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 Minority Health and Health Disparities (NIMHD) (http://www.ncmhd.nih.gov)
Title: NIMHD
Comprehensive Centers of Excellence (P60)
Announcement Type
This is a reissue of RFA-MD-08-005
Update: The following update relating to this announcement has been issued:
Key Dates
Release
Date: February 4, 2011
Letters of Intent Receipt Date(s): March 14, 2011
Application
Receipt Date(s): (New Date May 16, 2011 per NOT-MD-11-005), Original Date: April 14, 2011
Peer
Review Date(s): May/June 2011
Council Review Date(s): (New Date January 2012 per NOT-MD-11-008), Original Date: October 2011
Earliest
Anticipated Start Date: (New Date April 2012 per NOT-MD-11-008), Original Date:December 1, 2011
Additional Information To Be Available Date (Url
Activation Date): Not
applicable.
Expiration Date: (New Date May 17, 2011 per NOT-MD-11-005), Original Date: April 15, 2011
Due Dates
for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(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
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3.
Reporting
Section VII. Agency 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
I. Research
Opportunity and Background
The National Institute on Minority Health and Health Disparities (NIMHD) Comprehensive Centers of Excellence (COE) program since its inception in 2002, provides support to academic institutions for the conduct of research independently or in formal partnership with one or more institutional partners, research training opportunities to students, researchers and junior faculty from health disparity populations, engagement in health promotion, and health information dissemination activities through established partnerships with community based organizations. This initiative provides opportunities to accelerate scientific knowledge by providing support for: 1) innovative multi- and trans-disciplinary research to promote minority health and to eliminate health disparities; 2) increasing the numbers of individuals from minority and other health disparity populations engaged in clinical research activities, including clinical trials, 3) research infrastructure and capacity building, 4) establishing or strengthening of exemplary research training/education activities for increasing the numbers of well trained researchers from minority and other health disparity populations; and 5) engaging minority and other health disparity communities in effective and sustainable activities for improving the health of their communities including increasing health literacy and knowledge of health disparities.
The NIMHD, guided by the NIH Strategic Plan and Budget for Eliminating Health Disparities and the findings of the historic 2008 NIH Summit: The Science of Eliminating Health Disparities, seeks to expand centers of excellence for health disparities and further accelerate extramural efforts to address a clear and pressing national issue of improving minority health and the elimination of health disparities. Between 2003 and 2006, health inequities were estimated to account for 30.6% of the direct medical care expenditures for African Americans, Asian Americans, and Hispanics. During that same period, the combined costs of health inequities and premature deaths in the United States rose to over 1.2 trillion dollars (Joint Center for Economic and Political Studies).
II. Objectives
The NIMHD Comprehensive COE grant award provides a means through which an institution or consortium of institutions can:
1) integrate and centralize ongoing minority health and health disparities research and related research-based activities into a single interdisciplinary and trans-disciplinary research enterprise;
2) establish novel effective partnerships with organizations and communities for conducting original and innovative cutting-edge research leading to improvements in minority health, the elimination of health disparities, or both;
3) develop, enhance or strengthen existing research training activities that prepare researchers from health disparity populations to conduct meritorious minority health and health disparities research; and
4) establish, enhance or strengthen community engagement/outreach and institutional partnerships for improving minority health and the health of health disparity populations.
III. Scientific Knowledge to be Gained
It is expected that the NIMHD COE program will produce advances in biomedical and behavioral knowledge that will be invaluable for improving minority health and for eliminating health disparities within and across the priority areas of cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity, as well as lung and liver diseases, psoriasis, scleroderma, and glomerular injury, and other diseases and conditions of public health importance. New knowledge is also expected to result from the competing renewal and continuation of research initiated under previous NIMHD COE support.
Healthy People 2010 identified the following six critical determinants of health: biology, behaviors, the social environment, the physical environment, policies, and access to care. It is expected that research conducted at an NIMHD COE will discover knowledge on the interactions of significant biological factors with behavioral and social variables, how they affect each other, and how these interactions influence and contribute to minority health conditions and health disparities. This new knowledge is expected to lead to the development of new interventions, strategies, policies and practices for improving minority health and eliminating health disparities.
In addition to the above, NIMHD anticipates that this program will contribute to increasing the number of individuals from health disparity populations: 1) trained to conduct minority health and health disparities research, 2) enrolling in clinical trials, and 3) engaged in improving the health of their communities though sustained partnerships and programs with NIMHD COE institutions.
IV. Examples of Research, Research Training/Education, and Community Engagement/Outreach Activities
An NIMHD Comprehensive COE should propose to conduct original and innovative basic laboratory, behavioral, clinical, or population based research directed toward improving minority health, eliminating health disparities, or both, in any of the following diseases or conditions: cardiovascular disease, stroke, cancer, diabetes, HIV/AIDS, infant mortality, mental health, and obesity or other disease or conditions of major public health importance. Research associated with lung and liver diseases, psoriasis, scleroderma, and glomerular injury is also encouraged when significant disparities for racial and ethnic populations and medically underserved populations are known to exist. Intervention research studies and intervention trials exploring multiple factors that cut across a single or multiple diseases or conditions are of interest. Translational research is strongly encouraged.
Applicants may want to consider the following research areas and themes when developing activities for the COE. These are examples and are not meant to suggest priority areas, nor are they comprehensive or restrictive.
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 P60 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
The estimated amount of funds available for support of 16-18 projects awarded as a result of this announcement is $24-26 million for FY 2012 with a maximum of $950,000 direct costs per year for a period of up to 5 years. Future year amounts will depend on annual appropriations.
Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the 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:
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 program support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of
Applications. Applicant institutions may not submit more than one application. For
institutions of higher education, separate institutions for purposes of this
FOA are entities governed by either different Chancellors or Presidents. An eligible institution may only submit a single application as
the sole or lead institution. If more than one application is received
identifying the same institution as the sole applicant or as the lead applicant
in a partnership or consortium, all applications from this institution may be
returned without review. The NIMHD strongly encourages collaboration of
various schools of multi-component institutions by joining together in the
submission of a single application. There are no limitations on the
number of inter-institutional partnerships an institution may establish. An applicant
may be the lead institution on one application and be a non-leading partner or
consortium member on another. However, duplicative costs are not allowed.
Applicants will be required to declare and resolve any real or potential
overlap issues prior to the making of an award.
Level of NIH Institutional Funding. To be eligible for establishing an NIMHD Comprehensive COE under this FOA, applicant institutions must have substantial existing federal research support and/or research infrastructure as reflected in a level of NIH institutional funding of more than or equal to $80 million at the time of application. If the NIH institutional funding level is less than this figure, the applicant institution is ineligible and should consider applying for the NIMHD Exploratory COE (P20) award (RFA-MD-11-002). See the following link maintained by the NIH Office of Extramural Research for determining the level of NIH funding for your institution, http://report.nih.gov/award/trends/FindOrg.cfm.
Current NIMHD Grantees. Current NIMHD COE, Research Infrastructure in Minority Institutions (RIMI), and Building Research Infrastructure and Capacity (BRIC) grantees with project periods which end in FY 2012 or FY 2013 are eligible to apply to this FOA. Prior to making a COE award to eligible applicants holding a current RIMI or BRIC award, NIMHD will negotiate the phasing-out of the existing RIMI or BRIC award. An institution, as defined by this FOA, cannot have more than a single NIMHD COE award nor have an active RIMI or BRIC award and a COE award at any one time.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are permitted in response to this FOA.
Compliance with Public Law 106-525 Criteria for Award Eligibility. There are specific eligibility criteria established by statute that must be satisfied in order to receive an award under this FOA. Pursuant to Public Law 106-525, awards under this program may only be made to institutions of higher education that meet the following criteria:
Section IV. Application and Submission Information
1. Address to
Request Application Information
The current 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
Prepare all
applications using the PHS 398 application forms and in accordance with the PHS
398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
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.
NIMHD Comprehensive Centers of Excellence (P60),
RFA-MD-11-003
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
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(s): March
14, 2011
Application Receipt Date(s): April 14, 2011
Peer Review Date(s): May/June 2011
Council Review Date(s): October 2011
Earliest
Anticipated Start Date(s): December
1, 2011
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:
Maryline
Laude-Sharpe, PhD
Office of Scientific
Review
Division of
Extramural Activities and Scientific Programs
National Institute on Minority Health & Health Disparities
National Institutes
of Health
6707 Democracy
Blvd., Suite 800, MSC 5465
Bethesda,
MD 20892-5465
Phone: (301) 451-9536
FAX:
(301) 480-4049
E-mail: mlaudesharp@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:
Maryline
Laude-Sharpe, PhD
Office of Scientific
Review
Division of Extramural
Activities and Scientific Programs
National Center on Minority Health & Health Disparities
National Institutes
of Health
6707 Democracy
Blvd., Suite 800, MSC 5465
Bethesda,
MD 20892-5465
Phone: (301) 451-9536
FAX:
(301) 480-4049
E-mail: mlaudesharp@mail.nih.gov
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.)
The NIMHD will not support more than three research subprojects during the 5 year project period.
Except under extenuating circumstances as discussed below, NIMHD funds may not be used to support any research project (regardless of the size of the budget or the length of the project period) that was not requested in the application, peer reviewed by NIH, and approved for funding by NIMHD at the time of award.
For example, a grantee may seek to replace a research project due to the departure of a PI from the institution. The institution must submit a written request, with sufficient justification, seeking to replace the current research project with a new research project and PI. Prior approval from NIMHD ensures that any applicable requirements for a change in scope or aims or deviation from award terms and conditions have been met. In such cases grantees are advised to discuss pending developments with the designated program official and grants management specialist.
6. Other Submission Requirements
Modify the PHS 398, starting with the Table of Contents, to include the following and in the following order:
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
Supplemental instructions for major areas:
The applicant must provide documentation addressing the Compliance with Public Law 106-525 - Criteria for Award Eligibility specified under Section III.3. (2-page maximum)
Description of the Proposed NIMHD Comprehensive Center of Excellence
I. Narrative Overview of the Proposed NIMHD Comprehensive Center of Excellence (12-page maximum)
Applicants must provide an overall description of the proposed COE. The scientific focus must be minority health, health disparities, or both. The description should also include, for example, the specific aims/goals and objectives, its mandatory cores, the type of research to be conducted, disciplines involved, disease/conditions, risk factors or determinants, etc. To the extent possible, discuss the expected improvement (such as a reduction in a disparity) over any relevant baseline for the proposed disease, condition, or significant activity. Describe the dedicated facilities to be utilized by the COE.
The NIMHD, through this FOA, will make a substantial investment in each COE and expects similar commitments of the institution(s) to the COE. Discuss and provide evidence (for example, a letter from the provost) of the institutional commitments to the center, including the recognition of the center as a formal organizational component, the provision of space, administrative, faculty and staff positions and discretionary resources, the authorities of the director; the status of the director in comparison to department chairs; institutional lines of authority, and responsibilities of institutional leaders to ensure the long-term stability (viability) of the center, and the plans for assuring the continued commitment of the center in the event of a change in directorship.
If establishing a partnership, discuss briefly the history of previous partnerships with the proposed partners, if any, and the rationale, scientific or geodemographic, for partnering. Describe what steps were taken to ensure that the partnership is equitable given the roles and responsibilities of each partner and how it will be sustained beyond the grant project period. Describe how the partnership was established, and describe the complementary institutional strengths and expertise; for example, strengths and expertise in basic, clinical, or population-based research, research training, community engagement, etc, as appropriate, that contribute to the likelihood that this partnership will achieve the proposed scientific goals and objectives and thereby make significant contributions to improving minority health or eliminating health disparities. Describe efforts that have been taken to ensure the success of the partnership generally and the steps taken to ensure that it is and will remain a true partnership throughout the course of the award. Describe the conflict resolution process that will be used to resolve conflicts between partners and or partnering institutions. Specifically address and justify the proposed distribution of essential resources and administrative responsibilities between the partnering institutions, organizations, faculty and staff. Describe any official letters of understanding established between the partnering institutions and any significant inter-institutional commitments. Applicants should decide what and how much is appropriate to include about the partnership in this section versus the administrative core.
II. Summary Progress Report - required for renewals only
Previously funded NIMHD COE must include a section with the above title and provide a progress report describing how the success of the center has been measured, what the center considers its most important successes and accomplishments and how these accomplishments have contributed to realizing the funded goals and objectives of the center. For example, describe significant scientific discoveries and successes, awards and additional grant funding obtained by NIMHD funded investigators, accomplishments in community outreach, dissemination, dissemination, and efforts towards the development of new and future health disparity researchers. Address successes in developing the capacity and the infrastructure of the institution to conduct health disparities research.
III. Administrative Core (12-page maximum)
Applicants should describe the administrative structure of the center and the roles and responsibilities of all key personnel. The administrative core is responsible for: 1) the allocation and oversight of all COE resources, 2) establishing and maintaining all partnerships, advisory and executive boards, cores, and research training and community activities essential to the success of the COE, 3) the selection of key personnel and the minority health or health disparities research to be conducted within the center, 4) establishing and overseeing the process for the initial solicitation, review, and selection and justification of the research projects and activities included in the application, and 5) for working with the local IRB(s) to ensure that all projects involving human subjects or vertebrate animal subjects are in full compliance at all times and that appropriate measures and safe guards are in place and utilized for ongoing data safety and data monitoring.
All NIMHD Comprehensive COE are expected to establish and maintain a website.
Additionally, through the efforts of the administrative core, each NIMHD COE is expected to become a valued, trusted, institution-wide resource for expanding the capacity and competence of the institution, and that of NIH funded researchers and students in conducting minority health and health disparities research. The center director is also expected to interact with the administrative leadership of the institution to enhance the success of the center, including its partners.
IV. Research Core (12-page maximum for the narrative description of the core) and Research Subprojects (12-page maximum for items 2-5 of research plan)
Within the research core
narrative describe the overall purpose, structure, function, and the
qualifications of the core director. Provide a brief description of the
proposed research projects.
An NIMHD Comprehensive COE application can not propose
more than three research subprojects.
Each research subproject will be reviewed on its own merit and must include all of the components (face page, project description, table of contents, etc.) described in the PHS 398 guidelines for research projects and adhere to all of the PHS 398 page limits and guidelines within. Do not exceed PHS 398 page limits for the research plan (items 2-5) of a given project. Include detailed budget pages for each project in the composite budget section and within each research project (do not use modular budgets) along with a narrative budget justification. Also include the role and responsibilities of all of the members of the research team. If an NIMHD COE subproject, previously or currently funded is continuing, provide a progress report. If multiple PD/PI will be designated, include a multiple PD/PI Leadership Plan.
Each research subproject must address a significant issue in minority health or health disparities. A single principal investigator or multiple co-investigators from the same or different institutions may conduct the proposed research. The research team can include senior and junior faculty, post-doctoral or other trainees, as well as community members, all with the appropriate justification. Expected improvements in health relative to an existing baseline measure for the health disparity population(s) under study should be provided when possible. For example, if the proposed research involves an intervention documented to be effective for only 50% of a given population, the applicant should make the case for increasing the effectiveness to 75%, and address the basis for the expected improvement.
Applicant institutions proposing human subjects research subprojects (including those meeting Exemption criteria) or subprojects involving vertebrate animals must complete the Protections of Human Subjects and/or the Vertebrate Animals section(s) of the PHS 398, as applicable.
No NIMHD funds may be used to support any research project (regardless of the budget or length of the project period) that was not peer reviewed by the scientific review group and approved for funding by NIMHD at the time of award.
In case of extenuating circumstances, such as the departure of a research project PD/PI from the institution, the grantee may submit a written request to NIMHD for the re-budgeting of allocated funds. When submitting such requests, the instructions specified in NOT-MD-08-002 must be followed.
V. Research Training/Education Core (12-page maximum)
Research training activities may be provided at the undergraduate, graduate, post-doctoral, or junior faculty level.
Undergraduate/Graduate Students. Research training components for students may include establishing academic term and/or summer research training opportunities. The enhancement of existing curricula to include subjects related to minority health and health disparities may be proposed. The development of curricula for preparing students to conduct research on minority health or health disparities is of special interest. For consortia arrangements, new research training programs might provide students the opportunity to fulfill their research requirements in research laboratories at the partner institution or to take courses not offered at the student’s home institution.
Post-Doctoral Research Training. Research training components may also support post-doctoral research training activities for individuals that have earned the doctorate degree or equivalent and who are from health disparity populations.
Health Disparity Population Faculty. Support for mentoring may be developed to provide assistance in learning new methodologies or to encourage faculty participation in minority health or health disparities research. Support for new faculty research positions to build capacity in biomedical and behavioral research and research training activities specifically addressing minority health or health disparities can be requested. Applicants must justify the position(s) relative to the goals and objective of the proposed COE.
The applicant institution and its partners must demonstrate or give reasonable assurances that it has the capacity to train predoctoral and/or postdoctoral students for careers in biomedical, behavioral, epidemiological or health services research. For partnerships and consortia, research training initiatives should represent true collaborations that function across institutional boundaries.
Training in the Responsible Conduct of Research. Every research trainee supported by the COE grant must receive instruction in the responsible conduct of research (see http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research.
Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the predoctoral research trainees appointed to the program.
Plans must address the subject matter of the instruction, the format of the instruction, the degree of training faculty participation, research trainee attendance, and the frequency of instruction.
The rationale for the proposed plan of instruction must be provided.
(Note: Stipends and payments made for educational assistance (e.g., scholarships, fellowships, and student aid costs) may not be paid from NIH research grant funds even when they would appear to benefit the research project. See the NIH Grants Policy Statement for allowable forms of student compensation, available at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm#_Toc54600125.)
VI. Community Engagement/Outreach Core (12-page maximum)
The mission of each Community Engagement/Outreach Core is expected to vary depending on the overall goals of the COE, the proposed research, and the needs and capabilities of the community and of the applicant institution. Ideally, activities within this core should contribute to improvements within the community and not simply provide a service. Improvements can be, for example, in health literacy, including knowledge of health disparities and ways to recognize, prevent, reduce or eliminate them. Activities that are service only will not be supported. All proposed activities must include a means of assessing the effectiveness and or efficacy of the activities. In disseminating health information to a minority or health disparities community, an applicant might seek to determine what dissemination methods are most effective in preventing, reducing or eliminating health disparities associated with a given disease and or condition. Is it important to disseminate health science research information in a culturally sensitive way? What fraction of the community actually uses the information? Applicants should describe how the use and effectiveness of the disseminated information would be measured. Accordingly, this core may focus on 1) how to access and build public trust, 2) how to engage the community for potential participation in clinical studies and clinical trials and for eventual partnering in the conduct of community-based health disparity interventions; and 3) how to engage the community in science education activities (e.g., K-12 science programs within area middle schools, high schools, or adult community groups) and assessing the effectiveness of these activities in contributing to improving minority health or the elimination of health disparities, or increasing the pool of researchers from health disparity and minority populations.
An NIMHD COE may request support for disseminating health information, as well as sponsor activities that encourage community participation in research as study participants or that equip community-based organizations for partnering in and/or conducting disease prevention and/or intervention activities. In particular, for information dissemination purposes, the audiences should include health care students and professionals, community-based organizations and researchers at the host institution as well as investigators at partnering institutions. Information transfer activities may include, but are not limited to activities such as research training programs, short research-related courses, telemedicine, presentations at professional meetings and publications. Applicants should address the expected effectiveness of the proposed activities and describe how the actual effectiveness of these activities will be measured and documented. .
With respect to equipping health disparity communities to develop and manage their own culturally sensitive programs for educating their populations and/or participating in prevention and intervention activities, the focus could be, for example, on addressing community level and individual risk factors for priority diseases and conditions, chronic disease management, screening, prevention, and decision making with respect to available therapeutics and behavioral interventions. Plans to evaluate the success and/or effectiveness of the proposed community outreach/information dissemination should be described. Activities for engaging the health provider community in improving minority health or eliminating health disparities at the local, regional or state levels should also be considered.
Applications which do not include a scope of the project that covers all required Core areas will be deemed incomplete and will not be forwarded for scientific review.
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. 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 should 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: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(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/.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Review Process
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 NIMHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The initial review for scientific and technical merit of applications will emphasize three major aspects: (1) the review of each mandatory core: administrative, research, research training/education, and community engagement/outreach; (2) the quality of the research projects within the research core; and (3) the review of the proposed Center as an effective platform for focusing on improving minority health, eliminating health disparities, or both, and its potential to favorably establish or enhance the fields of minority health or health disparities research at the institution.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are
potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. . For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. Resubmissions are not applicable to this FOA.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. Revisions are not applicable to this FOA.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
The ADMINISTRATIVE CORE will be evaluated with the following criteria:
Investigator: Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate, if different than the PI? Is there an appropriate time and effort commitment made by the Administrative Core Director? If applicable, is there evidence that the researchers and faculty of the partnering institutions have worked closely together in the preparation of the application or will do so in meeting the proposed objectives?
Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the project? Does the application describe how day-to-day management will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate? Are contractual and consortium arrangements adequately described if applicable? What is proposed for long-term management and periodic evaluation of goal attainment? If a partnership is involved, are the resources and responsibilities appropriately distributed and justified given the goal and objectives of the proposed COE? Does the grantee describe an effective process for resolving conflicts between the partners? Are plans in place to sustain efforts, partnerships, and relationships with engaged communities and community organizations past the proposed project period?
Environment: Is institutional commitment to the pursuit of minority health and health disparities research and other proposed activities, including provision of resources, administrative authority and recognition, convincing?
The RESEARCH CORE will be evaluated with the following criteria:
Investigator: Are the qualifications, experience, commitment and administrative competence of the Research Core Director appropriate? Is there an appropriate time and effort commitment made by the Research Core Director? Are there adequate plans for communication and cooperation among investigators?
Approach: Are the goals of the Research Core significant and explained in the context of potential to contribute to improving minority health, the elimination of health disparities, or both? Is there evidence that the applicant utilized an effective process for selecting the research projects submitted in the application? What are the quality control and oversight mechanisms in place for the proposed projects?
Environment: Are there appropriate plans for resource allocation? Does the scientific environment in which the work will be done contribute to the probability of success? If the research sites are not all located on a single campus, do the additional sites contribute to the probability of success?
The RESEARCH SUBPROJECTS within the RESEARCH CORE will be evaluated with the following criteria:
Significance: Does this study address an important minority health or health disparity problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? How will minority health be improved? Will a disparity be eliminated or significantly reduced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? For a continuing research project, has adequate progress been made in achieving the stated goals of the previously funded research?
Investigators: Are key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?
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?
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?
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? Has the applicant appropriately recognized, designed, and considered the role of culture and ethnicity for all proposed research and activities?
The RESEARCH TRAINING/EDUCATION, and COMMUNITY ENGAGEMENT/OUTREACH, will be evaluated with the following criteria:
Significance: Is there evidence that these cores will make significant contributions to the goals/specific aims of the COE? Will the proposed activities of the community engagement/outreach core contribute to the translation of research findings to the community? Does the community engagement core contribute increased health literacy, increased enrollment in clinical trials, and increased knowledge of health disparities and ways to identify, prevent, reduce, or eliminate them? Does the research training core contribute to increasing the number of individuals from health disparity populations engaged in research? Does the applicant’s plan provide adequate trainee instruction in the responsible conduct of research?
Investigator: Are the qualifications, experience, commitment and administrative competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Are there adequate plans for communication and cooperation among core participants?
Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the program? Do the proposed cores benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
Selection Process
The following will be considered in making funding decisions:
NIH considers the following in evaluating Center grant applications:
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.
Any
application awarded in response to this FOA will be subject to the DUNS, CCR
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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:
Dorothy Castille, PhD
Division
of Extramural Activities and Scientific Programs
National Center on Minority Health and Health
Disparities
Suite 800, MSC 5465
6707
Democracy Boulevard
Bethesda, MD 20892
Telephone:
(301) 594-9411
FAX:
(301) 480-4049
Email: castilled@mail.nih.gov
2. Peer Review Contacts:
Maryline Laude-Sharpe, PhD
Office of
Scientific Review
Division
of Extramural Activities and Scientific Programs
National Center on Minority Health and Health
Disparities
National
Institutes of Health
6707
Democracy Boulevard, Suite 800, MSC 5465
Bethesda, MD 20892-5465
Telephone:
(301) 451-9536
FAX:
(301) 480-4044
Email: mlaudesharp@mail.nih.gov
3. Financial or Grants Management Contacts:
Priscilla Grant, JD, CRA
Chief
Grants Management Officer
National Center on Minority Health and Health
Disparities
National
Institutes of Health
6707
Democracy Boulevard, Suite 800, MSC 5465
Bethesda, MD 20892-5465
Telephone:
(301) 594-8412
Fax:
(301) 480-4049
Email:
grantp@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).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule.
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 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-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In
accordance with the NIH Public Access Policy (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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations: This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 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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