctions on any alcohol consumption by women. Thus research teams will be expected to demonstrate the requisite knowledge of culturally-based norms about drinking. In addition, investigative teams must demonstrate the cultural competency to exercise sensitivity in performing assessments of women who consume alcohol during pregnancy and their children to avoid undue stigmatization of individuals, families, members of racial/ethnic groups, or other communities considered at high risk for FASD. Recruitment in special high-risk populations may require expertise in establishing collaborative working relationships with communities. Applicants should demonstrate an established relationship with selected communities at the time of submission.
Applicants should include the following elements in describing their research approach:
- Establish thorough diagnostic thresholds for recruitment, referral and selection of individuals along the continuum of FASD severity. Due to the variability in clinical, cognitive, behavioral and psychosocial features prior to and after puberty, recruitment should be limited to children between the ages of 3 and 12 years of age. Applicants are free to propose a narrower age range for recruitment of study participants within the 3- to 12-year old limit. Investigators are encouraged to use a referral base that affords high probability of capturing FASD cases from the general population such as pre-school or elementary school systems. Assessment methods should include clear criteria for excluding individuals presenting clinical features of developmental disabilities similar to FASD but caused by genetic or teratogenic factors other than alcohol (e.g., non-alcohol related brain injury, prenatal or childhood malnutrition, or other substance abuse exposures).
- In order to successfully exclude affected individuals with non-alcohol related developmental disorders, successful applications should contain a multidisciplinary research team. Applicants should strongly consider inclusion of expertise across a broad range of disciplines, such as (but not limited to): sampling statistics, dysmorphology, clinical genetics, anthropometrics, psychology, neuropsychology, special education, physical, occupational, speech and language pathology, and social work.
- Sampling approaches should aim to select samples comprising defined geographic units of the U.S. such as counties or cities/metropolitan areas. To the extent possible, applicants should consider selecting sampling units that are distributed across U.S. geographic regions to permit generalization to the regional level. Applicants must demonstrate that samples within distinct geographic units are representative of and generalizable to the geographic unit sampled; and the application must address ways to overcome differences in reporting rates and reliability (e.g., selected neighborhood- or community-level differences). Applicants should consider strategies for stratification according (but not limited) to risk categories, population demographics, or patterns of risk for maternal alcohol consumption. The research plan should address statistical adjustments (e.g., varying case weights) for population-based variation in case ascertainment (e.g., the likelihood of identifying cases in high- versus low-risk population segments) in order to ensure that overall prevalence estimates are representative of sampled geographic units. Designs proposing oversampling in areas of high risk (e.g., specific high-risk communities or referrals from genetic, developmental clinics) must include strategies for developing sampling weights and other statistical methods to account for variation in sources of referral in order to arrive at non-biased estimates of prevalence.
- Measures may require establishing norms for selected groups across a spectrum of risk. Data collection protocols should consider inclusion of measures on prenatal history (including history of alcohol consumption) among birth mothers, before, during and after birth of an FAS child, as well as current drinking quantity and frequency. In addition, to the extent possible, applicants may consider inclusion of measures on maternal nutrition, and demographic factors, such as nutritional status of maternal grandmothers.
- Active case ascertainment requires the development of standardized, culturally relevant, diagnostic case definitions and criteria for referral, establishment of referral networks, referral procedures, and age-appropriate examination. Assessment of children should include a physical examination for facial features and growth and central nervous system impairments, behavioral assessments, and evaluation of executive functioning using valid neuropsychological testing methods. These procedures will require that investigative teams possess the competency to validly and reliably determine physical indices of FASD in cultural groups. Research approaches must specifically address efforts to insure optimal cross-cultural validity and reliability of selected neuropsychological protocols based on published or pilot studies.
- Ultimately, in addition to demonstrating cultural competency, as necessary, projects should address procedures for appropriate referral of cases to follow-up care.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the Cooperative Agreement (U01) award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The estimated amount of funds available for support of 1-3 Collaboration on FASD (CoFASP) projects awarded as a result of this announcement is $2 million for fiscal year 2010. Future year amounts will depend on annual appropriations. Applicants may request a project period of up to five years. The direct costs budgeted for each cooperative agreement award may range from $500,000 to $1.4 million per year, depending on the number of final awards made.
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.
The U01 award will provide support for:
- Administrative costs for managing the effort such as salaries for key personnel, travel for key personnel equipment, and supplies to support an administrative structure
- Research costs for the conduct of collaborative research projects
- Recruitment costs for study participants and agency referrals
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible to apply:
Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Small Businesses
For-Profit Organizations (Other than Small Businesses)
State Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribally Designated Organizations
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Other(s):
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
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: GrantsInfo@nih.gov.
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 in item (box) 2 only of the face page of the application form and the YES box must be checked.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 22, 2009
Application Receipt Date: December 22, 2009
Peer Review Date: March-April 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
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 sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
Telephone: (301) 443-9737
FAX: (301) 443-6077
Email: bautista@mail.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the forms 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:
Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2089
Bethesda, MD 20892
Telephone: (301) 443-9737
FAX: (301) 443-6077
Email: bautista@mail.nih.gov
3.C. Application Processing
Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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 NIH Grants Policy Statement.
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 award if such costs: 1) are necessary to conduct the project, and 2) 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 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
Cooperative Agreement Terms: Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
Study Population: Due to the variability in clinical, cognitive, behavioral and psychosocial features prior to and after puberty, recruitment should be limited to children between the ages of 3 and 12 years of age. Applicants are free to propose a narrower age range for recruitment of study participants within the 3- to 12-year old limit.
Application and Performance Requirements: CoFASP project site applicants should have relevant experience in screening and identification of at-risk maternal drinking in addition to dysmorphology and neurodevelopmental assessment. In order to successfully exclude affected individuals with non-alcohol related developmental disorders, successful applications should contain a multidisciplinary research team. Research approaches for the CoFASP projects must specifically address efforts to insure optimal cross-cultural validity and reliability of selected neuropsychological protocols based on published or pilot studies. These procedures will require that investigative teams possess the competency to validly and reliably determine physical indices of FASD in cultural groups. Applicants are strongly encouraged to consider inclusion of the following expertise as part of the research team: demography, sampling statistics, dysmorphology, pediatrics, anthropometrics, psychology, neuropsychology, special education, physical, occupational, speech and/or language pathology, and/or social work/nurse/community outreach worker.
Applications should include a Data Analysis Coordination Component (DACC). NIAAA may select only one of the awardees to pursue this function. The study design should propose practical solutions for data management and analysis. The applicant must have demonstrated prior experience in coordination and statistical analysis of data from clinical and/or epidemiological studies, data monitoring and coordination, and maintaining quality assurance of data. (See Resource Sharing Plan(s) section below for additional DACC instructions.)
Awardees must agree to meet as a Steering Committee two times in the first year to establish standardization in protocols and one time per year thereafter. These 1-day meetings of the CoFASP Steering Committee will be held for the purpose of discussing progress on establishing standardization in protocols and implementation of plans for data synchronization and creation of a database that is accessible to the public within a year of study completion. The CoFASP Steering Committee also will meet via teleconference calls bi-monthly during Year 01 and quarterly thereafter.
Budget: Investigators should budget for travel to the Washington, DC area to attend two face to-face Steering Committee meetings in the first year and one meeting per year for the remainder of the project period.
There are a number of Special Requirements and Provisions with which each CoFASP Collaborative Structure must comply:
To facilitate the collaboration of teams with highest expertise in each of the domains of the research objectives, this RFA has been designed to include projects, which will work collaboratively as a team. The Collaboration on FAS Prevalence (CoFASP) is defined as the final group of awardees (Principal Investigators) funded through this RFA. This may include one or more Research Projects in their entirety as originally submitted and/or may include individual Research Project components chosen to add value to the overall effort. CoFASP members will form a Steering Committee to facilitate consensus on standardization of clinical criteria, study protocols and measures. Applications should include a Data Analysis Coordination Component (DACC). NIAAA may select only one of the awardees to pursue this function. CoFASP members will be expected to work in collaboration with each other, the CoFASP Steering Committee, the selected Data Analysis Coordination Component, and the NIAAA Project Scientist(s) to achieve the goals of the initiative. Collaboration on FAS Prevalence (CoFASP) Applicants must meet the Special Requirements noted for each of the individual components (see below).
For Collaboration on FAS Prevalence (CoFASP) Project Applicants:
- Demonstration of a documented link with the community(ies) targeted for assessment of FASD risk. Documentation of a reasonable likelihood of identifying individuals with characteristics of alcohol-related fetal effects and/or risk drinking for adverse pregnancy outcomes (see Fetal Alcohol Syndrome: Diagnosis, Epidemiology, Prevention, and Treatment, Institute of Medicine, National Academy Press, 1996) within the community(ies).
- A demonstrated willingness to work with the community (e.g., elected officials, school superintendants, school principals, etc.) to allow clinical studies to be performed and ensure that human subjects protection issues are addressed.
- CoFASP project site applicants may be a consortium of sites (that is, linked sites).
- CoFASP project site applicants should have experience in multi-site research investigations.
- CoFASP investigative teams must demonstrate appropriate sampling/biostatistical, data collection, and data management, expertise and capability.
- CoFASP project site applicants should have relevant experience in screening and identification of at-risk maternal drinking in addition to dysmorphology and neurodevelopmental assessment. Applicants are strongly encouraged to consider inclusion of the following expertise as part of the research team: demography, sampling statistics, dysmorphology, pediatrics, anthropometrics, psychology, neuropsychology, special education, physical, occupational, speech and/or language pathology, and/or social work/nurse/community outreach worker.
- The investigators should be prepared to meet as a Steering Committee two times in the first year to establish standardization in protocols and one time per year thereafter. The CoFASP Steering Committee also will meet via teleconference calls bi-monthly during Year 01 and quarterly thereafter.
- The investigators should be prepared to work collaboratively with the NIAAA, and the Data and Analysis Coordination Component (DACC; see below) to achieve the goals of this solicitation.
- Departmental and institutional commitments to collaborative research should be clearly documented by providing letters to the Principal Investigator that should accompany the application.
- The applicant must exhibit a preparedness to pursue capitation of particular operational costs of the protocol (see Budget Preparation).
For the Data Analysis Coordination Component of the Application:
- The applicant must have demonstrated prior experience in coordination and statistical analysis of data from clinical and/or epidemiological studies.
- The applicant must have experience in developing and maintaining a quality control system, and should demonstrate experience in maintaining quality assurance of data.
- The applicant must have experience in data monitoring and coordination.
- The study design should propose practical solutions for data management and analysis.
- The DACC must be prepared to cooperate with the CoFASP awardees and NIAAA in all data coordination and analysis functions.
- The DACC, in collaboration with the CoFASP Steering Committee, will develop and implement plans to create a database that is accessible to the public within a year of study completion.
Final Protocol Development
In order to develop a final FASD prevalence dataset and to ensure optimal data compatibility for analysis, the CoFASP Subcommittee and DACC will collaboratively establish consensus on consistent approaches for:
- Diagnostic surveillance, recruitment, referral and selection of individuals along the continuum of FASD severity, including, as necessary, determining a narrower age range for recruitment of study participants within the 3- to 12-year old limit.
- Classification systems including standardized case definitions and criteria for diagnosis of clinical and complementary neurological and neurocognitive features to establish reasonable prevalence of FAS, pFAS, and ARND.
- As necessary, refinement of research instruments used to determine maternal risk factors and clinical features of FAS, pFAS and ARND.
Research Plan Page Limitations
All applications and proposals for NIH funding must be self contained within specified page limitations: 25 page limit per CoFASP project and 12 page limit per DACC component.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe 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 of, and advance 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. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. 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 (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Data Collection and Sharing
The Data Analysis Coordination Component (DACC) will coordinate plans for data compatibility and merging, and address issues related to human subjects protection including confidentiality and community needs (e.g., cultural sensitivity), and data sharing with investigators outside of the awardees.
There will be central data management and analysis for this study. The Data Analysis Coordination Component, in collaboration with the CoFASP Steering Committee, will develop and implement plans to create a database that is accessible to the public within a year of study completion.
Because consensus on the final data elements will be established after award, the DACC study design should address a hypothetical situation for sharing data on FASD risk and clinical findings. The study design should propose practical solutions for data management and analysis. The study design may propose analytical and statistical procedures for combining and analyzing data sampled and collected at multiple levels. Although the outline of a model strategy is given above, applicants should develop and fully elaborate the key elements of the data analysis and coordination design.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute on Alcohol Abuse and Alcoholism and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
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. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
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.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. 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?
Approach. 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?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. 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?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.
Other Criteria for Review of Collaboration on FAS Prevalence (CoFASP) project Applications:
- Adequacy of documentation of the patient population as outlined in supplemental instructions.
- Adequacy of ability to implement clinical, biological, or epidemiological studies, based upon links to low and high-risk communities.
- Ability to address related biological measures of alcohol effect on the mothers and their children.
- Ability to address culturally sensitive neuropsychological and psychosocial measures on mothers and their children.
- Adequacy of existing collaborative arrangements with communities in which the studies will take place, or plans to develop such arrangements.
- Adequacy of plans for scientific and operational collaboration between the CoFASP and the DACC.
Criteria for Review of Data Analysis and Coordination Component (DACC) of Applications:
- Qualifications, Experience, and Commitment of Key Personnel: Scientific and administrative abilities of the Principal Investigator and other team members; experience of the Principal Investigator and other key personnel in statistical data management, quality control, study coordination, and administrative procedures.
- Protocols and Procedures: Quality of past performance and proposed plans for data coordination, analysis and monitoring.
- Facilities and Management: Evidence of satisfactory facilities and supporting environment, including space and equipment for work proposed (any new equipment requested under this award must be adequately justified); evidence of institutional support for participation in a long-term collaborative project.
Additional Review Criteria
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, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
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. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
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.
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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Selection Process
The following will be considered in making funding decisions:
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/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.
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. See Also Section IV.5. Funding Restrictions.
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 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
The Primary Rights and Responsibilities of the Awardees
Collaboration on FAS Prevalence (CoFASP) Projects
The applicant organization for the CoFASP should be able to conduct clinical, epidemiological, and physiological studies that address the association between alcohol consumption during pregnancy and its relation to risk for FAS, pFAS and ARND. Based on their relationships to variable-risk communities, the CoFASP project should be able to design and implement appropriate clinical, neurodevelopmental, biological, and epidemiological assessments. Because the objective is to be able to study the largest possible segment of high- and low-risk populations, the applicant organization should have either an existing collaborative arrangement or should be able to develop such partnerships, within a reasonable timeframe, with the communities in which the studies will take place. It is possible for an applicant organization to link with more than one community. In addition, each successful applicant will collaborate with all other awarded projects in developing policies for data collection, data collection tools and data management procedures, and guidelines for interim analyses to be shared and ultimately integrated through the Data Analysis and Coordination Component (DACC) with the overall research teams. Applications should describe steps the investigative team will take to collaboratively arrive at consensus with other teams on a standardized approach to sampling, screening and assessment protocols and diagnostic criteria.
All awardees will agree to accept the participatory and cooperative nature of the group process. All awardees are required to submit annual progress reports to NIAAA, as appropriate, and to provide study and site performance information as stipulated by NIAAA.
The Principal Investigator of each CoFASP Project will play an important role in the design of the CoFASP plan of action. Each Principal Investigator will have primary responsibility for work that establishes a community connection at their site and to gather preliminary information necessary to prepare their site for recruitment and clinical assessment. The awardees will retain custody of, and primary rights to their data developed under this award, subject to Government rights of access, consistent with current HHS, PHS, and NIH policies.
Each investigator will have the right to publish based on the work of their individual research programs, according to the publication policies developed by the CoFASP Steering Committee.
All CoFASP awardees will:
- Work cooperatively with other CoFASP Projects, the DACC and the CoFASP Steering Committee to develop standardized clinical criteria and study protocols.
- Carry out pilot studies developed by the CoFASP Steering Committee.
- Present research concepts, plans, progress, and results to the CoFASP Steering Committee.
- Publish and disseminate results of both independent and shared research. When joint protocols are completed, publish in collaboration with other involved sites.
- Collaborate with other CoFASP awardees and NIAAA.
- Obtain local institutional review board (IRB) approval of all study protocols implemented at U.S. sites and comply with both IRB and CoFASP Steering Committee policies and procedures.
- Attend and participate in all CoFASP Steering Committee meetings.
In addition, each CoFASP Project specifically will:
- Develop active community connections at their site to sustain the development and conduct of study protocols.
- Be responsible for conducting standardized diagnostic and research procedures on enrolled subjects.
In addition, the Data Analysis and Coordination Component specifically will:
- Be responsible for central data coordination, quality control, management, and analysis;
- Be responsible for contracting with consultants to the CoFASP Steering Committee on an as needed basis.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
2. A.2. NIH Responsibilities
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
NIAAA Responsibilities
NIAAA Project Scientist(s)
The NIH Project Scientist(s) will be staff from the NIAAA who will have substantial involvement above and beyond the normal program stewardship of the award. The Project Scientist is a partner within the research team representing the government's interest in the substantive work of the research team. The primary role of the Project Scientist(s) is to facilitate the work of the awardees and the Steering Committee.
He/she will:
- Assist in all functions of the CoFASP Steering Committee, including: reviewing and commenting on each stage of the program before subsequent stages are started; recommending the options of adding, modifying or terminating aspects of the program.
- Recommend consultants for appointment to the CoFASP Steering Committee on an as needed basis.
- Assist with accomplishing the objectives of the program.
- Assist in the analysis, interpretation, and reporting of findings in the scientific literature and other media to the community at large and the public policy community within the Federal government.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
NIAAA Project Officer
NIAAA will appoint a Project Officer, apart from the Project Scientist(s), who will:
- Have the option to withhold support to a participating institution if technical performance requirements, such as compliance with the protocol, are not met.
- Carry out continuous review of all activities to ensure objectives are being met..
2.A.3. Collaborative Responsibilities
CoFASP Steering Committee
The overall guidance and management of the research program will be provided by a Steering Committee. The Steering Committee (SC) will be assembled from among all CoFASP awardees. In the planning phase, the Steering Committee will provide a forum to share program activities regarding sample selection, inclusion/exclusion and diagnostic criteria, recruitment, assessment and data collection. The SC will consist of the Principal Investigators and Co-Principal Investigators of all awarded grants, and the NIH Project Scientist(s). Each awardee and NIAAA, will have one vote on the Steering Committee. The Steering Committee will be charged with the task of combining multiple perspectives and research agendas across sites into a coherent plan of action. Applicants should request funds to attend two meetings in the Washington, D.C. area for the purpose of protocol development and information sharing in the first year.
The Steering Committee will:
- Plan the design and implementation of the CoFASP plan of action.
- Participate in decision-making regarding gathering preliminary information at the participating sites and operationalizing key measures relevant to establishing case definitions at participating sites and a representative sample of the selected U.S. geographic areas.
- Formulate publication policy and appoint a Publication Subcommittee, as judged necessary by the CoFASP Steering Committee. Publish results, conclusions, and interpretations of the cooperative planning activity. Due publication credit will be given to all work done cooperatively.
- Agree to accept the coordinating role of the DACC and the cooperative nature of the group process.
Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
Data Analysis and Coordination Component (DACC)
Each applicant will provide a representative to the serve on the Data Analysis and Coordination Subcommittee.
One applicant also will be selected to serve as the Data Analysis Coordination Component (DACC). The selected DACC applicant will collaborate with all CoFASP projects in developing policies for data collection, data collection tools and data management procedures, and guidelines for interim analyses. The DACC also will conduct data analyses, share them with the investigators, and integrate them with the overall research teams. There will be a single DACC component selected.
All awardees will work together to develop a comprehensive approach to arrive at a reasonable estimate of FASD prevalence. Year 01 will be devoted to standardization of sampling, screening and assessment protocols; and Years 02-05 to data collection and data analysis.
Data Safety and Monitoring Committee
A Data Safety and Monitoring Committee (DSMC) will be established by NIAAA, and will advise the Steering Committee on research design issues, data quality and analysis, and ethical and human subject issues.
2.A.4. Dispute Resolution Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
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. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Marcia S. Scott, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane
Room 2083, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 402-6328
FAX: 301-443-8614
Email: mscott@mail.nih.gov
2. Peer Review Contacts:
Ranga V Srinivas, Ph.D.
Chief, Extramural Project Review Branch
Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 2085
Bethesda, MD 20892-9304
Telephone: (301) 451 2067
FAX: (301) 443-6077
Email: srinivar@mail.nih.gov
3. Financial or Grants Management Contacts:
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3023
Bethesda, MD 20892
Telephone: (301) 443-4704
FAX: (301) 443-6077
Email: jfox@mail.nih.gov
Section VIII. Other Information
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.
Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.
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 public 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.
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-09-116.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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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. 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.
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NIH Funding Opportunities and Notices
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