and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating OrganizationsComponents
of Participating Organizations
National Center on
Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov/)
National
Cancer Institute (NCI) (http://www.nci.nih.gov )
Title: NCMHD Community-Based Participatory Research (CBPR) Initiative in Reducing and Eliminating Health Disparities: Intervention Research Phase (R24)
Announcement
Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-MD-07-003
Catalog
of Federal Domestic Assistance Number(s):
93.307, 93.393, 93.394, 93.395, 93.396, 93.399
Key Dates
Release
Date: May 30, 2007
Letters of
Intent Receipt Date(s): July
31, 2007
Application
Receipt Date(s): August 31, 2007
Peer
Review Date(s): October-November 2007
Council
Review Date(s): May 2008
Earliest
Anticipated Start Date(s): July 2008
Expiration
Date(s): September 1, 2007
Due Dates
for E.O. 12372
Not
Applicable
Additional Overview Content
Executive Summary
Table of Contents
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 and Review and Anticipated Start
Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency 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
The overall goal of the NCMHD Community-Based Participatory Research (CBPR) initiative is to support community-based participatory research in planning, implementing, evaluating and disseminating effective interventions for diseases disproportionately affecting racial and ethnic minority and health disparity populations with low socioeconomic status, the medically underserved populations, and those living in rural areas in the U.S. The goal of the CBPR initiative is to reduce and eventually eliminate health disparities through partnerships between heath disparity populations and researchers. This initiative will use the NIH resource -related research projects (R24) award mechanism.
The National Center on Minority Health and Health Disparities (NCMHD) is one of the 27 institutes/centers at the National Institutes of Health (NIH). It was organized in 2001 after the passing of the Public Law 106-525, the Minority Health and Health Disparities Research and Education Act of 2000. As stated in Section 485E of this law, the main mission of NCMHD is the conduct and support of research, training, dissemination of information and other programs with respect to minority health conditions and other populations with health disparities. NCMHD leads, coordinates, supports and assesses the NIH effort to eliminate health disparities. The NCMHD programs focus on expanding the nation’s ability to conduct minority and health disparities research, and to build a diverse, culturally-competent research workforce to eliminate health disparities. (http://www.ncmhd.nih.gov)
In this FOA, NCMHD is interested in supporting the development, implementation and evaluation of effective disease intervention research studies using community-based participatory research (CBPR) principles and methods to reduce and eventually eliminate health disparities in major diseases of public health importance which disproportionately affect racial and ethnic minorities, individuals with low socioeconomic status, the medically underserved populations, and those living in rural areas. Diseases of major public health importance may include cancer, cardiovascular disease, HIV/AIDS, diabetes, hepatitis B or other conditions of concern to the community.
The NCMHD CBPR initiative has three phases. It started with a three-year planning grant (first phase) in 2005 http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html. It will be followed by a competitive five-year intervention grant (second phase) which is the purpose of this current FOA. It will conclude with a competitive three-year dissemination grant (third phase). Receipt of a planning grant or intervention grant does not guarantee obtaining the subsequent intervention or dissemination grant. Subsequent grant awards will be based on scientific merit of the research, progress, quality of the research proposal, availability of funds, and other funding criteria listed in Section V (1) of this FOA.
In 2005, NCMHD issued the RFA-MD-05-002 http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html to invite applications for a three-year planning grant proposal. The first year of the planning grant was devoted to partnership development, community needs assessment, identifying the disease/condition for intervention research, and planning the intervention methodology with substantial input from the community. During the second and third year, a pilot disease intervention research study was conducted with community participation.
This FOA invites applications for a five-year intervention research grant proposal (second phase) using CBPR principles and methods. This FOA is open to current NCMHD CBPR planning grantees and other interested applicants. In order to be considered to be responsive to this FOA, applicants who are not current NCMHD CBPR planning grantees must demonstrate that they have fulfilled all the required activities outlined in the planning grant phase of this initiative. See RFA-MD-05-002 at http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html. This includes partnership development with the community, undertaking a community needs assessment, identifying the disease/condition for intervention research in collaboration with the community, and planning the intervention methodology with substantial input from the community. Subsequently, a pilot disease intervention research study should be developed with community partnership. Preliminary findings from the pilot intervention study must be submitted in this grant application. The responsiveness criteria are listed under Other Special Eligibility Criteria in Section III.3 of this FOA. The NCMHD program officials will use these responsiveness criteria in deciding if an application will be sent for further review by the Special Emphasis Review Panel.
The main focus of this FOA is the development, implementation and evaluation of an effective disease intervention(s) targeting one or more diseases of major public health importance; for example, cancer, cardiovascular disease, HIV/AIDS, diabetes, Hepatitis B, etc. affecting racial/ethnic minorities, populations with low socioeconomic status, the medically underserved populations, and those living in rural areas. The decision as to disease or condition of focus will have been made in partnership with the community. As noted above, the development, implementation and evaluation of the disease intervention(s) should use CBPR principles and methods.
The first year of this five-year intervention research grant is devoted to the development of the CBPR logic model/conceptual framework, research design and methodology for the implementation of the disease intervention(s), and the development of a rigorous evaluation plan. The second to fourth year will be the full implementation of the intervention(s) and evaluation study. Ongoing data analysis and interpretation with engagement of the community and scientific partners should continue throughout this process. The fifth year will be focused on evaluation of the effectiveness of the intervention(s), and planning the dissemination of the research findings to improve the health conditions in the target communities/populations.
In the NIH Health Disparities Strategic Plan, Fiscal Years 2004-2008, the health disparity populations are the racial and ethnic minority groups delineated within Section 1707(g), Public Law 106-25, as well as populations with low socioeconomic status and those living in rural areas. The racial and ethnic minority groups refer to American Indians (including Alaska Natives, Eskimos, and Aleuts), Asian Americans, Native Hawaiians and other Pacific Islanders, Blacks and Hispanics. Hispanics are individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or any other Spanish-speaking country. The other health disparity populations are population groups who suffer health disparities when compared to the general population. (http://www.ncmhd.nih.gov/)
Community-based participatory research (CBPR) is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions to communication of results). CBPR is characterized by substantial community input in the development of the grant application (http://www.niehs.nih.gov/translat/cbpr/cbpr.htm).
For the purpose of this FOA, community refers to populations that may be defined by: geography, race, ethnicity, gender, illness or other health condition, or to groups that have a common interest or cause, such as health or service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with public health concerns. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community.
Successful partnership between researchers and community members and developing a plan for disease intervention research, based on a pilot intervention research study with preliminary data using CBPR principles and methods, are required for participating in this application.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
For more information about CBPR, review the following major references:
Methods in Community-Based Participatory Research for Health. Barbara Israel, Eugenia Eng, Amy Schulz, Edith Parker, Editors. Jossey-Bass, San Francisco, 2005.
Community-Based Participatory Research for Health. Meredith Minkler & Nina Wallerstein, Editors. Jossey-Bass, San Francisco, 2003.
Community-Based Participatory Research: Assessing the Evidence. Viswanathan M, Ammerman A, Eng E, et al. Evidence Report/Technology Assessment No. 99. AHRQ Publication 04-E022-2. Rockville, MD: Agency for Healthcare Research and Quality. July 2004. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1a.chapter.44133. A summary of this report is available at: http://www.ahrq.gov/clinic/epcsums/cbprsum.htm.
CBPR guidelines for reviewers and applicants are available as Exhibits 1-2 under Evidence-Based Practice, EPC Reports and Publications, at http://www.rti.org/
Successful Models of Community-Based Participatory Research (2000). O'Fallon, L., Tyson, F., and Dearry, A. (Editors), National Institute of Environmental Health Sciences: Research Triangle Park, NC. Available at: http://www.niehs.nih.gov/translat/cbr-final.pdf.
Institute of Medicine (2000). Promoting Health Intervention Strategies from Social and Behavioral Research. Smedley, B.D. & Syme, L., Editors. National Academy Press: Washington DC.
1. Mechanism(s) of Support
This funding opportunity will use the NIH resource- related research projects (R24) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
By using the R24 mechanism, the NIH seeks to support research projects that will enhance the conduct of biomedical research through the development of infrastructure or resources. It also seeks to foster the introduction of novel scientific ideas, techniques, models, tools, agents, targets, methodologies, technologies, and applications that have the potential to substantially advance biomedical, behavioral and clinical research on health-related topics.
This funding opportunity uses just-in-time concepts. Just-in-time (JIT) refers to information that NIH requests after an application has been peer reviewed and is within the range of funding. It also uses the non-modular budget format. Please follow the instructions for non-modular research grant applications in the PHS application instructions. (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the Initial Budget Period and the Entire Proposed Period of Support is to be submitted with the application. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.
R24 applications must request a project period of up to five years with a budget for direct costs of up to $400,000 per year for the five-year period. The request should be tailored to the needs of your project.
2. Funds Available
The National Center on Minority Health and Health Disparities intends to commit approximately $12 million dollars in FY 2008, to fund approximately 20 grants in response to this FOA. New and/or competing continuation grants responding to this FOA may request a project period up to 5 years and a budget for direct costs of up to $400,000 per year. The anticipated start date is July, 2008.
It is important to note that because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plan of the NCMHD provides support for this program, awards are contingent upon the availability of funds, the receipt of a sufficient number of meritorious applications and other funding criteria listed in Section V.1. NCMHD will use the review criteria outlined in Section V.2 and Section V.2.A. in making its funding decisions.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
To be responsive to this FOA, eligible institutions/organizations must have experience working with minority and health disparity populations in the United States. These institutions/organizations must demonstrate history and/or evidence of partnerships between community-based organizations and academic research institutions. Evidence of partnerships may include current or previous research collaborations. A Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) should clearly delineate the roles and responsibilities of the collaborating individuals and organizations/institutions.
The partnerships must demonstrate evidence of community-based participatory research planning activities including pilot intervention studies with preliminary data as outlined in RFA-MD-05-002 http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html which was issued in 2005 for the research planning phase of the NCMHD CBPR initiative.
Additional responsiveness criteria are listed in Section III.3 under Other-Special Eligibility Criteria. Non-responsive applications will not be reviewed. Foreign organizations are not eligible. Collaborators at foreign organizations are not allowed.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed community-based participatory research is invited to work as Principal Investigator (PI) with his or 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 programs.
Eligible individuals must have experience working with health disparity populations. These individuals must demonstrate history and/or evidence of partnerships between community-based organizations and academic research institutions. Evidence of partnerships may include current or previous research collaborations. A Memorandum of Agreement (MOA) or Memorandum of Understanding (MOU) should clearly delineate the roles and responsibilities of the collaborating individuals and organizations/institutions.
The partnerships must demonstrate evidence of research planning activities including pilot intervention studies with preliminary data as outlined in RFA-MD-05-002 http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html which was issued in 2005 for the research planning phase of the NCMHD CBPR initiative.
Additional responsiveness criteria are listed in Section III.3 under Other-Special Eligibility Criteria. Non-responsive applications will not be reviewed.
2. Cost Sharing or Matching
Cost sharing is not required.
3. Other-Special Eligibility Criteria
NCMHD will review the responsiveness of the applications based on the research planning activities described in RFA-MD-05-002 issued in 2005 for the research planning phase of the NCMHD CBPR initiative, see http://grants2.nih.gov/grants/guide/rfa-files/RFA-MD-05-002.html. Non-responsive applications will not be reviewed.
The responsiveness criteria include:
Current NCMHD CBPR Planning grantees and Excellence in Partnerships for Community Outreach, Research on Health Disparities and Training (Project EXPORT) grantees are eligible to apply. In addition, other qualified institutions meeting the requirements for responsiveness (as outlined in Section III.1a and Section III.3 of this grant application) are eligible to apply. A list of current NCMHD CBPR Planning grantees and Project EXPORT grantees is located at: http://www.ncmhd.nih.gov/.
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: [email protected]. For general information on NIH grant application, see the website http://grants2.nih.gov/grants/outreach.htm.
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 on line 2 of the face page of the application form and the YES box must be checked.
The following elements should be included within the 25-page limit of the research plan in the applications submitted in response to this announcement:
A. Specific Aims State the disease intervention research questions/ study aims.
B. Background and Significance
B1. Literature Review- Provide a brief literature review and significance of the proposed disease intervention research to be undertaken.
B1. Demographic and Epidemiological Data- Provide epidemiological data on the disease selected for the community who will participate in the research. It will serve as baseline data for the evaluation of the proposed disease intervention research project.
B2. Conceptual Framework - Describe a CBPR logic model/conceptual framework which will guide the development of the research design and methodology.
C. Preliminary Studies
C1. Research Planning Activities- Describe the required research planning activities of the academic and community partnerships as outlined in Section III.3 of this FOA.
C2. Pilot Intervention Study- Provide the preliminary data and findings of your pilot intervention study(s) conducted in this community using the CBPR approach.
C3. Qualifications of Key Partners- Describe the skills and experiences of the scientific and community partners including history and evidence of research collaboration.
D. Research Design and Methods
D1. Study Design and Methods- Provide research hypotheses, study design, sample size, power calculations, study participants recruitment and retention plan, and data analysis plan. A combination of quantitative and qualitative research methods may be used in the study.
D2. Evaluation Plan- Provide a rigorous process and outcome evaluation plan.
D3. Community Participation- Describe how community partners are actively engaged throughout the study.
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.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, interested applicants are highly encouraged to submit these letters. The information that it contains alerts the NCMHD program official if there will be more than one application from the same institution. The NCMHD program official will immediately inform applicants to avoid duplication of efforts of applicants from the same institution. It also allows NCMHD staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Francisco
S. Sy, MD, DrPH
Chief,
Office of Community-Based Participatory Research and Outreach
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 six copies
of the appendix material must be sent to:
Lorrita
Watson, Ph.D.
Director, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Center on Minority Health and Health Disparities. Incomplete and 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.
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 http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).
Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
continuation award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing continuation 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
Plan for
Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All
applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All
investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of
the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of
the resources sharing plan and any related data sharing plans will be
considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
The review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
2. Review and Selection Process
Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR). Responsiveness will be evaluated by NCMHD program staff using the criteria listed in Section III.3 Other Special Eligibility Criteria . Incomplete and/or non-responsive applications will not be reviewed.
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCMHD in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Special guidelines for the review of CBPR applications include the applicant's ability to incorporate the following elements:
1. 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?
2. Approach. Are the CBPR logic model or conceptual 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?
3. 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?
4. 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)?
5. 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?
6. Translation
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
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 E on Human Subjects in the PHS Form 398).
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).
NOTE: Randomized trials
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions 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. Sharing Research Data
Data
Sharing Plan: The reasonableness of the data sharing plan or the rationale for not
sharing research data will be assessed by the reviewers. However, reviewers
will not factor the proposed data sharing plan into the determination of
scientific merit or the priority score. The presence of a data sharing plan
will be part of the terms and conditions of the award. The funding organization
will be responsible for monitoring the data sharing policy. See http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement
and Award Dates
July 2008
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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).
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Francisco
S. Sy, MD, DrPH
Chief, Office of Community-Based Participatory Research and Outreach
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]
Kenneth Chu, Ph.D.
Disparities Research Branch
Center to Reduce Cancer Health Disparities National Cancer
Institute
6116 Executive Boulevard, Room 602, MSC 8341 Bethesda, MD 20892-8341
(for
U.S. Postal Service express and regular mail) Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8589
Fax: 301-435-9225
Email: [email protected]
2. Peer Review Contacts:
Lorrita
Watson, Ph.D.
Chief, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd., Suite 800
MSC 5465
Bethesda, MD 20892-5465
Telephone:
(301) 402-1366
FAX: (301) 480-4079
Email: [email protected]
Financial or Grants Management Contacts:
Priscilla
Grant, JD
Chief Grants Management Officer, Office of Extramural Activities
National Center on Minority Health and Health Disparities
National Institute of Health
6707 Democracy Boulevard, Suite 800, MSC 5465
Bethesda, MD 20892
Telephone: (301) 402-1366
FAX: (301) 480-4049
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use
of Animals in Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations
(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. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
Access to Research
Data through the Freedom of Information Act:
The Office of Management
and Budget (OMB) Circular A-110 has been revised to provide access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with Federal funds and (2) cited publicly and officially by a Federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement 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:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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 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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