Ancillary Studies

characterization of an ancillary study

Ancillary studies may use data, technology, biospecimens or other Kidney Precision Medicine Project (KPMP) resources that have already been collected; collect new data or biospecimens; or perform observational or interventional studies accessing the KPMP study participants. Ancillary studies using biospecimens or other Kidney Precision Medicine Project (KPMP) non-renewal resources or requesting access to KPMP patients is subject to review by the KPMP Ancillary Studies sub-Committee.

The main goal of the ancillary study review process is to ensure minimal burden to study participants, manage project scope overlap, and assess prudent use of limited KPMP resources (tissue and bio samples) in the ancillary study.

Approved Ancillary Studies Collaborators will be expected to uphold the Ancillary Studies policy.

Biospecimens available for ancillary studies

biospecimen Rates

All molecular services
Rate
Rate + indirect costs
Standard automated aliquoting, per 96-well plate
$216.90
$279.80
Manual viscous biosample plating to 96-well plates, per sample
$2.50
$3.23
Manual viscous biosample aliquoting to cryovials
$2.40
$3.10
Automated DNA extraction from whole blood or Buffy Coat (QiaSymphony)
$29.70
$38.31
Automated DNA extraction from whole blood (Perkin Elmer)
$32.40
$41.80
Automated DNA Extraction from Oragene saliva kit (QiaSymphony)
$28.50
$36.77
Automated RNA extraction from PaxGene RNA whole blood (QiaSymphony)
$56.90
$73.40
Ethanol precipitation and Resuspension of DNA (1-12 samples)
$41.20
$53.15
PicoGreen Quantification
$6.30
$8.13
Other Services
Rate
Rate + indirect costs
Distribution (per hour project management time)
$36.60
$47.21
Specimen or plate retrieval from storage
$1.00
$1.29
Accessioning samples not tracked in LabVantage
$2.30
$2.97
Relabeling samples
$2.50
$3.23
The KPMP biorepository is maintained by the University of Michigan Central Biorepository. KPMP Ancillary study rates are equivalent to rates charged to University of Michigan investigators, plus mandatory indirect costs applied.

How to submit a KPMP ancillary study

The Submission Process

An ancillary study proposal should be submitted to the KPMP Ancillary Studies sub-Committee at least 16 weeks prior to the anticipated date of submission for external funding. After approval, the proposal must be submitted to the funding entity within 6 months. Proposals submitted for funding should include the KPMP letter of approval and budgets from all KPMP sites involved, as well as the Central Hub. The ancillary study Investigator must notify the sub-Committee of the funding entity’s decision within two weeks of receipt of the award notification.

To submit an ancillary study proposal, please fill out this concept form. Completed forms can be submitted to ancillarystudies@kpmp.org.

The Review Process


Ancillary Study Review Criteria for All Projects (Self-Funded or Requesting Funding)

The proposed study must:

  1. Not interfere with the completion of the main objectives of KPMP or with continued participation and adherence of study participants to the KPMP protocol and policies.
  2. Have adequate resources to effectively carry out the project, including sufficient budget and staff with requisite expertise.
  3. If the nature of the proposed study is not subject to a pre-determined, external peer review (e.g. an NIH study section) by an external funding organization, the proposal will then undergo a rigorous external peer review managed by the KPMP, utilizing external reviewers appropriate for the proposed study’s scope.

Proposal Review of Suitability and Approval Process (6–12 weeks plus External Peer Review)

Ancillary study review process figure

Detailed information about the review and approval process can be found in the Ancillary Studies Policy.

Approved Ancillary Studies

Ancillary Studies that are approved will be provided with a letter of approval from KPMP to submit with their funding. After approval, the proposal must be submitted to the funding entity within 6 months. Proposals submitted for funding should include the KPMP letter of approval and budgets from all KPMP sites involved, as well as the Central Hub. The ancillary study Investigator must notify the sub-Committee of the funding entity’s decision within two weeks of receipt of the award notification.

Ancillary studies are expected to start within 18 months after KPMP final approval. In the event that an approved study is not funded, the KPMP approval will remain in effect for resubmission for funding or for application to an alternative funding source. Resubmission of the ancillary study proposal to KPMP is necessary if there is a change in resources required from KPMP or if 18 months have elapsed since initial approval (for studies not yet started).

All funded Ancillary Studies will be expected to sign the KPMP Data Use Agreement, Materials Transfer Agreement, Confidentiality Disclosure Agreement, and the Publications & Presentations Charter with no changes to all agreements.

currently Approved Ancillary Studies

Submitted
7
Approved
6

If you have any questions about the KPMP Ancillary Study process, please reach out to Alexa Plisiewicz

Pavan Bhatraju, MD, MSc (University of Washington)
Identification and Validation of Biological Sub-phenotypes of Sepsis-induced Acute Kidney Injury: A Precision Medicine Approach to Improve Clinical Outcomes

Anand Srivastava, MD, MPH (University of Illinois Chicago)
Functional MRI for Enhanced Phenotyping of CKD

Danielle Janosevic, DO (Indiana University School of Medicine)
Transcriptomic Diagnosis and Staging of Sepsis-Associated Acute Kidney Injury

Sylvia Rosas, MD, MSCE (Joslin Diabetes Center)
Impact of diabetes heterogeneity in kidney disease

Andy Hoofnagle, MD, PhD (University of Washington)
Using urine concentrations of type III procollagen fragments to investigate type III collagen remodeling during development of fibrosis in kidney disease"

Dennis Moledina, MD, PhD, FASN (Yale School of Medicine) & Chirag Parikh, MBBS, PhD (Johns Hopkins Medicine)
Leveraging KPMP participant samples to validate biomarkers of acute interstitial nephritis

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