Key Dates

Related Announcements

PAR-22-161 - Cancer Epidemiology Cohorts: Building the Next Generation of Research Cohorts (U01 Clinical Trial Not Allowed)

Issued by

National Cancer Institute (NCI)

Purpose

The purpose of this Notice is to inform the applicant community of changes to the Funding Opportunity Announcement (FOA) PAR-22-161 Cancer Epidemiology Cohorts: Building the Next Generation of Research Cohorts (U01 Clinical Trial Not Allowed).

The following sections of PAR-22-161 have been amended:

Part 2. Full Text of Announcement, Section I. Funding Opportunity Description

Currently reads:

Expectations and Requirements for this FOA

Applicants responding to this FOA are expected to include the following elements:

• Scientific justification of the research gap to be addressed in both exposures and outcomes (See Cancer outcomes below). For survivor cohorts, the exposures could be the cancer site or specific survivor-related exposures and endpoints must be justified.
• This FOA intends to fund new cancer epidemiology cohorts. Applicants are encouraged to review existing cohorts [e.g., those listed in the Cancer Epidemiology Descriptive Cohort Database (CEDCD) to avoid overlap.
• Justification of the study population and sample size (including, if applicable, appropriate considerations of statistical precision for future subgroup analyses) as driven by the proposed science.
• Accrual of study population must be completed by year 5 of a 5-year grant period.
• Demonstration of innovation and novelty in addressing proposed research questions.
• Description of the sustainability and preservation of cohort resources that extend beyond the life of the award.
• Detailed data/resource sharing plans 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. Applicants must include detailed plans for the facilitation of timely data and resource sharing after each wave of data collection as well as informed consent for deposition of data into NIH-recommended repository when applicable. A mutually agreed upon letter of agreement for the data/resource sharing plan from the parent institution must be provided prior to award.

Revised to Read (in bold italics):

Expectations and Requirements for this FOA

Applicants responding to this FOA are expected to include the following elements:

• Scientific justification of the research gap to be addressed in both exposures and outcomes (See Cancer outcomes below). For survivor cohorts, the exposures could be the cancer site or specific survivor-related exposures and endpoints must be justified.
• This FOA intends to fund new cancer epidemiology cohorts. Applicants are encouraged to review existing cohorts [e.g., those listed in the Cancer Epidemiology Descriptive Cohort Database (CEDCD)] to avoid overlap.
• Justification of the study population and sample size (including, if applicable, appropriate considerations of statistical precision for future subgroup analyses) as driven by the proposed science.
• Accrual of study population must be completed by year 5 of a 5-year grant period.
• Demonstration of innovation and novelty in addressing proposed research questions.
• Description of the sustainability and preservation of cohort resources that extend beyond the life of the award.
• Detailed data/resource sharing plans 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 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.

Section I. Funding Opportunity Description, Scientific Research Objectives

Currently reads:

Non-responsive Applications

Applications that propose any of the following will be deemed non-responsive and will not be reviewed, including those that:

• Are not limited to human populations;
• Does not incorporate a longitudinal study design;
• Continue support to or research solely from an established cohort (defined as those with advanced or completed study enrollment);
• Use primarily secondary data from existing cohort data;
• Do not collect validated cancer outcomes;
• Include foreign components (e.g., countries or exposures) that do not reflect direct relevance to U.S. populations;
• 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).

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:

• Are not limited to human populations;
• Does not incorporate a longitudinal study design;
• Continue support to or research solely from an established cohort (defined as those with advanced or completed study enrollment);
• Use primarily secondary data from existing cohort data;
• Linkage-only studies that use extant registries (e.g., cancer or occupational registries) or biorepositories;
• Do not collect validated cancer outcomes;
• Include foreign components (e.g., countries or exposures) that do not reflect direct relevance to U.S. populations; and
• 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).

Inquiries

Please direct all inquiries to:

Tram Kim Lam, PhD MPH
National Cancer Institute (NCI)
Telephone: 240-276-6967
Email: l [email protected]