Cancer Epidemiology Cohorts: Core Infrastructure and Methodological Research Funding Opportunity Announcement FAQs


Importance of Cancer Epidemiology Cohorts

Cancer epidemiology cohorts (CECs) have helped advance the understanding of the complex etiology of cancer and provided fundamental insights into key environmental, lifestyle, and genetic determinants of this disease. Findings from these cohorts are also critical for cancer risk prediction analyses and models. The findings may also serve as a basis for risk prediction models, cancer control trials, intervention strategies, and/or the design and testing of many preventive and therapeutic interventions. Large biorepositories established by cohort studies already support genomic and epigenetic studies, and are beginning to support proteomic and metabolomic studies.

High quality, population-based cohort studies can provide a foundational framework for epidemiology across the cancer continuum from etiology to survivorship. Successful cohorts of the 21st century will need to be maximally suited to participate in a large, worldwide network of cohorts to achieve the statistical power needed to address increasingly complex scientific questions, and accrue large and diverse population samples.

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NCI Support of Cancer Epidemiology Cohorts

The National Cancer Institute (NCI) recognizes that cancer epidemiology cohorts are valuable resources that benefit the entire cancer research community. The Epidemiology and Genomics Research Program (EGRP) in NCI's Division of Cancer Control and Population Sciences (DCCPS) has long been a supporter of cancer epidemiology cohorts.

NCI published a notice in the NIH Guide for Grants and Contracts of a Funding Opportunity Announcement (FOA) to provide support for core functions of cancer epidemiology cohorts, PAR-17-233, Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01)External Web Site Policy. The ultimate goal of this Program Announcement with Review (PAR) is to consolidate all infrastructure components of a given NCI-supported cancer epidemiology cohort under a single cooperative agreement and enable NCI to more efficiently and effectively manage NCI's portfolio of cancer epidemiology cohorts and foster data sharing and collaboration. Note: Research projects relying on a given cohort's infrastructure will continue to be supported separately through investigator-initiated grant mechanisms (R01, P01, etc.).

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Frequently Asked Questions

  1. What is the purpose of this FOA?
  2. What mechanism of support will this FOA utilize?
  3. How much funding is available through this FOA?
  4. What functions related to cancer epidemiology cohorts will be supported under this PAR?
  5. What funding mechanisms are available to support scientific, hypothesis-driven research utilizing cancer epidemiology cohorts?
  6. Who is eligible to apply for support through this FOA?
  7. Study participants in my cohort were selected from individuals with a particular occupation, but the research is not focused specifically on potential occupational factors and cancer risk. May I still apply for this funding?
  8. Are there specific types of new cancer epidemiology cohorts that NCI encourages investigators to submit new funding applications in response to this FOA?
  9. I have a cancer epidemiology cohort that has been previously funded, but not through NCI. Am I eligible to submit an application for funding in response to this FOA?
  10. What are some of the key elements that must be included in an application in response to this FOA?
  11. Are there any specific processes or timelines I need to be aware of when preparing to submit an application in response to this FOA?
  12. Is a Letter of Intent required?
  13. The budget for my application is not likely to exceed $500,000 in direct costs in any one year. Do I still need to request approval from the Division of Cancer Control and Population Sciences to submit an application in response to this FOA?
  14. How will applications submitted in response to this PAR be evaluated?
  15. What are the key terms of this FOA?
  16. How are "existing" cohorts defined in this FOA?
  17. Can a new cohort or existing cancer survivor cohort be supported under this FOA?
  18. If I have an existing cohort, must I use this FOA to support it?

1. What is the purpose of this FOA?

This Funding Opportunity Announcement (FOA) invites grant applications for targeted infrastructure support of the core functions of existing CECs and methodological research. See Question #4 for examples of core functions and methodological research.

NOTE: Research projects relying on cancer epidemiology cohort infrastructure are NOT appropriate for this FOA. Such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01External Web Site Policy and P01External Web Site Policy projects).

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2. What mechanism of support will this FOA utilize?

This FOA will utilize a Cooperative Agreement (U01) mechanism.

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3. How much funding is available through this FOA?

The subtotal direct costs for any year may not exceed $1.25M. However, because the nature of each cancer epidemiology cohort (CEC) and scope of the proposed core functions vary, it is anticipated that the size and duration of each award will also vary. For example, established CECs that are focused on follow-up and case ascertainment should request smaller awards than young CECs continuing infrastructure development and collecting data. Awards pursuant to this FOA are contingent upon the availability of funds.

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4. What functions related to cancer epidemiology cohorts will be supported under this PAR?

Specific core functions that can be supported for existing or newly proposed cohorts include, but are not limited to:

  • Follow-up (active and passive) of enrolled participants;
  • Efforts to maintain high retention and encourage study participant engagement;
  • Validation, quality control, standardization, harmonization, and/or calibration of data across cohorts;
  • Biospecimen management and collection;
  • Additional data collection to supplement existing information;
  • Data management, and administrative and communication tasks;
  • Preparation and distribution of data and specimens to other investigators;
  • Utilization of modern approaches, such as mobile web-based technologies for data collection and storage; and
  • Support for staff related to cohort maintenance and operation.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description; and Section IVExternal Web Site Policy, Application and Submission Information.

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5. What funding mechanisms are available to support scientific, hypothesis-driven research utilizing cancer epidemiology cohorts?

Research projects relying on cancer epidemiology cohort infrastructure are NOT appropriate for this FOA. Such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01External Web Site Policy and P01External Web Site Policy projects).

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6. Who is eligible to apply for support through this FOA?

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.

For more details, see Section IExternal Web Site Policy, Funding Opportunity Description, of the FOA.

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7. Study participants in my cohort were selected from individuals with a particular occupation, but the research is not focused specifically on potential occupational factors and cancer risk. May I still apply for this funding?

Yes. Cohorts established to assess the role of exposures in the workplace on risk of cancer (i.e., "occupational cohorts") may be appropriate for this FOA, but only if they were established to examine a broad range of exposures potentially experienced by the general public and/or genomic factors affecting cancer risk outcomes after cancer diagnosis. Cohorts focusing primarily on cancer risks associated with one exposure limited to the workplace are not appropriate for this FOA.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description.

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8. Are there specific types of new cancer epidemiology cohorts that NCI encourages investigators to submit new funding applications for in response to this FOA?

This FOA does not support infrastructure for new CECs. However, infrastructure support for new CECs is appropriate for research grants (i.e., investigator-initiated R01External Web Site Policy and P01External Web Site Policy projects).

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9. I have a cancer epidemiology cohort that has been previously funded, but not through NCI. Am I eligible to submit an application in response to this FOA?

Yes, if the cohort meets the criteria described in Question #6 and in the FOA. Potential applicants are strongly encouraged to contact Dr. Joanne Elena several months before the anticipated submission date (generally, 4-6 months) to determine whether the proposal is appropriate for this FOA and to discuss the pre-submission process and timeline. See Questions #12 and #13 for more information about processes and timelines to be aware of when preparing to submit an application in response to this FOA.

For more details, see Part II of the FOA, specifically Section IExternal Web Site Policy, Funding Opportunity Description; Section IVExternal Web Site Policy, Application and Submission Information; and Section VIIExternal Web Site Policy, Agency Contacts.

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10. What are some of the key elements that must be included in an application submitted in response to this FOA?

All application instructions outlined in the SF424 Application Instructions are to be followed, with the additional requirements:

  • SF 424(R&R) Other Project Information
  • Each application must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication.
  • Research Strategy (limited to 30 pages)
  • Program (Cohort) Overview (~5 pages)
  • Background and Experience
  • Overall description and summary purpose of proposed cohort
  • Progress
  • Infrastructure Design and Methods (~18 pages)
  • Cohort Infrastructure
  • Core Infrastructure Activities
  • Organization Structure
  • Broad Research Agenda (~4 pages)
  • Leadership and Administrative Structure (~3 pages)
  • The experience with cancer epidemiology cohorts (CEC) for proposed PD/PI(s) must be described, specifically documenting their respective abilities to organize and manage a CEC and related activities.
  • Resource sharing plan (i.e., data sharing plan).
  • All applications, regardless of the amount of direct costs requested for any one year require a Data Sharing Plan that is compliant with NIH data sharing policies, including the NIH Genomic Data Sharing PolicyExternal Web Site Policy.

More details about the application process are available in Part II of the FOA, Section IVExternal Web Site Policy, Application and Submission Information.

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11. Are there any specific processes or timelines I need to be aware of when preparing to submit an application in response to this FOA?

Potential applicants are strongly encouraged to consult with EGRP/Dr. Joanne Elena to clarify the expectations, requirements, and limitations of infrastructure support through this FOA. Approval for applications with subtotal direct costs in any one year that equal or exceed $500,000 will need to submit an Awaiting Receipt of Application (ARA) at least eight weeks prior to submission.

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12. Is a Letter of Intent required?

No, a letter of intent is not required for this announcement.

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13. The budget for my application is not likely to exceed $500,000 in direct costs in any one year. Do I still need to request approval from the Division of Cancer Control and Population Sciences to submit an application in response to this FOA?

No.

For more details, see Part II of the FOA, specifically Section IVExternal Web Site Policy, Application and Submission Information; Section VIIExternal Web Site Policy, Agency Contacts; and view more information about the procedure for submitting an awaiting receipt of application (ARA).

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14. How will applications submitted in response to this PAR be evaluated?

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  • Significance,
  • Investigator(s),
  • Innovation,
  • Approach, and
  • Environment.

For more detailed information about the evaluation criteria, see Part II of the FOA, specifically Section VExternal Web Site Policy, Application Review Information.

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15. What are the key terms of this FOA?

Awardees will be expected 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. CECs are required to maintain a website that details the procedure for requesting and obtaining data for external Investigators. 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 a 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.

Awardees will evaluate and document compliance with NCI's Best Practices for Biospecimen ResourcesExternal Web Site Policy for collection, processing, and storage of future and past biospecimens.

Awardees will be required to explore, with NCI staff and other awardees of this FOA, the feasibility of pooling exposure data across cohorts. Awardees will be required to provide descriptive data and metadata on cohort characteristics through a pooled NCI database.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. For more detailed information, see Part II of the FOA, specifically Section VExternal Web Site Policy, Application Review Information.

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16. How are "existing" cohorts defined in this FOA?

Existing cohorts are those that have already enrolled participants and collected baseline data.

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17. Can a new cohort or existing cancer survivor cohort be supported under this FOA?

No, applications for new cohorts or cancer survivor cohorts are encouraged to seek funding through research grants (i.e., investigator-initiated R01External Web Site Policy and P01External Web Site Policy projects).

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18. If I have an existing cohort, must I use this FOA to support it?

No, you may use other mechanisms e.g. R01External Web Site Policy, if you prefer, to support the infrastructure for your cohort.

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