September 28, 2022
PAR-22-162 – Research Opportunities in Established Cancer Epidemiology Cohort Studies (U01 Clinical Trial Not Allowed)
National Cancer Institute (NCI)
The purpose of this Notice is to inform the applicant community of changes to the Funding Opportunity Announcement (FOA) PAR-22-162 Research Opportunities in Established Cancer Epidemiology Cohort Studies (U01 Clinical Trial Not Allowed).
The following sections of PAR-22-162 have been amended.
Part 2. Full Text of Announcement, Section IV. Application and Submission Information
Currently reads:
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.
The following modifications also apply:
- Regardless of the amount of direct costs requested for any one year, all applications are expected to include a data sharing plan with: 1) the extent and type of data that have been and will be shared, 2) the data repository to which the data will be submitted (repository must be publicly accessible or controlled access, use of NIH repositories is encouraged, but not required, see www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html for a full listing of NIH repositories), and 3) the timeline for the data to be shared after each wave of data collection.
- Applications must include hypothesis-based research using data from an established cohort study and are expected to include support for cohort maintenance, continued follow-up, and sharing of the existing resources in addition to addressing research questions across the cancer control continuum.
- CECs are required to maintain a website that details the procedure for external investigators requesting and obtaining data; procedures and criteria for access must be compliant with NIH data sharing policies. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI. Resource sharing plans should follow the FAIR principles and be fully compliant with NIH policies, including the NIH Genomic Data Sharing Policy (https://datascience.cancer.gov/data-sharing/genomic-data-sharing).
Revised to read (in bold italics):
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.
The following modifications also apply:
- Regardless of the amount of direct costs requested for any one year, all applications are expected to include a data sharing that are consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles for Resource Sharing Plans as provided in SF 424 Application Guide. Data collected under support from this FOA are required to be submitted to an NIH designated repository. The NCI-approved data sharing plan will become a term and condition of award. The data sharing plan must include details as outlined below:
- The repository where the data generated under support from this FOA will be deposited, details how to access the data, and limitations (if any) for use of the data;
- Timely data and resource sharing after each wave of data collection
- Informed consent for the sharing and deposition of data into an NIH-designated repository when applicable; and
- A mutually agreed upon letter of agreement for the data/resource sharing plan from the parent institution must be provided prior to award.
- Applications must include hypothesis-based research using data from an established cohort study and are expected to include support for cohort maintenance, continued follow-up, and sharing of the existing resources in addition to addressing research questions across the cancer control continuum.
- CECs are required to maintain a website that details the procedure for external investigators requesting and obtaining data; procedures and criteria for access must be compliant with NIH data sharing policies. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI.
Section I. Funding Opportunity Description, Scientific Research Objectives
Currently reads:
Non-responsive Applications
Applications that propose any of the following will not be reviewed, including:
- Initiate new cohorts or propose new participant recruitment;
- Applications designed solely to support cohort infrastructure;
- Do not include hypothesis-based research in the specific aims that is based on data from an established longitudinal cohort study;
- Do not focus on cancer-related endpoints and outcomes;
- Have data and/or resource sharing plans that do not comply with NIH policy and follow the FAIR (Findability, Accessibility, Interoperability, Reusability) principles; or
- Are based on cohorts that are currently funded by PAR-20-294 (These applications are not eligible until after the expiration of their current grant).
Revised to read (in bold italics):
Non-responsive Applications
Applications that propose any of the following will be deemed non-responsive and will not be reviewed, including those that:
Applications that propose any of the following will not be reviewed, including:
- Initiate new cohorts or propose new participant recruitment;
- Applications designed solely to support cohort infrastructure;
- Do not include hypothesis-based research in the specific aims that is based on data from an established longitudinal cohort study;
- Do not focus on cancer-related endpoints and outcomes;
- Linkage-only studies that use extant registries (e.g., cancer or occupational registries) or biorepositories;
- Have data and/or resource sharing plans that do not comply with NIH policy and follow FAIR principles (https://www.go-fair.org/fair-principles); or
- Are based on cohorts that are currently funded by PAR-20-294 (These applications are not eligible until after the expiration of their current grant).
Joanne Elena, PhD MPH
National Cancer Institute (NCI)
Telephone: 240-276-6818
Email: joanne.elena@nih.gov
and Human Services (HHS)
