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
Aging (NIA), (http://www.nia.nih.gov/)
Title: Aging Research Dissertation Awards to Increase
Diversity (R36)
Announcement Type
This Funding
Opportunity Announcement replaces PAR-05-061,
which was released on March 1, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and should be started at least four weeks in advance of the planned submission.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PAR-06-117
Catalog of Federal Domestic Assistance Number(s)
93.866
Key Dates
Release/Posted
Date: January 11, 2006
Opening
Date: February 15, 2006 (Earliest date an application may be submitted to
Grants.gov).
Letters of Intent Receipt Dates: February 15, 2006, October 16, 2006, February 15, 2007, October 16, 2007, February 15, 2008.
Application Submission Dates: March 15, 2006; November 15, 2006; March 15, 2007; November 15, 2007; March 15, 2008.
Peer
Review Date(s): June-July, 2006, 2007, 2008;
February-March, 2007, 2008. http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): September-October, 2006, 2007,
2008; May-June, 2007, 2008. http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest
Anticipated Start Date: December 2006, July 2007, December
2007, July 2008 and December 2008. http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional
Information To Be Available Date (Url Activation Date): Not applicable
Expiration
Date: March 16, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The
National Institute on Aging (NIA) announces the availability of dissertation
awards (R36) in all areas of research within the Institute's mandate to
increase the diversity of the research workforce on aging. These awards are
available to qualified predoctoral students in accredited research doctoral
programs in the United States (including Puerto Rico and other U.S. territories or possessions).
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.
Sending an Application 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 Contacts
1.
Scientific/Research Contact
2. Peer Review
Contact
3. Financial/Grants
Management Contact
Section VIII. Other Information - Required Federal
Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
This Funding Opportunity
Announcement (FOA) issued by the National Institute on Aging ( NIA), National Institutes of Health (NIH), publicizes the
availability of dissertation awards in aging research to increase the diversity
of the research workforce. These awards are available to qualified predoctoral
students in accredited research doctoral programs in the United States (including Puerto Rico and other U.S. territories or possessions).
The NIA, as part of the NIH, recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to:
Substantial evidence indicates that biomedical research, including aging research in particular, and the broader educational environment will benefit from broader representation of individuals from diverse ethnic, cultural and socioeconomic backgrounds. Recent studies have supported the argument that diversity enhances the quality of education in multiple settings. Studies have also suggested that racially and culturally concordant scientific staff may be more successful in recruiting research participants from minority groups into clinical trials. Racially similar physician-patient dyads may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settings. Recent preliminary evidence from a related NIA program indicates that graduates of the program preferentially conduct research on health disparities related to aging an important overall priority of the NIA and the NIH.
This dissertation research award announcement is intended to stimulate the participation of individuals from the following groups:
A.
individuals from underrepresented racial and ethnic groups;
B.
individuals with disabilities; and
C.
individuals from socially, culturally, economically, or educationally
disadvantaged backgrounds that have inhibited their ability to pursue a career
in health-related research.
The NIA is encouraging applications for dissertation support across all areas of research supported by the Institute. The broad research areas supported by the NIA are: Biology of Aging; Behavioral and Social Research on Aging; Neuroscience and Neuropsychology of Aging; and Geriatrics and Clinical Gerontology. Priority areas within these programs are described on the individual web sites. The NIA particularly encourages interdisciplinary research whose focus may span the areas of interest of more than one program. In general, the NIA takes a broad view of aging-related research, including research focused on understanding the process of aging as well as links connecting the aging process and susceptibility to age-related diseases. The NIA encourages the application of the highest quality science in appropriate model systems applied to research on aging. In general, the NIA considers a topic to be on aging when the research involves: age comparisons in biological, clinical, behavioral, or social processes where emphasis is on age differences or changes during adult life; longitudinal studies focusing on later life outcomes; the role of the aging process in diseases and medical conditions that primarily affect older adults including the origins of these conditions at any stage of life; or molecular, cellular, animal, or simulation models of age-related processes. The NIA supports both primary data collection and secondary analyses of existing data sets related to the above.
Potential applicants are encouraged to visit the Web sites listed above and to contact the Scientific/Research Contact listed in Section VII to gain more information on the relevance of the topic to NIA's mission.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1.
Mechanism of Support
This funding
opportunity will use the Dissertation Award R36 grant mechanism. The predoctoral student is the Project Director/Principal Investigator (PD/PI) of
the application and is responsible for planning, directing, and executing the
proposed project under the supervision, and with the approval, of a
university-approved and appointed doctoral committee. The student-PD/PI must
have an appointment at the applicant institution (e.g., instructor, research
associate).
This funding
opportunity uses the just-in-time budget concepts. It also uses the non-modular
budget format. Use the SF424 Research and Related (R&R) Budget component
described in the SF424 (R&R) Application Package and SF424 (R&R) Application
Guide.
Dissertation awards are not renewable nor may they be transferred to another PD/PI.
2. Funds Available
The NIA expects to award
$250,000 to $300,000 annually beginning in Fiscal Year 2007 to support 6 to 8
dissertation awards;
Although the financial plans of the
NIA provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You
may submit an application(s) if your organization has the following
characteristics:
In
addition, the applicant institution must be the institution at which you are
pursuing your doctoral studies and the doctoral program in which you are
participating must be accredited by the appropriate professional organization.
1.B. Eligible Individuals
Eligibility
is related to contributing to the diversity of the research workforce on aging.
As discussed in Section I, the NIA is particularly interested in assisting the following classes of candidates to complete their research doctoral education:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/wmpd/). In addition, it is recognized that underrepresentation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the applicant institution are eligible for support under this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who were raised in a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary of Health and Human Services for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or that they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Eligibility related to predoctoral and dissertation-eligible status
You are eligible to apply for this award provided that:
Note that individuals supported under Ruth L. Kirschstein National Research Service Award mechanisms, including F30 and F31 predoctoral fellowships and predoctoral trainees on NIH institutional research training awards, are eligible to apply for a dissertation award. However, as these awards cover full-time effort and provide a small amount that may be used to support dissertation research expenses, such students may only receive the up to $15,000 allowed for additional, non-salary expenses, and must provide a statement that these expenses are not supported through the active training grant or fellowship. The request for support must also satisfy institutional policies.
2. Cost Sharing or Matching
This program does not
require cost sharing as defined the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Not applicable
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To
download an Application Package and 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:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution can submit an application through Grants.gov. See "Preparing for Electronic Receipt" at http://era.nih.gov/ElectronicReceipt/preparing.htm.
1) Organization/Institutional Registration in Grants.gov/Get Started
2) Organization/Institutional Registration in the eRA Commons
3) Principal Investigator Registration in the eRA Commons: Refer to the eRA Commons User Guide
NOTE: Both the Principal Investigator (PD/PI) and Signing Official (SO) need separate accounts in Commons since both need to verify the application.
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 two weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants
must download the SF424 (R&R) application forms and SF424 (R&R) Application
Guide for this FOA through Grants.gov/Apply.
Note: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the "Attachment" files may be useable for more
than one FOA.
For further
assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY (301) 451-5936.
2. Content and Form of Application Submission
Prepare
all applications using the SF424 (R&R) application forms and the SF424
(R&R) Application Guide (MS Word or PDF)
instructions.
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 Tips and Tools for Navigating Electronic Submission on the front page of 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 Form
All instructions for
the SF424 (R&R) must be followed, with these qualifications:
4.2 Cover component.
4.5 Senior/Key Person Profile(s) Component. Key personnel include the predoctoral student, the supervisor, dissertation chair, and all members of the named dissertation committee. Any other individuals who contribute in a substantive way to the scientific development or execution of the project should also be listed as Other Significant Contributors directly after the listing of Key personnel.
Use SF424 (R&R) 4.7 Budget Component to complete a detailed, non-modular budget.
5.5 Research Plan Component: Do not exceed a total of 10 pages for Items 2 to 5 of the Research Plan. The Introduction (Item 1) to a resubmission application must be limited to one additional page. Plans for Instruction in the Responsible Conduct of Research (see Section IV.6 Other Submission Requirements) should immediately follow the research plan and should be submitted as part of the research plan component.
5.5 Research Plan Component, Item 4. Preliminary studies/Progress report: This section may include descriptions of ongoing work conducted in the laboratory or section in which the student is based and which is relevant to the proposed dissertation project. The student-PD/PI does not have to have been involved directly in this prior work for it to be described here.
5.5 Research Plan Component, Item 13. Letters of support: The supervisor of the student-PD/PI) and the dissertation chair (or another committee member if the supervisor is the dissertation chair) should submit letters of support as described below in Section IV.6. Other Submission Requirements.
5.5 Research Plan Component, Item 15, Appendix. The only materials allowed in the Appendix are:
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening
Date: February 15, 2006 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Dates: February 15, 2006; October 16, 2006; February 15, 2007; October 16, 2007; February 15, 2008.
Application Submission Dates: March 15, 2006; November 15, 2006; March 15, 2007, November 15, 2007; March 15, 2008.
Peer
Review Date(s): June-July, 2006, 2007, 2008;
February-March, 2007, 2008. http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): September-October, 2006, 2007,
2008; May-June, 2007, 2008.http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest
Anticipated Start Date: December 2006, July 2007, December
2007, July 2008 and December 2008.
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of
intent that includes the following information:
Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows NIA staff to estimate the potential review
workload and plan the review.
The letter of intent
is to be sent by the date listed in Section IV.3.A.
The
letter of intent should be sent to:
Robin A.
Barr, D.Phil.
Office of
Extramural Activities
National
Institute on Aging, NIH
Gateway Building, Room 2C218
7201
Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-9322
Fax:
(301) 402-2945
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.
PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted to Grants.gov on or after January 17, 2006 (i.e., the Open Date on Grants.gov) and must be
submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission
dates described in Section IV.3.A. If an application is not received
by that date, the application may be delayed in the review process or not
reviewed.
Upon receipt, applications will be transferred from Grants.gov to the
NIH Electronic Research Administration process for validation. Both the PD/PI and
the Signing Official for the organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.
Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this FOA that
is essentially the same as one currently pending initial merit review unless
the applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. This does not
preclude the submission of an application already reviewed with substantial
changes, but such application must include an Introduction addressing the
previous critique. Note such an application is considered a
"resubmission" for the SF424 (R&R).
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to
the assignment of an application to the Scientific Review Group is also in the Commons.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
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
or competing renewal (formerly competing continuation ) 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
or competing renewal 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
Instructions in
the Responsible Conduct of Research: Applications must include the student-PD/PI’s plans for
obtaining instruction in the responsible conduct of research, including the
rationale, subject matter, appropriateness, format, frequency and duration of
instruction. The amount and nature of faculty participation must be
described. No award will be made if an application lacks this component.
The application must include a transcript of the student's record to date in the doctoral program of which the dissertation is a part. The transcript should be placed in the Appendix.
The supervisor of the student principal investigator must submit a letter, co-signed by the dissertation chair, to be included with the application confirming that:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.
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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Plan for Sharing
Research Data
Not applicable
Sharing Research
Resources
Not applicable
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
submitted for this funding opportunity will be assigned to the NIA on the basis
of established PHS referral guidelines.
Applications that
are complete will be evaluated for scientific and technical merit by an
appropriate review group convened by the Division of
Extramural Activities, NIA in accordance with the review
criteria stated below.
As part of the initial merit
review, all applications will:
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. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that by its nature is
not innovative but is essential to move a field forward.
Significance: Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the student-PD/PI acknowledge potential problem areas and
consider alternative tactics?
Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?
Investigator/Mentor(s): Is the work proposed appropriate to
the experience level of the student-PD/PI? Are the supervisor/dissertation
chair and other doctoral committee members appropriately qualified to provide
guidance as needed? Have the supervisor/dissertation chair and any other
actively participating members of the committee indicated that they will
provide sufficient time to allow completion of the dissertation?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
2.A. Additional
Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed. See item 6 of the Research Plan component
of the SF424 (R&R).
Inclusion
of Women and Minorities in Research: The adequacy of plans to include
subjects from both genders, and all racial and ethnic groups (and subgroups) as
appropriate for the scientific goals of the research will be assessed. Plans
for the recruitment and retention of subjects will also be evaluated. See item
7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to be used in the project, the five items
described under item 11 of the Research Plan component of the SF424 (R&R)
will be assessed.
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.
Contribution to Diversity in the Research Workforce on Aging: The strength of the
descriptions in the supporting letters of the supervisor and one other
committee member of how this individual's advancement in research will
strengthen diversity either at the institution or nationally among researchers
focused on aging will be assessed.
Instruction in the Responsible Conduct of Research: Quality and appropriateness of proposed training in the responsible conduct of research.
2.B. Additional
Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
Period of
Support: The appropriateness of the requested period of support in relation to
the proposed research.
2.C.
Sharing Research Data
Not applicable
2.D. Sharing
Research Resources
Not applicable.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General.
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5., Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of the 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.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contact:
Robin A. Barr, D.Phil.
Office of
Extramural Activities
National
Institute on Aging, NIH
Gateway Building, Room 2C218
7201
Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-9322
Fax:
(301) 402-2945
Email: [email protected]
2. Peer Review Contact:
Mary Nekola, Ph.D., Chief
Scientific
Review Office
National
Institute on Aging, NIH
7201
Wisconsin Avenue
Suite 2C212
Bethesda, MD 20892-9205
Telephone:
(301) 496-9666
Fax:
(301) 402-0066
Email: [email protected]
3. Financial or Grants Management Contact:
Linda Whipp, Chief
Grants
and Contracts Management Office
National
Institute on Aging, NIH
7201
Wisconsin Avenue
Suite 2N212
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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).
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
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); 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 (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant
Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet addresses
(URLs) should not be used to provide information necessary to the review
because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.
Healthy People
2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA 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 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 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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