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  5. Frequently Asked Questions: KPMP Tissue Interrogation Sites

Frequently Asked Questions: KPMP Tissue Interrogation Sites

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  1. How many pages is a Tissue Interrogation Site application?
  2. Can a single institution submit multiple applications for a Tissue Interrogation Site?
  3. Are studies of animals or model systems allowed?
  4. Are foreign institutions allowed to apply for a Tissue Interrogation Site?
  5. What is the UG3/UH3 mechanism?
  6. How long are the UG3 and UH3 phases?
  7. Will the Tissue Interrogation Sites transition to the UH3 phase?
  8. What are the budget differences between the UG3 and UH3 phases?
  9. Can a Tissue Interrogation Site propose to interrogate non-biopsy kidney tissue?
  10. What’s the difference between “state-of-the-art” and “next generation”?
  11. How many samples should the Tissue Interrogation Sites propose to analyze?
  12. How will the KPMP develop a common analytic pipeline for tissue interrogation?
  13. Whom should I contact if I have other questions about the Tissue Interrogation Sites?

How many pages is a Tissue Interrogation Site application?

The Research Strategy section is limited to 12 pages.

Can a single institution submit multiple applications for a Tissue Interrogation Site?

Yes. Assuming no scientific or budgetary overlap, a single institution can submit multiple applications for a Tissue Interrogation Site.

Across the KPMP, a single institution can submit multiple applications for Recruitment Sites and/or Tissue Interrogation Sites. That same institution can also submit one application for the Central Hub. A single institution cannot submit multiple applications for the Central Hub.

Are studies of animals or model systems allowed?

No. The KPMP will only support human studies and applications that include animal or model systems are not responsive.

The Tissue Interrogation Sites should support agnostic discovery on human kidney tissue. They should not support validation of pathways and targets previously implicated in kidney injury and/or disease. Further downstream characterization of cells, pathways, and targets in animal models, or model systems, is supported by other mechanisms (e.g., R01).

Are foreign institutions allowed to apply for a Tissue Interrogation Site?

Yes. Foreign institutions can apply for a Tissue Interrogation Site.

What is the UG3/UH3 mechanism?

It is a phased award and will be used to support both the KPMP Recruitment Sites and Tissue Interrogation Sites.

The initial UG3 phase is limited to 2 years and supports milestone-driven exploratory research. The most promising UG3 projects may be approved for transition to the UH3 phase. The UH3 phase is limited to 3 years and supports the implementation of research activities initiated under the UG3 phase. You must address both the UG3 and UH3 phases in your application.

The UG3/UH3 mechanism is a cooperative agreement. This is different than a standard R01 grant and means that there will be substantial scientific and programmatic involvement by the NIDDK. Substantial involvement means that, after the award is made, the NIDDK will assist, guide, coordinate, or participate in all activities.

How long are the UG3 and UH3 phases?

The UG3 phase is limited to two years. The UH3 phase is limited to three years.

Will the Tissue Interrogation Sites transition to the UH3 phase?

There is no guarantee that any given UG3 award will successfully transition to a UH3 award or that the requested budget escalation will occur.

The application should specify the milestones for transition in the “Approach” section of the Research Strategy. These milestones will be evaluated during peer-review. Final milestones will be approved by the NIDDK during the first year of the UG3 phase and used as the basis of programmatic review at the transition time.

Transition will also depend on the NIDDK program priorities, leadership approval and availability of funds.

What are the budget differences between the UG3 and UH3 phases?

The direct costs for UG3 awards are expected to be approximately $200,000-$300,000 per year. The direct costs for UH3 awards are expected to be approximately $400,000-$600,000 per year.

There is no guarantee that any given UG3 award will successfully transition to a UH3 award or that the requested budget escalation will occur.

Can a Tissue Interrogation Site propose to interrogate non-biopsy kidney tissue?

Yes. Other sources of existing healthy or diseased data and samples (including archived tissue) will be used for optimization, discovery, and validation efforts. Please be aware that any existing data or samples discussed in the application must be made available to the KPMP upon award. Applicants should document a willingness to share all de-identified data and samples and discuss how they will be harmonized with new efforts. Applicants should also state a willingness to share all protocols and technologies.

What’s the difference between “state-of-the-art” and “next generation”?

Current “state-of-the-art” methods should be supported by evidence that they are ready to interrogate human kidney tissue now.

“Next generation” methods should be supported by preliminary evidence that they will improve or complement the interrogation of human kidney tissue after further development.

Tissue Interrogation Sites should have documented experience with current “state-of-the-art” methods that can be used or adapted to interrogate human kidney tissue. Preliminary data in animals may be acceptable, but data in human kidney is preferred. The initial UG3 exploratory phase will be to demonstrate that the site can interrogate existing tissue samples (e.g., obtained from transplant, nephrectomy, autopsy) and small numbers of new biopsies. The UG3 phase will also encourage the development of “next generation” tissue interrogation technologies that probe the structural, histologic, functional, and molecular complexities of kidney tissue. UG3 projects that have met their milestones will be administratively considered by the NIDDK and prioritized for transition to the UH3 implementation phase. UH3 awards will support further validation, scale-up and technology development.

How many samples should the Tissue Interrogation Sites propose to analyze?

The initial UG3 exploratory phase will be used to demonstrate that the site can interrogate existing tissue samples and small numbers of new biopsies. Applicants should estimate the number of samples to be analyzed given the cost of the proposed method(s), the Tissue Interrogation Site budget and the KPMP objectives.

The direct costs for UG3 awards are expected to be approximately $200,000-$300,000 per year. The direct costs for UH3 awards are expected to be approximately $400,000-$600,000 per year.

There is no guarantee that any given UG3 award will successfully transition to a UH3 award or that the requested budget escalation will occur.

The Central Hub will pay for all shipping and handling of data and samples (including biopsies) to and from the Recruitment Sites and Tissue Interrogation Sites.

How will the KPMP develop a common analytic pipeline for tissue interrogation?

The KPMP Steering Committee will be responsible for prioritizing methods and distribution of biopsy tissue for analysis.

Whom should I contact if I have other questions about the Tissue Interrogation Sites?

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