and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov/)
Components
of Participating Organizations
National
Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Nursing Research
(NINR), (http://www.ninr.nih.gov/)
Title: HIV
Treatment Adherence Research (R21)
Announcement Type
This
is a reissue of PA-01-073, which was
previously released March 20, 2001.
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 weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-340
Catalog
of Federal Domestic Assistance Number(s)
93.242,
93.279, 93.361
Key Dates
Release/Posted Date: March 27, 2007
Opening Date: April 2, 2007 (Earliest date an application may be submitted
to Grants.gov)
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).
AIDS Application Submission/Receipt 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
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: January 8, 2010
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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
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
PURPOSE
This funding opportunity announcement (FOA) calls for research to advance the scientific understanding of HIV treatment adherence and to enhance and expand available intervention strategies to promote, improve, and sustain adherence. The overarching emphasis is on the development of innovative behavioral and structural adherence interventions that could be rapidly translated into clinical practice, community venues, and public health policy within domestic and international settings. Any descriptive studies should therefore be undertaken with the aim of informing the mechanisms of adherence interventions. Interventions may target patient adherence to antiretroviral medications or other aspects of HIV treatment that can be shown to affect patient outcomes and public health (e.g., linkage to primary care, medical appointment attendance, and service utilization). Investigators are encouraged to consider incorporation of clinical outcomes (e.g., viral load, CD4 T-cell count, drug resistance) into intervention trials when feasible and scientifically appropriate. Studies are also needed that will advance knowledge of effective approaches for promoting the dissemination, adoption, and sound implementation of tested adherence interventions. A well-articulated and empirically based conceptual framework is essential for all applications solicited under this announcement. Approaches based on basic behavioral and social scientific principles such as cognition, emotion, decision-making, motivation, social interaction, structural factors, and cultural context are invited. Proposals for interdisciplinary and community-collaborative research addressing HIV treatment adherence are particularly encouraged.
The R21 mechanism is specifically intended to encourage new exploratory and developmental research projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm.
BACKGROUND
The efficacy of combination antiretroviral therapies (ART) for the treatment of HIV disease has been well documented. ART can inhibit viral replication and reduce viral load to a point where viral particles are undetectable in the blood plasma of infected individuals. Sustained suppression of HIV replication and associated increases in CD4 T-cell count are strongly associated with improved patient outcomes. The efficacy of ART has produced dramatic declines in HIV/AIDS-related mortality in nations where ART is widely available.
Optimal clinical benefits associated with ART, however, demand rigorous adherence to medication dosing schedules and other aspects of treatment. Among many factors that can influence treatment success or failure, research has identified high adherence to ART regimens as the most important predictor of viral suppression, improved CD4+ T-cell count, delayed progression to AIDS, and patient survival. Although more potent medication regimens can allow for effective viral suppression at moderate levels of adherence, improving adherence to any degree can only increase the likelihood of suppressing the virus and postponing disease progression. Striving for the highest possible level of adherence therefore remains essential for optimizing HIV treatment outcomes.
The importance of treatment adherence for patient health is complemented by the importance of adherence for the public health. Partial or poor ART adherence can lead to the resumption of rapid viral replication and the development of mutant viral strains that are resistant to available antiretroviral drugs. The development and transmission of these drug-resistant strains of HIV can limit the treatment options available to newly-infected individuals. Drug-resistant HIV can additionally hamper the wide scale provision of treatment within resource-poor nations by compromising the use of affordable first-line therapies.
Despite the critical need for strong HIV treatment adherence, research indicates that many patients have difficulty realizing this goal. A meta-analysis of 59 studies conducted in North America and Africa reported that only 55% of North American patients demonstrated high levels of ART adherence (Mills et al., 2006). The percentage of African patients who achieved high adherence was more favorable (77%), but this proportion could decline over time as patients initiating therapy encounter the challenges of maintaining long-term adherence, and as treatment availability in these nations expands beyond those with early access to ART.
The understanding and enhancement of HIV treatment adherence within domestic and international settings therefore represents a vital goal for individuals receiving treatment, for those providing treatment, for health officials responsible for making treatment available, and for the public health at-large. Scientists and practitioners have made significant gains in assessing, understanding, and promoting adherence in recent years, but critical gaps remain in our knowledge and abilities for advancing HIV treatment adherence. Research is urgently needed to address these gaps and other longstanding challenges facing the field in order to strengthen and sustain approaches for maintaining high treatment adherence among HIV-seropositive patients.
RESEARCH SCOPE
This funding opportunity announcement (FOA) calls for a broad range of research that will help patients achieve and maintain close adherence to ART and other important aspects of medical care. A set of key challenges and gaps within the existing scientific literature are discussed below. This list of priority areas is neither comprehensive nor restrictive; it is offered to stimulate critical thinking and innovative approaches on HIV treatment adherence.
Formative Research and Theory Development
Empirical studies and theory development have elaborated important determinants of adherence to ART, particularly within Western clinic populations. The specific factors associated with adherence vary across patients, contexts, and time, but some of the most commonly reported factors include regimen complexity, side effects, patient motivation, self-efficacy, depression, substance abuse, and forms of social support. These findings, when combined with prior theory and research on other chronic disease conditions, have informed good working models for understanding and enhancing adherence to ART.
The conduct of formative research and the articulation of theoretical models are critical for designing effective adherence interventions. The preponderance of this scholarship to date, however, has focused on individual-level predictors of patient adherence (e.g., psychosocial factors, personality traits, behavioral correlates, and treatment characteristics). Comparatively fewer studies have systematically investigated various provider, system, and contextual-level variables, despite evidence that these factors can affect access to treatment and adherence to ART. For example, emerging research within multiple resource-limited countries has underscored the role of structural barriers to adherence, including treatment costs, food insecurity, and interruptions in drug stocks and prescription refills. To better inform future adherence interventions, more research will be needed to understand these and other structural determinants of adherence in both domestic and international settings. Research relevant to this point may include, but is not limited to, the following:
Novel Adherence Interventions
Research to date has generated a growing set of interventions with demonstrated efficacy in improving ART adherence. The first meta-analyses of this adherence intervention research have now been conducted, and their results are generally favorable. For example, a meta-analysis of 19 randomized controlled trials of ART adherence interventions found that participants who received an intervention were 1.5 times as likely to report 95% adherence and 1.25 times as likely to achieve an undetectable viral load than those in comparison conditions (Simoni, Pearson, Pantalone, Marks, & Crepaz, 2006).
Further research is necessary to expand the available interventions for HIV treatment adherence and enhance their efficacy. Documented intervention effects to date have generally been modest, and research trials incorporating extended follow-up periods often show that observed intervention effects decline over time. An important goal for new adherence research is therefore to identify and promote innovative methods for the long-term maintenance of patient adherence. In addition, the range of efficacious and non-efficacious adherence interventions remains so wide that it is not yet entirely clear what mechanisms are responsible for the observed successes or failures. Future intervention studies should therefore be powered to determine mediators of intervention efficacy, and could be designed to help evaluate reasons why certain interventions work and others do not work.
Developing effective interventions with sustained impact will require innovative approaches for promoting HIV treatment adherence. These studies include, but are not limited to, the following:
The National Institute on Drug Abuse supports Stage I, II, and III research on the development and testing behavioral interventions for drug abusers in treatment, including HIV medication adherence interventions. For information on the Stages of intervention development for individuals with drug use disorders, please see http://grants.nih.gov/grants/guide/pa-files/PA-06-486.html, http://grants.nih.gov/grants/guide/pa-files/PA-06-487.html, http://grants.nih.gov/grants/guide/pa-files/PA-06-488.html.
Research areas of interest include, but are not limited to:
The National Institute on Drug Abuse Clinical Trials Network (CTN) offers an ideal clinical research platform for multicenter, multidisciplinary national studies on HIV treatment adherence in the drug abuse population. The following types of studies are encouraged:
Broadening the Outcomes Targeted by HIV Adherence Interventions
Existing HIV treatment adherence research has primarily targeted patient adherence to daily ART dosage requirements as assessed through a variety of methods. Aspects of treatment adherence other than daily medication taking behavior, however, remain comparatively unstudied and may offer potentially important contributions to patient care and clinical outcomes.
For example, additional aspects of ART regimens may merit consideration. One concerns ART initiation. Indications of continued racial and ethnic disparities in ART initiation among eligible patients will require additional research to understand how both treatment providers and patients make decisions about when to start therapy. Further empirical research on effective approaches for preparing patients to initiate ART treatment may also be useful. A second consideration is inopportune ART treatment discontinuations or interruptions. Notable proportions of patients who initiate ART discontinue their treatment within one to two years due to side effects, psychosocial issues, or virologic failure. These discontinuations have been associated with deleterious clinical outcomes, particularly in patients with limited immune reconstitution. Interventions expressly designed to prevent the outcome of inopportune treatment discontinuations in vulnerable patients could therefore be helpful. A final example relates to ART drug stocks, distribution, and refills. Under a structural approach, interventions could potentially assist medication adherence by stabilizing available drug stocks in resource-limited settings and facilitating the timely provision of prescription refills.
Research on HIV treatment adherence should additionally broaden beyond aspects of medication-taking. A broad, multidimensional understanding of HIV treatment adherence argues for addressing important aspects of patient care other than ART. Many patients never initiate care after testing HIV seropositive, and those who enroll in HIV treatment often do not attend enough medical appointments to benefit. In addition, many HIV+ patients have unmet needs for services such as housing, public assistance, and psychiatric and substance abuse treatment, and these unmet needs have been associated with decreased likelihood of ART use and poor ART adherence. To complement the ongoing research on adherence to ART medications, innovative interventions to increase consistent utilization of HIV care and social services are needed.
Research designed to broaden the outcomes targeted by HIV adherence interventions may therefore encompass, but is not limited to, the following:
Research in International Settings and with Underserved Populations
After the first decade of HAART, the published randomized controlled trials of adherence interventions have been conducted in North America and Europe. Outside of these regions, ART rollout is occurring rapidly in many countries. There is an urgent need for further research to understand the mechanisms that shape treatment adherence in these settings. Studies that will develop and test sustainable, culturally-appropriate interventions within resource-limited settings are also critically important.
A related population of global concern is children and adolescents. Sizable populations of HIV-infected children and adolescents exist in many nations. Some of the first descriptions of adherence rates for children in resource-constrained settings suggest lower rates than has been observed for adults, suggesting that special efforts may be required to advance and maintain support for adherence in these groups. Within the U.S., the number of HIV diagnoses among youth has also been increasing over the past few years, particularly among teenage girls and minorities. Both domestically and internationally, developmental considerations and family dynamics are important factors that require closer examination as to their impact on ART adherence among children and adolescents.
Other specific groups could additionally benefit from effective adherence interventions. Innovative, effective interventions are needed to improve ART adherence and prevent drug treatment relapse among the severely mentally ill and both injecting and non-injecting drug users. Although persons with severe mental illness are at enhanced risk for HIV, relatively little is known about their ART adherence and such issues as interactions of ART medications with psychoactive medications. Among drug abusers, there are few data on potential risks of toxicity and drug interactions between illicit drugs and HIV therapies, as well as pharmacotherapies for substance abuse, mental health conditions, and other diseases. These interactions may influence adherence, reduce the effectiveness of HIV treatment, and cause morbidity.
Studies addressing HIV treatment adherence within international settings and with underserved populations may then include, but are not restricted to, the following:
Promoting the Translation of Efficacious Interventions into Practice
Translational research in the adherence domain could benefit from additional work. Relatively little is known about contextual issues that affect intervention adoption, adaptation, and effectiveness of adherence interventions that were tested in randomized clinical trials (RCTs). Organizational leadership, clinic personnel turnover, and organizational size are factors that may influence implementation of new interventions. An additional consideration for research is that, whether intentional or unintentional, interventions will be modified in real-world settings. The effectiveness of HIV treatment adherence interventions implemented outside of rigorous RCTs may rely on how well fidelity to the intervention protocols can be maintained in the face of competing clinic demands. How best to measure success in translational research also needs examination; success could be defined as whether or not an intervention is adopted and sustained for a specified time period, and/or success could be measured through direct assessment of patient outcomes.
Translational research in the adherence domain may include, but is not limited to, the following examples:
Understanding the Intersections of HIV Treatment Adherence and Prevention
Recent years have brought increasing recognition of prevention for positives as a key component of comprehensive HIV prevention in the U.S. and elsewhere. This necessarily involves behavioral interventions and risk reduction counseling, but treatment adherence may also have a role to play. Adherence to ART treatment can yield reductions in viral load that may help to reduce infectivity, which suggests that efforts to sustain medication adherence could potentially assist the goal of HIV prevention. At the same time, some studies suggest that patients with poor ART adherence are also likely to engage in unprotected sex. This confluence suggests that simultaneous attention to both issues may help to prevent transmission of drug resistant viral strains to uninfected individuals. Future initiatives are indicated to integrate risk reduction counseling and adherence interventions into the provision of primary care and services for HIV+ individuals. In addition, emerging biomedical prevention strategies targeted to HIV seronegative individuals, such as post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP), present new domains where understanding and promoting medication adherence may be critical for preventing new HIV infections.
Studies are needed that will further investigate important intersections between HIV treatment adherence and HIV prevention, including but not only:
The areas identified above represent only a small set of priority areas to help advance HIV treatment research. Studies are needed to address these issues as well as a wide variety of other domains to further our scientific understanding of efforts to foster, improve, and sustain HIV treatment adherence.
References
Mills, E.J., Nachega, J.B., Buchan, I., Orbinski, J., Attaran, A., Singh, S., Rachlis, B., Wu, P., Cooper, C., Thabane, L., Wilson, K., Guyatt, G.H., & Bangsberg, D.R. (2006). Adherence to antiretroviral therapy in sub-Saharan Africa and North America: A meta-analysis. JAMA, 296, 679-690.
Simoni, J.M., Pearson, C.R., Pantalone, D.W., Marks, G., & Crepaz, N. (2006). Efficacy of interventions in improving highly active antiretroviral therapy adherence and HIV-1 RNA viral load: A meta-analytic review of randomized controlled trials. Journal of Acquired Immune Deficiency Syndromes, 43 (Supplement 1), S23-S35.
See Section
VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
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.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
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 Institutes and
Centers (ICs) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the submission of
a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. 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.
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.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your
institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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 PD/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
Applicants may submit more than one application, provided each application is scientifically
distinct.
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, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
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 eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
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/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
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 and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
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., Special
Instructions,
regarding appropriate required budget component.)
Research
& Related Budget (required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
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:
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.
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 in item 15 of 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.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the 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 (section 14 of the Research Plan Component in the SF424 (R&R) or Section I of the Research Plan in the PHS 398), 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, including 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.
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: April 2, 2007 (Earliest date an application may be submitted to
Grants.gov)
AIDS Application Submission/Receipt 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.
3.C. Application
Processing
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.
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. 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 their 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 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: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new 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 the NIH
Grants Policy Statement.
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.
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
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
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).
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.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. 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.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
Not applicable.
Sharing Research
Resources
NIH policy expects that grant recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the
review process.
2. Review and
Selection Process
Applications submitted for this funding
opportunity will be assigned to the ICs on the basis of established Public Health Service (PHS) referral
guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan component is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in
all categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.
Significance: Does this study address an important problem? If the aims of the application
are achieved, how will scientific knowledge or clinical practice be advanced?
What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?
Approach: Are the conceptual or clinical framework, design, methods, and
analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the PD/PIs appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if
applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Resubmission Applications (formerly revised/amended
applications): Are the responses to comments from the previous
scientific review group adequate? Are the improvements in the resubmission
application appropriate?
Protection of
Human Subjects from Research Risk: The involvement of human subjects and protections
from research risk relating to their participation in the proposed research
will be assessed. See item 6 of the Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the
SF424 (R&R).
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research. The priority score
should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents 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 will be assessed.
2.C. Sharing Research Data
Not Applicable.
2.D. Sharing Research Resources
NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
Reporting.
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/her 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.
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:
Michael J. Stirratt, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6199, MSC-9619
Bethesda, MD 20892-9619
Telephone: (301) 443-6802
Fax: (301) 443-9719
Email: [email protected]
Lisa Onken, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH
6001 Executive Boulevard, Room 3172 MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 443-2235
FAX: (301) 443-6814
Email: [email protected]
Jeanette Hosseini, PhD
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5972
Fax: 301-480-8260
Email: [email protected]
2. Peer Review
Contacts:
Not Applicable
3. Financial or Grants
Management Contacts:
Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX: (310) 443-6885
Email: [email protected]
Debra Dudley
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Ron Wertz
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-2807
FAX: (301) 402-4502
Email: [email protected]
Section VIII. Other Information
Required
Federal Citations
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).
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.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
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 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405
of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR 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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