3. Large Research Projects. 

Large research projects are hypothesis driven studies focused on improving our understanding of injury and/or violence issues.  They may be lab or field projects that provide the basis for creation or improvement of interventions.  These projects are similar in size and scope to a R01 (investigator-initiated) grant proposal (annual budgets exceeding $150,000/year and durations of up to five years).  These projects typically will test hypotheses and employ more sophisticated methodologies and/or larger sample sizes than small studies.  Large research projects should target priority topics, be part of multidisciplinary efforts to address important problems, and avoid fragmentary efforts. 

One of the requirements of this FOA is that each application must have a minimum of one large research project approved by the Initial Review Group (IRG) in order for the application to be recommended for further consideration.  To give each applicant a better chance of meeting this requirement, two large projects may be submitted.  Both large projects will be peer reviewed and scored.  However, only one large research project per applicant will be funded.  The budget for the second large project will not be counted against the maximum limit of $905,500.  Only the top scoring large research project will be used when calculating the overall score of the application.

4. Small Research Projects.  

Small projects are smaller in size and scope than large projects ($25,000-150,000/year for one to three years duration).  These projects may be expansions of seed projects either further developing methods or hypotheses.  Small projects can be stand-alone investigations sufficient to yield results worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program or in preparation for a larger investigation.  They may also be done in anticipation of leading to a larger study or the submission of a federal RO1 level grant application. 

Additional Research Project Information  

At least one of the large or small research projects must address translation research. 

At least one of the large or small research projects must address primary injury and/or violence prevention research. 

Collaborations with foreign institutions are allowed if they provide injury prevention and control information relevant to important injury prevention and control problems in the United States.

Primary prevention in injury control the sum total of efforts intended to prevent the occurrence of an event with injury-producing potential.  It focuses on environmental or behavioral changes that are aimed at entire populations.  These interventions, programs or policies can be targeted universally or at selected or high-risk populations, but cannot be targeted at individuals who have already been injured, or in the case of violence, already engaged in the perpetration or been the victim of violence.  Anti-drunk-driving legislation and its associated enforcement is an example of primary prevention and is intended to keep a motor vehicle crash caused by an intoxicated driver from ever occurring. 

At least 80 percent of the costs (total direct and indirect costs) of the approved small and large research projects must be in alignment with the “CDC Injury Research Agenda,” http://www.cdc.gov/ncipc in order to be recommended for further consideration.

For the large and small research projects of this announcement, NCIPC is soliciting investigator-initiated research that will help expand and advance our understanding of fatal and nonfatal injuries and/or violence, and their related disabilities, their causes, and prevention strategies. Relevant research objectives include the following:

1. Translation Research:  

The purpose of translation research is to accelerate the translation of research findings into public health practice through implementation, dissemination, and diffusion research. For the purpose of this FOA, the following terminology is defined:

•   Translation research characterizes the sequence of events (i.e., process) in which a proven scientific discovery (i.e., evidence based public health intervention) is successfully institutionalized (i.e., seamlessly integrated into established practice and policy).  In the context of this RFA, translation research does not encompass pure biomedical or formative basic science research (e.g., discovery of a new gene, metabolic pathway or etiology research).  It also does not include the conduct of an initial or replication intervention efficacy or effectiveness trial.  Translation Research is comprised of many complex components which include specialized fields of study. Specifically, translation research is comprised of dissemination research, implementation research and diffusion research.  

•   Dissemination Research is the systematic study of how the targeted distribution of information and intervention materials to a specific public health audience can be successfully executed so that increased spread of knowledge about the evidence-based public health interventions achieves greater use and impact of the intervention.

•   Implementation research is the systematic study of how a specific set of activities and designed strategies are used to successfully integrate an evidence-based public health intervention within specific settings (e.g., primary care clinic, community center, school).  

•   Diffusion research is the systematic study of the factors necessary for successful adoption by stakeholders and the targeted population of an evidence-based intervention which results in widespread use (e.g., state or national level) and specifically includes the uptake of new practices or the penetration of broad scale recommendations through dissemination and implementation efforts, marketing, laws and regulations, systems-research and policies. 

2. Intervention Evaluation Research:

Evaluate the efficacy, effectiveness, and cost effectiveness of primary prevention or control interventions, programs, and policies to prevent injuries and/or violence and related disabilities.

Rigorous evaluations are needed to determine the effectiveness of interventions, programs, and policies addressing the prevention or control of injuries and/or violence. Experimental designs are strongly encouraged. However, NCIPC will consider other evaluation designs, if justified, as required by the needs and constraints in a particular setting.

For effective interventions, it is possible to do cost-effectiveness studies. To be comparable to other cost effectiveness studies, the studies should follow the guidelines in the following references:

Gold MR, Siegel JE, Russell LB, Weinstein MC.  Cost-effectiveness in Health and Medicine.  New York: Oxford University Press, 1996.

Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Second Edition. New York: Oxford University Press, 2003.

For randomized trials, applicants are encouraged to clearly state how study subjects, whether individuals or groups, were selected, randomized, and followed through the trial. One relevant useful guidance document is Moher D, Schulz KF, Altman D. The CONSORT Statement, JAMA 2001;285:1987-2001.

3. Developmental Research:

Developmental research supports the design and preliminary testing of potential strategies to prevent and control injuries and/or violence. Included are risk-factor research and pilot and feasibility studies that measure how interventions affect key variables in the causal chain.

4. Foundational Research:

Foundational research covers the basic studies and public health surveillance approaches that define and quantify the extent of an injury or violence problem. These activities establish the causes of injuries, create causal models for injury and/or violence prevention, and provide a foundation for developing theory-based interventions.

Detailed budget and justification are required for each component/research activity.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

 

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R49 activity code.

2. Funds Available

The participating Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit approximately $5,400,000 in FY2009 to fund six applications. The average award amount will be $905,500.  An applicant may request a project period of up to five years. An applicant may request up to $905,500 for the first 12-month budget period. An applicant may include of the description of a second large project in their application (maximum budget of $250,000/ year).  The budget for the second large project will not be counted against the maximum of limit of $905,500.  However if the applicant is successful in being selected for funding; only one of the two large projects will be funded.  The approximate total project period funded amount is $4,527,500 (including both direct and indirect costs), with a maximum of $905,500 per year. The anticipated start date for new awards is July 31, 2009.

All estimated funding amounts are subject to availability of funds.  If an applicant requests a funding amount greater than the ceiling of the award range, 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.

Use of Funds:

Center funding is to be designated for two types of activities; core activities and defined research projects. 

Core activities includes administration, management, general support services (e.g., statistical, library, media relations, and advocacy) as well as activities associated with research development, technical assistance, and education (e.g., training activities, collaborative and technical assistance activities with other groups, and seed projects).

Defined research projects constitute the second type of activity. These include large and small research projects. 

Core activities (administrative and education and outreach) and defined research projects (large and small projects) must each constitute between 25 percent and 75 percent of the operating budget of the center. These activities should be balanced in such a way that the center demonstrates productivity in research as well as teaching and service.  Applicants with less demonstrated expertise in research may devote a larger percentage of funds to defined research projects in order to establish their capability as research centers of excellence.

Grant funds will not be made available to support the provision of direct care.  Studies may be supported which evaluate methods of acute care and rehabilitation for potential reductions in injury effects and costs.  Studies may be supported which identify the effect on injury outcomes and cost of systems for pre-hospital, hospital, and rehabilitative care and independent living.

Tuition remission and other forms of compensations paid as, or in lieu of, wages to students (including fellows and trainees) under research grants are allowable, provided the following conditions are met:

• The individual is performing activities necessary to the grant.
• Tuition remission and other forms of compensation are consistently provided, in accordance with established institutional policy, to students performing similar activities conducted in non-sponsored as well as sponsored activities.
• During the academic period, the student is enrolled in an advanced degree program at a recipient or affiliated institution and the activities of the student in relation to federally sponsored research projects are related to the degree program.
• The tuition or other payments are reasonable compensation for the work preformed and are conditioned explicitly upon the performance of necessary work.
• It is the institution’s practice to similarly compensate students in non-sponsored was well as sponsored activities.

Eligible applicants may enter into contracts, including consortia agreements (as set forth in the PHS Grants Policy Statement, dated October 1, 2006  http://grants.nih.gov/grants/policy/policy.htm#gps ), as necessary to meet the requirements of the program and strengthen the overall application. 

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:

• Public nonprofit organizations
• Private nonprofit organizations
• For profit organizations
• Small, minority, and women-owned businesses
• Universities
• Colleges
• Research institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
• Federally recognized or state-recognized American Indian/Alaska Native tribal governments
• American Indian/Alaska Native tribally designated organizations
• Alaska Native health corporations
• Urban Indian health organizations
• Tribal epidemiology centers
• State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
• Political subdivisions of States (in consultation with States)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form.

For this FOA, applicants from all ten Department of Health and Human Services (DHHS) regions are eligible to apply.    

Note:  ICRC grant awards are made to the applicant institution/organization, not the Principal Investigator.

2. Cost Sharing or Matching

 

Cost sharing, matching, or cost participation is not required.

 

The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc

3. Other-Special Eligibility Criteria

Each applicant institution can submit only one grant application with the same principal investigator in response to this FOA.  Only one application per principal investigator will be funded under this announcement.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information

1. Request Application Information

 

The PHS 398 application instructions are available at   http://grants.nih.gov/grants/funding/phs398/phs398.html  in an interactive format.  Applicants must use the currently approved version of the PHS 398.  For further assistance, contact Grants Info, Telephone (301) 435-0714, E-mail GrantsInfo@nih.gov.  

If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff.  For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: 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 PHS 398 research grant application instructions and forms. 

Required Components:

Face Page    
Abstract

Table of Content 

List of all key research personnel and critical core staff and the percent effort to be devoted to activities described in the proposed program project 

Detailed Budgets

            Administrative core

            Education and outreach core

            Each large research project

            Each small research project

Description of Resources and Environment.

Research Plan

Administrative core

            Education and outreach core

            Each large research project

            Each small research project

Detailed Descriptions of Large and Small Research Projects 

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Abstract

It is important that the abstract (Description, PHS 398 form page 2) of your grant application reflects the overall application’s (both core and research) focus.  Note: If your application is funded, your abstract will become public information.

The language of the abstract must be simple and easy to understand for a broad audience.  For more information on how to write an abstract please see the “Structured Abstracts” section at: http://jama.ama-assn.org/ifora_current.dtl

Detailed Budgets

Provide a detailed budget (direct and indirect costs) and justification for the overall application for the initial budget period and for entire proposed project period.  The budget should reflect the composite figures for the grant.

Separate budgets (direct and indirect costs) and justifications should be provided for the following categories of activities: 

a.   Administrative Core activities, including management and administrative functions,

b.   Education and Outreach Core

c.   Research Studies:

(1)   Larger projects with annual budgets exceeding $150,000/year (total of direct and indirect costs) and lasting up to five years. 

(2)   Small projects of $25,000-150,000/year (total of direct and indirect costs) for one to three years duration.

Detailed budgetary support must be provided in the form, format, and to the level of detail as indicated in the CDC Budget Guidelines.  These can be located at:  http://www.cdc.gov/od/pgo/funding/budgetguide.htm

An applicant organization has the option of having specific salary and fringe benefit amounts for individuals omitted from the copies of the application which are made available to outside reviewing groups.  To exercise this option: on the original and two copies of the application, the applicant must use asterisks to indicate those individuals for whom salaries and fringe benefits are not shown; however, the subtotals must still be shown.  In addition, the applicant must submit an additional copy of page four of Form PHS-398, completed in full, with the asterisks replaced by the salaries and fringe benefits.  This budget page will be reserved for internal staff use only.

Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application.

Travel expenses for two, one day work-in-progress monitoring workshops (to be held in Atlanta) should be included in the applicant’s proposed budget.

Charge back of customs and import fees are not allowed for collaborating foreign organizations

Administrative (indirect) costs cannot be requested by collaborating foreign organizations.

Note: This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions. (Do not use the PHS 398 Modular Budget.)  

Research Plan

The applicants are to develop a range of research and other non-research activities that are designed to advance the field of injury and/or violence prevention and control through development of new scientific or surveillance methods, creation of new knowledge, and translation of knowledge into training, program and policy development and evaluation activities or other applications that will ultimately reduce injuries and violence or their effects.  ICRC applications should articulate how the activities of their program are integrated with each other.

A research plan for the center should be included, in accordance with NCIPC’s performance goal (as stated in Section I. Funding Opportunity Description, 1. Research Objectives) including hypothesis, expected outcome, value to the field, and measurable and time-framed objectives consistent with the activities for each project within the proposed grant.  The focus of the research should be based on recommendations in “Healthy People 2010” (http://www.healthypeople.gov), the “CDC Injury Research Agenda” (http://www.cdc.gov/ncipc/pub-res/research_agenda.htm), and the “Acute Injury Care Research Agenda” (http://www.cdc.gov/ncipc/didop/ACRAgenda.pdf).