Frequently Asked Questions (FAQs) - Planning for the TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (R34 Clinical Trial Not Allowed)

Frequently asked questions will be updated periodically.

Question: The RFA language seems to suggest the need for large interdisciplinary teams to be able to comprehensively address the goals of the future Collaborative. How large of a team should be assembled, and should the proposal be a multi-site proposal?
Answer: There is no requirement for multi-site participation on an application in response to this planning grant RFA, but multi-site participation is encouraged if expertise at the applicant institution is insufficient to carry out the scope of the work proposed. Applications may also expand on collaborations during the planning grant award period to obtain the needed expertise, leverage highly relevant resources/infrastructure, and/or reach the desired patient populations.

Question: The RFA language emphasizes patient-centered research and translatability of research. What does this mean for basic research and does this mean that it is much more important to have strong clinical teams and expertise than basic research teams? What is the expected balance of clinical and basic research capacity at the time of application?
Answer: There is no preference, or preconception of the “right” balance of basic and clinical research during the planning grant stage. Both basic and clinical research are essential in accomplishing the goals of the future Collaborative, but any gaps in the compendium of approaches can be developed or acquired during the planning grant award period.

Question: Is focusing on just basic research or just clinical research sufficient for this planning grant proposal?
Answer: Most likely too focused to be the broad, integrated, interdisciplinary, and multi-level approach to address TMD comprehensively from the whole-person perspective. Although balance is not prescriptive, proposals should have more along the translational spectrum than just basic/preclinical or just clinical.

Question: Since the Planning Grant is not intended to support a single R01-like project, is any data collection or analysis allowed or supported?
Answer: The Planning Grant award can support collection of preliminary research data. Can also support landscape analysis or limited population health/epidemiological research to inform/support the research agenda or proposed approaches.

Question: What kind of details are needed in the future Collaborative "design?" How can one describe the functional and structural fit within the larger Collaborative when it will be designed by the NIH prior to the release of the future Collaborative FOA(s)?
Answer: The structure of the future Collaborative can be proposed as the applicants envision, as long as such a structure can address all stated goals of the future Collaborative. This will allow assessment of the current capacity of the interdisciplinary team against this construct and allow development of milestones toward this framework. Emphasis on the functional, scientific, research, and governance aspects of the design is recommended.

Question: What is meant by “These planning grants are intended to enable institutions to develop the necessary partnerships, infrastructure, and capabilities needed to address the major goals of the future Collaborative.” Does this mean that reviewers for these R34 applications will be assessing only whether applicants should be able to meet all 4 of the goals of the future Collaborative by the end of the planning grant, or will the degree to which applicants are able to well address some of the goals be given equal consideration?
Answer: Reviewers will be instructed that both are important, but that teams are very unlikely to be able to comprehensively address all goals, so both are acceptable and will allow NIH to select from these two approaches to build the framework for the Collaborative.

Last Reviewed
March 2023