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EGRP News Flash - December 14, 2010

Clarification of Application Requirements for PAR-10-283: Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts

In September 2010, the National Cancer Institute (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-10-283: Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01). Application receipt dates for 2011 are March 8, July 6, and November 10. The PAR expires November 9, 2013. NCI has received several questions from potential applicants about the information that should be submitted in the Research Plan sections of the grant application.

The PHS 398 Research Plan sections for PAR-10-283 applications are:

1. Introduction (required for a resubmission application) is limited to 1 page.
2. Specific Aims is limited to 1 page.
3. Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to: 12 pages for Program (Cohort) Overview; 12 pages for Research Program (Infrastructure Design, Methodologic Research and Broad Research Agenda), and 6 pages for Leadership and Administrative Structure.

The Cohort Overview section should include the following content (up to 12 pages):

• Background and Experience. Describe the group’s history and experience in designing and implementing cancer epidemiology cohorts (CECs).
• Progress (existing cohorts only). Include a progress report describing the CEC’s accomplishments relative to both infrastructure and supported research. Include a summary of accrual, data and biospecimen collection, and follow-up over the past project period, and a report describing compliance with the data sharing plan as originally proposed.

The Infrastructure Design and Methods section should include the following content (up to 12 pages):

• Cohort Infrastructure. The application must delineate its catchment area. A description of the study population in the application’s catchment area, with a breakdown by percentage of gender and racial/ethnic subpopulations, using categories described in http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm, should be provided. The CEC’s design and projected or known composition must be described in detail. Approaches and methods proposed for recruitment, follow-up, collection and management of biospecimens, high-throughput assays, data management, quality control, and internal data sharing policies must be described.
• Core Infrastructure Activities. Describe the planned activities related to the core functions described in Section 1 of this FOA.
• Organizational Structure. The application must describe the current and/or planned organizational structure under which the CEC proposes to operate. An organizational chart showing how the group will function must also be included. The availability of facilities, including laboratories, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization (Note: Include letters of institutional commitment under Letters of Support [e.g., Consultants] and/or documentation of consortium arrangements must be provided. Also include Letters of Intent to Establish a Consortium under "Letters of Support." Applicants, whose applications are considered for funding, will have to provide fully executed consortium agreements as a Just-in-Time requirement). In addition, 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. The description of this space may be included under the Resources section or under Organizational Structure.
• Methodologic Research. The application should describe the group’s plans for methodologic research aimed at developing, testing, and validating new methods and approaches to improve the proposed cohort infrastructure.
• Broad Research Agenda. The application should describe the scientific rationale underpinning the need for the cohort and a broad research agenda the cohort will be designed to support in the short, medium, and long range.

The Leadership and Administrative Core section should include the following content (up to 6 pages):

• Key/Senior Personnel. A designated contact Project Director/Principal Investigator (PD/PI) is required. The multiple PI mechanism is encouraged. A substitute PD/PI candidate should be identified to assure continuity in the event of resignation of the PD/PI. The qualifications and experience of both persons must be described, specifically documenting their respective abilities to organize and manage a CEC and related activities. In addition, the application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility and how the responsibility is delegated among key/senior individuals.
• The qualifications, experience, and proposed duties of all proposed support personnel should be described.

Other sections of the PHS 398 Research Plan remain unmodified and should be completed following standard instructions. NOTE: An application from a currently funded or ongoing cohort must include a progress report under Research Strategy – Program Overview.

• Answers to other Frequently Asked Questions
• NIH Guide PAR-10-283

The contact for general questions is Deborah M. Winn, Ph.D., Deputy Director, Division of Cancer Control and Population Sciences; e-mail: winnde@mail.nih.gov.