For studies that address improving clinical care of TSC, advanced practice providers, genetic counselors, or nurses are eligible to be named as a Principal Investigator (PI), Initiating PI or Partnering PI.

• Supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including the diagnosis, prognosis or treatment of TSC.
• Studies advancing clinical trial readiness through the development of biomarkers, clinical endpoints, and validation of pharmacokinetic/pharmacodynamics, as well as studies piloting clinical trials that include behavioral interventions, are of particular interest.
• Supports studies that encompass the analysis of existing real-world data practices to develop/improve guidelines for better outcomes in defined areas relevant to the focus areas of the program.
• Preference will be given to studies that involve human samples/patients or leverage existing clinical data and/or ongoing clinical studies.
• Preclinical studies may be appropriate, but must include a clinical component.
• Projects that are exploratory and/or strictly animal research will not be considered for funding.
• Applications may include a small, pilot clinical trial intended to inform the next step in the continuum of translational research.
• Clinical Translational Potential, Impact, and Research Strategy are important review criterion.
• A Partnering PI Option is available.

• Maximum of $1 million for direct costs (plus indirect costs)


• Maximum of $1.15 million for direct costs (plus indirect costs) for applications including a Partnering PI Option


• Maximum period of performance is 3 years.

For studies that address improving clinical care of TSC, advanced practice providers, genetic counselors or nurses are eligible to be named as a PI.

• Supports the initial exploration of innovative, high-risk, high-gain and potentially groundbreaking concepts in the TSC research field.
• Projects involving human subjects or human biological substances must be exempt under Title 32, Code of Federal Regulations (CFR) Section 219.101(b)(4); or be eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.
• Research projects must be innovative, feasible and supported by a strong rationale.
• Innovation is an important review criterion.
• Preliminary data are not required.
• Clinical trials are not allowed.

• Maximum of 200,000 for direct costs (plus indirect costs)


• Maximum period of performance is 2 years.

or 

New-to-the-Field Investigators:
Independent investigators at the level of instructor/staff scientist, Assistant Professor (or equivalent), or above; or established independent investigators in an area other than TSC at or above the level of Assistant Professor seeking to transition to a career in TSC, thereby bringing their expertise to the field.

Must not have received more than $300,000 in total direct costs for previous or concurrent TSC research as a PI of one or more federally funded, non-mentored peer-reviewed grants. (National Institutes of Health K Awardees are eligible to apply.)

• Supports new ideas that have the potential to yield high-impact findings and new avenues of investigation.
• Impact and Research Strategy are important review criteria.
• Preliminary data are expected.
• Clinical trials are not allowed.
• The New-to-the-Field Investigators option supports the continued development of promising independent investigators that are early in their faculty appointments; and/or the transition of established investigators from other research fields into a career in TSC research.
• Applications from Established Investigators will be peer and programmatically reviewed separately from New-to-the-Field Investigators.

• Maximum funding of $500,000 for direct costs (plus indirect costs)


• Maximum period of performance is 3 years.