Frequently Asked Questions (FAQs) - TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (U54 Clinical Trial Optional)

Question: Can we have more Cores than the required?

Answer: Submitting more than the required cores or any disallowed attachment would be grounds for an administrative withdrawal of the entire application.

Question: Is the outreach and education component allowed in international settings (foreign institutions and communities)? Or does it have to be restricted domestically?

Answer: While foreign organizations are not eligible, foreign components of the domestic applications are allowed. Thus, outreach and education can be allowed in international settings, though the primary intent of the National Centers is to provide primary outreach and education in the U.S.

Question: How many pages are allowed for the research projects?

Answer: The Research Project Component is allowed up to 12 pages per research project, so up to 36 pages for three projects. A single research project may not use more than 12 pages even if a second research project within the Center uses less than 12 pages. Each project can be shorter than 12 pages, so the total pages for all the research projects may be shorter than 36 pages.

Question: What about pages for the Specific Aims? For example, are there Specific Aims pages for each project component, or is it one page for Specific Aims, and 11 pages for the Research Strategy?

Answer: The Specific Aims is one page and does not count toward the 12-page limit (e.g., one page for the Specific Aims of a research project, and 12 pages for the Research Strategy). Therefore, for example, each of the research projects are allowed one Specific Aims page and up to 12 pages for the Research Strategy.

Question: Is there a Specific Aims page for each of the components?

Answer: Each component has its own Specific Aims page that does not count towards the maximum page limit listed in the Page Limitations Table of the NOFO (e.g., Admin Core has one Specific Aims page and 6 pages for the Research Strategy section).

Question: Will each reviewer review the whole application?

Answer: Each assigned reviewer will be provided with the whole application. As with all NIH applications, the Data Management and Sharing Plan (DMSP) is not reviewed by the reviewers. Further specificity of review assignments has not yet been determined.

Question: Can you describe more about patient and community participation in the Collaborative?

Answer: Ideally, patients/advocacy groups should be well-integrated in all aspects of the Center(s) activities, including, for example, participation in governance structure and inclusion of patient perspectives in research questions and research design. Outreach, dissemination, and education should involve all stakeholders, from patients and trainees to clinicians, health care providers, and mentors/trainers.

Question: Will the subcontracts be pass through, or will they be taken out of the directs from the leading institution?

Answer: If there is a subcontract, there is a subcontract agreement between the institutions. Subcontract costs are part of the direct costs; however, subcontract indirect costs are not part of the direct cost limitation. See NOT-OD-05-004.

Question: Can the Principal Investigator (PI) have only a D.D.S./D.M.D., only an M.D., or both a D.D.S. and M.D.? Can the lead PI have a combined D.D.S./M.D.?

Answer: In the NOFO, eligible individuals (Program Director/Principal Investigator) can be any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research. 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.

Question: Is the listed specific areas of research project "Mechanistic studies on molecular pathogenesis, disease progression, pain chronification, or resilience that correlate with stratification approaches and TMD clinical heterogeneity including sex differences that predisposes females more than males to develop a TMD; as well as mechanisms that sustain or promote endogenous resolution of chronic TMD pain and/or prevent the transition from acute to chronic pain" related to clinical basic science or preclinical animal models or either? 

Answer: These mechanistic studies can be clinical or preclinical studies.

Question: Is there a minimum level of effort expected for PIs?

Answer: No, however, effort must be commensurate with involvement that ensures the Center or Core(s) the PI is directing will operate and run smoothly to complete the tasks and overall goals of the program.

Question: If there will be only two awards, does each application have to limit the budget request to $3.5 million total cost per year?

Answer: No. However, budgets must be extremely well justified and total cost allowance for this NOFO is $7 million per year.

Question: The NOFO language on training the future TMD biomedical workforce seems to include research training of junior to early-career investigators and research education for medical and dental health care providers. Does the Training Core have to include research training and research education to this broad spectrum of career stages and career paths?

Answer: The language in the NOFO highlights needs and priorities and is aspirational in nature. Multiple training and/or research education programs are not expected in a single application.

Question: The NOFO language states that the research framework of the TMD IMPACT Collaborative is interdisciplinary, addressing TMD-related research questions that single independent research projects cannot tackle and covering a broad swath of the translational spectrum. Define “broad swath.” Will both basic and clinical research be required?

Answer: The Collaborative as a whole will encompass both basic and clinical research, however an individual center grant application in response to this NOFO is not required to encompass both. At least two domains, for example, clinical trial and epidemiology; health services research, epidemiology, and clinical research; basic and clinical mechanistic research; clinical, computational, and technology development are encouraged.