EPR Center Pilot Projects

Frequently Asked Questions for the Dart-Dose CMCR Pilot Projects

Note: Recent changes are denoted by blue text.

Pre-Awards
Post-Awards
1. General
2. Second Year of Funding
  1. What is the process of applying for a second year of funding?

1.1.1 Q: Who is eligible to apply? [back to top]

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 CMC 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 PIs are expected to hold faculty appointments in academic institutions, we will consider other types of positions and organizations, as well as graduate students with appropriate supervision 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.
Dart-Dose CMCR personnel funded wholly on the Dart-Dose CMCR are ineligible. However, others from Dartmouth are eligible to apply, so long as their proposed project (as is true for all pilot projects) does not significantly overlap with work already funded by the Dart-Dose CMCR.
Other: 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.

1.1.2 Q: What criteria will be used to judge White Papers and Formal Proposals? [back to top]

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 is not desirable, but a general relevance to the overall goals of NIAID's 8 funded CMCRs will be an important criterion if there is no direct link to the Dart-Dose CMCR.
FORMAL PROPOSAL (STEP 2): 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 Q: Who will review the proposals? [back to top]

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 programs 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 Q: How do we know what is in the Dart-Dose CMCR Cores and its key Projects? [back to top]

1.1.4 A: These are posted and described elsewhere on this website.

1.1.5 Q: How do we know who is a Dart-Dose CMCR investigator? [back to top]

1.1.5 A: The key members of leadership are listed here. The investigators within each Core and Project with be listed on the project and core pages and described further in the People section of this website.

1.1.6 Q: Can we be late in submitting our proposal and still be considered? [back to top]

1.1.6 A: Because we intend to have 4 cycles annually, we expect to adhere to the stated deadlines. If there are unusual circumstances, investigators may communicate by email in advance with the Core Director of the Pilot Projects (Dr. Ann Barry Flood). Mitigating circumstances may be considered in accepting late submissions. Note: permission must be sought and granted in advance of the deadline.

1.1.7 Q: Can we submit appendices? [back to top]

1.1.7 A: No

1.1.8 Q: 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? [back to top]

1.1.8 A: The page limits are as follows:

The White Paper is one page, not including the budget and biosketch.
The Formal Proposal is five pages, not including the budget, resources, and biosketches and any evidence of approval of human subjects protection or animal welfare.

Font and size maximum: Arial 11; margins: 1/2 inch minimum on all margins; single-spaced.

1.2 White Papers: [back to top]

1.2.1 Q: What details are needed in the White Paper? [back to top]

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.):

Provide a brief [4 page maximum] biosketch of the principal investigator, using NIH-style format. Please see the biosketch form and instructions on this webpage. We do not require a eRA commons name but would like the information detailed in the NIH biosketch for the PI.
Please also briefly answer these seven questions:
1. 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.)
2. Is this a Full Pilot Project or a Focused Pilot Project?
3. 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.)
4. Provide names and degrees and current positions of any other key personnel.
5. 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?
6. What is the name of the organization that will be responsible if awarded?
7. How did you learn about the Dart-Dose CMCR Pilot Project Call for Proposals? Please list any that apply:
  - Dart-Dose CMCR webpage
  - General email announcement
  - From a friend or colleague
  - At a conference or meeting
  - From NIAID
  - Other (Please specify.)

1.3 Proposals: [back to top]

1.3.1 Q: What details are needed in the Formal Proposal? [back to top]

1.3.1 A: Staying within the 4 page limit, the same basic components as for the White Paper are needed in the Formal Proposal, although with greater detail to allow better assessment of the feasibility and significance of work that can be completed within the proposed time and budget.

Scientific Proposal. This should follow the outline and address the content requirements in the NIH 398 form. The length for Dart-Dose pilot proposals is 4 pages maximum. See here for details. It is important to specify products, IPs, and other deliverables expected and provide a timeframe for accomplishing them.
Provide a biosketch of all key personnel, using the NIH-biosketch form and instructions. See this webpage. We do not require a eRA commons name but would like the information detailed in the NIH biosketch for all key personnel.
Provide a budget, listing key personnel supported and percent effort and other expenses using NIH categories. Use the NIH budget form located here. Provide a brief budget justification of major expenses. It is not necessary to use a specific form for the justification, but do label it "Budget Justification" and follow the NIH instructions for what it should specify. (Note: Indirects are not allowed; maximum funding per year is $50,000, and funding for a second year requires a competitive renewal process.)
Briefly answers these questions:
1. Is this a Full Pilot Project or Focused Pilot Project?
2. 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.)
3. 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 it will speed up funding to have them ready at the time of submission of the Formal Proposal.
4. 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.
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.
  You may choose to provide these documents JIT after we have notified you that we would like to seek final approval from NIAID to fund your formal application, but it may add a small delay.

1.3.2 Q: What is needed/allowed in the budget? [back to top]

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 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, if requested, such 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.

1.3.3 Q: Why aren't indirect expenses allowed? [back to top]

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 apply the full amount to support the direct needs to carry out the proposed work and not to request indirect costs.

1.3.4 Q: Can the pilot project funding be used to supplement existing funding? [back to top]

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. Notification of Awards: [back to top]

1.4.1 Q: Will we get detailed feedback from the reviews? [back to top]

1.4.1 A: Yes, in modest detail.

1.4.2 Q: Can we resubmit after being turned down once? [back to top]

1.4.2 A: Yes, at any subsequent deadline.

2. POST AWARDS: [back to top]

2.1 General: [back to top]

2.1.1 Q: What are the expectations about reports and deliverables if awarded? [back to top]

2.1.1 A: There will be brief quarterly progress reports due at 3, 6, and 9 months after the award date. Final reports and deliverables must be completed within the 12 months beginning at the award start date.

2.1.2 Q: How long after the end of funding will awardees be expected to provide information about publications and grants and other products resulting from this work? [back to top]

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!)

2.1.3 Q: How do we acknowledge support for this funding in publications and professional presentations? [back to top]

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. Full answer is pending confirmation from NIAID about their policy.

2.1.4 Q: How do we know what pilot projects have been funded? [back to top]

2.1.4 A: A list of the funded pilot projects is available here.

2.2 Second Year of Funding: [back to top]

2.2.1 Q: What is the process for applying for a second year of funding? [back to top]

2.2.1 A: The process is 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 cycle of applications most closely matching the fourth quarter of their award. Competitive renewals should also submit a progress report and a specific rationale as to why a second year is needed.