Frequently Asked Questions: KPMP Recruitment Sites

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  1. How many pages is a Recruitment Site application?
  2. Can a single institution submit multiple applications for a Recruitment Site?
  3. Are foreign institutions allowed to apply for a Recruitment Site?
  4. What is the UG3/UH3 mechanism?
  5. How long are the UG3 and UH3 phases?
  6. Will the Recruitment Sites transition to the UH3 phase?
  7. What are the budget differences between the UG3 and UH3 phases?
  8. Can a Recruitment Site recruit both AKI and CKD participants?
  9. Is recruitment of a particular patient group not within the scope of KPMP?
  10. Do I need a Letter of Support from the local IRB?
  11. When does the KPMP expect to start participant recruitment?
  12. How many participants should the Recruitment Sites propose to recruit?
  13. Does a Recruitment Site have to obtain biopsies?
  14. Who should perform the biopsies?
  15. How long should Recruitment Sites propose to follow participants?
  16. Do the Recruitment Sites have to share their local pathology slides and tissue blocks?
  17. What information will be returned to the participants at the Recruitment Sites?
  18. Whom should I contact if I have other questions about the Recruitment Sites?

How many pages is a Recruitment Site application?

The Research Strategy section is limited to 12 pages.

Can a single institution submit multiple applications for a Recruitment Site?

Yes. Assuming no scientific or budgetary overlap, a single institution can submit multiple applications for a Recruitment 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 foreign institutions allowed to apply for a Recruitment Site?

Yes. Foreign institutions can apply for a Recruitment 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 Recruitment 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 Recruitment Site recruit both AKI and CKD participants?

No. Each Recruitment Site must initially choose to focus on either AKI or CKD.

Is recruitment of a particular patient group not within the scope of KPMP?

Pediatric patients are currently not within the scope of the KPMP.

Any patient groups currently being recruited or studied by other publicly funded consortia obtaining kidney tissue are not within scope.  Specifically, these include lupus nephritis (AMP lupus) and glomerulonephritis (NEPTUNE) and (Cure GN).

Do I need a Letter of Support from the local IRB?

Yes. A letter from the local IRB should be included in the application indicating their willingness to review future common protocol(s) for obtaining research kidney biopsies. The NIH realizes that the common protocol(s) will need to be approved by all IRBs at a later date.

When does the KPMP expect to start participant recruitment?

It is anticipated that participant recruitment will begin by April 2018.

How many participants should the Recruitment Sites propose to recruit?

Applicants should propose to study either AKI or CKD, specify initial cohorts of interest, provide inclusion/exclusion criteria, and estimate the number of participants to be recruited given the Recruitment Site budget and 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.

Does a Recruitment Site have to obtain biopsies?

Yes. While kidney tissue from transplant, nephrectomy, and autopsy will be used for optimization, discovery and validation efforts, these tissues do not provide the quality and diversity to meet the KPMP objectives. The KPMP requires research kidney biopsies (or clinical biopsies with a research core) linked to longitudinal clinical phenotypic data and biosamples.

Recruitment Sites will also be expected to supply other sources of existing healthy and diseased kidney tissue (e.g., obtained from transplant, nephrectomy, autopsy) 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.

Who should perform the biopsies?

Applicants should include collaborators knowledgeable and skilled in biopsy of the kidney. Such individuals should have an exceptional safety record and provide statistics regarding complications from kidney biopsies they have performed. The safety record of the biopsy team is a scored review criterion.

How long should Recruitment Sites propose to follow participants?

Complete follow-up of study participants will be necessary to avoid bias. Applicants should discuss how participants will be followed and propose protocols for the collection of longitudinal data, including follow-up visits and biosample collection. The efficient use of EHRs for follow-up is encouraged. Applicants should also discuss the ethics and feasibility of repeat biopsies.

Do the Recruitment Sites have to share their local pathology slides and tissue blocks?

Yes. The Recruitment Sites must submit all data and samples to the Central Hub, including routine clinical pathologic slides, tissue blocks (FFPE, frozen), and clinical pathology reports. The Central Hub will in turn perform conventional and advanced (e.g., omic, 3-Dimensional imaging) pathologic reading of all available tissue, compare to the clinical diagnosis and local site pathologic analysis, and examine if it is feasible to provide clinical feedback to the practitioner caring for participants enrolled in the KPMP. The Central Hub will pay for all shipping and handling of data and samples (including pathology slides and tissue blocks) to and from the Recruitment Sites.

What information will be returned to the participants at the Recruitment Sites?

The KPMP will encourage the return of diagnostic and other individually relevant data to study participants and the (re)incorporation into EHR systems as feasible and appropriate.

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

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