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  5. Frequently Asked Questions: Kidney Precision Medicine Project (KPMP)

Frequently Asked Questions: Kidney Precision Medicine Project (KPMP)

Applying

  1. Is the KPMP undergoing an open competition and looking to add new sites?
  2. Do I need to submit a Letter of Intent?
  3. What is the minimum required percent effort?
  4. When are applications due?
  5. I did not have a KPMP award in the previous cycle. Can I apply now?
  6. Can a single investigator submit multiple applications to the KPMP?
  7. Can a single institution submit multiple applications to the KPMP?
  8. Are foreign applications allowed?
  9. When will the KPMP awards be made?

Objectives

  1. What are the goals of the KPMP?
  2. What has the KPMP accomplished in the first 5 years? What does the KPMP expect to accomplish in the next 5 years?
  3. How much money does the NIDDK plan to commit to the KPMP?
  4. How do the various KPMP activities fit together?

Collaboration

  1. Will the KPMP investigators have to share and collaborate?
  2. How will the KPMP ensure quality?
  3. Will the proposed KPMP studies be undertaken exactly as planned?
  4. How will patient partners and participants inform the KPMP?
  5. What is the KPMP Community Engagement Committee?
  6. How often will the KPMP investigators have to travel to Bethesda?
  7. What is the governance structure of the KPMP?
  8. Will Industry be involved?
  9. What is the KPMP Opportunity Pool?

Applying

Is the KPMP undergoing an open competition and looking to add new sites?

Yes. The KPMP is undergoing an open competition and is looking to add new sites.

Do I need to submit a Letter of Intent?

Although a Letter of Intent is not required and does not impact review, it allows the NIDDK to plan the peer-review. If you intend to submit an application to any of the four KPMP FOAs, please email a Letter of Intent by August 23, 2021 to NIDDKLetterofIntent@mail.nih.gov. Please include:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of the FOA

What is the minimum required percent effort?

PIs must declare a minimum effort of 2.4 person-months (20%) per year on all KPMP applications. Applications proposing Multiple PIs must have a minimum combined effort of 2.4 person months (20%) per year.

When are applications due?

All KPMP applications are due September 23, 2021.

I did not have a KPMP award in the previous cycle. Can I apply now?

Yes. KPMP is undergoing an open competition for new and renewal applications.

Can a single investigator submit multiple applications to the KPMP?

Yes. As long as there is no scientific or budgetary overlap and the PI(s) meets the required minimum effort of 2.4 person-months (20%) effort per year per application.

Can a single institution submit multiple applications to the KPMP?

Yes. Assuming no scientific or budgetary overlap, a single institution can submit multiple applications for Recruitment Sites, Tissue Interrogation Sites, the Central Hub, and/or the Kidney Tissue Atlas Coordinating Center.

Are foreign applications allowed?

No. Foreign Institutions are not eligible to apply. Well justified foreign components are allowed.

When will the KPMP awards be made?

It is anticipated that the all of the KPMP awards will be made in July 2022.

Objectives

What are the goals of the KPMP?

The objectives of the KPMP are:

  • Diverse longitudinal cohort. Recruit adults from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds with AKI and CKD to undergo protocol research biopsies linked to longitudinal clinical data and biosamples.
  • Public resource. Create a publicly available data hub with de-identified clinical, physiologic, imaging, cellular, and molecular data using FAIR principles (findable, accessible, interoperable, and reusable).
  • Kidney tissue atlas. Create a collection of maps to locate and classify different cell types and interstitial components accounting for health, disease, age, sex, race, ethnicity, socioeconomic, and geographic backgrounds. The atlas will help define disease subgroups and identify critical cells, interstitial components, pathways, and targets for novel therapies.
  • State/transition markers. Identify cellular and molecular markers that classify cells as healthy, injured, activated, or undergoing recovery via adaptive or maladaptive repair.
  • Clinical subgroups. Use all available data to define disease subgroups to allow for clinical stratification into distinct endophenotypes.
  • Molecular pathways. Identify and understand healthy and disease pathways that are activated in a cell type in a subgroup of people.
  • Biomarkers. Discover sets of subgroup and pathway biomarkers.

What has the KPMP accomplished in the first 5 years? What does the KPMP expect to accomplish in the next 5 years?

Please see KPMP.org and the KPMP Structure and Stages document (PDF, 470.55 KB)  for ongoing efforts and accomplishments. In the next 5 years, the KPMP aims to increase the number and diversity of individuals biopsied; enhance the throughput and depth of clinical and molecular phenotyping; expand the capacity of the KPMP bio-repository; and provide more dedicated effort to data analysis and visualization.

How much money does the NIDDK plan to commit to the KPMP?

The NIDDK intends to commit at least $14,660,000 per year for 5 years starting in FY 2022. We anticipate awarding ~7 Recruitment Sites, ~8 Tissue Interrogation Sites, 1 Central Hub, and 1 Kidney Tissue Atlas Coordinating Center.

The exact allocation of funds will be determined by the NIDDK based on scientific merit (as recommended by peer-review) and programmatic priority (in consultation with the NIDDK National Advisory Council).

How do the various KPMP activities fit together?

The KPMP will include 4 distinct, but highly interactive activities:

  1. Recruitment Sites (RS): enroll adults with AKI and/or CKD from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds into a longitudinal cohort study that includes a research kidney biopsy [RFA-DK-20-026; U01].
  2. Tissue Interrogation Sites (TIS): use and develop innovative technologies to analyze human kidney tissue [RFA-DK-20-028; U01].
  3. Central Hub (CH): collect and de-identify all clinical and social risk data and samples, and provide quality control, project management, and administrative support for the entire KPMP [RFA-DK-20-029; U24].
  4. Kidney Tissue Atlas Coordinating Center (KTACC): clean, harmonize, store and curate all de-identified KPMP data, perform integrative analyses, and create an interactive Kidney Tissue Atlas [RFA-DK-20-027; U01].

Collaboration

Will the KPMP investigators have to share and collaborate?

Yes. All KPMP sites and investigators must share all data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets), protocols (including analytical methods), ontologies, technologies, biological samples (including, but not limited to, biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool), and other research resources. All de-identified KPMP data will be released to the research community immediately upon validation. KPMP data will only be made publicly available once the risk of explicit or inferred identification has been mitigated in consultation with the KPMP Community Engagement Committee and the DSMB. The Central Hub will house all personally identifiable data (under the control of an Honest Broker), while the KTACC will house all de-identified data. The KTACC will support a publicly available and highly interactive data hub with de-identified clinical, physiologic, imaging, cellular, and molecular data using FAIR principles (findable, accessible, interoperable, and reusable) to promote data retrieval, exploration, discovery, and analysis by the community.

It is expected that the KPMP will seed future partnerships, ancillary studies, investigator-initiated endeavors, and industry collaborations, and play an active role in recruiting and training the next generation of kidney researchers. Importantly, this will include a dedicated effort to recruit, train, and retain underrepresented scientists and stakeholders.

All KPMP institutions, investigators and collaborators must sign the KPMP Confidential Disclosure Agreement (CDA) and Material/Data Transfer Agreement (MTA) documents. No edits to either the CDA or MTA will be allowed.

How will the KPMP ensure quality?

All KPMP activities must propose and implement rigorous quality assurance and quality control (QA/QC) standards. As such, all KPMP sites and investigators must contribute to the development of a KPMP-wide quality management plan that spans every step of the project (including clinical phenotyping, tissue/sample collection, handling, processing, transportation, interrogation, analysis, and visualization). The Central Hub will lead a KPMP-wide effort to maximize the QA/QC of all data, workflows, and biosamples, including the implementation and surveillance of fit-for-purpose internal and external controls.

Will the proposed KPMP studies be undertaken exactly as planned?

No. The KPMP investigators will collaboratively devise a set of studies that will be reviewed by the Consortium Management Board (CMB) and Data and Safety Monitoring Board (DSMB) and approved by the NIDDK. Thus, all studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken. It is unlikely that any proposed research will be undertaken exactly as planned, or exclusively at an individual site.

How will patient partners and participants inform the KPMP?

People with kidney disease will be equal partners in the conduct of the all KPMP activities (e.g. as study investigators). KPMP research subjects (study participants) will work closely with study investigators to ensure that their viewpoints, priorities, and preferences inform study conduct and research directions.

What is the KPMP Community Engagement Committee?

The Administrative Core of the Central Hub will support a Community Engagement Committee to:

  • Identify key patient-centered factors to be included in the development of common protocols for obtaining informed consent and performing kidney research biopsies.
  • Develop novel approaches for actively engaging relevant and diverse local stakeholders (e.g., participants, physicians, IRB representatives, ethicists, providers) in the development of research kidney biopsy protocols that ensure safety, minimize risk and adhere to the principles delineated in federal guidelines for research.
  • Identify and promote best practices to ensure equitable engagement of participants from Hispanic, Black, and Indigenous racial and ethnic groups.
  • Disseminate engagement strategies, based on patient partner, patient participant and provider input.
  • Develop and implement a plan for continued engagement with participants as the research progresses, including a patient-centered information system for participant use that will offer clinical diagnoses for the enrolled participants and their providers and update them on the progress of research in the KPMP.
  • Solicit participant and provider input and feedback to inform all aspects of the KPMP.
  • Contribute to a communication plan to disseminate proposed operating procedures and results to the larger research and patient communities in collaboration with the KPMP Communication Coordinator.

How often will the KPMP investigators have to travel to Bethesda?

It is anticipated that all key personnel will need to travel in-person to the Bethesda MD/Washington DC area at least two times per year throughout the project period, including the launch meeting, which is planned for September 20-22, 2022. Please budget accordingly.

What is the governance structure of the KPMP?

All aspects of the study will be governed by the KPMP Steering Committee (SC) and overseen by two NIDDK-appointed boards: (1) a Data and Safety Monitoring Board (DSMB) focused on participant safety, study burden and scientific validity of the clinical data, and (2) a Consortium Management Board (CMB) focused on the overall scientific progress and direction. Do not propose DSMB or CMB members in your application.

Will Industry be involved?

Industry (Pharmaceutical and Biotechnology) may participate in the KPMP to expand the scope, size, and/or complexity of the project. In your application you should state a willingness to work with Industry partners/collaborators in a pre-competitive research arena.

All KPMP institutions will allow the Central Hub institutional representatives to centrally manage negotiations with industry and external partners in academia and nonprofit institutions on behalf of the KPMP.

All KPMP institutions, investigators and collaborators must sign the KPMP Confidential Disclosure Agreement (CDA) and Material/Data Transfer Agreement (MTA) documents. No edits to either the CDA or MTA will be allowed.

What is the KPMP Opportunity Pool?

It is a flexible pool of KPMP funds – administered by the Central Hub – to address gaps or form new partnerships. Specifically, the KPMP Opportunity Pool Program will:

  • Support the KPMP Steering Committee in its yearly assessment of infrastructure and resource needs.
  • Help develop and publicly announce requests for applications, advertise solicitations, manage acceptance, and organize external peer-review.
  • Establish an administrative structure to disburse and track awards.
  • Establish procedures, formats, and timelines for integrating awardees and monitoring and reporting progress and outcomes (e.g., publications, subsequent awards).
  • Establish a plan to integrate and harmonize the activities of supported projects with the activities of the KPMP.
  • Allow for both animal studies and international collaboration via the Opportunity Pool.
  • Applications for the Central Hub should address each of the above in their research strategy