Ancillary Studies

characterization of an ancillary study

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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.

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View the KPMP Ancillary Studies policy

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

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Biospecimens available for ancillary studies

The Submission Process

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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.

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

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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.

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

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

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.