Please note the following amendments were made to this FOA on Wednesday, August 20, 2008:
1. Additional instructions on the format, content, and budget were added to Section IV. Application and Submission Information, 2. Content and Form of Application Submission.
2. A descriptive title of the anticipated proposed core research project or pilot study is being requested in the LOI in Section IV. Application and Submission Information, 3.A.1. Letter of Intent. Applicants are to submit only one research proposal using CBPR.
3. Additional instructions on the contents of a complete application packet were added to Section IV. Application and Submission Information, 3.B. Submitting an Application to CDC.
4. Additional information was added to the Appendix Instructions in Section IV. Application and Submission Information, 6. Other Submission Requirements.
5. Clarification on the initial merit review of applications was added to Section V. Application Review Information, 2. Review and Selection Process.
Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (NCCDPHP/CDC), at http://www.cdc.gov/nccdphp/
Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/
Components of Participating Organizations
Coordinating Center for Health Promotion (CoCHP), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), at http://www.cdc.gov/nccdphp/
Title: Health Promotion and Disease Prevention Research Centers (U48)
The policies,
guidelines, terms, and conditions of the HHS Centers for
Disease Control and Prevention (CDC) stated in this
announcement might differ from those used by the HHS
National Institutes of Health (NIH). If written guidance
for completing this application is not available on the CDC
website, then CDC will direct applicants elsewhere for that
information.
Authority:
Section 1706 of the Public Health Service Act (PHS Act), 42
U.S.C. 300u-5, as amended.
Announcement Type: New
Funding Opportunity Announcement (FOA) Number: RFA-DP-09-001
Catalog of Federal Domestic Assistance Number: 93.135
Key Dates
Release/Posted
Date:
August 1, 2008
Earliest Anticipated Start Date: September 30, 2009
Additional Information to Be Available Date: Category 1 Applicants: Tuesday, August 12, 2008, 3:30 PM (ET), Category 2 Applicants: Thursday, August 14, 2008, 3:30 PM (ET)
Expiration Date: Add Information Here
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
·
This FOA will support a network of Health Promotion and Disease Prevention Research Centers (PRCs) that: 1) focuses on the major causes of disease and disability, with an emphasis on underserved and minority populations; 2) improves public health practice through community-based participatory research; and 3) designs, tests, disseminates, or translates effective public health programs at the state and community levels. This FOA will fund PRCs in academic health centers in two categories: 1) centers with a comprehensive organizational infrastructure, strong community collaborations, and plans in place with their partners to conduct a community-based participatory core research project; and 2) centers that need to develop infrastructure or community relationships in order to develop and implement a pilot research study. The funding provided through this FOA will support the center’s key elements of infrastructure and administration, community engagement and partnerships, communication and dissemination, training, evaluation, and· The participating organization intends to commit a total of $25,000,000 in FY 2009 to this FOA.
· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
· Anticipated number of awards to be issued under this FOA: up to 33·
It is anticipated that the size of each award will vary. The total amount awarded will depend upon the category, quality, and costs of the applications received.·
Budget Period, Project Period, and Award Amounts: The award range for the first 12-month project period is $700,000 - $1,000,000 (total costs) for Category 1 awards and $300,000 - $500,000 (total costs) for Category 2 awards. The total project period for applications submitted in response to this FOA may not exceed five years. · Eligible Organizations: Academic health centers that meet the eligibility criteria stated in Section 1706 of the Public Health Service Act, 42, U.S.C. 300u-5 and as listed in this FOA.·
See Section IV.1 for application materials. The PHS 398 Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/phs398/phs398.doc (MS Word); http://grants1.nih.gov/grants/funding/phs398/phs398.pdf (PDF).·
For general information on the PHS 398 Application and Submission, see the following Web site: http://grants1.nih.gov/grants/funding/phs398/phs398.html.·
HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview
Information
Part II Full Text
of Announcement
Section I.
Funding Opportunity Description
1. Research
Objectives
Section II. Award
Information
1. Mechanism
of Support
2. Funds
Available
Section III.
Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
2.Cost
Sharing or Matching
3.Other -
Special Eligibility Criteria
Section IV.
Application and Submission Information
1. Request
Application Information
2. Content
and Form of Application Submission
3. Submission
Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Submitting an Application to CDC
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
A.
Cooperative Agreement
1.
Recipient Rights and Responsibilities
2.
HHS/CDC Responsibilities
3.
Collaborative Responsibilities
3. Reporting
Section VII.
Agency Contact(s)
1.
Scientific/Research Contact
2. Peer
Review Contact
3.
Financial/Grants Management Contact
4. General
Questions Contact
Section VIII.
Other Information - Required Federal Citations
Section IX.
Application Evaluation Criteria
1. Category 1
A. Center Review Criteria – Key Elements
B. Core Research Project Review Criteria
2. Category 2
A. Center Review Criteria – Key Elements
B. Core Research Project Review Criteria
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA supports the “Healthy People 2010” overarching goals of increasing quality and years of healthy life and eliminating health disparities in the focus areas of arthritis, osteoporosis, and chronic back conditions; cancer; diabetes; disabilities and secondary conditions; educational and community-based programs; environmental health; family planning; health communication; heart disease and stroke; nutrition and overweight; physical activity and fitness; sexually transmitted disease; tobacco use; and vision and hearing. This FOA is also in alignment with NCCDPHP’s performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions. For more information see, www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.
Nature of the Research Opportunity
This FOA will support a network of Health Promotion and Disease Prevention Research Centers (PRCs) that: 1) focuses on the major causes of disease and disability, with an emphasis on underserved and minority populations; 2) improves public health practice through a community-based participatory research process; and 3) designs, tests, disseminates, or translates effective public health programs at the state and community levels. Funded centers will involve researchers, representatives from state and local health departments, community members, and public health professionals as collaborating partners to utilize available resources and expand each other’s capacity for conducting applied research in disease prevention and control. They will also function as a part of a networked environment to support and advance health promotion and disease prevention research and serve as a national resource for developing and applying effective public health programs at the state or community level.
Background
The establishment of centers for research and demonstration of health promotion and disease prevention was authorized by Congress in 1984 by Public Law 98-551. Congress mandated that the centers be located at academic health centers capable of providing multidisciplinary faculties with expertise in public health, relationships with professionals in other relevant fields, graduate training and demonstrated curricula in disease prevention, and a capability for residency training in public health or preventive medicine. This legislation was supported by the Association of Schools of Public Health which viewed the PRC Program as a way to enhance health promotion activities by fostering better linkages between the schools of public health and the public health practice community and between academia and CDC. CDC was selected to administer the Prevention Research Centers (PRC) Program and to provide leadership, technical assistance, and oversight.
The PRC Program is now the largest extramural research program supported by CDC. It is comprised of 33 academic research centers that are associated with schools of public health or medicine in 26 states across the country. In accordance with the 1984 legislation, the PRCs conduct research in health promotion, disease prevention, and methods of appraising health hazards and risk factors. They also serve as demonstration sites for the use of new and innovative research in public health techniques to prevent chronic diseases.
In addition to conducting core research, the PRCs work with partners on Special Interest Projects (SIPs), as well as projects funded through other sources, as a way to increase the center’s research activities. The partnerships and expertise each PRC builds strengthens its competitiveness for additional funding by federal agencies and private foundations. The SIP mechanism, created in 1993, allow the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies that want to utilize their resources to fund research that promotes better public health practice in specific areas. As a result, the PRCs’ research portfolio can include approximately 400 projects at any given time.
Prevention research includes all applied and public health research that develops and evaluates health promotion and disease prevention and control strategies that are community- and population-based. It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary, secondary, or tertiary prevention; or may improve health and prevent disease through approaches that involve changes to individual behavior, policy or environmental structure, health systems, or socio-economic factors. Prevention research may provide initial evidence of the efficacy or effectiveness of a health promotion or prevention strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice-based strategy. It may also include etiological research if there is a clear gap in the knowledge about main determinants of the disease or conditions.
In 1995, CDC asked the Institute of Medicine (IOM) to review the PRC Program to examine the extent to which the program is providing the public health community with workable strategies to address major public health problems in disease prevention and health promotion. Their report, Linking Research and Public Health Practice: A Review of the CDC’s Program of Centers for Research and Demonstration of Health Promotion and Disease Prevention (1997), identified areas of strengths and areas needing improvement. Two major recommendations from the IOM review were that the PRC Program adopt a community-based approach to their research and dissemination efforts and develop strategies to improve community input into the PRCs. While PRCs collaborated with their communities before the 1997 IOM report, the PRC Program formally integrated Community-Based Participatory Research (CBPR) into its expectations for each PRC’s prevention research activities.
The PRC Program defines CBPR as “a joint effort that involves researchers and community representatives in all phases of the research process. The joint effort engages community members, employs local knowledge in the understanding of health problems and the design of interventions, and invests community members in the processes and products of research. In addition, the collaborative is invested in the dissemination and use of research findings to improve community health and reduce health disparities.” CBPR alters the traditional relationship between researchers, the community, and research participants such that there is shared decision-making as well as mutual ownership of the research process and products. The importance of CBPR is based on the assumption that if the community is involved in setting research questions, gathering and analyzing data, and interpreting results, they are more likely to apply the results.
CDC seeks to improve health and to do so in economically responsible ways. The PRC Program, with its access to a wide array of public and professional audiences, is uniquely positioned to promote cost effective prevention strategies that are relevant to the U.S. population. In the 1999 report, An Ounce of Prevention….What are the Returns?, CDC outlined 19 strategies that demonstrated the economic benefits of population-based, prevention strategies. Smoking, for example, is the leading cause of preventable death in the United States. Smokers incur between $9,000 - $10,000 more in medical care costs over their lifetime than nonsmokers. Brief advice and counseling by a physician about quitting smoking costs $705 to $2,058 per life-year gained depending on the person’s gender and age. Other strategies, such as increasing physical activity, may promote healthy lifestyles. Coronary heart disease, for example, is the leading cause of death in the United States accounting for over 500,000 deaths annually. Total direct care and lost productivity due to coronary heart disease cost the United States $90.9 billion in 1997 while increasing physical activity cost only $3,433 per life-year gained.
Since its inception, the CDC PRC Program has made substantial progress in improving the quality of people’s lives by preventing disease, injury and disability. The network of PRCs has served as a national resource for developing and applying effective prevention strategies at the community level and has been in the forefront of developing and practicing CBPR. Through scientific rigor, collaborative partnerships, practical application, and community participation the PRC Program will continue to strive to find new ways to improve the health of all Americans.
Scientific Knowledge to be Achieved through Research Supported by this Program
As the US population ages and health care costs increase, prevention becomes even more critical to the national health care agenda. Many chronic diseases, injuries, and some infectious diseases are caused by behavioral and environmental factors that can be changed. Prevention research is critical to helping people change risk factors in their lives and their communities. The gaps between findings in prevention research and their translation into public health programs, practice, and policy must be eliminated so that new knowledge is effectively applied in states and communities throughout the country.
This FOA will support academic health centers to build on the strong achievements of the PRC Program to date and to further advance the program’s mission and research activities. It is anticipated that the network of PRCs supported by this FOA will continue to conduct innovative and important studies in prevention research that are relevant for communities and that will result in improved health for people across the United States.
The PRC model involves researchers, community members, representatives from state and local health departments, and public health professionals as equal collaborating partners to utilize available resources and expand each other’s capacity to address health issues. The partners design, test, and disseminate strategies—often as new policies or recommended public health practices. Centers share a common goal of addressing behaviors and environmental factors that contribute to chronic diseases that affect the health of individuals, such as cancer, heart disease, and diabetes, and that impact communities. Several PRCs also address injury, infectious disease, mental health, oral health, and global health. In efforts to eliminate health disparities and create healthy communities, the PRCs will remain at the forefront in advancing CBPR and sharing knowledge and expertise in applied research aimed at improving public health programs.
Experimental Approach and Research Objectives
The intent of
this FOA is to support a network of PRCs in academic health
centers across the country that will conduct health
promotion and disease prevention research that focuses on
the major causes of death and disability, improves public
health practice within communities, and cultivates effective
state and local public health programs. The funding
provided through this FOA will support the center’s
infrastructure and at least
one a
CBPR project.
As national leaders in health promotion, disease prevention, and CBPR, the academic health centers that comprise the PRC network must demonstrate: 1) elements of an infrastructure and environment to lead and advance public health research, and 2) the ability to conduct CBPR research aimed at eliminating health disparities and creating healthy communities. This FOA solicits applications from academic health centers to fund PRCs in two categories:
Category 1: Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.
Category 2: Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.
Key Elements of Prevention Research Centers
Each PRC is expected to have appropriate and effective administrative and organizational capabilities to conduct a core research project using CBPR and to plan, manage, and evaluate center activities. Key elements of a PRC include infrastructure and administration, community engagement and partnerships, communication and dissemination, training, and evaluation. Proposed approaches, methodologies, and tools within these key elements should support a comprehensive, effective, and efficient PRC.
Academic health centers should provide a supportive institutional environment that engages a wide spectrum of disciplines to support the activities of the PRC and their core research project. The environment should foster research excellence, support methodological innovation, facilitate multidisciplinary collaborations and coordination of efforts, and encourage relationships with outside agencies and entities as appropriate to facilitate planned research.
Category 1 applicants are expected to have a comprehensive organizational infrastructure and leadership model with experience supporting multidisciplinary prevention research and have a defined partner community. In addition, they must have a solid history of experience in CBPR activities that include communication and dissemination, training, and evaluation. Category 1 institutions should be able to implement innovative, high-quality prevention research that is consistent with the PRC Program.
Category 2 applicants must demonstrate an environment and the availability of resources to support the development of a comprehensive center capable of leading CBPR and related endeavors. The center should have the capability to support long-range planning and implementation of PRC key element activities in community engagement and partnerships, communication and dissemination, training, and evaluation. Evidence of the institutional commitment to the PRC Program, its mission, and goals should be clear and convincing.
Each year, PRCs funded under this FOA will be eligible to compete for SIP supplemental funding to design, test, and disseminate effective prevention research strategies in specific areas sponsored by CDC and other HHS agencies. The SIP mechanism is designed to maximize the expertise and resources offered by each center and the PRC network as a whole. Funded PRCs are encouraged to apply for SIPs that will expand and strengthen the center’s mission and increase their research activities.
Many of the activities of the PRCs complement National Institutes of Health (NIH)-funded institutions conducting activities under RFA RM08-002 Institutional Clinical and Translational Science Award (CTSA). PRCs in academic health centers with CTSAs are strongly encouraged to work collaboratively on shared goals and priorities and to foster an innovative, synergistic approach to advancing health promotion, disease prevention, and CBPR.
PRC Core Research Projects
Each PRC will conduct a core research project in health promotion and disease prevention research that bears an essential relationship to the PRC’s mission and the community and that efficiently uses and contributes to the center’s resources.
Institutions
funded under Category 1 are expected to conduct
at least one
a high quality core
prevention research project using CBPR. Utilizing
appropriate research design and methods, each PRC funded
under Category 1 is expected to implement a determinant,
intervention, or dissemination research project. Research
activities may include: 1) hypothesis testing research on
causality of diseases and conditions, 2) efficacy or
effectiveness of interventions, or 3) translation,
implementation, or evaluative studies. Intervention or
dissemination research projects are encouraged, when
appropriate, to identify or modify an existing
evidence-based or practice-based intervention for
implementation within or dissemination to a different
setting (e.g., community-based rather than clinic based) or
population. Practice-based interventions must have
undergone sufficient implementation to be proven acceptable
by the community, sustainable due to evidence of appropriate
partnerships and available resources, and likely effective.
Category 1 applicants may propose a core research project
that develops a new intervention; however, a rationale for
doing so must be provided that demonstrates that no
applicable intervention exists, there is a gap in the
literature, and that a need for it exists in the community.
Applicants that propose a core research project that is
dissemination research need to demonstrate that there is
evidence behind the intervention and that the results will
include information and guidance for implementation of the
intervention by other agencies, organizations, or
communities.
Institutions funded under Category 2 are expected to develop and implement a pilot study using CBPR that will form the basis for a determinant, intervention, or dissemination research project. Category 2 PRCs should utilize available resources and expertise in the development of their core research project. In their proposal, Category 2 applicants must describe how they will collaborate with their community and engage partners during the development, implementation, and evaluation of the pilot project.
The PRCs funded under this FOA will function as a network and will serve as local, regional, and national resources for developing and applying effective prevention programs and strategies at the community level. The PRC Program will be guided by seven committees (Steering, Program, Research, Policy, Communications and Dissemination, National Community, and Evaluation) that will provide recommendations to the PRCs on program standards and policies and on research and other activities throughout the project period. Membership of the standing committees will be comprised of representatives from a consortium of partners, including the PRCs, their communities, and CDC’s PRC Program office. The Steering Committee will serve as the executive committee to the CDC PRC Program office.
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 U48 activity code. The HHS/CDC U48 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The participating Center, Institute, and Office (CIO) NCCDPHP intends to commit approximately $25,000,000 in total dollars (direct and indirect costs) in FY 2009 to fund up to 33 awards. An applicant may request a project period of up to five years. The approximate funded amount is $125,000,000 in total costs for the entire five-year project period. The FY 2009 award range for the 12-month budget period for the two categories is as follows:
Category 1: $700,000 - $1,000,000 in total costs (direct and indirect)
Category 2: $300,000 - $500,000 in total costs (direct and indirect)
Up to three PRCs may be funded under his category.
Since the scale and range of project activities will depend on the category under which an institution is funded, award amounts will vary in size based on the category and within each category.
If an applicant requests a funding amount greater than the ceiling of the award range for the specific category, HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements. All estimated funding amounts are subject to availability of funds. The anticipated start date for new awards is September 30, 2009.
Although the financial plans of the CIO 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.
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:
In addition to the above criteria, eligible academic health centers must meet the following requirements:
1. Have a multidisciplinary faculty with expertise in public health and which has working relationships with relevant groups in such fields as medicine, psychology, nursing, social work, education and business; 2. Have graduate training programs relevant to disease prevention;
3.
Have core faculty in epidemiology, biostatistics, social sciences, behavioral and environmental health sciences and health administration;4.
Have demonstrated curriculum in disease prevention;5.
Have capability for residency training in public health or preventive medicine; and6.
Meet such other qualifications as the Secretary may prescribe.
An institution may submit, or be part of, only a single application in response to this FOA. Multiple applications from different divisions, faculties, centers, schools, etc. of the same university, school of public health, medicine, or osteopathy will be returned without further consideration by CDC.
An institution may apply under one of the following categories but not both:
Category 1: Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.
Category 2: Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.
2. Cost Sharing or Matching
Cost sharing, matching funds, or cost participation are not required under this program.
The most current
HHS Grants Policy Statement is available at:
http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
3. Other-Special Eligibility Criteria
Not applicable.
Section IV. Application and Submission Information
1. Request Application
Information
The Public Health
Service Grant Application (PHS 398) instructions are
available at
http://grants1.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 PGO TIMS: Telephone (770) 488-2700 or
PGOTIM@cdc.gov.
HHS/CDC
Telecommunications for the hearing impaired: TTY (770)
488-2783.
2. Content and Form of
Application Submission
Applications must be prepared using the most current version of the PHS 398 research grant application forms and in accordance with the
instruction guide (http://grants1.nih.gov/grants/funding/phs398/phs398.doc). Applicants must have a Dun & Bradstreet 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 website 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 PHS 398 Application Guide is critical to submitting a complete and accurate application to HHS/CDC.
The following sections supplement the instructions found in the PHS 398 and should be used for preparing and submitting an application in paper format. A complete application will contain two separate proposals prepared using the PHS 398: 1) a proposal for the center, and 2) a proposal for the core research project or pilot study. Applications that do not include both proposals will be incomplete and HHS/CDC will consider the application non-responsive and it will not enter into the review process.
Applicants should clearly indicate whether they are applying as a Category 1 or Category 2 institution. An institution may apply under only one category.
Supplemental instructions for preparing the PHS 398 for the center application:
A complete PHS 398 application should be prepared and submitted for the center application. The PHS 398 forms (Face Page, Description, Budget, etc.) should be a composite of the overall center, key elements and core research activities. The Research Plan section (Specific Aims, Background and Significance, etc.) should be specific to the key elements of the center.
· PHS 398 Face Page – This should be the first page of the entire application. Indicate if applying for Category 1 or 2 in the Title of Project. The information on the Face Page should be a composite of the overall center, key elements and core research activities.
·
Budget – The funds requested and justification provided should be a composite for the center and include the total budget for the core research project or pilot study for the first 12-month budget period and estimates for years 2-5 of the project period. The total budget (direct and indirect costs) for the core research project or pilot study should be listed as a line item in Other Expenses on the detailed budget form. The overall center budget should adhere to the limits stated in the FOA for the specific category.· Senior/Key Personnel – List the PD/PI for the overall center. Include all individuals that will participate in the execution of the PRC. Note: CDC does not accept applications reflecting multiple PDs/PIs. Information on individuals who will be contributing in a substantive, measurable way should be entered in the Senior/Key Personnel or Other Significant Contributors section of the PHS 398.
·
Research Plan – Specific to the center proposal and limited to 25 pages. In this section, applicants should describe in detail the organizational and administrative structure of the center, including the chain of responsibility for decision-making and administration, and address the key elements of a PRC. Applicants funded under PA04-003 must include a progress report that highlights PRC achievements from the previous funding cycle.Supplemental instructions for preparing the PHS 398 for the core research project or pilot study application:
A complete PHS 398 application should be prepared specific to the core research project or pilot study, bundled separately, and should follow the center application. Keeping in mind that the core research activities will be reviewed and evaluated separately, and independent of the center application, the PHS 398 forms (Face Page, Description, Budget, etc.) should be specific to the core research project or pilot study. Prepare the PHS 398 Research Plan section (Specific Aims, Background and Significance, etc.) in the same level of detail required for the traditional individual research grant application so that the scientific and technical merit of the core research activities can be judged on the basis of the application alone.
· PHS 398 Face Page – Indicate if Research Project or Pilot Study in the Title of Project. All information should reflect the core research activities only.
·
Budget – The funds requested and justification provided should be specific to the core research activities for the first 12-month budget period and estimates for years 2-5 of the research. These amounts must be listed as a line item in Other Expenses in the center application overall budget.· Senior/Key Personnel – List the PD/PI for the core research activities only. Include all individuals (even if previously listed in the center application) who will contribute to the scientific development or execution of the core research project activities in a substantive, measurable way.
·
Research Plan – Specific to the core research project or pilot study only and limited to 20 pages.Note: While both budget components are included in the PHS 398 forms package, the CDC U48 activity code uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)
Information Sessions:
CDC will conduct informational sessions (web cast) for academic health centers considering submitting an application in response to this FOA. Representatives from the CDC PRC Program office and from the CoCHP Extramural Research Program Office will provide information and answer questions pertinent to preparing applications in response to this FOA.
Web cast for Category 1 applicants:
Date: Tuesday, August 12, 2008
Time: 3:30 pm – 5:30 pm (ET)
Audio Participant Access
Toll-free Number: 1-888-469-3092
Passcode: 4133408
Leader: Jo Anne Grunbaum
Net Conference Participant Access
URL: https://www.mymeetings.com/nc/join/
Conference Number: PG2668708
Audience Passcode: 4133408
Participants can join the event directly at:
https://www.mymeetings.com/nc/join.php?i=PG2668708&p=4133408&t=c
Web cast for Category 2 applicants:
Date: Thursday, August 14, 2008
Time: 3:30 pm – 5:30 pm (ET)
Audio Participant Access
Toll-free Number: 1-888-469-3092
Passcode: 4133408
Leader: Jo Anne Grunbaum
Net Conference Participant Access
URL: https://www.mymeetings.com/nc/join/
Conference Number: PG2668726
Audience Passcode: 4133408
Participants can join the event directly at:
https://www.mymeetings.com/nc/join.php?i=PG2668726&p=4133408&t=c
Multiple participants from the same institution are encouraged to access the webinar from a single location.
Information on the PRC Program and this FOA is available at: http://www.cdc.gov/prc/news/2008-foa-announcement.htm.
3. Submission Dates and Times
See Section IV.3.A for details
3. A. Submission, Review and Anticipated Start Dates
Letter of Intent
Receipt Date:
September 8, 2008
Application Submission Receipt Date: October 8, 2008
Peer Review Date: December 2008
Council Review Date: January 2009
Earliest
Anticipated Start Date:
September 30, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent (LOI) that includes the following information:
· Descriptive title of the proposal (Indicate if the LOI is for Category 1 or 2.)
·
Descriptive title of the anticipated core research project or pilot study·
Name, address, and telephone number of the PD/PI·
Names of other key personnel·
Participating institutions·
Number and title of this funding opportunity
Although a LOI is not required
, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential reviewer workload and plan the review.
The LOI is to be sent by the date listed in Section IV. 3.A. The LOI should be sent to:
Beth Patterson, M.Ed.
Extramural
Research Program Office, CoCHP
4770 Buford
Highway NE
Mailstop K-92
Atlanta, GA
30341
Telephone: (770)
488-8390
Fax: (770) 488-8046
Email: BPatterson@cdc.gov
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement. Only paper submissions are allowed for this FOA.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
Otherwise,
HHS/CDC will not notify you upon receipt of your paper
submission. If you have a question about the receipt of
your application, first contact your courier. If you still
have a question, contact the PGO-TIMS staff at: (770)
488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for
HHS/CDC to process and log submissions.
Submit the complete application packet to the following address:
Technical Information Management Section – DP09-001
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: (770) 488-2700
A complete application packet includes: 1) a signed, typewritten original of the center proposal, including the PHS 398 checklist, three signed photocopies, and the CD appendices, and 2) a signed, typewritten original of the core research project or pilot study proposal, including the PHS 398 checklist, three signed photocopies, and the CD appendices. The comprehensive Table of Contents should be the first page of the application packet.
This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
3.C. Application Processing
HHS/CDC must receive
applications on
or before 5:00 P.M. Eastern Time on the application
submission date described above (Section IV.3.A.). If
HHS/CDC receives an application after that submission date
and time, the application may be delayed in the review
process or not reviewed.
Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Health Promotion (CoCHP) Extramural Research Program Office (ERPO) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
5. Funding Restrictions
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. Additional guidance can be found at HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place. · Reimbursement of pre-award costs is not allowed.
6. Other Submission Requirements
A complete application will contain the following two separate proposals prepared using the PHS 398: 1) a proposal for the center, and 2) a proposal for the core research project or pilot study. Applicants should clearly indicate whether they are applying as a Category 1 or Category 2 institution. (Note: An institution may apply under only one category.) Each proposal should address the other submission requirements listed for the center key elements and core research project or pilot study under the specific category. The plan for the center and the core research project or pilot study should address activities that will be conducted over the entire project period.
Application Contents
Category 1: Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.
Center Key Elements for Category 1 Applications
A. Infrastructure and Administration
Institutions should describe and/or provide evidence of the following infrastructure elements:
1. An organizational chart illustrating the location of the PRC within the institution, including reporting lines and other participating schools and departments within the institution. The organizational chart should reflect an appropriate leadership model and delegation of work activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center.
2. A description of the PRC’s mission, goals, and health priorities and disparities that the PRC will address.
3. Clear, detailed evidence of institutional commitment. This may take the form of office space, personnel, equipment, other resources, return of indirect costs, additional funding, etc.
4. A description of the qualifications of the PD/PI (PRC Director) and the planned percentage of time that they will devote to the PRC. The PD/PI should be an established researcher with the leadership and institutional authority to direct the activities of the PRC. The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing a research center, research in health promotion and disease prevention, funding history, and publications in peer-reviewed journals.
5.
A staffing plan describing the PRC faculty and staff, their role and planned percent of effort.6.
A multidisciplinary faculty with expertise that is complementary to the PRC’s mission and planned activities. Faculty should have experience partnering with the community with which the core prevention research is conducted.7.
Faculty and staff with demonstrated experience and expertise in conducting CBPR, statistical analysis, developing community partnerships, communicating and disseminating project materials to both scientific and lay audiences, implementing training programs, providing technical assistance and mentoring, and conducting evaluations.8.
Evidence of on-going prevention projects and activities that are supported by other sources of funding. Include source of funds, amount, and dates of funding.9.
Evidence of financial support for the PD/PI and other appropriate PRC faculty and staff to participate in the semi-annual Directors’ meetings, one of which will take place during the annual PRC Program meeting.
B. Community Engagement and Partnerships
Institutions should submit documentation that describes the partner community and provides evidence of experience in community engagement and establishing partnerships that includes:
1.
Expertise and experience in engaging in CBPR.2.
A defined partner community which is, or includes, the community with which the research activities will occur (population size, geographic boundaries, racial and ethnic makeup, socioeconomic status, etc.).3.
An existing community committee whose composition, role, and structure reflect the community with which the research will occur. Include the community committee’s mission or purpose, role in center planning and activities, and communication procedures between the committee and PRC faculty and staff. If there is more than one committee that will provide guidance or leadership to the PRC, provide this information for all committees.4.
Community support for the center and buy-in to the proposed research activities as evidenced through specific, detailed letters of support from committee and community members and other key partners describing their planned involvement.5.
A plan for obtaining community input into research, communication, training, and evaluation activities.6.
Engagement with appropriate partners, including state and local health departments, education agencies, etc., at local, state, and federal levels as appropriate for research, communication, training, and evaluation activities.7.
Identification of at least one community person from the community committee to be a member of the PRC Program’s National Community Committee. Evidence of financial support for this person to participate in and travel to at least two appropriate activities and meetings should be included.
C. Communication and Dissemination
Institutions should submit documentation that demonstrates expertise in communication and dissemination that includes:
D. Training
Institutions should submit documentation that demonstrates expertise in training, technical assistance, and mentoring that includes:
E. Evaluation
Institutions should submit documentation that demonstrates expertise in evaluation that includes:
Core Research Project for Category 1 Applications
Institutions
funded under Category 1 are expected to conduct
at least one
a high quality core
prevention research project using CBPR that
bears an essential relationship to the PRC mission and the
community, and efficiently uses center resources.
Category 1 applicants must show evidence of successful and
timely implementation of a collaborative, CBPR project
within the past five years.
The research project plan should include the following information:
1.
Specific aims, including a description of the relationship of the research project to the center’s mission and health priorities, Healthy People 2010 focus areas, CDC public health research agenda, and the needs of the research community. Include a specific description of the research community if it differs from the partner community.2.
Background and significance, including how the research furthers the fields of prevention research and public health. Include evidence of community and partner support for, and endorsement of, the research topic, methods, and partnering community through letters of support.3.
Evidence of community and partner input into identification of health priorities and disparities and a description of how they will be engaged throughout the research process.4.
Preliminary Studies/Progress Report should include information on the project team’s experience in conducting research with the community in which the project will be implemented and experience in the research topic and methods5.
A description of the study participants, including recruitment and retention strategies.6.
Power calculations.7.
Implementation timeline.8.
Plans to report and disseminate research results and a description of community and partner involvement in planned dissemination.
Core Research Project Guidelines:
Category 1 applicants should implement a determinant (hypothesis testing research on causality of diseases and conditions), intervention (efficacy, effectiveness), or dissemination (translation, implementation, or evaluative) core research project that utilizes appropriate research designs such as quantitative (i.e., observation, quasi-experimental, or experimental), qualitative (i.e., ethnographic, focus groups, in-depth interviews), or mixed methods (e.g., combination of quantitative and qualitative).
Applicants that propose to conduct an intervention or dissemination core research project are encouraged, when appropriate, to identify or modify an existing evidence-based intervention for implementation within or dissemination to a different setting (e.g., community-based rather than clinic-based) or population. The proposed intervention must be evidence-based in that it has undergone sufficient scientific evaluation to be proven efficacious or effective. The applicant must provide evidence of efficacy or effectiveness of the intervention and justify the intervention’s relevance to the study population. Evidence of effectiveness can be found in a variety of places, including:
§
Scientific evaluation in peer reviewed publication of 1) quantitative or qualitative research, 2) evaluation reports, 3) systematic reviews of literature, or 4) descriptive or survey research.§
The CDC PRC Program website, The Guide to Community Preventive Services, Research Tested Intervention Programs (RTIPs), SAMHSA’s National Registry of Evidence-based Programs and Practices, Cochrane Public Health Group reviews and protocols, and The Guide to Clinical Preventive Services.
Applicants that propose to conduct an intervention or dissemination core research project may identify or modify an existing practice-based intervention for implementation within or dissemination to a different setting (e.g., community-based rather than clinic-based) or population. The proposed intervention must be a practice-based strategy that has undergone sufficient implementation to be proven acceptable by the community, sustainable due to evidence of appropriate partnerships and available resources, and likely effective (i.e., intervention initiation precedes minimal positive effect and change over time).
Applicants that propose a core research project to develop a new intervention need to provide a rationale for doing so and demonstrate that no applicable intervention exists. The applicant needs to demonstrate that there is both a gap in the literature and a need for the intervention in the partner community. The applicant needs to describe the design of the intervention and demonstrate that adoption of the intervention will be feasible for state or local agencies or community-based organizations in terms of cost and other practical limitations.
Applicants that propose a core research project that is dissemination research need to demonstrate that there is evidence behind the intervention and that their results will include information and guidance for implementation of the intervention by other agencies, organizations, or communities.
Category 2: Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.
Center Key Elements for Category 2 Applications
A. Infrastructure and Administration
Institutions should describe a plan to develop an infrastructure capable of supporting the activities of the PRC and its core research project. Applicants should include:
1. An organizational chart illustrating the location of the PRC within the institution, including reporting lines and other participating schools and departments within the institution.
2. A description of the PRCs mission, goals, and health priorities and disparities that the PRC will address.
3. Clear, detailed evidence of institutional commitment. This may take the form of office space, personnel, equipment, other resources, return of indirect costs, additional funding, etc.
4. A description of the qualifications of the PD/PI (PRC Director) and the planned percentage of time that they will devote to the PRC. The PD/PI should be an established researcher with the leadership and institutional authority to direct the activities of the PRC. The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing a research center, research in health promotion and disease prevention, funding history, and publications in peer-reviewed journals.
5.
A staffing plan describing the PRC faculty and staff, their role and planned percent of effort.
B. Community Engagement and Partnerships
Institutions should provide evidence of their capacity to engage communities and partners in research activities and describe a plan to develop relationships with a community and appropriate partners. Applicants should include:
C. Communication and Dissemination
Institutions should submit documentation that demonstrates previous experience and expertise in communication that includes:
D. Training
Institutions should submit documentation that demonstrates expertise in training, technical assistance, and mentoring that includes:
1. Previous experience in and evidence of skill in providing training, technical assistance, and mentoring to community members, partners, practitioners, researchers, and students.
2. A description of how training, technical assistance, and mentoring activities will be integral to CBPR and capacity-building of the community and other partners.
E. Evaluation
Institutions should submit an evaluation plan that includes:
Core Research Project for Category 2 Applications
Category 2 PRCs are expected to develop and implement a pilot study using CBPR. Institutions should submit documentation that includes:
Research Project Guidelines:
Category 2 applicants should describe resources available to develop and implement a pilot research study that will form the basis for a determinant (hypothesis testing research on causality of diseases and conditions), intervention (efficacy, effectiveness), or dissemination (translation, implementation, or evaluative) research project utilizing appropriate research designs such as quantitative (i.e., observation, quasi-experimental, or experimental), qualitative (i.e., ethnographic, focus groups, in-depth interviews), or mixed methods (e.g., combination of quantitative and qualitative).
Other Submission Requirements for Applicants that were funded under PA04-003
Academic health centers funded under PA04-003 should include a report on their accomplishments and achievements from the previous funding period. Evidence should be provided that the center has enabled efficient and timely implementation and dissemination of high caliber prevention research that is consistent with the mission of the PRC Program. The report should include information on previous specific aims, progress made on each specific aim, collaborations, innovative work, and highlight important research findings. Relevant publications and other products produced in the previous funding period should be listed and included.
In the center application, previously funded PRCs should describe how they have served as a local, state, or national resource to the field and address how they will continue to do so.
Appendix Instructions
Appendix instructions, material, and limits apply to the two proposals separately; each proposal appendix (center and core research) must follow PHS 398 guidelines.
Ten CDs will be submitted in the same package with the application; five identical CDs containing all appendix material must be submitted for the center proposal and five identical CDs containing all appendix material must be submitted for the core research project or pilot study proposal. When preparing CDs:
·
Use PDF format. Where possible, applicants should avoid creating PDF files from scanned documents. CDC recommends producing the documents electronically using text or work-processing software and then converting to PDF. Scanned documents are generally of poor quality and difficult to read.·
Label each disk with the PD/PI name and application title.·
If burning CD-ROM disks on a Mac, select the ISO 9660 format.·
Do not use compression techniques for the electronic files.·
Do not use password protection, encryption, digital signature and/or digital certification in the PDF files.
A summary listing all of the items included in the appendix is encouraged, but not required. When including a summary, it should be the first file on the CD. Applications that do not follow the appendix requirements may be delayed in the review process.
The following materials may be included in the appendix:
·
Up to 3 publications of the following types. In each case include the entire document:o
Manuscripts and/or abstracts accepted for publication but not yet published.o
Published manuscripts and/or abstracts where a free, online, publicly available journal link is not available.o
Patents directly relevant to the project.Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication.
·
Surveys, questionnaires, and other data collection instruments, clinical protocols, and informed consent documents.
Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.
Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review the specific FOA for any additional program-specific guidance on Appendix material and other application requirements.
Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information.”
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions 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). 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 HHS/CDC data sharing policy is available at
http://www.cdc.gov/od/pgo/funding/ARs.htm under
Additional Requirements Release and Sharing of Data. 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
HHS
policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc). 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.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process:
·
Scientific merit of the proposed project as determined by peer review·
Availability of funds·
Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services·
Equitable geographical distribution of the centers among areas containing a wide range of population groups which exhibit incidence of diseases which are most amenable to preventive intervention, as specified in PL 98-551 · Proposals that demonstrate a focus on underserved populations or those with a disproportionally high burden of morbidity and mortality
2. Review and Selection Process
Applications that
are complete and responsive to the FOA will be evaluated for
scientific and technical merit by an appropriate peer review
group convened by the CoCHP ERPO in accordance with the
review criteria stated in this section.
As part of the
initial merit review, all applications will:
· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
· Receive a written critique that consists of;
o A separate evaluation of the center and its key elements
o A separate evaluation of the core research project or pilot study
o An overall application score that will be the average of the scores of the center proposal and core research project or pilot study proposal
· Receive a second level of review by HHS/CDC CoCHP.
Applications submitted in response to this FOA will compete for available funds with all other eligible applications.
See Section IX. Application Evaluation Criteria for the specific review criteria that will be used to evaluate the scientific and technical merit of applications submitted in response to this FOA.
In order to allow for the differential expectations and activities of the two categories of institutions, different criteria will be used to review and evaluate Category 1 and Category 2 applications. The two components within each category, center key elements and the core research activities, will be reviewed and evaluated separately. An application will receive one single numerical score that reflects the overall evaluation of the center, its key elements and the core research activities.
2.A.
Additional Review Criteria
In addition to
the above criteria, the following items will be considered
in the determination of scientific merit and the priority
score:
Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research [see the Research Plan, Section II on Human Subjects in the PHS 398 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm]. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research: Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.
See Section IX. Application Evaluation Criteria for the additional review criteria that will be used in the review of applications submitted in response to this FOA.
2.B. Additional Review
Considerations
Budget and Period
of Support:
The reasonableness of the proposed budget and the
appropriateness of the requested period of support in
relation to the proposed research may be assessed by the
reviewers. Is the number of person months listed for the
effort of the PD/PI appropriate for the work proposed? Is
each budget category realistic and justified in terms of the
aims and methods? The evaluation of the budget should not
affect the priority score.
See Section IX. Application Evaluation Criteria for the additional review considerations that will be used in the review of applications submitted in response to this FOA.
2.C. Sharing Research Data
Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan; 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.
2.D. Sharing Research Resources
HHS
policy requires that recipients of grant awards make unique
research resources readily available for research purposes
to qualified individuals within the scientific community
after publication. Please see
http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should
include a plan on sharing research resources.
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. The
effectiveness of the resource sharing will be evaluated as
part of the administrative review of each non-competing
Grant Progress Report (HHS/PHS 2590
http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
It is anticipated
that awards will be announced in February 2009. The award
start date is September 30, 2009.
Section VI. Award Administration Information
1. Award Notices
After the peer
review of the application is completed, the applicant
organization will receive a written critique called a
“Summary Statement.”
The
applicant organization and the PD/PI will be able to access
the Summary Statement via the eRA Commons.
HHS/CDC will contact t
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 (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is 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
The Code of
Federal Regulations 45 CFR Part 74 and Part 92 have details
about requirements. For more information on the Code of
Federal Regulations, see the National Archives and Records
Administration at the following Internet address:
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
Additional requirements are available Section VIII. Other
Information of this document or on the HHS/CDC website at
the following Internet address:
http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be
incorporated into the NoA by reference.
The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.
2.A. Cooperative Agreement
The following
terms of award are in addition to, and not in lieu of,
otherwise applicable Office of Management and Budget (OMB)
administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), and
other HHS/CDC grant administration policies.
The
administrative and funding instrument used for this program
will be the cooperative agreement U48 an "assistance"
instrument (rather than an "acquisition" instrument), in
which substantial HHS/CDC programmatic involvement with the
awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the HHS/CDC
purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly
with the award recipients in a partnership role; it is not
to assume direction, prime responsibility, or a dominant
role in the activities.
Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as
a whole, although specific tasks and activities may be
shared among the awardees and the HHS/CDC may share specific
tasks and activities, as defined above.
2.A.1. Recipient Rights and Responsibilities
The Recipient
will have the primary responsibility for the following:
Recipient
Organization will retain custody of and have primary rights
to the information, data and software developed under this
award, subject to U.S. Government rights of access
consistent with current HHS/CDC policies.
2.A.2. HHS/CDC Responsibilities
An HHS/CDC
Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship
role in awards, as described below:
1.
Convening semi-annual meetings of the PRC Directors (one of which will take place during the annual PRC Program meeting) to facilitate research collaboration and information sharing.2.
Conducting on-site visits of PRCs to provide consultation and technical support and help recipients meet program objectives and cooperative agreement requirements.3.
Providing consultation and other technical assistance to help recipient use the PRC Information System for developing work plans and progress reports.4.
Providing consultation and other technical assistance to help recipient use the PRC national evaluation data collection system for recording PRC inputs, activities, outputs, and outcomes.5.
Collecting, organizing, and disseminating information on PRC research projects.6.
Serving as a scientific and professional resource for the PRCs’ standing committees.7.
Informing recipients about the laws and regulations pertaining to human subjects research and conduct inquiries concerning allegations of scientific misconduct.8.
Evaluating and monitoring recipients’ progress toward meeting program objectives and goals.
Additionally, an
HHS/CDC agency program official or Scientific Program
Officer (SPO) will be responsible for the normal scientific
and programmatic stewardship of the award and will be named
in the NoA.
The CoCHP ERPO will appoint a SPO who
will:
1. Carry out continuous review of all activities to ensure objectives are being met; 2. Attend committee meetings and participate in conference calls for the purposes of assessing overall progress and for program evaluation purposes; 3. Provide scientific consultation and technical assistance in the conduct of the project; and
4.
Conduct site visits to determine the adequacy of the research and to monitor performance against approved project objectives.
2.A.3. Collaborative Responsibilities
The PRC program functions as a consortium of partners. Representatives from the PRC’s academic and community partners and CDC’s PRC Program office will serve on standing committees that will provide recommendations to the PRCs on standards and policies and make recommendations for research and other activities. Following are the standing committees responsible for guiding the PRC Program throughout the project period:
The PRC Steering Committee will serve as an executive committee to the CDC Program office. It will be comprised of the chairpersons of the six standing committees as well as an overall leader elected from one of the PRCs.
3. Reporting
Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:
1. Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.
2.
An annual work plan (that includes 5-year goals, 1-year SMART objectives, and 1-year activities) and progress report through the PRC Information System. 3. Financial status report, no more than 90 days after the end of the budget period. 4. Final financial and performance reports, no more than 90 days after the end of the project period.
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
Although the financial plans of the HHS/CDC CIO provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
Section VII. Agency Contacts
HHS/CDC
encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas – scientific/research, peer review, and financial or grants management issues:Beth Patterson, M.Ed.
Extramural
Research Program Office
Coordinating
Center for Health Promotion
Centers for Disease Control and Prevention
U.S. Department
of Health and Human Services
Koger
Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA 30341
Telephone: (770)
488-8390
Email:
BPatterson@cdc.gov
2. Peer Review Contacts:
Juliana Cyril, PhD, MPH
Scientific Review Service
Office of Public
Health Research
Centers for
Disease Control and Prevention
U.S. Department
of Health and Human Services
1600 Clifton Road
NE, MS D-72
Atlanta, GA
30333
Telephone: (404)
639-4639
Email:
JCyril@cdc.gov
3. Financial or Grants Management Contacts:
Lucy Picciolo
Procurement and Grants Office
Center for Disease Control and Prevention
U.S. Department
of Health and Human Services
2920 Brandywine
Road, Room 3000
Atlanta, GA
30341
Telephone: (770)
488-2777
Email:
LPicciolo@cdc.gov
4. General Questions Contacts:
Technical
Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required Federal Citations
Human Subjects
Protection
Federal
regulations (45 CFR Part 46) require that applications and
proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of
the research to the subjects and others, and the importance
of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional HHS/CDC Requirements under AR-1 Human Subjects
Requirements can be found on the Internet at the following
address:
http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for
Inclusion of Women and Racial and Ethnic Minorities in
Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Inclusion of
Persons Under the Age of 21 in Research
The policy of CDC is that persons under the age of 21 must
be included in all human subjects research that is conducted
or supported by CDC, unless there are scientific and ethical
reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human
subjects, including research that is otherwise exempt in
accordance with Sections 101(b) and 401(b) of
45 C.F.R. Part 46, HHS
Policy for the Protection of Human Subjects.
Therefore, proposals for research involving human subjects
must include a description of plans for including persons
under the age of 21. If persons under the age of 21 will be
excluded from the research, the application or proposal must
present an acceptable justification for the exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.
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
www.healthypeople.gov.
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation.
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.
Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:
a.
Section 106 of the National Historic Preservation Act (NHPA) states:The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b.
Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
Section IX. Application Evaluation Criteria
In order to allow for the differential expectations and activities of the two categories of institutions, different criteria will be used to review and evaluate Category 1 and Category 2 applications. The two components within each category, center key elements and the core research activities, will be reviewed and evaluated separately. An application will receive one single numerical score that reflects the overall evaluation of the center, its key elements and the core research activities.
In addition, applications will be reviewed for protection of human subjects from research risk and inclusion of women and minorities in research. The appropriateness of the budget will be discussed, but will not affect the priority score.
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.
1. Category 1
Category 1 academic health centers must have a comprehensive organizational infrastructure, strong community relationships and plans in place with their community partners to conduct a core research project using CBPR.
1.A. Center Review Criteria – Key Elements
Significance: Does the proposed center have the potential to significantly impact public health programs, prevention research, and other relevant fields at the academic health center? Does the applicant describe the health priority and health disparity needs within their partner community and do these needs align with the PRC’s mission and goals?
Approach: Does the applicant describe anticipated challenges to implementation of CBPR and propose solutions to address those challenges? Is there evidence of community and partner input into identification of health priorities and health disparities?
Innovation: Are novel approaches, methods, technologies, etc. proposed that could facilitate the dissemination and/or translation of effective public health programs at the state and community levels and to both lay and scientific audiences?
Investigators: Is the PD/PI an established researcher with the leadership and institutional and decision-making authority to direct the activities of the PRC? Is the PD/PI’s commitment of time and effort sufficient to direct the scientific, administrative, budgetary, and operational aspects of the center? Is there a multidisciplinary faculty with experience in CBPR and partnering with communities? Does the faculty and staff have demonstrated experience and expertise in conducting CBPR, statistical analysis, developing community partnerships, communicating and disseminating project materials, implementing training programs, and conducting evaluations?
Environment: Does the organizational chart reflect an appropriate leadership model and delegation of activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center? Is the institutional commitment sufficient? Has the institution been successful in attracting additional sources of funding and leveraging resources for prevention research?
Community Engagement and Partnerships: Is there a defined partner community which is, or includes, the community with which the research activities will occur? Is there evidence of the communities input into the PRC’s mission and goals? Is there an existing community committee, appropriate representation from the community and appropriate partners on the committee, and the existence of or plans to develop committee guidelines? Is there adequate evidence of community support for the center from committee members, community members, and other key program partners? Does the applicant describe appropriate mechanisms for community input into research, communication, training, and evaluation activities? Will appropriate partners be engaged in key activities and the core research project and are the roles of the partners and the community committee in the activities clearly described? Are the partnerships maintained throughout the project period?
Communication and Dissemination: Is the communication plan integrated into research, training, evaluation, and community activities and appropriate and feasible for communicating with the community and partners? Does the applicant have the capacity and experience to disseminate materials to appropriate stakeholders including communities, partners, and the scientific community? Does the staff have experience communicating activities related to research projects through websites, marketing materials, and the media?
Training, Technical Assistance, and Mentoring: Is there an appropriate level of experience in training, technical assistance, and mentoring for community, partners, practitioners, researchers, and students? Do the goals, objectives, activities, and partner collaborations of the training, technical assistance and mentoring plan reflect and support the mission of the PRC? Are the training, technical assistance, and mentoring activities integrated in CBPR and will they contribute to building the capacity of the community and other partners?
Evaluation: Is the logic model tailored to the PRC with clearly articulated inputs, activities, outputs, and outcomes? Is the evaluation plan realistic and focused and aligned with the PRC logic model? Does it clearly describe the purpose of the evaluation, mechanisms for engaging stakeholders in evaluation activities, key local-level evaluation questions, and evaluation methods? Is there evidence of an appropriate infrastructure to support proposed evaluation and monitoring activities? Does it describe how the evaluation results will be used?
1.B. Core Research Project Review Criteria
Significance: Does this study address an important problem in prevention research? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventive interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, implementation, timeline 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?
Does the proposed core research project include a determinant, intervention, or dissemination study that utilizes appropriate research designs? Does the core research project appropriately incorporate CBPR? Are there appropriate plans to report and disseminate research results?
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?
Does the proposed core research project present a novel approach or methods to CBPR? If the core research project is an intervention study, does the applicant clearly and appropriately justify the selection of an existing intervention or the development of a new intervention?
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?
Is there evidence that the applicant has partnered with the community with which the core prevention research will be conducted? Has the research team been successful in implementing a CBPR project within the past five years? Does the research team provide evidence of ongoing prevention research activities supported by other sources of funding?
Environment: Does the scientific environment in which the applicant will do the work 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 community support and buy-in for the core research project from the community committee, key program partners, and the community with which the project will be implemented?
Applicable to academic health centers funded under PA04-003: During the previous funding period, was the center successful in conducting a CBPR project in a timely manner that provided new knowledge and impacted the field of prevention research for an underserved community?
2. Category 2
Category 2 academic health centers need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.
2.A. Center Review Criteria – Key Elements
Significance: Does the proposed center have the potential to significantly impact public health programs, prevention research, and other relevant fields at the academic health center? Does the applicant adequately describe the health needs within their proposed community and how a pilot study will both impact those needs and support the mission and priorities of their center? Does the applicant adequately describe the significance of community and partnership development?
Approach: Is there evidence of community and partner input into identification of health priorities and health disparities? Does the applicant demonstrate skill and expertise developing and implementing a CBPR project in a timely manner and disseminating results in the peer-reviewed literature?
Investigators: Is the PD/PI an established researcher with the leadership and institutional and decision-making authority to direct the activities of the PRC? Is the PD/PI’s commitment of time and effort sufficient to direct the scientific, administrative, budgetary, and operational aspects of the center? Is there access to multidisciplinary faculty familiar with the community with which the PRC plans to work? Is there access to faculty and staff with experience conducting CBPR research, developing community partnerships, and communicating and disseminating prevention research materials to both scientific and lay communities?
Environment: Does the organizational chart reflect an appropriate leadership model and delegation of work activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center? Will the organizational structure effectively promote multi- and cross-discipline collaborations? Is the institutional commitment sufficient? Will the environment support long-range planning and implementation of PRC key element activities in communication and dissemination, training, and evaluation?
Community Engagement and Partnerships: Is there a clear description of the community with which they plan to work? Does the applicant have experience in engaging in CBPR? Is there evidence of experience in developing community relationships that includes the successful and timely implementation of research projects within the community? Is there an existing community committee or a proposal of how a community committee will be developed and plans to develop guidelines for this committee? Is there evidence of demonstrated partnerships and collaborations, or a plan to build partnerships and collaborations with appropriate local, state, and federal government agencies, non-governmental organizations, or for-profit sector companies? Will the level of support from community members and appropriate partners be adequate for the successful development of the center?
Communication and Dissemination: Is there evidence of adequate previous experience in communicating with communities and partners? Do they have the ability to develop a communication plan that will include the development and maintenance of a program website? Does the applicant have the capacity and experience to disseminate materials to appropriate stakeholders including communities, partners, and the scientific community? Does the staff have experience communicating activities related to research projects through marketing materials and the media?
Training, Technical Assistance, and Mentoring: Is there evidence of skill in providing training, technical assistance, and mentoring for community members, partners, practitioners, researchers, and students? Does the applicant describe how training, technical assistance, and mentoring activities will be integrated into CBPR and how they contribute to building the capacity of the community and other partners?
Evaluation: Is the proposed logic model based on the PRC national logic model, tailored to the PRC, and have clear, specific inputs, activities, outputs, and outcomes? Will the staff have access to experts in evaluation? Is the evaluation plan/process realistic and focused? Does it tie to the logic model and assess progress in the development of the infrastructure, community and partner relations, and the core pilot research project? Does it describe how the evaluation results will be used?
2.B. Core Research Project Review Criteria
Significance: Does this study address an important problem in prevention research? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventive interventions that drive this field?
Are the health needs within the proposed core research community adequately described?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the pilot study? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Does the proposed core pilot study form the basis for a determinant, intervention, or dissemination study that utilizes appropriate research designs? Does the proposed core pilot study utilize a multidisciplinary approach? Is the timeline reasonable and achievable?
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?
What is the likelihood that the proposed pilot study will contribute to the development of multidisciplinary programs and additional research endeavors?
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?
Has the research team successfully implemented and disseminated the results of a CBPR project within the past five years?
Environment: Does the scientific environment in which the applicant will do the work 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?
Will the proposed study actively engage community and partners in the development and implementation of the research project?
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm