Frequently Asked Questions for the Dart-Dose CMCR Pilot Projects
- Who is eligible to apply?
- What criteria will be used to judge White Papers and Formal Proposals?
- Who will review the proposals?
- How do we know what is in the Dart-Dose CMCR Cores and its key Projects?
- How do we know who is a Dart-Dose CMCR investigator?
- Can we submit appendices?
- What are the page limits and how do you define a page, e.g., are there requirements about margins, font type and size? Can we go over the page limit?
- White Paper
- Formal Proposals
- Notification of Awards
- What are the expectations about reports and deliverables if awarded?
- How long after the end of funding will awardees be expected to provide information about publication and grants and other products resulting from this work?
- How do we acknowledge support for this funding in publications and professional presentations?
- How do we know what pilot projects have been funded?
- What are the expectations about communicating with the Dart-Dose CMCR.
- Second Year of Funding
1.1.1 A: "Anyone with an innovative and effective idea to advance biodosimetry!" is the basic spirit behind our response to this question. Additionally, we will consider outstanding proposals that advance the broad goals of the CMCR program supported by NIAID. Nonetheless, there are a few other qualifications:
- Applicant individuals need to be a member of an organization that is eligible to be the recipient of the funds and oversee their use and to ensure, if appropriate, that approved animal protocols or protection of human subjects are in place. In defining eligible applicant organizations, we will be guided by the NIH NIAID definitions and those of Dartmouth.
- While most principal investigators (PIs) are expected to hold faculty appointments in academic institutions, we will consider other types of positions and organizations, as well as postdoctoral fellows with appropriate oversight of their project.
- International applicants are welcomed. If the successful international applicant's organization is not already NIH-approved for receipt of funds, we will assist in the process to be eligible to receive funds.
- EPR Center personnel funded on the Dart-Dose CMCR are ineligible to apply. However, all others from Dartmouth are eligible to apply.
- Non-citizens may apply; visa status of non-citizens applicants residing in the US must comply with US immigration laws. We encourage qualified disadvantaged minorities and women to apply.
- By NIAID's rules for all current CMCRs, no one funded under any CMCR or on any CMCR external scientific advisory committee can be budgeted on any pilot application from any CMCR. This implies they cannot be a PI or key personnel, but can be advisors or otherwise unbudgeted collaborators.
- By NIAID's rules no PI previously receiving two years of pilot project funding may serve as the PI on subsequent pilot projects; however, they may serve as investigators. Institutions previsouly receiving project funding are eligible for additional funding, subject to the above.
1.1.2 A: The criteria for the White Papers and Formal Proposals are listed separately:
- WHITE PAPERS (STEP 1): The principal criteria for review of the White Papers will be their potential scientific merit, innovativeness, feasibility, and overall specific relevance to the aims of the Dart-Dose CMCR (see the specific aims for Project 1, Project 2, and Project 3). Significant overlap with the Dart-Dose CMCR projects or core activities is generally not desirable, but projects that augment our research are desirable. At a minimum, the project must be related to the overall goals of NIAID's 8 funded CMCRs if there is no direct link to the Dart-Dose CMCR.
- FORMAL PROPOSAL (STEP 2): Invited formal proposals will be evaluated for originality and scientific design, and particular attention will be paid to relevance to the CMCR aims especially, but not limited to, those of the Dart-Dose CMCR. In addition, standard NIH review criteria for significance, design and methods, innovativeness, feasibility in time and funding level requested, investigator qualifications, other key personnel qualifications, and suitable resources available will be applied. Importance and feasibility of products will also be explicitly considered.
- For Full Pilot Project proposals, feasibility of plans for future independent funding and potential for further development of products will be evaluated. While not required, the fit to a particular Core or Project and/or personnel within the Dart-Dose CMCR will be evaluated.
- For Focused Pilot Project proposals, relevance to improve and advance or redirect the Dart-Dose CMCR's current work will be key. In addition, identification of which Core, Project and personnel within the Dart-Dose CMCR that will form the basis of the collaboration will be key. For concerns about human subjects protection, suitability of gender and racial distribution of human subjects, and animal protocols will be examined at this stage but are not an explicit part of the review criteria. Evidence of approval as appropriate for human subjects or animal subjects will be required before funding can commence, and therefore applicants are encouraged but not required to submit proof of such approvals at this stage. Regarding applicants, there will be no discrimination based on age, sex, race, religion, national origin, etc., and proposals from women and underrepresented minorities will be encouraged.
1.1.3 A: The various review groups are listed below:
- White Papers will be reviewed by members of the Pilot Project Scientific Review Committee (PP-SRC). Critiques may be sought from members of other departments or CMCR programs and from our external Advisory Committee who have a particular expertise in certain areas.
- Formal Proposals will be reviewed by the PP-SCR supplemented with ad hoc reviewers as necessary. Prior to final funding, decisions will be subject to approval by the Dart-Dose CMCR Director and approval of representatives from the NIAID for NIAID funds.
- The Dart-Dose CMCR External Advisory Committee will review the Pilot Projects funded on at least an annual basis in order to review the merit and potential of the research and the fit with previously funded pilot projects, with an aim to have a broad mix of projects over the five year period and that also meet rigorous criteria for high quality and productivity.
- Current members (in alphabetical order) of the Pilot Project Scientific Review Committee (PP-PRC) are:
- Eugene Demidenko, Ph.D. (Biostatistician). Dr. Demidenko is a recognized expert on the analysis of complex multidimensional repeated measurements biological data based on the mixed model approach. He has published papers on mixed models, sample size and power calculations, asymptotic hypothesis tests comparison, optimization in statistics, image reconstruction, inverse problems, financial mathematics, partial differential equations, statistical analysis of image and shapes, and tumor response to treatment.
- Jiang Gui, Ph.D. (Biostatistician). Dr. Gui has proposed several new ideas on spectral decomposition and new statistics to test whether spectral shapes are identical. He also applied state-of-art smoothing techniques to get better resolution of signal/noise from the spectra.
- Ann Barry Flood, Ph.D. [Chair] (Organizational Sociologist/Health Policy Expert). Dr. Flood is an expert on survey and outcomes research methods and in health policy, quality, costs and quality improvement and decision-making in teams and health care systems.
- Eva C. Guinan, M.D. (Hematologist/Oncologist/Pediatrician). Dr. Guinan is a clinical investigator with over 25 years of experience in myeloablative hematopoietic stem cell transplantation. She has published widely in transplant conditioning mediated toxicity, the impact of genetic makeup on risk for regimen-related toxicity during transplantation, and novel agents for the prevention or treatment of regimen-related toxicity.
- James S. Hyde, Ph.D. (EPR Instrumental Expert). Dr. Hyde is internationally recognized as the leading expert in EPR instrumentation and MRI technologies and applications. He has published more than 370 articles in medical and physical science peer-reviewed journals and has 33 U.S. patents.
- Piotr Lesniewski, M.S.E. (Hardware Engineer). Mr. Lesniewski is a world-recognized leading expert in the development of EPR hardware, including resonators for use in human subjects. He has extensive experience in resonator development, especially L-Band, and in microwave bridges, especially L-Band.
- Steven Swarts, Ph.D. (Analytical Chemist). Dr. Swarts is an analytical chemist with 28 years of experience in the development and validation of instrument-based qualitative and quantitative methods, including EPR, liquid chromatography (HPLC and LC-MS), and gas chromatography- (GC-MS) based analytical methods for detecting and quantifying free radicals and their end-products.
- Harold M. Swartz, M.D., Ph.D., M.S.P.H. (Expert in Clinical Applications of EPR). Dr. Swartz is considered by many to be the world's leader in the biomedical applications of EPR, especially clinical applications and in vivo EPR spectroscopy. He has more than 450 publications, including more than 200 on in vivo EPR and EPR biodosimetry and 6 U.S. patents in this field.
- John B. Weaver, Ph.D. (Medical Physics). Dr. Weaver is a highly experienced and well-regarded physicist with an active research program in fast MRI, wavelet encoding MRI, wavelet based signal processing, magnetic resonance elastography, magnetic nanoparticle bio-sensing, measuring molecular binding and temperature using magnetic nanoparticle tags and on magnetic resonance elastography.
- Benjamin B. Williams, Ph.D. (Medical Physicist). Dr. Williams an expert in both EPR oximetry as well as biodosimetry, and his experimental work includes work in both human and animal models.
1.1.4 A: These are posted and described elsewhere on this website.
1.1.5 A: The key members of leadership are listed here. The investigators within each Core and Project are listed on the project and core pages and described further in the People section of this website.
1.1.6 A: No
1.1.7 A: The page limits are as follows:
- The White Paper is one page, not including the budget and biosketches.
- The Research Plan included in the Formal Proposal is four pages, not including the references, budget, resources, biosketches, and other NIH required forms, and any evidence of approval of human subjects protection or animal welfare.
Font and size: Arial, minimum font size of 11; margins: 1/2 inch minimum on all margins; single-spaced.
1.2.1 A: Staying within the one page limit, briefly describe the overall goals and rationale for the proposed pilot study, and the methods to achieve them within the allowed time and budget. Also provide these two types of required information when submitting the White Paper (Note: these materials do not count toward the one-page limit described above.):
- Using NIH-style format for biosketches, provide biosketches of the principal investigator and co-investigators and consultants. See the NIH biosketch form and instructions on this webpage. If available, include the eRA commons name for the PI.
- Please also briefly answer these six questions:
- What is the total proposed budget? (Note that there is a maximum of $50K, for one year, and all institutions are requested to waive indirects. A second year of funding is possible for successful projects but only via a competitive renewal application; please do not budget for two years.)
- Is this a Full Pilot Project or a Focused Pilot Project?
- To which Dart-Dose CMCR Project, Core, and/or Investigators does your proposed pilot project apply? (Note that this answer is required for Focused Pilot Projects and optional for Full Pilot Projects.)
- Provide names, degrees and current positions of key personnel.
- Will your pilot project require Human Subjects Protection or Animal Welfare approval (i.e., review and approval by an Institutional Review Board or the Institutional Animal Care and Use Committee?)? If yes, do you currently have such approvals?
- What is the name of the organization that will be responsible if awarded?
1.3.1 A: Staying within a 4 page limit for the research plan section, the same basic components as described in the White Paper are needed, although with greater detail to allow better assessment of the significance of work and the feasibility that it can be completed within the proposed time and budget.
- Research Plan. This should follow the outline and address the content requirements in the NIH 398 form. The length of a Dart-Dose CMCR pilot project research plan is 4 pages maximum. See here for details. It is important to specify products and other deliverables to be provided to the EPR Center and to provide a timeframe for accomplishing them, although these items and any references do not count toward the 4 page maximum. Also descibed expected IPs.
- Provide biosketches of all key personnel, using the NIH-biosketch form and instructions. We do not require that key personnel obtain an eRA commons name if not already assigned.
- Provide a budget usng the NIH budget forms located here. In the first year budget, list all personnel and express their level of effort in calendar months. Note other expenses using NIH categories. Provide a brief budget justification and follow the NIH instructions for what it should specify. (Note: Indirects are requested to be waived by each institution so that $50,000 maximum funding per year can be appled to the scientific effort; funding for a second year requires a competitive renewal process so do not specify more than one year at a time in the budget and research plan.)
- Provide a brief answer to these questions:
- Is this a Full Pilot Project or Focused Pilot Project?
- To which Dart-Dose CMCR Project, Core, and/or Investigators does your proposed pilot project apply? (Note that this answer is required for Focused Pilot Projects and optional for Full Pilot Projects.)
- Will your pilot project require Human Subjects Protection or Animal Welfare approval (i.e., review by an Institutional Review Board or an Institutional Animal Care and Use Committee?) If yes, do you currently have such approvals? Note: funding cannot be awarded until such assurances are in place and so we cannot send to NIAID any proposals that we recommend for funding until these approvals are provided to us.
- Has the organization that will be responsible, if awarded, already reviewed and approved your budget and proposal? Note: funding cannot commence until these institutional approvals are in place and so it is recommended that these be secured at least at the time of submission of the Formal Proposal. We request that you use the face page for NIH's 398 application for this purpose. It can be downloaded here. It is helpful to provide a copy of the face page in your application too; you may choose to wait to obtain signatures until we request JIT requirements as noted in #5.
- Just-in-Time Information (JIT). As noted above, before we can finalize funding of any pilot project,
NIAID requires that we provide them with JIT information about:
- "Other Support" for every key personnel on the pilot project. The form and the instructions for listing all current and pending 'other support' can be downloaded here. Please note that this information is different from the information requested on the biosketch form.
- Proof and number of IRB approval or IACUC approvals from your institution must be submitted to NIAID before funding can be approved (as noted in 3).
- Institutional sign-off (as noted in 4) using the NIH face page.
1.3.2 A: We need enough detail to indicate how the funds will be allocated to complete the proposed tasks and to ensure that the budget will be acceptable to NIAID for funding they support. Please keep the following principles in mind:
- All expenses should be directly related to carrying out the pilot project; these direct expenses include salary of personnel and project related materials and consumables as well as any travel to Hanover and/or telephone conference calls with the Dart-Dose CMCR personnel that are not otherwise covered by the U19, i.e., funding for the Dart-Dose CMCR.
- Limited funds for travel and expenses to professional meetings are allowed if critical to achieve the goals of the pilot project, and therefore justification should be provided.
- In some cases, support, including salary, may be allowed for a postdoctoral fellowship to carry out a proposed Focused Pilot Project at the laboratory and clinical facilities at the Dart-Dose CMCR. (Be sure to specify this intent in the White Paper so that it can be evaluated and approved.)
- Travel and hotel/food expenses can be budgeted for someone from the applying institution to spend part of his/her time at Dartmouth to gain a better understand of the specifics of what is needed and/or to transfer the technology to Dart-Dose CMCR.
- It is expected that each funded pilot project PI, or designee from the project's research team,will attend the annual two-day Dart-Dose CMCR meeting in New Hampshire, and that the expenses associated with attendance will be borne by the pilot project's funding award. Travel expenses associated with attendance should be included in the budget. Attendance at the annual meeting can be included in a longer stay to allow for collaborative work with members of the EPR Center.
1.3.3 A: These rules apply to all pilot projects funded under the auspices of the Dart-Dose CMCR. There is a maximum of $50,000 per year per project at the Dart-Dose CMCR, and we ask all applicant institutions to not request indirect costs and instead apply the full amount to support the direct needs to carry out the proposed work. To date (updated October 2013), all institutions have agreed to this request. If indirects are included, the total of $50,000 must not be exceeded.
1.3.4 A: The pilot projects are intended to be an independent and novel addition to work already being carried out. Thus, it will be imperative to show why this work is not already being funded and/or a part of the existing plans if supplemental funds are requested.
1.4.1 A: Yes, in modest detail.
1.4.2 A: Yes, but if a proposal is resubmmitted it is expected that reviewers' concerns will be addressed.
2.1.1 A: There will be brief monthly progress reports due beginning with first month of the award period. Deliverables must be completed within the 12 months beginning with the award start date. Final Reports and deliverables are due within one month following the end of the award period. However, for pilot projects seeking a second year of funding, a progress report for the initial year should be included in the application and submitted at least 2 months prior to the end of the first year of funding in order to permit time for a competitive review at the Dart-Dose CMCR and submission to NIAID for approval.
2.1.2 A: Publications that derive from the funding, regardless of time after the award, should acknowledge the support. (This will help perpetuate and expand the pilot grant program!) The PIs for each pilot project should also continue to inform the Dart-Dose CMCR about any IP, publications, presentations, or funding that result from this work for at least 5 years post-funding. (This will become a part of the formal CMCR records at NIAID, which will enable them to continue this approach to funding!) PIs are expected to report NIH funding to any journals that accept publications resulting from this work.
2.1.3 A: Basically, all products and results related to work carried out under any awarded Pilot Project from the Dart-Dose CMCR should acknowledge pilot project funding from the Dart-Dose CMCR for all publications and presentations. The language to use is: The authors would like to acknowledge funding from the Pilot Project Program of the Dartmouth Physically Based Center for Medical Countermeasures Against Radiation, with NIH funding from the National Institute of Allergy and Infectious Diseases (U19-AI091173).
2.1.4 A: A list of the funded pilot projects is available here.
2.1.5 A: In addition to reports and deliverables, three types of communications are expected:
- Upon being recommended for funding, each pilot project will have a designated staff member at Dart-Dose CMCR assigned as a scientific liaison. This person, selected for having appropriate expertise, will actively communicate and monitor progress throughout the funded period, reading and reacting to reports as well as communicating information about related research on-going at the Dart-Dose CMCR.
- All pilot projects are expected to send at least one key personnel to the annual Dart-Dose CMCR meeting held at Hanover. (This should be included in the budget.)
- About 4 pilot projects will be selected annually to provide a poster reporting their projects to the national meeting of the seven CMCRs supported by NIAID.
2.2.1 A: Application for second year funding is competitive. The process and forms to be used are the basically the same as for the initial award, since second year requests for funding are considered to be 'competitive renewals'. Investigators should apply during the fourth quarter of their award. In addition to a research plan, competitive renewals should also submit a progress report covering the first yearof funding and a specific rationale as to why a second year of funding is needed.