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Multidisciplinary Collaborative Research Consortium to Reduce Oral Health Disparities in Children: Data Coordinating Center (U01) Questions and Answers RFA-DE-15-007

View RFA-DE-15-007

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 NIDCRQandADCC@mail.nih.gov.

Update​
Added 11/25/2014 

  1.  Question: The RFA suggests that there will be an annual face-to-face meeting of the Consortium including the ESAC. For budgeting purposes, is there anticipated to be additional face-to-face meetings of the Steering Committee?
  1. Answer:  RFA-DE-15-007 describes the DCC as “serving as the MCRC for OHDC organizational and logistical center” and provides examples of how this will be accomplished including the example that “with the individual UH2/UH3 investigators and NIDCR, providing logistical and financial support for the annual face-to-face meeting of the Consortium and the annual External Scientific Advisory Committee.”  The cost of the Steering Committee at both the Consortium and the ESAC annual meetings should be budgeted.
​Added 11/14/14
  1.  Question: The RFA mentions the requirement of a strong background in bioinformatics and GWAS are mentioned specifically later in the document. Should the DCC be prepared to analyze other types of bioinformatics data than GWAS?
  1. Answer: Please refer to item #4 that was added to this Question and Answer webpage on 8/28/14 below.  
  2. Question: Is the DCC responsible for monitoring of clinical sites (either on site or remotely)? If so, is there an intended frequency for these monitoring visits?
    Answer: The DCC is not responsible for on-site clinical monitoring of the sites and should not include costs for such monitoring.   The DCC may be asked to provide support for remote monitoring of sites.  Monitoring plans will be tailored for each study according to the UH2 / UH3 study complexity and level of risk. However RFA-DE-15-007 provides under the Research Strategy section a list of duties that includes other types of monitoring for which costs should be included. 
    • “Designing questionnaires, data collection forms, and database structures and implementing systems for data collection, including participant accrual, follow-up rates, adherence to protocol, and data quality that are available to all UH2/UH3 investigators on a 24-hour, 7-days-a-week basis with appropriate feedback, monitoring, backup, and security;”
    • “Implementing a method for timely monitoring and reporting of adverse events, unanticipated study events and protocol deviations to ensure participant safety, including notification and reports to the NIDCR, their clinical operations contractor, and the Data and Safety Monitoring Board.”

  3. Question: The DCC budget must include reimbursement for ESAC members. Approximately how many members may be involved and how often will the ESAC be meeting?
    Answer: Please refer to item #1 that was added to this Question and Answer webpage on 7/28/2014 and item #1 that was added to this page on 10/16/14 below.

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 10/16/14

  1. NIDCR has received requests for additional detailed information regarding the Data Coordinating Center budget. RFA-DE-15-007 states that the applicant should describe the plans for carrying out duties listed in the FOA and any additional functions needed to support the complex array of studies described in the FOA and its companion RFA-DE-15-006.  RFA-DE-15-007 provides examples of costs under the R&R or Modular Budget section.  Given that the types of studies, their locations, the number of Collaborative Working Groups, numbers of needed conference calls and webinars, etc. are unknown, applicants should provide budget estimates and justifications that include the assumptions that were used in calculating the estimates.  For example, estimated costs for meeting space for in-person meetings could be based on an assumption that the meetings would be held in a city in the middle of the country, held at the DCC or the sponsor’s facilities, or scheduled as satellites to a major meeting.  Applicants are reminded that the RFA states that “Application budgets are limited to $2,200,000 total costs per year…..”.  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.   

Questions and Answers​

Added 10/16/14

  1. Question: Please confirm whether or not the DCC will be expected to provide clinical project management (i.e. leading study meetings, assisting in protocol development, etc.) for the studies supported under RFA-DE-15-006 (UH2/UH3 sites).
    Answer:
    Please refer to the descriptions provided in RFA-DE-15-007 under the headings of Research Strategies and R&R or Modular Budget.  Delineated are duties that include, but are not limited to  “Supporting the UH2/UH3 PDs/PIs during the development of an individual protocol and Manual of Procedures (MOP) for each final UH3 study”, “Planning and conducting regular meetings…”, “Hosting webinars and teleconferences...”

 

Added 10/7/2014

  1. Question: The U01 Data Coordinating Center RFA and the UH2/UH3 companion RFA both refer to Oral Health Disparities Collaborative Working Groups (CWG).  Should Data Coordinating Center applicants budget costs for CWG conference calls? Should applicants make assumptions and state them in the DCC budget?
    Answer:
    Yes, applicants should include in their budgets costs for conference calls.  Assumptions should be made and stated in the DCC budget justification.

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-15-007 states that “Application budgets are limited to $2,200,000 total costs per year for fiscal year 2015. Future year amounts will depend on annual appropriations.” Does this mean that the $2,200,000 for fiscal year 2015 includes both the direct and our institution’s indirect costs or does it only refer to the direct cost part?
    Answer: Per RFA-DE-15-007, application budgets are limited to $2,200,000 total costs per year for fiscal year 2015 and future year amounts will depend on annual appropriations. This means that the direct costs and the parent institution’s indirect costs combined cannot exceed these amounts. 

Added 8/28/2014

  1. Question: How is the community engagement to work with the DCC?
    Answer: As stated in the FOA, the type of research that will be conducted by the UH2/UH3 awardees “must be multidisciplinary and community engaged. Research teams may include individuals with expertise in diverse areas, including dentistry and dental hygiene, medicine, nutrition, social and behavioral sciences, microbiology, genetics, epidemiology, health policy, health economics, and biostatistics. It is also essential to forge partnerships within and outside of the health sector -The DCC will have primary responsibility for developing common resources; facilitating the conduct of studies; designing and implementing a strategy for data collection that is appropriate for each individual project. -The DCC will be expected to work closely with the UH2/UH3 PDs/PIs, to participate intellectually in all aspects of the Consortium, including developing Consortium procedures and committees, assisting with writing protocols and sample informed consent documents, and helping with recruitment and retention strategies.” Therefore, the DCC should be able to design questionnaires, data collection forms, and database structures and systems that can be used in a variety of community settings by investigator teams with varying levels of research abilities, and help with recruitment and retention strategies in underserved settings.
  2. Question: How will analyses be distributed between DCC and UH2/UH3 projects?  UH2/UH3 conduct project specific analyses and DCC cross project analyses?
    Answer: As stated in the FOA, the DCC’s roles include “Preparing and distributing periodic technical and statistical reports of study activities and progress.”  This would include reports for recruitment and retention for each individual UH2 / UH3 project, monthly reports for each UH2 / UH3 project to monitor study progress and the periodic reports and additional requested reports for oversight committees for each UH2 / UH3 project.  The DCC will be expected to conduct many project specific analyses to support the launch and implementation of each study.  The UH2 / UH3 awardees will analyze the final study results from final datasets provided by the DCC.
  3. Question: Can the PI of the DCC be the PI of a UH2/UH3?
    Answer: Yes. Please also see questions 5 and 6 of the Questions and Answers posted 7/28/2014.
  4. Question: What is the role of bioinformatics?   Is this IT for data management, for large genetic databases or EHRs?
    Answer: The role of bioinformatics is primarily IT for data management.
  5. Question: Is it possible to do any cross-site projects, especially in phase 2?
    Answer: As stated in the FOA “The Multidisciplinary and Collaborative Research Consortium to Reduce Oral Health Disparities in Children structure mandates robust and productive collaborations between the individual UH2/UH3 projects to achieve the Consortium's goals.“  This would permit cross-site projects. However, any cross-site projects would need to be endorsed by Consortium members in a collaborative project.
  6. Question: Should the DCC work to standardize instruments/measures across studies?
    Answer: Yes.  As stated in RFA-DE-15-006 that solicits applications for the individual UH2 / UH3 projects “During the UH2 phase, the individual project awardees and key personnel, the DCC and the NIDCR will form Collaborative Working Groups to finalize study designs, decide on use of common approaches and outcome measures as appropriate.”  Applicants responding to RFA-DE-15-007 are strongly urged to read RFA-DE-15-006.
  7. Question: The DCC is responsible for establishing and maintaining a computer system and software needs for the storage and analysis of study data, including audiovisual data.  Can you clarify what types of audiovisual data may be expected?
    Answer: As stated in RFA-DE-15-006 that solicits applications for the individual UH2 / UH3 projects “Data may be collected through mixed methods that gather qualitative as well as quantitative data; social network analysis; systems modeling; health impact assessments; organizational contextual and process assessments; key informant interviews and focus groups.”  Data from key informant interviews, focus groups and fidelity monitoring for behavioral interventions might include audiovisual data.
  8. Question: Please clarify the sort of secure infrastructure and dissemination service envisioned in the data coordinating center specification in RFA DE 15-007, "Devising and maintaining a secure infrastructure for storing and disseminating data that might include identifiable information about human subjects. This includes serving as the central locus for accepting requests for the use of such materials and for providing a secure means for approved users to access those materials".
    Answer: As stated in RFA-DE-15-006 that solicits applications for the individual UH2 / UH3 projects “Data may be collected through mixed methods that gather qualitative as well as quantitative data; social network analysis; systems modeling; health impact assessments; organizational contextual and process assessments; key informant interviews and focus groups surveys and questionnaires; chart audits; case studies and secondary data analysis.”  This means the DCC will need the ability to receive identifiable materials such as medical records and video recordings that need de-identification for analysis by approved users, and the ability to provide approved users with identifiable materials in a secure electronic or other manner.
Added 7/28/2014

 

  1. Question: For the ESAC and DSMB, is the DCC expected to provide honoraria and reimburse for any travel? If so, for budgeting purposes what is the expected number of people per committee and how many in-person meetings and teleconferences are anticipated per year?
    Answer: The NIDCR is responsible for the scheduling and personnel-related expenses of the DSMB. Applicants for the DCC should include in the budget honoraria and expenses for a six member ESAC that will meet once each year in person and once each year by teleconference.
  2. Question: It is clear that for any one project the UH2/UH3 split in the 5-yr duration can reasonably be either 2/3 years or 1/4 years. What mix of these two basic options should be assumed for budgeting effort? Should we make an assumption and state it in the DCC budgeting?
    Answer: Yes, applicants should make an assumption and state it in the DCC budget justification.
  3. Question: We assume the DCC will prepare all reports for the DSMB and for the Collaborative Working Groups – is this correct?
    Answer: Yes, the DCC is responsible for preparing reports including those related to the Data Safety and Monitoring Board, the Collaborative Working Groups, the ESAC, and the Consortium Steering Committee.
  4. 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.
  5. 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.
  6. 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 5 (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.

Added 6/27/2014

  1. Question: The companion FOA (RFA-DE-006) uses a UH2/UH3 mechanism – how does it work and will the DCC be expected to be involved in both the UH2 and the UH3 phases?
    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. Per RFA-DE-15-007, a single DCC is expected to support and coordinate activities during both the UH2 and UH3 phases – see Section I. Research Objectives for detailed information.
  2. Question: Does the usual 12 page limit for the Research Strategy Section apply to DCC applications?
    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 DCC Research Strategy Section is 12 pages.
  3. Question: Could applicants for the UH2/UH3 propose Phase III clinical trials for efficacy testing of a drug or device?
    Answer: No, applicants cannot use RFA-DE-15-006 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.
  4. Question: Must all intervention research be designed as a randomized clinical trial?
    Answer: The UH2/UH3 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.
  5. Question: Do proposed 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.
  6. 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.
  7. 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.
  8. Question: Must a letter of intent be submitted?
    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 02, 2014