Notice Number: NOT-CA-18-055
Key Dates
Release Date: March 19, 2018
PAR-17-233
Issued by
National Cancer Institute (NCI)
Purpose
The purpose of this Notice is to notify the community of additional information in PAR-17-233 "Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01)".
This Notice revises the criteria for eligible cohorts and provides more detail on the resource sharing plans required.
The following sections of PAR-17-233 have been modified (in italics):
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Current Language: [for the examples of Types of Qualifying Cancer Cohorts]
Types of Qualifying Cancer Cohorts.
Support through this FOA is available for existing CECs with at least 10,000 study participants that are capable of supporting studies to examine the effects of multiple exposures and study participants’ characteristics on the risk of multiple types of cancers.
Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., “occupational cohorts”) are not appropriate for this FOA, unless they were established to examine a broad range of exposures potentially experienced by the general public. Applications designed primarily to support biorepositories are not appropriate for this FOA. Cancer surveillance activities and registry-based studies that do not address identification of risk factors are not appropriate for this FOA.
This FOA is designed to support basic CEC infrastructure. Support for hypothesis-based scientific research should be sought through other funding mechanisms, such as investigator-initiated R01 and P01 grants. Research projects addressing specific scientific questions are NOT appropriate for this FOA.
New Language: [For the examples of Types of Qualifying Cancer Cohorts]
Types of Qualifying Cancer Cohorts.
Support through this FOA is available for:
1) Existing CECs prospectively following at least 10,000 study participants to support research examining the effects of multiple exposures and study participants’ characteristics on the risk of multiple types of cancers; or
2) Existing CECs prospectively following at least 2,000 cancer patients/survivors per cancer site to support research addressing determinants of cancer progression, recurrence, mortality, incidence, and other cancer/health-related outcomes.
Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., “occupational cohorts”) are not appropriate for this FOA, unless they were established to examine a broad range of exposures potentially experienced by the general public. Applications designed primarily to support biorepositories are not appropriate for this FOA. Cancer surveillance activities and registry-based studies that do not address identification of cancer risk factors and/or determinants of cancer/health-related outcomes are not appropriate for this FOA.
This FOA is designed to support basic CEC infrastructure. Support for hypothesis-based scientific research should be sought through other funding mechanisms, such as investigator-initiated R01 and P01 grants. Research projects addressing specific scientific questions are NOT appropriate for this FOA.
Section IV. Application and Submission Information
2. Content and Form of Application Submission
PHS 398 Research Plan
Current Language: [for the examples of Resource Sharing Plan]:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
NCI expects awardees to propose and implement a robust data sharing plan that details how external investigators gain access to data and biospecimens to ensure that this resource is used widely. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year are expected to include a Data Sharing Plan that is compliant with NIH data sharing policies, including the NIH Genomic Data Sharing Policy (https://gds.nih.gov/03policy2.html).
CECs are required to maintain a website that details the procedure for requesting and obtaining data for external Investigators as appropriate and consistent with achieving the goals of the program. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI.
Awardees are strongly encouraged to deposit individual-level de-identified datasets to NCI’s centralized, controlled-access database, called the Cancer Epidemiology Data Repository (CEDR). More information about this resource is available at https://epi.grants.cancer.gov/CEDR.
New Language: [for the examples of Resource Sharing Plan]
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
NCI expects awardees to propose and implement a robust data sharing plan that details how external investigators gain access to data and biospecimens to ensure that this resource is used widely. Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
- All applications, regardless of the amount of direct costs requested for any one year are expected to include a Data Sharing Plan that is compliant with NIH data sharing policies, including the NIH 2003 Data Sharing Policy (NOT-OD-03-032) and the NIH Genomic Data Sharing Policy (NOT-OD-14-124). Examples of projects that fall within the scope of the GDS Policy are available on the NCI Genomic Data Sharing webpage (https://gds.nih.gov/03policy2.html). The data sharing plan should include, at a minimum: 1) a statement of all NIH resource sharing policies relevant to the proposed grant application, 2) the extent and type of data that will be shared, 3) the data repository to which the data will be submitted (Repository must be publicly accessible/controlled access, but is not limited to NIH repositories, See www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html for a full listing of NIH repositories), and 4) the timeline for the data to be shared.
- CECs are required to maintain a website that details the procedure for requesting and obtaining data for external investigators as appropriate and consistent with achieving the goals of the program; procedures and criteria for access must be compliant with data sharing policies. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI.
All other aspects of this FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Joanne Elena, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-6818
Email: joanne.elena@nih.gov
and Human Services (HHS)
