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Multidisciplinary Collaborative Research Consortium RFA-DE-15-006 – Questions and Answers

NIDCR Multidisciplinary Collaborative Research Consortium to Reduce Oral Health Disparities in Children: A Multilevel Approach (UH2/UH3)

View RFA-DE-15-006​

NOTE: This site for Questions and Answers will be updated periodically. Applicants are encouraged to check this website for up-to-date information. If you have a question that is not included here, please email it to NIDCRQAMCRC@nidcr.nih.gov.

Questions and Answers
Added 12/14/14

  1. Question:  Are you accepting applications that focus on HIV/AIDS for a February due date?

    Answer: As stated in RFA-DE-15-006, HIV/AIDS-related applications are being accepted with a due date of February 27, 2015 by 5:00 pm local time of the applicant organization.  While not required, please submit a Letter of Intent per the RFA instructions as it would assist NIDCR’s planning.

Added 11/18/2014

  1. Question: The RFA states "All projects will be milestone-driven, and all UH2 grants will need to meet milestones to have an opportunity to move to the implementation phase (UH3)."  Does this mean that in the application only milestones for the UH2 phase must be provided?

    Answer: 
    Only milestones for the UH2 phase must be provided in the application.
  2. Question: We are unsure as to how and for whom to complete the PHS 398 “Planned Enrollment” tables in the SF424 application

    Answer: Applicants with questions regarding planned enrollment are directed to NIH Grants Policy Guidance regarding the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page http://grants.nih.gov/grants/funding/women_min/women_min.htm  This site provides comprehensive information including a section on Frequently Asked Questions.
  3. Question: As an applicant for RFA-DE-15-006, and given the role of the Data Coordinating Center (DCC) described in RFA-DE-15-007, can we assume that the DCC will provide most data processing and management services, and that only limited staff time would be required to upload or otherwise transmit data to the DCC from an individual RFA-DE-15-006 project?​

    Answer:  RFA-DE-15-006 Part 2.

    Section 1. Overall Program Structure and Scope s
    tates:
    “The DCC will be expected to support and coordinate activities during both the UH2 and UH3 phases.” “Applicants for the MCRC for OHDC program are strongly encouraged to read the FOA for the DCC (RFA-DE-15-007)” in which the duties of the DCC are described.  After reading the duties of DCC, applicants for RFA-DE15-006 should make provisions in their budgets for all other activities necessary for the successful completion of the research proposed including the timely publication of results.  Applicants are reminded that all/any costs requested must be commensurate with the work being proposed and all costs must be allocable, reasonable, and allowable.  The Data Coordinating Center and the consortium studies will be funded as cooperative agreements, U01 and UH2/UH3 respectively.   

Added 11/14/14

  1. Question: Can matching funds from a partnering organization be incorporated into the budget of an application  in response to RFA-DE-15-006?
    Answer: In general, per the SF424 Application Guide, http://grants.nih.gov/grants/funding/424/index.htm#inst, (pg. 51) Non-Federal Funds (matching funds) should not be included in the requested budget or estimated Project Funding unless cost sharing is a requirement for the specific announcement.

    15. Estimated Project Funding Field Name Instructions 
    Total Federal Funds Requested
    Enter total Federal funds requested for the entire project period. This field is required. Please ensure number(s) complies with application requirements.
    Total Non-Federal Funds
    Enter total non-Federal funds proposed for the entire project period. This field is required. For NIH and other PHS agencies, enter “0” in this field unless cost sharing is a requirement for the specific announcement.
    Total Federal & Non-Federal Funds
    Enter total estimated funds for the entire project period, including both Federal and non-Federal funds. This field is required. For NIH and other PHS agencies applicants, this field will be the same as Total Federal Funds Requested above unless the specific announcement indicates that cost sharing is a requirement.
    Per http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-15-006.html, this FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
    From the NIH Website about developing your budget found at: http://grants.nih.gov/grants/developing_budget.htm
    Despite popular myth, proposing a cost-sharing (matching) arrangement where you only request that NIH support some of the funding while your organization funds the remainder does not normally impact the evaluation of your proposal. Only a few select programs require cost-sharing, and these programs will address cost-sharing in the FOA.
    All that said, it would be reasonable to include a brief description of plans to supplement the requested NIH funding in the budget justification.


Added 11/7/14

  1. Question: Could NIDCR provide advice about who can serve as a Principal Investigator including information about multiple Principal Investigator partnerships?
    Answer: NIH provides the following guidance “The Program Director/Principal Investigator (PD/PI) is defined as the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant. The applicant organization may designate multiple individuals as PD/PIs who share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the applicant organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program including the submission of all required reports.”

    RFA-DE-15-006 states the following:

    “Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.”

    “All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.” “All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.”

    In addition the RFA states “For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.”

    Additional information can be found at: http://grants.nih.gov/grants/multi_pi/ and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-118.html

Update
Added 11/6/14

NIDCR has received requests for additional detailed information regarding the budget for studies responding to RFA-DE-15-006.  Applicants should provide budget estimates and justifications that include the assumptions that were used in calculating the estimates. For example, the estimated costs for two persons to attend the SC and ESAC meetings could be justified as being based on the assumptions that the meetings would be 2 days in length and held in the middle of the country, or another example might be that the meetings would be 3 days in length and held in the sponsor’s location. Applicants are reminded that the RFA states that “Application budgets are limited to $625,000 total costs per year for up to two years of the UH2 phase and $1,200,000 total costs per year for each year of the UH3 phase.” “Total costs must include the costs for all research conducted, including work performed at an organization other than the PD/PI institution.” All/any costs requested must be commensurate with the work being proposed and all costs must be allocable, reasonable, and allowable. The consortium studies and the Data Coordinating Center will be funded as cooperative agreements, UH2/UH3 and U01 respectively.

Added 11/5/14

  1. Question: Who is eligible to serve as a reviewer?
    Answer: Individuals who are eligible to serve on an NIH peer review panel must first and foremost have the requisite scientific expertise and experience, as evidenced primarily by a relevant publication record and research funding history. They must be recognized authorities in their field and be active scientists and dedicated to high quality and fair reviews. Members of a peer review panels must certify that they have no real or perceived conflicts-of-interest with the grant applications under review, per NIH guidelines. Reviewers must also certify that they are not registered federal lobbyists, i.e. they are not paid to lobby and are not registered with the federal government as lobbyists. A Special Emphasis Panel will be convened by the NIDCR to review the applications submitted in response to this FOA. NIDCR review staff will follow all the NIH best practices and policies to select the expert reviewers for this panel. Applicants are NOT allowed to propose names of potential reviewers in their NIH application Cover Letter. Additional information can be found in Section III.2 of the RFA.

     

Added 11/3/14

  1. Question: RFA-DE-15-006 specifies that applications may “evaluate outcomes of an existing program or policy intended to reduce health disparities and inequalities.” It also specifies per standard NIH guidelines that “the following materials are allowed in the appendix: surveys, questionnaires, and other data collection instruments, clinical protocols, and informed consent documents.” If the program/policy we are proposing to evaluate is a clinical protocol already in practice – can the detailed description of that protocol be included in the appendix?
    Answer: Yes, a detailed description of that clinical protocol may be included in the appendix. However sufficient information about that protocol must be provided in the 12 page research strategy for reviewer assessment. Please refer to the NIH guidelines (NOT-OD-10-007) that specify permissible material in Appendices http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-077.html

Added 10/29/14

  1. Question: RFA-DE-15-006 provides examples of studies for some of the areas of research that might be proposed. Does this mean that one UH2/UH3 application should include multidisciplinary teams to address all of the areas of research listed as examples?
    Answer: A UH2/UH3 application does not need to address all of the examples of areas of research listed.
  2. Question: RFA-DE-15-006 says that studies must be based on a clearly articulated multilevel theoretical/conceptual framework, that factors from at least three levels of influence must be addressed, and that investigators must identify and justify which factors within the framework will be addressed. Are the social ecological model and the expanded chronic care model considered two levels of influence?  Please describe or name factors from at least three levels of influence that investigators must address.
    Answer: RFA-DE-15-006 states that “Investigators may draw from existing theoretical/conceptual framework/causal models or develop their own model, providing justification for their choice”. The social ecological model and the expanded chronic care model are examples of existing frameworks – they are not levels of influence. As indicated in the RFA, it is the investigators who “must identify and justify which factors within the framework will be addressed”.

Added 10/28/14

  1. Question: Do we have to submit applications for both announcements or can we just apply for one?
    Answer: Neither RFA-DE-15-006 nor RFA-DE-15-007 stipulates that applications must be submitted in response to both announcements.  Applications may be submitted in response to one or to both announcements.

Added 10/10/2014

  1. Question: Innovation is not listed in the “additional instructions” for RFA-DE-15-006 however it is required in the SF424 (R&R) application guide.  Do proposals for this funding mechanism need to include “Innovation”?
    Answer: RFA-DE-15-006, under the heading PHS 398 Research Plan, states that “All instructions in the SF424 (R&R) Application Guide must be followed” – this would include innovation.

Added 10/8/2014

  1. Question: Do we calculate the budget for both the UH2 and UH3 phase and present a total budget for the 5 years? Since the RFA indicates that UH3 funding will be dependent on milestones met in the UH2 phase, we are not sure about the budget for the UH3 phase.
    Answer: Yes, you would calculate the budget for both the UH2 and UH3 phases. The FOA states:

    “The total cost for each application cannot exceed $625,000 annually for the UH2 phase (years 1-2) and $1,200,000 dollars annually for the UH3 phase (up to 3 or 4 years). It is not a requirement to request both years of UH2 support, but at least one year of UH2 phase planning is required. Total costs must include the costs for all research conducted, including work performed at an organization other than the PD/PI institution. Budgets should include costs for statistical analysis of the final UH3 project and travel costs as detailed below.

    Years 1 to 5
    Two persons attending one SC meeting to be held in locations convenient/central to the participants.

  2. Two persons attending an annual External Scientific Advisory Committee. This committee will be appointed by NIDCR.”

Added 10/6/2014

  1. Question: The RFA states that applicants need to include a timeline of milestones to achieve during each year of funding within the 12-page Research Strategy. Is it possible to include this timeline as an appendix document with a cross reference to the timeline in the Research Strategy?
    Answer: No. Both FOAs (RFA-DE-15-006 and RFA-DE-15-007) specify that the description of plans should include a timeline as well as the milestones to be achieved for each proposed year of funding. This information must be included only in the Research Strategy. Please refer to the NIH guidelines (NOT-OD-10-077) that specify permissible material in Appendices.

Added 9/24/2014

  1. Question: RFA-DE-15-006 states that “Application budgets are limited to $625,000 total costs per year for up to two years of the UH2 phase and $1,200,000 total costs per year for each year of the UH3 phase.” Does this mean that the $625,000 per year for the UH2 phase and $1,200,000 per year for the UH3 phase includes both the direct and our institution’s indirect costs or does it only refer to the direct cost part?
    Answer: Per RFA-DE-15-006, application budgets are limited to $625, 000 total costs per year for up to two years of the UH2 phase and $1,200,000 total costs per year for each year of the UH3 phase. This means that the direct costs and the parent institution’s indirect costs combined cannot exceed these amounts.\

Added 9/8/2014

  1. Question: The RFA does not appear to preclude secondary data analysis. Would a study conducted solely using methods of secondary data analysis be responsive to the RFA?
    Answer: The RFA does not preclude studies that are solely secondary data analyses. The RFA states “Numerous study designs may be appropriate for this type of complex research. This FOA will support intervention studies as well as studies designed to rigorously evaluate the outcomes of existing programs or policies to assess their capacity to influence oral health disparities and inequalities in U.S. children.”

Added 8/28/2014

  1. Question:This FOA is clear that efficacy testing of drugs or devices (Phase I, II, III) is not allowed. It does seem that this FOA only allows implementation of evidence-based interventions on multiple levels. Does this mean that the FOA will not allow other effectiveness studies addressing new drugs/devices/behavioral interventions?  
    Answer: With respect to drugs and devices, the FOA “cannot be used for the efficacy testing of drugs or devices (Phase I, II or III clinical trials).  Applicants are referred to the NIDCR Clinical Trials Program website.    Applications proposing such trials will be deemed non-responsive and will not proceed to review”.   The FOA is not intended to support studies that seek to determine if dental device A is more effective than dental device B, but rather to determine how best to implement effective healthcare practices into communities with greatest need.

    NIH defines implementation science as “the study of methods to promote the integration of research findings and evidence into healthcare policy and practice. It seeks to understand the behavior of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions.  The intent of implementation science is to investigate and address major bottlenecks (e.g. social, behavioral, economic, management) that impede effective implementation, or to test new approaches to improve health programming.”  Implementation studies of interventions using drugs and devices for which strong evidence of efficacy has been established are allowed, as long as the studies fulfill the requirements of the FOA.

    With respect to behavioral interventions, efficacy, effectiveness and implementation studies are allowable under this FOA since the understanding of individual, provider, organizational and community behaviors are crucial. 

  2. Question: If evidence-based interventions are tested on a multi-level, is a control group allowed.
    Answer: The FOA states that “numerous study designs may be appropriate...” “…applicants should propose the strongest research design that is appropriate, acceptable and feasible to answer the research question and to evaluate the varied elements of a multi-level intervention or an existing program or policy.“  Control or comparator groups may be appropriate for the research design.  Applicants are reminded that proposed studies must be acceptable to the community.
  3. Question: Can one individual submit two different project proposals with two different partners and separate institutions?  Can the individual be the PI on both of these project proposals, and with other PIs or Co-PIs as long as the projects are totally separate and without any conflicts?
    Answer: The FOA states that “any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Directors(s)/Principal Investigator(s) (PD(s)/PI(s) is invited to work with his/her organization to develop an application for support.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH Support. -For institutions/organizations proposing multiple PDs/PIs visit the Multiple Program Director/Principal investigator Policy and submission details in the Senior/Key Person Profiled (Expanded) Component of the SF 424 (R&R) Application Guide.”  The FOA goes on to say that “applicant organizations may submit more than one application provided that each application is scientifically distinct.”  The FOA goes on to discuss duplicate and highly overlapping applications.  Please see Section III -1 and 3.
Added 7/28/2014

 

  1. Question: Is it anticipated that $5M in total costs for all the UH2/UH3s will be awarded each of the 5 years?
    Answer: No, the total UH2/UH3 funding will depend on the size and scope of meritorious awards and the availability of funds in the NIDCR budget. It is anticipated that the UH2 and the UH3 per year project caps will be consistent with those stated in the RFA.
  2. Question: Can some personnel be proposed on both a DCC U01 and a MCRC for OHDC UH2/UH3?
    Answer: Yes, personnel may be proposed on applications for both the DCC U01 and the MCRC for OHDC UH2/UH3. However the roles of the proposed personnel must be distinct and justified.
  3. Question: Can a PI of a multiple PI team be proposed on both a DCC U01 and a MCRC for OHDC UH2/UH3?
    Answer: The RFA states "Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide."
    Yes, a PI of a multiple PI team can be proposed on both a DCC U01 and a MCRC for OHDC UH2/UH3. However an individual proposing a leadership role for both the DCC and an MCRC project must ensure that DCC resources are equitably available to all MCRC projects. In addition, a detailed conflict of interest plan that is approved by the NIDCR must be in place should this situation arise.
  4. Question: Can a PI submit both a DCC U01 and a MCRC for OHDC UH2/UH3?
    Answer: Yes, a PI can submit both a DCC U01 and a MCRC for OHDC UH2/UH3. But as stated in Question 3 (7/28/2014), an individual proposing a leadership role for both the DCC and an MCRC project must ensure that DCC resources are equitably available to all MCRC projects. In addition, a detailed conflict of interest plan that is approved by the NIDCR must be in place should this situation arise.

Posted 6/27/2014

  1. Question: What is a UH2/UH3 mechanism?
    Answer: A UH2/UH3 mechanism is a cooperative agreement award mechanism that consists of two phases/stages. The UH2 phase is a planning phase that can be used for exploratory and formative work, determining the level of disease of interest, quantifying potentially modifiable factors associated with oral health disparities and inequalities, determining the prevalence of these modifiable factors in populations under study, piloting testing components of the interventions or program evaluations, planning, feasibility testing and developing study documents, including the study protocol and manual of procedures. The multi-level intervention or rigorous evaluation of an existing program, policy or natural experiment will be deployed during the UH3 implementation phase.
  2. Question: The FOA says that a multilevel conceptual framework/model must guide proposed studies and that factors from three levels must addressed. Is it all right to select three factors within a single level such as the individual or family level as long as a conceptual model is included?
    Answer: No, this FOA supports research that takes a holistic, multilevel approach to reducing oral health disparities and inequalities in vulnerable U.S. children 0-21 years of age and states that to be responsive factors from at least three levels of influence must be addressed. Refer to Section I. Purpose, Background and Research Objectives and Section IV. 2. Research Strategy for additional information.
  3. Question: Does the usual 12 page limit for the Research Strategy Section apply to this FOA that uses the UH2/UH3 mechanism or is it 12 pages for the UH2 phase and an additional 12 pages for the UH3 phase?
    Answer: The FOA states that all page limitations described in the SF 424 Application Guide and the Table of Page Limits must be followed. Per the Table of Page Limits the total number of pages allowed for the UH2/UH3 Research Strategy Section is 12 pages.
  4. Question: The FOA indicates that the funding for an exploratory stage should last at least one and up to two years. Does the amount of time it takes to carry out the exploratory stage affect the number of years allowable for the implementation stage?
    Answer: Yes, the FOA states the UH2/UH3 cooperative agreement award is for up to five years of funding, so if the exploratory UH2 stage takes two years the implementation UH3 stage may receive funding for up to three years where as if the UH2 stage takes one year the UH3 stage may receive funding for up to four years.
  5. Question: Would a proposal for a Phase III clinical trial for efficacy testing of a drug or device be acceptable?
    Answer: No, this FOA cannot be used for the efficacy testing of drugs or devices. Applications proposing such trials will be deemed non-responsive and will not proceed to review. Applicants interested in conducting such trials are directed to the NIDCR Clinical Trials Program website.
  6. Question: Must all intervention research be designed as a randomized clinical trial?
    Answer: The FOA states that numerous study designs may be appropriate for holistic, population health approaches that address a range of determinants and risk factors at varied level of influence. Applicants are encouraged to propose the strongest research designs that are appropriate, acceptable and feasible to answer the research questions and to evaluate the varied elements of a multi-level intervention or an existing program or policy. Randomized trial designs may be used where appropriate to establish the efficacy or effectiveness of an approach. However designs other than RCTs may be proposed. Examples of other types of clinical studies include cohort or longitudinal studies and the rigorous evaluation of natural experiments.
  7. Question: Do intervention studies have to include plans for cost analyses?
    Answer: Yes, cost analyses of interventions are a requirement of this FOA. In addition, investigators must consider issues of sustainability.
  8. Question: Can applicant organizations submit applications for both RFA-DE-15-006 and RFA-DE-15-007?
    Answer: Yes, an applicant organization may submit separate applications to both funding opportunities. Note that there is no requirement that applicant organizations must submit applications for both.
  9. Question: Can applicant organizations submit more than one application?
    Answer: Yes, the FOA states that applicant organizations may submit more than one application, provided that each application is scientifically distinct. Refer to Section III. 3 for additional information.
  10. Question: Will applications be considered that propose multiple Program Directors/Principal Investigators?
    Answer: Yes, multiple PD/PIs can be proposed in the application. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
  11. Question: The FOA says that during the UH2 phase study documents must be prepared including the study protocol and manual of procedures and that there are policies regarding the monitoring and the terms and conditions of the award. Where can I get more information about what is expected?
    Answer: The NIDCR website includes helpful information in the Toolkit for Clinical Researchers. The Toolkit includes information about clinical terms of award, data and safety monitoring and protocol templates.
  12. Do we have to submit a letter of intent?
    Answer: While a letter of intent is not required, is not binding and does not enter into the review of a subsequent application, the information that a letter of intent contains does assist the Institute staff in estimating the potential review workload and plan the review. Letters of intent are due November 9, 2014. Additional information about the letter of intent is found in Section IV. 2 of the FOA.
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This page last updated: December 17, 2014