Department of Health and Human
Services
Participating Organizations
National Institutes
of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute of Allergy and
Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Cancer Institute (NCI), (www.nci.nih.gov)
National Heart Lung and Blood Institute (NHLBI), (www.nhlbi.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (www.niaaa.nih.gov)
National Institute of Child Health and Human
Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA), (www.nida.nih.gov)
National
Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/ )
Title: U.S.-India
Bilateral Collaborative Research Partnerships (CRP) on the Prevention of
HIV/AIDS (R21)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
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.
Request For Applications (RFA) Number: RFA-AI-07-031
Catalog of Federal Domestic Assistance Number(s)
93.242, 93.273, 93.279, 93.393, 93.394, 93.396, 93.855,
93.856, 93.865, 93.839
Key Dates
Release/Posted Date: July
18, 2007
Opening Date: August 18, 2007 (Earliest
date an application may be submitted to Grants.gov)
Letters of
Intent Receipt Date(s): September 18, 2007
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 Submission/Receipt
Date(s): October 18, 2007
Peer Review
Date(s): January 2008
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): April 2008
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: October 19, 2007
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
The purpose of the U.S.-India Bilateral Collaborative Research Partnerships (CRP) on the Prevention of HIV/AIDS is to support innovative and basic research on strategies to prevent HIV infection and transmission that will advance the field of HIV/AIDS prevention through the collaborative efforts of U.S. and Indian investigators and their institutions.
Background
The National Institutes of Health (NIH) supports international collaborative research and research training on HIV/AIDS and the exchange of scientific information by HIV/AIDS researchers around the world. Scientific cooperation between the U.S. and India has been successfully conducted for over forty years under a variety of bilateral agreements. Recognizing that continuing cooperative research and research training focused on HIV/AIDS would be of mutual benefit to the U.S. and India, the U.S. Secretary of Health and Human Services (HHS) and the Indian Minister of Health and Family Welfare signed a “Joint Statement for Collaboration on Prevention of Sexually Transmitted Diseases and HIV/AIDS”(http://www3.niaid.nih.gov/research/resources/PDF/US-IndiaStatmnt_HIV_STD.pdf) in June 2006.
The lead U.S. agency identified to implement activities under this Joint Statement is the HHS, NIH, and the lead Indian agencies are the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT). The Joint Statement calls for the establishment of a Joint Working Group (JWG) to develop strategic plans for collaboration and to facilitate the expedited review and clearance of proposed bilateral projects. Both the U.S. Secretary of Health and Human Services (HHS) and India, (Indian Minister of Health and Family Welfare) have pledged funds to support joint activities pursued under this bilateral program.
Collaborative Research Partnerships
A critical feature of this FOA is the establishment and support of CRPs among researchers and institutions in the U.S. and India. Applications may be derived from existing collaborations with an established history of interaction, or from new partnerships developed in response to this FOA. The CRP must be based on an interactive relationship that maximizes the expertise of the individual U.S. and Indian research teams as well as the interaction between their parent institutions and granting agencies. It is expected that the unique opportunity available through the U.S.-India Collaborative Research Program will foster collaborative partnerships that will develop and mature, leading to the establishment of joint programs intended to pursue and develop HIV/AIDS prevention strategies/interventions beyond the scope of the proposed R21 application.
Research Objectives and Scope
As the HIV pandemic has continued and more information is obtained on the role of other microbes (i.e. viruses, bacteria, etc.), on the behavioral and social interactions, epidemiological factors and co-morbidities associated with HIV transmission, (e.g., mental health, substance abuse [alcohol and drugs], and with HIV infection, [Kaposi’s sarcoma (KS)]) is obtained, it has become apparent that controlling the HIV/AIDS pandemic will require the development of a multi-faceted approach to prevention. Therefore this FOA supports not only individual prevention strategies/interventions, but also combination prevention strategies. A combination prevention strategy is defined as being composed of multi-level or multi-modal prevention/intervention approaches to achieve the stated goals of this FOA. Examples include the ethical considerations associated with microbicide clinical trials; for instance, where an obligation exists to both counsel and provide condoms, or to integrate prevention strategies such as the use of a vaccine along with a microbicide.
Highest priority will be given to collaborative research projects that focus on HIV prevention programs that test microbicides. Projects that develop and test other prevention strategies also will be considered. Applications may include, but are not limited to collaborations addressing the following aspects of HIV/AIDS prevention:
The R21 innovation grant mechanism does not allow for the conclusive and powered testing of proposed single and combination prevention strategies in its short duration. However, this mechanism does accommodate the performance of incremental studies or interventions that can either support progression to more comprehensive studies or provide evidence that the proposed intervention is not effective. CRP applications should incorporate activities that can test and pilot specific prevention interventions.
The proposed studies must take into account the time limit and budget imposed by this mechanism (See Section 2: Award Information). It is expected that where possible the proposed applications will be interactive with ongoing prevention efforts in India and the U.S., and/or propose to integrate with existing Indian government-supported prevention programs.
CRP interactions may include:
Applications may address key aspects using a broad range of study populations including men and women that are at-risk for HIV/AIDS infection and uninfected and HIV/STI-infected infants and children. Other specific at-risk populations of interest include, but are not limited to:
Because this FOA represents a broad-based international collaborative program to address HIV/AIDS prevention, applicants are encouraged to discuss the scope of their proposed application and its responsiveness to the FOA with the relevant Program contacts listed in Section VII.
Specific areas of interest for this FOA include studies that may address or be focused within one or more of the following broad research areas:
1. Infectious Diseases and HIV/AIDS Co-morbidities
The development of safe, effective and acceptable prevention strategies, including microbicides, must integrate efforts to understand how biochemical, pharmacological and biophysical factors affecting susceptibility and progression to HIV/AIDS disease interact with the implementation of any given prevention strategy. Efforts in this area may also address biological issues that could alter the potential effectiveness of interventional prevention strategies in at-risk individuals or populations. Examples of potential approaches include:
2. Behavioral and Social Sciences
Primary and secondary prevention strategies addressing behaviors of at-risk persons or populations with the potential for scale-up to support larger populations are critical to the development of effective and sustainable single and combination prevention strategies. Examples of interventions and areas of interest that could be tested and/or developed in response to this FOA include:
3. Epidemiology (Behavioral and Population)
Applications proposing behavioral and population epidemiology may include assessment and evaluation of the scope of the Indian HIV/AIDS epidemic. Local, regional and national incidence and/or prevalence of HIV and STIs associated with HIV acquisition and HIV/AIDS co-morbidities in the Indian population will have a significant impact on the success or failure of proposed prevention efforts. Specific examples of interest include, but are not limited to:
4. Alcohol Abuse and Alcoholism
This area of interest within the FOA includes the use and abuse of alcohol as it may directly or indirectly (through alterations in risk behaviors) alter and/or promote the acquisition and/or progression of HIV/AIDS, STIs associated with HIV acquisition and HIV/AIDS co-morbidities. Examples of intervention/research of interest to this FOA include:
5. Drug Use and Abuse
This area of interest within the FOA includes the use and abuse of both injection and non-injection drugs, that may be classified as legal or illegal, depending upon local, regional or national laws. These substances may directly or indirectly (e.g., through alteration in both sexual and substance use risk behaviors) alter acquisition, transmission and/or progression of HIV/AIDS, STIs associated with HIV acquisition, and HIV/AIDS-associated co-morbidities. Examples of intervention research of interest include:
6. Prevention of Mother-To-Child Transmission (MTCT)
Effective interventions to prevent mother-to-child transmission of HIV that are applicable in resource-limited settings are now available. However, implementation of these strategies has been slow. Limitations include lack of access to antenatal care, lack of antenatal HIV counseling and testing, lack of more effective regimens (e.g., single dose nevirapine plus short course zidovudine), home delivery (emphasizing evaluation of innovative methods for providing single-dose nevirapine), and breastfeeding. Examples of prevention strategies include:
See Section
VIII, Other Information - Required Federal Citations, for policies related to
this announcement.
Section
II. Award Information
1. Mechanism
of Support
This Funding Opportunity Announcement
(FOA) will use the NIH R21 Exploratory/Developmental grant award mechanism. The applicant will be solely responsible for planning,
directing, and executing the proposed project.
This FOA uses just-in-time concepts. For the R21, applicants must complete and submit detailed budget requests using the SF424 Research and Related (R&R) Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 4.7, “R&R Budget Component,” of the Application Guide). Modular budgets are not permitted for this funding opportunity.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly "competing continuation") and resubmission applications will not be accepted.
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) and Indian partners
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 two 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 USD over an R21 two-year period, with no more than $200,000 USD in direct costs in any single year.
The participating institutes intend to commit approximately 3 million total dollars in FY2008 to fund 8 to 10 applications.
NIH grant policies described in the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm will apply to the applications submitted and awards made in response to this FOA.
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 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.
The PD/PI must be from a U.S.-funded institution and must collaborate with an Indian investigator at an Indian institution and possessing complementary expertise.
Investigators not qualifying for the U.S.-India Bilateral CRP are encouraged to apply for the NIH-wide R21 exploratory/developmental research grant program (see http://grants2.nih.gov/grants/guide/pa-files/PA-06-181.html), or other announcements.
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.
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 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-0088.
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. (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
Research &
Related Budget
PHS398
Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter
File
Research &
Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, this FOA for which all applications must include a foreign component uses ONLY the Research & Related Budget. (Do not use the PHS398 Modular Budget.)
Foreign Organizations
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Application from foreign organizations must:
SPECIAL INSTRUCTIONS
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.
3. Submission
Dates and Times
See
Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 18, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of
Intent Receipt Date(s): September 18, 2007
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 Submission/Receipt
Date(s): October 18, 2007
Peer Review
Date(s): January 2008
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): April 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a Letter of Intent that includes the following information:
Although a LOI is not required, is not binding, and does
not enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan the
review.
The
LOI is to be sent by the date listed in Section IV.3.A,
The LOI should be sent to:
Sujata Vijh, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3118, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip: 20817-7616
Tel: (301) 594-0985
Fax: (301) 480-2408
Email: vijhs@niaid.nih.gov
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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application, That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and text must not be marked to indicate changes from the previous unfunded version of the application.
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. 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-Applications Guide, Electronic Submission of Grant Applications.”
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 are to be followed, incorporating “Just-in-Time” information concepts and with the following requirements for applications:
Supplementary Instructions
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 relevant policies and procedures may be delayed in the review process.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigators are planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing, the format of the final dataset, the
documentation to be provided, whether or not any analytic tools also will be
provided, whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a
data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be
appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
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
Only
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate review group convened by NIH in accordance with the review
criteria stated below.
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 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.
Significance: Does this study address
an important scientific health 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? Is the proposed
collaborative team positioned to accomplish the
proposed research, and does the collaboration of U.S.-funded investigators and Indian investigators add significantly to the approach being proposed?
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 in the area of HIV/AIDS prevention?
Investigators: Are the PD/PI(s) and other key personnel 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 PD/PI(s) and
investigative team bring complementary and integrated expertise to the project
(if applicable)?
Environment: Do(es) the scientific
environment(s) 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:
Collaborative Plan: Is the collaborative plan well-defined with identifiable responsibilities for the U.S. and India partners? Is a plan for management of the collaboration presented, as well as descriptions of what each participant proposes to supply to the collaborative partnership? Is there a clear and well thought out advantage to bringing the U.S. and Indian partners together in a collaborative partnership and is it clear how coordination will contribute to advances in prevention science?
Protection of Human Subjects from
Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed. See the “Human Subjects Sections” of the
PHS398 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 the “Human Subjects Sections” of the PHS398
Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component
of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing
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.”
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant’s decision to distribute the resource or deposit it in a repository, and other relevant considerations.
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:
Direct inquiries
regarding scientific, programmatic, and review matters to the appropriate
Program Official listed below:
NCI
Kishor Bhatia, Ph.D., MRCPath
Office
of AIDS Malignancy Program
National Cancer Institute
Room
6114, MSC-7204
6120 Executive Boulevard
Bethesda, MD 20892-7204 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for FedEx, UPS and other courier services)
Telephone: (301) 496-4995
Fax: (301) 480-4137
E-mail: bhatiak@mail.nih.gov
NHLBI
Cheryl L. McDonald, M.D.
AIDS Coordinator
National Heart, Lung, and Blood Institute
Room 8114, MSC-7940
6701 Rockledge Drive
Bethesda, MD 20892-7940 (For courier services use Zip 20817)
Telephone: (301) 435-0560
Fax: (301) 480-2858
E-mail: mcdonalc@mail.nih.gov
NIAAA
Kendall Bryant, Ph.D.
HIV/AIDS Research
National Institute on Alcohol Abuse and Alcoholism
Room 2069, MSC 9304
5635 Fishers Lane
Rockville, MD 20892-9304
Telephone: (301) 402-9389
Fax: (301) 443-8614
E-mail: kbryant@mail.nih.gov
NIAID
Jim A. Turpin, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5114, MSC-7628
6700B Rockledge Drive
Bethesda, MD 20892-7628
Phone: (301) 451-2732
Fax: (301) 496-8530
Email: jturpin@niaid.nih.gov
NICHD
Danuta
Krotoski, Ph.D.
National Institute of Child Health and Human
Development
Room
2A01, MSC 7510
6100 Executive Boulevard
Bethesda, MD 20892-7510
Phone: (301) 435-7566
Fax: (301) 435-0009
E-mail: krotoskd@mail.nih.gov
NIDA
Katherine
Davenny, M.P.H.
AIDS Research Program
National Institute on Drug Abuse
Room 4215, MSC 9581
6001 Executive Boulevard
Bethesda, MD 20892-9581
Telephone: (301) 443-2146
Fax: (301) 443-9127
E-mail: kdavenny@nida.nih.gov
NIMH
Willo
Pequenat, Ph.D.
Division
of Mental Disorders
National Institute of Mental Health
Room 6219B, MSC-9619
6001
Executive Boulevard
Bethesda, MD 20892-9619
Telephone: (301) 443-1187
Fax: (301) 443-9719
E-mail: wpequegn@mail.nih.gov
2. Peer Review Contacts:
Sujata Vijh, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3118, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
FedEx Zip: 20817-7616
Tel: (301) 594-0985
Fax: (301) 480-2408
Email: vijhs@niaid.nih.gov
3. Financial or Grants Management Contacts:
Kimberly Chatman
Division
of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room
2241, MSC-76146700-B
Rockledge Drive
Bethesda, MD 20892 (express zip 20817)
Direct Line: (301) 402-6580
GMP: (301) 496-7075
Fax: (301) 493-0597
E-mail: chatmank@niaid.nih.gov
Section VIII. Other Information
Required Federal
Citations
Use of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(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 IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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.
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.
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-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
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 in the following citations: 93.242, 93.273, 93.279, 93.393, 93.394, 93.396, 93.855, 93.856, 93.865, and 93.839, 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
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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