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: Alcohol Use Disorders: Treatment, Services Research, and Recovery (R03)
Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PA-07-215.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-10-101
Catalog of Federal Domestic Assistance Number(s)
93.273
Key Dates
Release/Posted
Date: March 17, 2010
Opening Date: May 16, 2010 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 30, 2013 per issuance of PA-13-162 (Originally: May 8, 2013)
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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically 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
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
1.
Research Objectives
NIAAA Research
Objectives
Purpose
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), invites applications to support research on various topics in the field of alcohol treatment and services for alcohol use disorders. The scope of interest is wide-ranging. It includes pharmacologic and behavioral treatments; recovery strategies; interventions for alcohol-induced tissue damage; and the organizational, financial, management, and environmental factors that facilitate or inhibit the delivery of evidence-based services for alcohol use disorders.
Research objectives of this Funding Opportunity Announcement (FOA) include, but are not limited to, research within the following four broad research domains: (1) medications development for the treatment of alcohol use disorders and alcohol-induced tissue damage; (2) behavioral therapies and mechanisms of behavioral change; (3) health services research; and (4) recovery research. Cutting across these domains, NIAAA encourages treatment and health services-related studies on a number of special emphasis populations and topics including: (a) psychiatric/substance abuse/medical comorbidity, (b) adolescents, (c) fetal alcohol spectrum disorders, (d) health disparities/special populations, and (e) use of novel methods and technologies.
Broad Research Domains
1. Medications Development for the Treatment of Alcohol Use Disorders and Alcohol-Induced Tissue Damage
Efforts to develop medications for alcohol use disorders have expanded rapidly in recent years. Three agents disulfiram, naltrexone, and acamprosate are now approved for use in the United States and many other countries. Recently, topiramate also has been shown to be effective in treating alcohol-dependent patients. However, because of the heterogeneous nature of alcohol use disorders, many patients have limited or no response to these medications. Therefore, developing new medications and evaluating their use in combination with other medications and with behavioral therapies are important steps toward improving treatment outcomes for all individuals with alcohol use disorders. A variety of new compounds are being investigated in clinical trials, including gabapentin, ondasentron, levetiracetam, quetiapine, baclofen, zonisamide, pregabalin, prazosin, and kudzu.
Alcohol-seeking behavior and drinking are influenced by multiple neurotransmitters, neuromodulators, hormones, and intracellular networks. Thus, there are many potential targets for drug development. Research to date has focused on opioid, serotonin, dopamine, glutamate, and gamma-aminobutyric acid (GABA); cannabinoids, corticotrophin-releasing factor (CRF), nicotine, adenosine, and neuropeptide systems (e.g., neuropeptide Y); signal transduction pathways (e.g., protein kinase A and protein kinase C); and gene transcription factors (e.g., delta fos B and cAMP response element-binding protein [CREB]). Efforts to define different elements of addiction include reward and motivation, negative affect, cue conditioning/craving/wanting, disinhibition/impulsivity/compulsivity/habituation, memory, executive function/cognitive function, and interoception/self-awareness. It is important to identify the neurocircuits underlying these elements and investigate their interactions and integration. The ultimate goal is to target specific sites in these neurocircuits with compounds that modulate them.
Advances also have been made in understanding the mechanisms of alcohol-induced tissue damage. Oxidative stress and inflammation play a major role in the pathogenesis of alcohol-associated injuries of various organs, including the liver, pancreas, heart, lungs, brain, and peripheral nervous system. Potential therapeutic agents include those that attenuate the actions of pro-inflammatory cytokines (e.g., the tumor necrosis factor (TNF)-a), and antioxidants (e.g., S-adenosyl-L-methionine (SAMe), glutathione, and vitamins A and E). Other potential new treatments of alcoholic liver disease include cannabinoid CB1 antagonists and CB2 agonists, metformin (an insulin-sensitizing agent), antifibrotic agents, prebiotics, probiotics, and zinc.
Finally, to improve safety, efficacy, and efficiency of medications, it is important to identify and characterize patients who respond positively to the medications and those who experience adverse events. Progress in personalized medicine includes evaluating polymorphisms of the mu opioid gene, such as A118G, which appears to modify responses to naltrexone, and the L versus’s allele on the serotonin transporter gene, which may influence responses to ondansetron. These and similar discoveries may someday enable clinicians to tailor treatment to the biological profile of individual patients, and thereby to achieve better treatment outcomes.
Specific areas of research include, but are not limited to, the following examples:
2. Behavioral Therapies and Mechanisms of Behavioral Change
Over the past 20 years, research on the behavioral treatment of alcohol use disorders has progressed substantially. Behavioral interventions that have demonstrated efficacy include motivational enhancement therapy, cognitive behavioral therapy, brief interventions, behavioral couples therapy, twelve-step facilitation therapy, and the community reinforcement approach. Interestingly, several studies have suggested that these behavioral therapies appear to have similar efficacies when compared with standard treatments. Currently, very little information is available on how and why these behavioral treatments are effective. Understanding the underlying mechanisms of action of an intervention involves identifying the active processes and their specific effects on diverse patient groups, including racial/ethnic minority, rural, and low-income populations. Because many individuals with alcohol use disorders change their drinking behavior without help from addiction treatment providers or self-help groups, it is as vital to understand how and why people change their drinking outside of specialized treatment settings as it is within them.
Toward this goal of understanding the mechanisms of behavioral change, new transdisciplinary, multilevel, and collaborative approaches are needed that integrate multiple domains of knowledge , including cognitive, affective, and social neuroscience; neuroimaging; genomics; proteomics and metabolomics; social psychology; economics; and computational science. Progress in this complex and challenging area of treatment research will represent a major milestone for the alcohol treatment community.
Specific areas of research include, but are not limited to, the following examples:
Behavioral Therapies
3. Health Services Research
Based on data from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC), a national survey of the non-institutionalized population in the United States, it has become clear that the U.S. population is characterized by a continuum of drinking types, ranging from low-risk drinkers to high-risk and chronic, relapsing alcohol-dependent drinkers. Approximately 65 percent (144 million) of adult Americans drank alcohol at various times during the past year. Of those, 59 million Americans exceeded high-risk drinking limits and 18 million of these had a diagnosis of alcohol use disorders. Only an estimated 13 percent of people identified as alcohol dependent had ever received specialty alcohol treatment. Epidemiological data such as these demonstrate the need to broaden and enhance the continuum of health care for alcohol-related problems and disorders. The menu of alcohol services, and the organizations that deliver them, needs to be diversified, enhanced, extended, and provided in a range of settings that meet the needs of underserved groups needing interventions tailored to their specific alcohol-related issues. Treatments that are attractive, affordable, accessible, and effective for different types of drinkers need to be identified, tested, and adopted. For example, stepped care would be appropriate for reducing binge drinking in a college population, whereas collaborative care models that integrate treatments for addiction and co-occurring conditions in primary care would be more appropriate for alcohol-dependent individuals with co-occurring medical and/or psychiatric conditions.
These research challenges provide many exciting opportunities for advancing services research. Barriers to treatment must be identified and effective strategies developed to offset these barriers in a variety of settings, including specialty addiction settings, general medical settings (e.g., primary care and mental health care), and settings outside the medical sector (e.g., the workplace and criminal justice, social welfare, and school systems). At a minimum, services should include screening, brief intervention, and referral, if needed. New approaches to establishing more effective evidence-based practices include adaptive models personalized to subtypes of drinkers, long-term management of chronic alcohol dependence, concurrent management of multiple comorbidities, and the patient-centered medical home model. These and other innovative health care approaches need to be adapted and tested for application in real-world practice settings.
Comparative effectiveness studies are encouraged as a tool for identifying the most effective and cost-effective evidence-based interventions. For example, comparing two or more pharmacological and/or behavioral therapies in the same study can be insightful in determining the better choice in certain populations and settings. In the end, this will make the treatment process more efficient and less costly. Also needed is treatment outcome research that identifies, evaluates, and tests long-term outcome measures in clinical effectiveness trials. This research should focus on how best to measure outcomes including drinking outcomes, quality of life, and alcohol-related consequences as well as measures of treatment quality and process from a multidisciplinary perspective. Applicants are also encouraged to discover and derive robust outcome measures from archival, policy, and other secondary data.
A recent review of the NIAAA health services research portfolio revealed a decade of significant advances in critical research areas while at the same time highlighting several important research gaps. As a result of the review and current trends in research on alcohol-related treatment, NIAAA encourages research from among the following five priority areas: implementation science, disease management, access to care, health disparities, and health economics.
Specific areas of research include, but are not limited to, the following examples:
Implementation Science
Disease Management
Access to Care
Health Disparities.
Health Economics.
4. Recovery Research
The term recovery refers to the disappearance of the signs and symptoms of alcohol use disorder accompanied by a state of well-being following an episode of alcohol use disorder. Research indicates that there is a substantial level of recovery from alcohol dependence. Twenty years after the onset of alcohol dependence, about three-fourths of individuals are no longer dependent. Moreover, more than half of those individuals drink at low-risk levels without symptoms of alcohol dependence. Approximately 75 percent of persons who recover from alcohol dependence do so without seeking any kind of help, including specialty alcohol programs and Alcoholics Anonymous (AA). Recovery outside of treatment is more likely in those with fewer symptoms of dependence and fewer comorbid psychiatric disorders. Notwithstanding the high rates of natural recovery from alcohol dependence, in most cases, it is a chronic relapsing illness with serious, often devastating psychological, medical, and social consequences for affected individuals and families over time. In many cases, whether or not affected individuals ever seek treatment, the adverse consequences of alcoholism extend well beyond the period of dependent drinking and may even span multiple generations.
What causes change in drinking behavior that leads to recovery? Because most individuals recover without treatment, it is important to study natural recovery by evaluating mediators and moderators of drinking behavior in subtypes of alcohol users. Biological, psychological, and contextual factors should be considered, including, but not limited to, cultural and socioeconomic milieu, lifestyle, endophenotypes, cognitive functioning, and sleep and other medical disorders.
Specific areas of research include, but are not limited to, the following examples:
Special-Emphasis Populations and Topics
A) Treatment for Psychiatric/Substance Abuse/Medical Comorbidity
Alcohol-dependent individuals have exceptionally high rates of co-occurring psychiatric disorders. According to NESARC data, for example, alcohol-dependent individuals, as compared with non-alcohol-dependent individuals, are about four times more likely to have a mood disorder, three times more likely to have an anxiety disorder, seven times more likely to have an antisocial personality disorder, six times more likely to be nicotine dependent, and over thirty times more likely to be dependent on other drugs. Approximately half of individuals with schizophrenia suffer from an alcohol and/or substance use disorder. Similarly, 46 percent of those with bipolar disorder also have an alcohol use disorder. Moreover, in alcohol treatment populations, risk and prevalence rates of co-occurring psychiatric and substance use disorders are often much higher than those observed in the general population. For example, the rate of tobacco use among alcohol-dependent individuals seeking alcohol treatment is approximately 80 percent compared with 26 percent among non-dependent individuals in the general population. In addition, a significant number of alcohol-dependent individuals exhibit two or more comorbidities. Although individuals with comorbid alcohol dependence and psychiatric disorders are most likely to seek treatment, they have a poorer treatment prognosis, a higher risk for treatment dropout, less support for sobriety from family and the work environment, and a higher risk for suicide.
In addition to psychiatric and substance abuse comorbidities, a significant number of alcohol-dependent patients have comorbid medical disorders. For example, in the United States, approximately 20 percent of patients in treatment for HIV have been diagnosed with current co-occurring alcohol use disorders. Rates are even higher for a diagnosis of lifetime alcohol use disorders, with estimates of 26 to 60 percent in people living with HIV/AIDS as compared with 14 to 24 percent in the general population. Recent studies suggest that problematic drinking worsens the clinical course of HIV/AIDS. In addition, over 4 million Americans are living with hepatitis C infection. High-risk drinking also has been associated with hepatitis C, and like HIV/AIDS, drinking may accelerate the progression of this disease. Often HIV/AIDS and hepatitis C are co-occurring conditions that complicate the long-term treatment of this population.
Research on effective strategies to treat alcohol comorbidity is still in its early stages. The appropriate treatment strategy depends on the type and severity of the comorbidity as well as population subtypes within a comorbid population.
Specific areas of research include, but are not limited to, the following examples:
B) Treatment for Adolescents
Alcohol use remains a pervasive problem for adolescents in the United States, resulting in adverse and sometimes serious consequences. Approximately 12 percent of 12-year-olds, 30 percent of 14-year-olds, 60 percent of 16-year-olds, and over 70 percent of 18-year-olds consumed alcohol. Across all adolescents groups, there are approximately 7.2 million binge drinkers, 2.3 million heavy drinkers, and 1.5 million with alcohol use disorders. Most adolescents in treatment for alcohol and/or drug problems relapse after 6 months of conventional treatment. Researchers have begun to test a variety of behavioral therapies, including cognitive behavioral therapy, family-based interventions, multisystemic therapy, and motivational enhancement therapy. So far, only a few medications studies have been conducted in this population.
Research on adolescent treatment is still in early stages. To design more effective treatments, it is important to develop a multidisciplinary approach that integrates biological, psychological, and social factors across different stages of development. Furthermore, future research needs to focus on subgroups of adolescents, including those with a range of alcohol severities, different comorbidities, racial ethnic groups, and cultural differences. Studies also should evaluate different settings, including rural, community, schools, unemployment programs, and the juvenile justice system.
Specific areas of research include, but are not limited to, the following examples:
C) Treatment for Fetal Alcohol Spectrum Disorders (FASD)
The FASD umbrella encompasses an array of health consequences of prenatal alcohol exposure including birth defects and neurological abnormalities in children whose mothers consumed alcohol during pregnancy. Fetal alcohol syndrome (FAS), a condition at the most severe end of the FASD spectrum, is characterized by facial dysmorphology, growth retardation, and brain damage, resulting in cognitive and behavioral impairments. Today, FAS remains the leading known preventable cause of mental retardation and other neurobehavioral disabilities. It is estimated that 1 to 2 per 1,000 live births in the United States have FAS, and the incidence of all FASD is on the order of 1 per 100 live births. A host of secondary impairments stem from the behavioral deficits of those with FASD. Their characteristic poor judgment, faulty social skills, and failure to learn from experience commonly lead to complications, such as substance use, arrest/incarceration, failure in school, economic problems, unemployment, and psychiatric comorbidities. Sadly, FASD is frequently not recognized or treated. A major research effort is needed to improve the identification and treatment of children and adults with FASD.
Specific areas of research include, but are not limited to, the following examples:
D) Treatment for Health Disparities/Special Populations
NIAAA seeks to elucidate the importance of alcohol treatment, service delivery, and recovery research among racial/ethnic groups and rural and low-income populations. In addition to these populations already experiencing health disparities in the United States, the recent immigration of large numbers of people from diverse cultures requires examination of existing treatment methods for relevance, efficacy, and effectiveness across all levels of adaptation/acculturation. Other subgroups with specific needs that often are understudied include: youths ages 18 to 25 not attending college; youths in the juvenile justice system and/or foster care; adults over the age of 65; youths and adults living in rural or other areas where treatment access is difficult; women residing in shelters for victims of domestic violence; the unemployed; minorities (e.g., Native Americans, African Americans, Hispanic Americans, and Asian American/Pacific Islanders); and adolescents and adults with developmental disabilities due to prenatal alcohol exposure. Of particular interest is comparative effectiveness research in special populations.
Military personnel, veterans, and their families are also an NIAAA priority. In particular, NIAAA seeks research on the development of effective alcohol screening instruments and treatments for this population. Comparative effectiveness research to compare the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor harmful drinking and alcohol use disorders is needed in military settings and in veterans and military family environments. Treatment research should address a variety of comorbid conditions commonly found in this population, including posttraumatic stress disorder (PTSD), traumatic brain injury, depression, anxiety, sleep disturbances, and chronic pain. Of particular interest is research related to individuals who are serving or have served in Operation Enduring Freedom (Afghanistan) and Operation Iraqi Freedom (Iraq). In addition, research related to all phases of the deployment cycle (e.g., pre-deployment, deployment, reintegration, and separation) for all branches of the military and veterans is of interest. National Guard and Reserve service members, Individual Augmentees, and families have been identified as special needs populations that are of particular interest due to limitations in support related to not being attached to a military installation.
Specific areas of research include, but are not limited to, the following examples:
E) Use of Novel Methods and Technologies
Within the last decade, a number of novel methods and technologies have been developed to speed the course of alcohol treatment and related research. For instance, the widespread availability of the Internet, wireless technology, and computers has made possible a number of technological advances that capture important real-time information from patients in the field; synthesize, simulate, and statistically model large quantities of data in efficient and clinically meaningful ways; and deliver interactive computerized versions of promising behavioral interventions.
With the tremendous promise potentially afforded by these tools, research and development is continually evolving. More research is needed to further develop, refine, validate, and creatively implement these novel methods within alcohol clinical trials and treatment paradigms.
Specific areas of research include, but are not limited to, the following examples:
Technological Methods
Statistical Methods
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This FOA will use the Small Research Grant R03 award mechanism. 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 see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2.
Funds Available
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 NIH Institutes and Centers (ICs)
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.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility
Information
1.
Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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 (i.e., 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 and 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 electronic Research Administration (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 the multiple PD/PI option, 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 that each application is scientifically distinct. (NIH announcements should include this sentence unless there are specific deviations from this rule.)
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and renewal applications are permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. The R03 is not renewable.
Small grant support may not be used for thesis or dissertation research.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
Grants.gov Customer
Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
2) Organizational/Institutional Registration in the eRA Commons
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the Attachment files may be useable for more than one FOA.
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
Prepare all applications using the SF424
(R&R) application forms for this FOA through Grants.gov/Apply and in
accordance with the SF424 (R&R) Application Guide
(http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other
Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398
Modular Budget or Research
& Related Budget, as appropriate (See
Section IV.6. regarding appropriate required budget component.)
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
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:
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 (U.S.) or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered on the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section and the 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for
details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: May
16, 2010 (Earliest date an
application may be submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the NIH
To
submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to
NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.
3.C. Application Processing
3.C.1
Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons https://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
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.
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
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R03 applications:
Budget Component
U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
R03 applications will use the modular budget and non-modular budget format (Foreign organizations) and Just-in-Time information concepts, with direct costs requested in up to two $25,000 modules, or $50,000 per year, for up to two years (i.e., a maximum of $100,000 over two years in four modules of $25,000 each).
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
R03 Appendix materials may include ONLY pre-printed questionnaires or surveys. No publications or figures are allowed in the Appendix.
Do not use the Appendix to circumvent the page limitations. An application that does not observe these limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
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 submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the initial merit 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.
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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?
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Applications from Foreign Organizations. As applicable for the FOA or submitted application, 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.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. 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).
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.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications submitted in response to this FOA. 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 the Summary Statement (written critique) via the NIH 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 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 NoA. For these terms of
award, see the NIH Grants Policy Statement Part
II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of
NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants,
Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing 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.
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:
Angela Martinelli, Ph.D.
Division of Treatment and
Recovery Research
National Institute on
Alcohol Abuse and Alcoholism
5635
Fishers Lane, Room 2038
Bethesda, MD 20892-9304
{For express mail, use Rockville, MD 20852-1705]
Phone: (301) 451-8507
FAX: (301) 443-8774
Email: [email protected]
2. Peer Review Contacts:
Not Applicable
3. Financial or Grants Management Contacts:
Judy Fox
Chief, Grants Management
Branch
Office of Extramural
Activities
National Institute on
Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room
3023
Bethesda, MD 20892-9304
[For express mail, use Rockville, MD 20852-1705]
Phone: (301) 443-4704
Fax (301) 443-3891
Email: [email protected]
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 (45 CFR 46) 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 institutional review board (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/
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. Beginning October 1, 2004,
all investigators submitting an NIH application or contract proposal 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.
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.
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
SF424 (R&R) application; 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, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final,
peer-reviewed manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS
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) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 Part 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 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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