Notice Number: NOT-CA-19-031
Key Dates
Release Date: March 12, 2019
PA-18-591
NOT-CA-19-033
Issued by
National Cancer Institute (NCI)
Purpose
This Notice informs current awardees that the National Cancer Institute (NCI) is interested in Administrative Supplement applications that seek to prepare and submit cancer epidemiology data into NIH/NCI-supported data repositories (e.g., database of Genotypes and Phenotypes [dbGaP]).
Through these administrative supplements, the NCI seeks to enhance cancer epidemiologic data sharing. Specifically, NCI invites applications for supplemental funding to eligible NCI awards (P01, P20, U19, U54, R01, U01, and UM1) so that involved personnel (awardees) can prepare and deposit individual-level data from cancer epidemiology studies into NIH/NCI-supported, controlled-access databases including the dbGaP. Sharing of research data will accelerate scientific discovery and increase opportunities for collaboration to provide new clues to cancer etiology, determine risk factors, and improve cancer survivorship. Notably, data-sharing activities that are required and/or receive support in the parent grant are NOT appropriate for this FOA.
Data sharing remains a long-standing priority for the National Institutes of Health (NIH), which described data sharing as "essential for expedited translation of research results into knowledge, products, and procedures to improve human health" in the 2003 NIH-wide policy. Additionally, a recommendation of theCancer Moonshot Blue Ribbon Panel Report describes the critical need for systems and infrastructure to enhance data sharing "to enable all participants across the cancer research and care continuum to contribute, access, combine, and analyze diverse data that will enable new discoveries and lead to lowering the burden of cancer in our country." The cancer epidemiology scientific community has a rich history of sharing data, often through large collaborations such as NCI's Cohort Consortium. Traditionally, data are shared between cancer epidemiology studies on a project-by-project basis, which is costly and can be challenging logistically. To facilitate efficient data sharing, NCI seeks to support data sharing via NIH/NCI supported data repositories.
Through this notice, the NCI seeks administrative supplement requests (applications) from grantees to support preparing and submitting cancer epidemiology data for deposit into NIH/NCI-supported data repositories (e.g., dbGaP). Datasets from all types of observational cancer epidemiology studies, as well as partial datasets that complement or critically update previously shared data, will be considered.
National Cancer Institute (NCI)-specific Interests:
NCI’s interests include, but are not limited to:
- preparing datasets for submission by identifying missing and erroneous data (i.e., "cleaning" data);
- preparing datasets to update existing datasets with additional clinical variables;
- creating data dictionaries and related dataset documentation;
- submitting data to an NIH/NCI repository (e.g., dbGaP);
- communicating with NIH/NCI data repository staff to ensure proper formatting and documentation; and
- obtaining updated consent from participants for high priority (e.g., those with rare cancers or outcomes or populations) genomic datasets with restrictive data use limitations to allow for general research use would be considered.
Budget
Administrative supplements must support work within the scope of the original project of the eligible parent award. Interested, eligible awardees (as requestors) should be aware that only activities (i.e., augmented efforts) required for depositing and sharing data that are above and beyond the activities covered in the budget of the original grant are eligible for supplemental funding. Notably, data-sharing activities that are required and/or receive support in the parent grant (e.g., genomic data submissions that fall under the currentgenomic data sharing policy; data submissions that fall under the current data-sharing policy for large-budget grants) are NOT appropriate for this FOA.
NCI will consider application budget requests of no more than $150,000 in total costs and must reflect the actual needs of the proposed project.
The project and budget periods must be within the currently approved project period for the existing parent award. Projects must be able to be completed within one calendar year. Requests for no-cost extensions on the parent grant to accommodate a supplement will not be permitted.
Eligible Individuals (Program Director/Principal Investigator):
Individual(s) must hold an active eligible grant (P01, P20, U19, U54, R01, U01, and UM1). For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
Submitting Applications:
Supplements to Grants:
Investigators must submit applications in response to the parent active administrative supplement PA-18-591 and follow application instructions therein with the following additional instructions:
Applicants should begin their Research Strategies by referencing this Notice's number (NOT-CA-19--031) in their submission. Research Strategies must be 1-2 pages and summarize the activities of the parent grant that encompass those proposed in the supplemental request and describe how those activities are proposed for augmentation and/or enhancement in the supplemental request by describing:
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- The supplement's purpose;
- The relationship of the supplement request to the parent grant;
- How the application provides additional value to the underlying research (parent grant) of the PD(s)/PI(s) and the collaborating investigators;
- The data sharing-relevant activities currently supported/required in the parent grant (e.g. the parent grant data sharing plan)
- The activities to be covered by the supplemental funding, including:
- A table describing the data to be submitted, including information on the number of participants, demographics, and variables (behavioral, environmental, and biological) to be shared;
- The procedures for data cleaning and documentation;
- The timeline for preparing data to be submitted to the repository;
- Evidence demonstrating that the data can be shared through a controlled-access repository (e.g., IRB approval or other documentation).
Applicants should also inform Dr. Danielle Daee (Danielle.Daee@nih.gov) of the submission to ensure correct routing.
Due Date:
Submissions must be received by May 15, 2019 at 5:00 PM local time of applicant organization for FY 2019 funding. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Review Process:
NCI will conduct administrative reviews of applications submitted to their IC and will support the most meritorious applications submitted for consideration, based upon availability of funds.
Criteria:
1. Is the work proposed within the scope of the active award?
2. Does the work proposed address at least one of the components listed under the NCI research interests?
3. Will the proposed work make a valuable data resource accessible to a broader community?
Inquiries
Please direct all inquiries to:
Danielle Daee, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5744
Email: Danielle.Daee@nih.gov
and Human Services (HHS)
