and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),
(http://www.niams.nih.gov).
Title: Skin Diseases Research Core Centers (P30)
Announcement Type
This is a reissue of RFA-AR-05-002.
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: April 10, 2008
Letters of Intent Receipt Date: June 2, 2008 - (Changed to June 26, 2008 per NOT-AR-08-002)
Application Receipt Date: June 27, 2008 - (Changed to July 25, 2008 per NOT-AR-08-002)
Peer Review Date: October-November 2008
Council Review Date: January
2009
Earliest Anticipated Start Date: April 1, 2009
Expiration Date: June
28, 2008 - (New Expiration Date July 26, 2008 per NOT-AR-08-002)
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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated
Start Dates
1.
Letter of Intent
B. Sending an Application
to the NIH
C. Application Processing
D. Application
Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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
Research in skin biology and diseases is at a stage where rapid advances
frequently require access to sophisticated technologies and specialized
areas of expertise that can be shared by multiple laboratories and are best
provided by research core centers. Areas of skin research of interest to
NIAMS that could benefit from shared core facilities include, but are not
limited to:
The choice of research area(s) upon which the Skin Diseases Research Core Center would focus is made by the principal investigator and collaborating currently funded investigators. However, research focused on advanced skin cancers, including metastasis and treatment, is not in the NIAMS research mission and should not be the research base for a Core Center. Any questions with regard to cancer relatedness should be directed for clarification to the Program Director.
The Skin Diseases Research Core Centers will provide support for:
An Administrative Core should be proposed to coordinate the Center and administer the program enrichment activities. Core Center Directors are encouraged to propose a broad research base that includes multiple disciplines, departments, and institutions. Two or more research cores must be proposed. A research core is a facility shared by two or more Center investigators that enables them to conduct their independently funded individual research projects more efficiently and/or more effectively. Cores generally fall into one of four categories: (1) provision of a technology that lends itself to automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, and genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, and mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, systems biology, bioinformatics, biostatistics, and clinical). Core Center Directors are encouraged to leverage existing resources, such as registries, tissue banks and cohorts, and to coordinate with NIAMS-funded Musculoskeletal and Rheumatic Diseases Cores at the same and/or other institutions, particularly if they provide similar or overlapping technologies and services.
A pilot and feasibility study program provides modest research support ($20,000 - $50,000 direct costs yearly) for a limited time (1 to 3 years) to enable eligible investigators to explore the feasibility of a skin biology or disease-related concept and amass sufficient data to pursue it through other funding mechanisms. The initial set of pilot and feasibility studies must be part of the application. In addition, a plan for program management of the pilot and feasibility program will also be reviewed. The plan must include review of future pilot and feasibility applications during the tenure of the Core Center.
An investigator is eligible to be a principal investigator of a pilot and feasibility study only once every 5 years in a Skin Diseases Research Core Center. Eligible investigators include:
1. New investigators without current or past NIH research project support (e.g., R01 or P01) as a principal investigator to engage in innovative research (see http://grants.nih.gov/grants/new_investigators/resources.htm#definition for the definition of a new investigator). In addition, they should not have extensive research experience. However, although investigators should be clearly independent, with clear potential to be a productive independent investigator, they do not need to have a faculty appointment. Serving as a PI of a pilot and feasibility project will not change one’s status as a new investigator.
2. Established investigators with no previous work in research related to the focus of the Core Center who are willing to test the applicability of their expertise on a problem related to skin disease; and
3. Established investigators in the Core Center with a proposal for testing the feasibility of a new or innovative hypothesis that is related to the research focus of the Core Center, but represents a clear and distinct departure from the investigator's ongoing research interest.
Applicants from institutions that have a General Clinical Research Center (GCRC) or Clinical Translational Science Award (CTSA) funded by the NIH National Center for Research Resources may wish to identify the GCRC/CTSA as a resource for conducting the proposed research. Details of the interactions of the Core Center staff with the GCRC/CTSA staff and/or research personnel may be provided in a statement describing the collaborative linkages being developed. A letter of agreement from the GCRC Program Director or CTSA Principal Investigator must be included with the application.
Research Core Center Guidelines where application requirements are described in more detail can be found at http://www.niams.nih.gov/Funding/Funding_Opportunities/sdrcwww.pdf.
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 will use the P30 award mechanism(s).
The Project Director/Principal Investigator (PD/PI)
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
Future year amounts will depend on annual appropriations. Although the financial plans of the IC(s) 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.
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 institutions are not eligible to apply.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.
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
Previous Skin Diseases Research Core Center applicants may submit in response to this FOA, but will be
considered a new applicant.
Renewal applications will be permitted for this FOA.
Any institution or consortium with an active program of excellence in both basic and clinical biomedical research in skin diseases may qualify for support through a Skin Diseases Research Core Center. Only one application may be submitted per institution.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application instructions are available
at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative agreements.
The D&B number can be obtained by calling (866) 705-5711 or through
the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the
PHS 398 form.
The title and number of this funding opportunity
must be typed in item (box) 2 only of the face page of the application form
and the YES box must be checked.
Application instructions and materials specific to the P30 grant mechanism are available at http://www.niams.nih.gov/Funding/Funding_Opportunities/activity_codes.asp#4&Research%20Programs%20and%20Centers%20(%20P%20).
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A). Submission
times N/A.
3.A. Receipt,
Review and Anticipated Start Dates
Letter of Intent Receipt Date: June
2, 2008 - (Changed to June 26, 2008 per NOT-AR-08-002)
Application Receipt Date: June 27, 2008 - (Changed to July 25, 2008 per NOT-AR-08-002)
Peer Review Date(s): October-November
2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April
1, 2009
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 IC 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:
Cheryl Lapham, Ph.D
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Division of Skin and Rheumatic Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301)594-5032
FAX: 301-480-4543
Email: clapham@mail.nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the forms found
in the PHS 398 instructions for preparing a research grant application.
Submit a signed, typewritten original of the application, including the
checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer
permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of submission, two
additional copies of the application and all copies of the appendix material
must be sent to:
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Division of Skin and Rheumatic Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301)594-4952
FAX: 301-480-4543
3.C. Application Processing
Applications must be received on or before the application receipt date described
above (Section IV.3.A.). If an application is
received after that date, the application may be delayed in the review process
or not reviewed. Upon receipt, applications will be evaluated for
completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be
reviewed.
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 the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/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. The Grants Policy Statement can be found at 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 renewal award if such costs: 1) are necessary to conduct the project,
and 2) would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval,
the grantee must obtain NIH approval before incurring the cost. NIH prior
approval is required for any costs to be incurred more than 90 days before
the beginning date of the initial budget period of a new or 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Applicants must follow application preparation instructions in the Research Core Center Guidelines. The Guidelines are available at:
PDF version: http://www.niams.nih.gov/Funding/Funding_Opportunities/sdrcwww.pdf
Word version: http://www.niams.nih.gov/Funding/Funding_Opportunities/sdrcwww.doc
Research Plan Page Limitations
The research component (consisting of the equivalent to Specific Aims, Background and Significance, and Research Design and Methods sections) of each individual Core or Pilot and Feasibility Project is limited to a maximum of 15 pages. In addition, the description of the Administrative Unit is also limited to 15 pages.
Additional information on page limits for each section of the application is available at:
PDF version: http://www.niams.nih.gov/Funding/Funding_Opportunities/sdrcwww.pdf
Word version: http://www.niams.nih.gov/Funding/Funding_Opportunities/sdrcwww.doc
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Unique research resources may be generated in a core of the proposed Skin Diseases Research Core Center. If this is anticipated, include (a) resource sharing plan(s) in the core proposal.
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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAMS and in accordance with NIH peer review procedures (http://grants.nih.gov/grants/peer/), using the review criteria stated below
As part of the scientific peer 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 meritorious priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, or preventative interventions
that drive this field?
Approach: Are the conceptual or clinical framework, design,
methods, and analyses adequately developed, well integrated, well reasoned,
and appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are
the investigators appropriately trained and well suited to carry out this
work? Is the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the investigative team bring complementary
and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the
work will be done contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence
of institutional support?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
Skin Diseases Research Core Center Leadership:
Do the Director and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (Director, Associate Director, and executive committee) have the collective expertise to assure focused development and implementation of high quality and meaningful research projects?
Research Base:
Is there a substantial productive and funded research base? Is the research base sufficiently broad to foster new research? Will the proposed cores enhance the research base? Is there a definition of who will be a Center investigator and what this designation might mean?
Institutional Environment and Resources:
Is there evidence of a supportive institutional environment for the proposed Core Center? Will the Core Center add an important research element to the institutional environment? Does the proposed Core Center utilize available resources well? Is there support and commitment from the institutional authorities?
Applications Seeking Competitive Renewal:
Does the progress report reflect significant accomplishments that were derived from the Core Center, especially as reflected in publications and new research directions?
Pilot and Feasibility Program Management:
Is the management proposed appropriate for soliciting, reviewing and prioritizing pilot and feasibility project applications and for mentoring investigators in this program?
Administrative Unit:
Research Cores:
Pilot and Feasibility Projects:
After the review of the individual components of the application, an application may be judged to be less meritorious than others under evaluation and not scored, or may be discussed and assigned an overall priority score. This score will reflect not only the individual quality of the cores, administration and pilot projects, but also the quality of the research base and how the proposed Core Center will enhance the research base. The overall score may be higher or lower than the average of the descriptors, based on the assessment of whether the whole is greater than the sum of its parts.
The following elements will be evaluated for the overall priority score:
1. The scientific excellence of the Core Center's research, since the existence of a base of established independently supported biomedical research of high quality is a prerequisite for establishment of a Core Center.
2. The application must convey how the proposed Core Center will significantly enhance the established research base of the host institution. In a competing continuation application, the application should document an impact of the Core Center. This includes the qualifications, experience, and commitment of the Core Center investigators. This also includes efficient and effective use and/or planned use of enrichment funds including the contribution of these activities in enhancing the realization of the Core Center concept.
3. The appropriateness, quality, and relevance of the proposed cores, and the modes of operation, facilities, and potential for contribution to ongoing research.
4. The proposed management of the pilot and feasibility program and the scientific merit of the pilot and feasibility projects for which funds are requested from the Core Center grant. The effectiveness of the proposed program will serve as a basis for recommendations concerning the level at which pilot and feasibility studies will be supported throughout the project period.
5. The overall environment for a Core Center. This includes the institutional commitment to the program, including lines of accountability regarding management of the Core Center, and the institution's partnership with the Core Center, and the institutional commitment to individuals responsible for conducting essential Core Center functions. This also includes the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools.
NIH considers the following in evaluating Center grant applications:
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 rating:
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
Research Plan section on Human Subjects in the PHS 398 instructions).
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 Research
Plan section on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five
points described in the Vertebrate Animals section of the Research Plan
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.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research. The priority score
should not be affected by the evaluation of the budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 (designated in item 12 on the Application
Face Page). If a grantee is not email enabled, a hard copy of the NoA
will be mailed to the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions
from potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Carl C. Baker, M.D. Ph.D.
Division of Skin and Rheumatic
Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301)594-5017
FAX: 301-480-4543
Email: bakerc@mail.nih.gov
Cheryl Lapham, Ph.D.
Division of Skin and Rheumatic
Diseases
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301)594-5032
FAX: 301-480-4543
Email: clapham@mail.nih.gov
2. Peer Review Contacts:
Toby Behar
Acting Chief
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Extramural Program
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 594-4952
FAX: (301) 402-2406
Email:
Toby_Behar1@nih.gov
3. Financial or Grants Management
Contacts:
Steve Austin
Grants Management Branch
National Institute of Arthritis and Musculoskeletal
and Skin Diseases
Extramural Program
6701 Democracy Boulevard, Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email: austins2@mail.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 (45CFR46) 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).
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/.
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 public 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).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 Requirement:
In accordance with the NIH Public Access Policy
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their
final, peer-reviewed manuscripts that arise from NIH funds and are accepted
for publication as of April 7, 2008 to PubMed
Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication.
As of May 27, 2008, investigators must include the PubMed Central reference
number when citing an article in NIH applications, proposals, and progress
reports that fall under the policy, and was authored or co-authored by the
investigator or arose from the investigator’s NIH award. 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 (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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information
necessary for 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 RFA 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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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