and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National
Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Pre-Application for the 2011 NIDA Avant-Garde Award Program
for HIV/AIDS Research (X02)
Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-10-068.
Update: The following update relating to this announcement has been issued:
Program
Announcement (PA) Number: PAR-10-287
NOTICE: Applications
submitted in response to this Funding Opportunity Announcement (FOA) for
Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.279
Key Dates
Release/Posted Date: September 23, 2010
Opening Date: January 11, 2011 (Earliest date an application
may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Due Date(s): February 11, 2011
Peer Review
Date(s): April 2011
Council Review
Date(s): Not applicable
Earliest Anticipated Start Date(s): Not
applicable
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: February 12, 2011
Due Dates for E.O.
12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview
Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement
and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3.
Reporting
Section VII. Agency Contacts
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
This
award is designed to support individual scientists of exceptional creativity who propose cutting edge and possibly
transformative approaches to major challenges in biomedical and behavioral
research on HIV/AIDS that are relevant to drug abuse. The term avant-garde is
used to describe highly innovative approaches that
have the potential to be transformative. It is hoped that this high-impact
research will open new areas of HIV/AIDS research and/or lead to new avenues
for treatment and prevention of HIV/AIDS among drug abusers. Proposed research
should reflect ideas substantially different from
those already being studied by the investigator or others. Biomedical and
behavioral research is defined broadly in this announcement as encompassing
scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and
mathematical sciences. The award is meant to support individuals who intend to
pursue research directions that are not readily supported by other NIH grant
mechanisms. The program is not intended simply to expand the funding of an already supported research project, but rather to
support highly creative researchers to pursue visionary concepts and approaches
to research on HIV/AIDS.
This announcement utilizes the X02 mechanism for submission of pre-applications. Pre-applications are a necessary first step in applying for a 2011 Avant-Garde Award. Pre-applications will be evaluated by a group of external experts. Those investigators whose projects are judged to be the most outstanding will be notified of the opportunity to submit full (DP1) applications under RFA-DA-11-002.
Avant-Garde awardees are required to commit the major portion (at least 51% or 6.1 person months) of their research effort to activities supported by the Avant-Garde Award program. Those who will not be able to meet this requirement should not submit pre-applications.
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 X02
mechanism for submission of pre-applications. Pre-applications are a necessary first step in applying for
a 2011 Avant-Garde Award. Pre-applications will be
assessed by a group of external reviewers. Those applicants whose
pre-applications are identified as being outstanding (individuals of
exceptional creativity with highly innovative projects that are not suited to
standard grant mechanisms) will be notified of the
opportunity to submit full applications under RFA-DA-11-002 (DP1). The Project Director/Principal Investigator (PD/PI) will be
solely responsible
for planning, directing, and executing the proposed project.
2.
Funds Available
All
awards will be made under RFA-DA-11-002.
No awards will be made under this FOA.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
Foreign (non-U.S.) organizations are not eligible to apply.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Investigators who have not been previously involved in drug abuse research are encouraged to consider the scientific opportunity to contribute to this field.
Investigators at all career levels who meet the eligibility criteria and are currently engaged in research are eligible to submit applications. The research proposed need not be in a conventional biomedical or behavioral discipline; if the individual’s experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance to HIV/AIDS and drug abuse.
This initiative is to support investigators who intend to pursue new research directions research that is distinct from that currently or previously conducted by the investigator. Applications for projects that are extensions of ongoing research should not be submitted. DP1 awardees are required to commit the major portion (at least 51% or 6.1 person months) of their research effort to activities supported by the Avant-Garde Award program. Those who will not be able to meet this requirement should not submit pre-applications.
Investigators who were not selected for an award in prior years may submit pre-applications this year; however, all pre-applications must be submitted as new applications regardless of any previous submission to the program.
Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the pre-application. NIH intramural investigators are not eligible for support under this program.
2. Cost
Sharing or Matching
This
program does not require cost sharing as defined in the current NIH Grants
Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. An individual may not submit more than one application. There is no limit to the number of applications institutions may submit.
Resubmissions. Resubmissions of applications are not allowed.
Renewals. Renewals applications are not permitted under this FOA.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1.
Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
o Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further
assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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
Optional
Components:
PHS398 Cover
Letter File
PHS 398
Cover Letter File should be submitted only when submitting a Changed/Corrected
Application after the submission date, and should include an explanation for
the late submission.
IMPORTANT: Special instructions for the Avant-Garde X02 pre-application are given in Section 6 (Other Submission Requirements).
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review and Anticipated Start Dates
Opening Date: January 11, 2011 (Earliest date an
application may be submitted to Grants.gov)
Application Due Date(s): February 11, 2011
Peer Review Date(s): April 2011
Council Review
Date(s): Not applicable
Earliest Anticipated Start Date(s): Not applicable
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/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All
attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.
3.C.
Application Processing
3.C.1
Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept an 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 an application that is essentially the same as one already reviewed.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
Not
applicable
6. Other Submission Requirements
SPECIAL INSTRUCTIONS
Pre-applications with Multiple PDs/PIs are not allowed.
ADDITIONAL APPLICATION INSTRUCTIONS
The following instructions are specific to the Avant-Garde Award X02 pre-applications and are exceptions to the general SF424 instructions. Pre-applications that do not conform to the specific instructions detailed below will not be assessed.
NOTE: Letters of reference are not required and will not be accepted with pre-applications. Reference letters will be required of those applicants submitting full (DP1) applications to RFA-DA-11-002.
1. SF424 (R&R) COVER COMPONENT:
Item Number1 Type of submission: Must be Pre-application
Item Number 4.b Agency Routing Identifier: Enter science Area Designation: Designate one area of science from the list below by entering the one-digit code and name of the scientific area (e.g., 1 Natural History and Epidemiology)
1 Natural history and Epidemiology
2 Etiology and Pathogenesis
3 Microbicides
4 Vaccines
5 Behavioral and Social Science
6 Therapeutics
Item Number 8. Type of Application: Must be New
Item Number 12. Proposed Project: Enter start date: 9/30/2011; Enter end date: 07/31/2016.
Item Number 15a. Total Federal Funds Requested: Enter $0.
Item Number 15b. Total Non-Federal Funds: Enter $0
Item Number 15c. Total Federal and Non-Federal Funds: Enter $0. (See note below.)
Item Number 15d. Estimated Program Income: Enter $0.
NOTE: $0 is entered for all budget items. No awards will be made under this pre-application FOA.
2. RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS COMPONENT: Complete as appropriate.
3. R&R OTHER PROJECT INFORMATION COMPONENT:
Item 1. Are Human Subjects Involved?
Check No. Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required and should not be submitted with this pre-application. This information will be required from only those individuals who submit a full application in response to RFA 11-002.
Item 2. Are Vertebrate Animals Used?
Check No. Detailed information regarding the use of vertebrate animals is not required at the time of submission. This information will be required only from those individuals who submit a full application in response to RFA 11-002,
Items 3-6b. Complete as appropriate.
Item Number 7. Project Summary/Abstract: Attach an abstract (not to exceed 30 lines) describing the goals of the project. Text only no figures, animations, or Web links are allowed.
Item Number 8. Project Narrative: Attach Public Health Relevance Statement: In 2-3 sentences written in plain language describe how the proposed research can positively impact HIV/AIDS treatment or prevention among drug abusers.
Item Number 9. Bibliography & References Cited: Do not use. Reference citations are not required, but may be included in the essay and would be included in the five-page limit.
Item Number 10. Facilities & Other Resources: Upload a brief statement (1 page maximum) of the facilities to be used for the conduct of the research.
Item Number 11. Equipment: Do not use.
Item Number 12. Most Significant Research Accomplishment : Attach a description of no more than one page of the applicant’s single most significant publication or research accomplishment. Applicants should submit one single accomplishment, not a summary of several accomplishments, multiple publications, or background narratives. Publications or other documents will not be accepted.
4. SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:
Profile PD/PI Attach Biographical Sketch: Complete only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel. Attach the two-page biographical sketch using the format shown in the Application Guide, Section 4.5, omitting Sections A and D. The biosketch should contain Section B (Positions and Honors) and Section C (peer-reviewed publications or manuscripts in press in chronological order). Do not include Section A (Personal Statement) or Section D (Research Support). Do not exceed the two-page limit.
Profile PD/PI Attach Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 51% or 6.1 person months of his/her research effort to the project supported by the Avant-Garde Award.
Profile Senior Key Person 1: Do not use.
5. PHS 398 COVER PAGE SUPPLEMENT: Complete all fields.
6. PHS 398 RESEARCH PLAN COMPONENT
Field 2. Research Plan Attachments
2.2 Specific Aims attachment is required and limited to 1 page.
2.3 Research Strategy-upload 5-page Essay here,
Detailed Instructions for Essay:
In five pages maximum, describe the applicant’s innovative vision for, and the significance of, the HIV/AIDS biomedical or behavioral problem to be addressed, and his/her qualifications to engage in groundbreaking research. The essay should describe the individual's view of the major challenges in HIV/AIDS biomedical or behavioral research to which he/she can make seminal contributions. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections in the order given with the headings as shown below:
Science area: The area of science must be included at the beginning of the Essay (e.g., 1 Natural history and Epidemiology). Applicants must choose a research area from the following list taken from the Trans-NIH Plan for HIV-Related Research:
1 Natural History and Epidemiology
2 Etiology and Pathogenesis
3 Microbicides
4 Vaccines
5 Behavioral and Social Science
6 Therapeutics
The areas of science are used by NIDA staff to assist in assigning pre-applications to the most appropriate reviewers. Include the area of science at the beginning of your essay.
Project title: The project title must be included at the beginning of the essay.
Project description: What is the scientific problem or challenge that will be addressed, and why is this important? What are the pioneering, and possibly high-risk, approaches that, if successful, might lead to groundbreaking or paradigm-shifting results?
Evidence of innovativeness: What concrete evidence can you provide for your claim of innovativeness? For example, qualities common to many highly innovative people include an interest in, and the ability to integrate, diverse sources of information; an inclination to challenge paradigms and take intellectual risks; persistence in the face of failure; an ability to attract the right collaborators; and the energy and concentration necessary to plan and execute effective strategies for accomplishing goals.
How the planned research differs from your past or current work: Describe how the project represents a new and distinct direction for your research.
Suitability for Avant-Garde Award program: Why is the planned research uniquely suited to the stated goal of the Avant-Garde Award program, rather than a traditional grant mechanism?
Information on collaborations may be included in the essay. Literature references are not required, but, if included, must fit within the five-page limit. Figures and illustrations may be included but must also fit within the five-page limit. Do not include links to websites to provide further information. No animations (movies) are allowed in any documents.
7. PHS 398 Cover Letter File (Optional):
Cover letters should be included only when submitting late applications or Changed/Corrected applications after the submission deadline. Do not submit cover letters for initial submissions or for changed/corrected applications submitted before the submission deadline. The cover letter should contain only the following information:
1. PD/PI name.
2. Funding Opportunity Title: Pre-application for 2011 NIDA Avant-Garde Award Program for HIV/AIDS Research (X02).
(See full instructions for submitting the Cover Letter Component in Section 5.2 of the Application Guide. Note: Items 3 6 of the Guide do not apply to Avant-Garde Award pre-applications.)
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) 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.
Appendix Materials
Appendices are not allowed and will not be accepted
Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
Pre-applications
that are complete will be evaluated by a multidisciplinary group of outside
experts convened by NIDA with expertise in HIV/AIDS and drug abuse, who will
evaluate pre-applications based on the criteria listed below. PIs with the
most outstanding pre-applications (best address the review criteria) will be
notified of the opportunity to submit full applications for the Avant-Garde
Award in response to RFA-DA-11-002. Please note that RFA-DA-11-002 includes additional review criteria of significance, investigator(s),
innovation, approach, and environment.
In particular, reviewers will evaluate:
Additional Review Criteria
None
Additional Review Considerations
None
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1.
Award Notices
Not Applicable
2. Administrative and National Policy Requirements
Not
Applicable
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jacques Normand, Ph.D.
Director, AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Rm 5274 MSC 9581
Bethesda, MD 20892
Telephone: 301-443-1470
Fax: 301-594-5610
Email: [email protected]
2. Peer Review Contact(s):
Mark
Swieter, Ph.D.
Chief
Extramural Affairs Branch
Office
of Extramural Affairs
National
Institute on Drug Abuse, NIH, DHHS
6101
Executive Boulevard, Suite 220, MSC 8401
Bethesda,
Maryland 20892-8401
Telephone:
(301) 435-1389
FAX:
(301) 443-0538
Email: m[email protected]
3. Financial/Grants Management Contact(s):
Carol Alderson
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD 20892-9541
Telephone: 301-933-6196
Fax: 301-594-6849
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals
in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants ( NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local institutional review board (IRB) rules, as well as local,
State and Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable Health
Information:
The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in
the Catalog
of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and
other considerations described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% or 6 person months 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
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||