1)  Does the pilot intervention study need to be conducted on the same disease topic as in the proposal?  For example, if we have worked with a community on a prior intervention in cancer prevention, and have conducted a needs assessment that identifies a new priority area in cardiovascular health, does the intervention in cancer prevention count as a pilot intervention study if it serves as the basis for the new intervention in cardiovascular health?

The pilot intervention study must be conducted on the same disease as the current proposal. The purpose of the pilot intervention study is to test the effectiveness of a particular intervention for a particular disease on a small scale.

2)  How can a current 3-year planning grant recipient (who has just begun the pilot intervention study) adequately respond to the requirement for the inclusion of preliminary findings?  That is, what kind of data is expected from the pilot projects at this time?  Further, do the data need to be outcome data, or are baseline and interim process data sufficient? 

Preliminary findings from a pilot community-level intervention study(s) conducted in the community using the CBPR approach must be included in the grant application.  The preliminary findings may be baseline data, initial process data, or data from the first follow-up at 3 months after the intervention was initiated. We expect only preliminary data, not final outcome data, in the grant application.

3)  Does the pilot intervention study need to be in the format of something that is published or can it be completed and reported within the application?

The pilot intervention study does not have to be completed or published at this time.

4)  If the pilot phase of a funded planning grant has been completed, what should be proposed for the initial year of the intervention research grant? Should one include pilot size in the description?

For those applicants who have already generated pilot data, a proposal for the further expansion of data collection during the initial year of the intervention research grant is appropriate.  Furthermore, pilot data can and should be included in the description of the proposed five-year intervention application.

IV. Targeted/Disease Conditions

Yes. As stated in the second paragraph on page 4, the target disease(s) must be of major public health importance and the particular disease or condition will be decided upon in partnership with the community using CBPR principles.

2)  Is obesity considered a chronic disease? With an initial focus on prevention and obesity, would the targeting of a chronic disease, such as diabetes, be appropriate for the implementation phase?

Yes

V. Study Design

1)  What is the best way to write a research question while staying true to the CBPR method of not making decisions for the community?  

As indicated in the last paragraph on page 3, Section 1.1,”….. Identifying the disease/condition for intervention research, and planning the intervention methodology with substantial input from the community”. 
In the 4th bullet under responsiveness criteria in Section 3 on page 7, it is clearly stated that “The community must participate in all phases of the research. “

In Section V.2 under review and selection process, special guidelines for the review of CBPR applications are presented on page 12. Approach: first bullet:

• How will the community be involved in all phases of the research effort (conceptualization, design, methods and analysis)?

2)  Will community level outcomes (e.g., number of new walking trails) and associated study designs be accepted or only individual behavior outcomes?

Individual, group and community-level outcome interventions and measures may be included in the study design. As stated in Section IV.2 under D. Research Design and Methods,” D2. Evaluation Plan- Provide a rigorous process and outcome evaluation plan.”

VI.  General Questions

1)  Why was the R24 funding mechanism selected for this RFA?
 
The R24 is a resource-related funding mechanism which is ideal for interdisciplinary collaborative research efforts. It still allows the use of a paper format for applications.

2)  How can social work research engage with others pursuing this FOA/RFA?

CBPR is ideal for interdisciplinary research. Social work researchers can collaborate with other public health researchers and community partners in this research effort.

3)  What are the areas of research which current grantees are focusing on in the planning and pilot project phase? 

At the end of the first year of the planning grant,  after conducting the needs assessments and meetings with their community partners, grantees are targeting cancer, cardiovascular disease, hypertension, HIV/AIDS, diabetes, obesity, dental caries, mental health, suicide etc.

4)  Do NCMHD planning grantees have special standing in the review process?  Are there a selected number of ‘slots’ reserved for ‘first time applicants?’

No. There is no special treatment for current grantees. There are no slots reserved for first time applicants.

5)  Does the higher education public health training institution involved in the community collaboration require CEPH accreditation to receive funding?

No.  This is not one of the criteria for funding.

6)  Are multiple collaborators encouraged?  What would be the criteria for justification?

Collaborations of one academic center with multiple community based organizations are encouraged if the collaborations are necessary for identification, justification or addressing the local community issues.  However, the collaboration of one community based organization with multiple academic centers is strongly discouraged.   

7) Will there be another RFA for the ‘research planning phase’?

Because of the current budget situation, we do not anticipate issuing another CBPR research planning grant at this time.

8) Clarify the definition of “community” for the purposes of this RFA. Given the broad definition of community in the RFA, are specific types of “community” more attractive than others?

As stated in Section 1.1 on page 4, paragraph 6, “For the purpose of this FOA, community refers to populations that may be defined by: geography, race, ethnicity, gender, illness or other health condition.”

9)  Are there specific criteria for the types of community assessment which needs to be performed?

No. You may use qualitative and quantitative methods.
 
10)  How many existing grantees are there who are eligible to compete for this RFA?

There are 25 current NCMHD research planning grantees who are eligible to compete for this RFA.

11)   Can a volunteer member of a Medical Advisory Board/Committee serve as the principal investigator? 

No.  The PI should be an employee of the applicant organization.

12)  Would applications for supplements be responsive to this RFA?  Are minority supplements available?

No.  The RFA is for applications for five-year intervention research grant proposals. Requests for supplements would not be responsive to this RFA nor would minority supplement requests.

13) Distinguish the conceptual model in year one and the evaluation model in subsequent years.

The conceptual model should provide a CBPR logic model/conceptual framework which will guide the development of the research design and methodology.  A description of this model is to be included in the 25 page limit. (see Section IV.2, B.2 of the RFA). The Evaluation plan (D.2) is also described in this section of the RFA and should be a rigorous process and outcome evaluation plan. Both logic model and evaluation plan should be included in the application. Collection of baseline epidemiological data will provide an opportunity to assess whether the intervention research project has changed the morbidity or mortality of the disease under study.

14)  Is it necessary to include a data safety monitoring plan?

Yes.  This is a special requirement for this RFA.

15)  Would studies addressing socio-economic interventions (obtaining health care, education, etc.) for individuals who are transitioning back into the community be responsive to the RFA? 

No.  The RFA requires that a particular disease is addressed in the intervention study.

16)  Without written partnerships (MOA, MOU, etc.), are there other means by which a history of working together can be demonstrated and meet the requirements of the RFA?

No.  The appropriate documentation must be included to demonstrate that a successful partnership between researchers and community organizations has already been established.

17)   Can the first year of the intervention grant be used to modify the current target intervention group by proposing to target another racial/ethnic population group?

Yes. 

VII. Review Process

1)  Will the review panel be comprised of an equitable mix of researchers and people from health disparity communities who have experience and expertise in CBPR?

Yes.

2)  How will these individuals be identified and selected?  Is there an open process for applying to become a reviewer?

Reviewers are identified through our previous experience with reviewers; our own Center database as well as NIH-wide databases; and recommendations from program staff.  There is no open process for applying to become a reviewer.  You may, however, send resumes to me for consideration, if you wish.

3)  How many and what composition of reviewers will review each application?   That is, will each application be reviewed by at least one researcher and one person from health disparity communities who have experience and expertise in CBPR?

Each application will be assigned three competent reviewers to lead discussion of the application; however, applications are further discussed and voted upon by the entire panel of reviewers, with all their varied expertise coming to bear.

4)  How will reviewers be oriented and prepared for the review, to ensure they are familiar with CBPR, the expectations of the RFA, and the review criteria?

Each reviewer will be selected, oriented and prepared for the review in accordance with NIH policies and guidelines.   Additional training, such as a teleconference orientation call, is also provided by NCMHD.

VIII. Review Criteria

1) Will participation or non-participation in Phase I (Planning) be an additional review criterion?

Those who did not receive the research planning grant (Phase 1) are eligible for review if they meet the responsiveness criteria outlined on page 7, Section III.3 “Other-Special Eligibility Criteria”. If it’s not responsive, it will not be reviewed.

2)  Will applicants who have planning grants be evaluated differently from those who do not have a planning (First Phase) grant?  That is, will the former have an advantage?
Both those who received and did not receive the research planning grant (Phase 1) must meet the responsiveness criteria outlined on page 7, Section III.3 “Other-Special Eligibility Criteria”. If the grant is not responsive, it will not be reviewed. See review criteria outlined in Section V. ”Application Review Information” (V.1 “Criteria”, page 12 and V.2 “Review and Selection Process, page 13).
Special guidelines for the review of CBPR applications include the applicant's ability to incorporate the following elements:
1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• What is the potential impact of the study on reducing health disparities through increased knowledge, behavioral and/or social change resulting from the community partnership?
• How will the applicant convey the perceived importance and relevance of the research questions and proposed study to community partners, and thus, the likelihood for increased buy-in and participation?

Does this study contribute to translational research?
2. Approach. Are the CBPR logic model or conceptual framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

• How will the community be involved in all phases of the research effort (conceptualization, design, methods and analysis)?
• Does the applicant present strong arguments for the proposed study design as the best possible balance of scientific rigor, implementation, constraints and ethical treatment of community partners?
• Does the applicant present the design of a rigorous process and outcome evaluation?
• Does the applicant provide a convincing rationale and adequate plan for how the community partnership is expected to enhance recruitment, retention, measurement design, data collection, and analysis/interpretation?
• Is there an adequate plan for facilitating dissemination and translation of study findings through the CBPR process?
• Are the potential limitations of the study design and CBPR approach adequately addressed? 

3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

• Does the applicant adequately describe how innovative ideas resulted from community participation in developing the research questions, methods, and/or intervention approaches?
• Does the applicant adequately discuss how community input generated innovative approaches to overcoming research challenges?

4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

• Does the applicant provide information indicating that the training, qualifications, experience and commitment of the investigators are appropriate and well suited to the project?
• Does the applicant indicate the degree to which and in what way university and community partners have collaborated in the past?
• Does the applicant describe the way in which community partners will be assured “a place at the table”?
• Does the applicant describe the specific expertise and strengths to be contributed by the community partners?
• Does the applicant adequately describe the community advisory board which has guided the design and conduct of the study?

5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

• Does the applicant provide credible evidence of institutional and community support through letters or memorandum of agreement (MOA) or understanding (MOU), and descriptions of prior collaboration?

6. Translation

• Will the proposed study apply evidence-based research in the community setting to translate research findings into practice?
• Will the CBPR approach in the study enhance the potential for dissemination of research findings and long-term sustainability of positive community practices?

 IX. Budget & Application Process

1)  Even though the applications are a paper submission, is a multiple PI leadership plan required? Can there be 2 Co-PIs; that is, one university based and the other community-based?

There will be a single Principal Investigator (PI) for each application.  Although NIH has no plans to recognize the “CO-PI” designation, key principal scientific and community partners may serve as co-investigators.  NIH’s implementation of electronic submissions and multiple PIs has not yet extended to R24s. See: http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm#1, 
http://grants.nih.gov/grants/multi_pi/index.htm, and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-069.html for more details. 

2)  What are the maximum and minimum dollar amounts that can be requested per year and for the entire five year project period?

The maximum amount that can be requested per year is $400,000 direct costs plus appropriate indirect/F&A (facilities and administrative) costs.  The maximum amount that can be requested over five years is $2,000,000 direct costs plus appropriate indirect/F&A costs.  F&A costs requested by consortium participants are not included in the direct cost limitation.  Because the nature and scope of the proposed research will vary, the size of each award will vary. Although the financial plan of the NCMHD provides support for this program, awards are contingent upon the availability of funds and the receipt of meritorious applications. 

3)  Are electronic submissions permitted for this particular FOA?

Electronic submissions will not be allowed for this FOA at this time.  According to the NIH transition plan, in the future, R 24 applications will be submitted electronically.  Please refer to the answer to question #1, above.

4)  Is there a page-limit on appendices (appendix materials)?

There is no page-limit; however you are cautioned that the Appendix may not be used to circumvent the page limitations of the Research Plan.  You are further cautioned that appendix material is not always carefully considered by reviewers and that whatever you deem critical to your application should be included in the body.  I refer you to NOT-OD-07-018 for new limits on appendix material for NIH.  Basically, what is expected in the appendix are manuscripts or abstracts accepted for publication, but not yet published; patent materials; or published manuscripts only when a free, online journal link is not available---only up to 3 of the above types.  Relevant to this RFA, you are also allowed to submit in the appendix: surveys, questionnaires, data collection instruments, clinical protocols and informed consent documents.  For a complete description, refer to the Guide Notice.