Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)   

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.cancer.gov)

Title: Core Infrastructure and Methodological Research for Cancer Epidemiology Cohorts (U01)

Announcement Type

New

Update: The following update relating to this announcement has been issued:

Looking ahead: As part of the Department of Health and Human Services’ implementation of e-Government, the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-10-283

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.396, 93.397

Key Dates - New Dates (Per NOT-CA-11-002)
Release Date: September 16, 2010
Letter of Intent Receipt Dates: February 8, 2011; June 6, 2011; October 10, 2011; February 6, 2012; June 6, 2012; October 8, 2012; February 8, 2013; June 10, 2013; October 8, 2013
Application Receipt Dates: March 8, 2011; July 6, 2011; November 10, 2011; March 6, 2012; July 6, 2012; November 8, 2012; March 8, 2013, July 10, 2013, November 8, 2013
Peer Review Dates: June/July 2011; October/November 2011; February/March 2012; June/July 2012; October/November 2012; February/March 2013; June/July 2013; October/November 2013; February/March 2014
Council Review Dates: October 2011; January 2012; May 2012; October 2012; January 2013; May 2013; October 2013; January 2014; May 2014
Earliest Anticipated Start Dates: December 2011; April 2012; July 2012; December 2012; April 2013; July 2013; December 2013; April 2014; July 2014
Expiration Date: Changed to May 8, 2011 (Per NOT-OD-11-048); Original Date November 9, 2013

Key Dates - Old Dates
Release Date: September  16, 2010
Opening Date: October 5, 2010 (Earliest date an application may be submitted to Grants.gov).
Letter of Intent Receipt Date(s):, February 8, 2011, June 6, 2011, October 10, 2011, February 6, 2012, June 6, 2012, October 8, 2012, February 8, 2013, June 10, 2013, October 8, 2013..
Application Receipt Date(s):, March 8, 2011, July 6, 2011, November 10, 2011, March 6, 2012, July 6, 2012, November 8, 2012, March 8, 2013, July 10, 2013, November 8, 2013.
Peer Review Date(s): February/March 2011, June/July 2011, September/October 2011, February/March 2012, June/July 2012, September/October 2012, February/March 2013, June/July 2013, September/October 2013.
Council Review Date(s): August 2011, October 2011, January 2012, August 2012, October 2012, January 2013, August 2013, October 2013, January 2014.
Earliest Anticipated Start Date(s): September 2011, December 2011, April 2012, September 2012, December 2012, April 2013, September 2013, December 2013, April 2014.
Additional Information: To Be Available Date (URL Activation Date): Not applicable
Expiration Date: November 9, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing   
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Awardee and Project Director/Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Dispute Resolution Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), invites grant applications to provide targeted infrastructure support for the core functions of Cancer Epidemiology Cohorts (CECs) and methodological research. This infrastructure can serve either the continuation of an existing CEC or the establishment of a new CEC. This FOA will support core functions for CECs currently funded through other grant mechanisms. This FOA must be used for all requests for support to continue existing CECs or to establish new CECs.

Background

Classic CECs are organized for large observational human population studies in which groups of people with a set of characteristics or exposures are followed systematically and prospectively for the incidence of new cancers, cancer mortality, and/or cancer-related outcomes. This definition includes large cohorts of cancer patients in observational studies involving responses to therapies and short- and long-term health outcomes occurring after diagnosis. Throughout the last two decades, CEC-based studies have helped to better understand the complex etiology of cancer and have provided fundamental insights into key environmental, lifestyle, and genetic determinants of this disease. Findings from CECs are critical for risk prediction analyses and models. These findings may also serve as a basis for cancer control measures for groups and populations at risk. Evidence generated by CECs has also been useful in providing the basis for the design and testing of many preventive and therapeutic interventions. Large biorepositories established by CECs already support genomic and epigenetic studies, and are beginning to support proteomic and metabolomic studies. Further, CECs are essential to genome-wide association studies (GWAS) and replication and/or expansion of prior GWAS findings) that has led and will lead to the identification of putative cancer susceptibility loci of low penetrance and high frequency, and will potentially lead to the identification of genes associated with prognosis and survival for a variety of cancers. As the genes present in these loci are identified and their functions are clarified, the prospective exposure data accumulated from CECs afford opportunities for in-depth analyses of gene-environment interactions, which will be critical for the design of public health interventions. NCI recognizes that CECs are valuable resources that benefit the entire cancer research community and, that in order to be successful as a population sciences research resource, CECs need to accrue large and varied population samples and continue to follow-up with study participants over an extended period of time.

Types of Qualifying Cancer Cohorts. Support is envisioned for two types of CECs through this FOA:

1) 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 incident cancers and cancer mortality; and

2) cohorts of cancer patients including at least 10,000 participants for research  addressing determinants of cancer prognosis, progression, and cancer-related outcomes among cancer survivors such as cancer recurrence, development of new primaries, survival, and health conditions and chronic diseases related to the cancer, cancer-directed therapy, or its consequences.

This FOA must be used for all requests for support to continue existing CECs or to establish new CECs.

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 or outcomes after cancer diagnosis. Cohorts focusing primarily on cancer risks associated with exposures in the workplace are not appropriate for this FOA.

This FOA is intended to support cohorts established to identify factors that increase or decrease the risk of developing cancer or the incidence of health outcomes after cancer. Therefore, cancer surveillance activities and development and maintenance of registries of persons with particular characteristics that do not address identification of factors increasing or decreasing risk are not appropriate for this FOA.

Scope of the FOA. The activities to be supported by this FOA include the establishment, maintenance, or upgrade of CECs’ core functions such as recruitment, retention, and biospecimen collection. Methodological research to validate or evaluate new or existing approaches to core infrastructure functions is also appropriate. Specific core functions that can be supported for the existing or newly proposed cohorts include, but are not limited to:

1.     ongoing or new accrual of the target population, and enrollment of special populations in the catchment area;

2.     follow-up (active and passive) of enrolled participants; systematic, high-throughput assessment of genetic or other biological markers when required to interpret new research findings and when these markers are not already available on all relevant cohort study subjects (e.g., tumor hormone receptor status);

3.     validation, quality control, standardization, harmonization, and/or calibration of data across cohorts; biospecimen collection and management; and

4.     data management and data sharing activities, and administrative and communication tasks.

Methodologic research may include, but is not limited to research investigating the following:

1.     Improved approaches to the systematic, high-throughput assessment of genetic or other biological markers;

2.     Validation of exposures and health outcomes, for example, the quality of self-reported data versus medical record information, or assessment of how well a biomarker measured through non-invasive means compares to that measured in an appropriate target tissue;

3.     Development and improvement of quality control (QC) and quality assurance activities related to laboratory work, data use, biospecimens, etc.;

4.     Methods for biospecimen collection and management;

5.     Virtual tissue repositories with metadata about available tissues across cohorts and connections to pathologic tissue image libraries.

Applicants responding to this FOA are expected to focus on activities that will: enable efficient planning and operation of cohorts; maximize their potential to respond to future scientific needs; enable the CECs to address cutting-edge research questions related to cancer susceptibility in human populations; and facilitate scientific collaborations across cohorts.

Note: Research projects relying on the CECs’ infrastructure are NOT appropriate for this FOA. As in the past, such projects are expected to seek support through appropriate research project mechanisms (such as investigator-initiated R01 and P01 grants).

Consolidation of CEC Support. Currently, core functions of a CEC may be supported by multiple research project grants. This fragmented support is not optimal (e.g., individual research project grants may have only partially overlapping funding periods). This FOA allows for the fragmented infrastructure components of a CEC to be consolidated under a single cooperative agreement (U01) award.

The transition to the consolidated infrastructure support may be initiated, for example, when a grant(s) that contains core infrastructure components becomes eligible for renewal. If the application is selected for funding, the overlap with other grants will be administratively adjusted.

As the awards under this FOA will use the cooperative agreement mechanism, the implementation will involve substantial involvement of NCI program staff members in various activities that are relevant to all CECs, such as data harmonization, facilitation of multi-CEC scientific opportunities, biospecimen resources optimization, and systematic assessment of molecular markers.

During the lifetime of the CEC, NCI staff will assess yearly progress toward achievement of the yearly milestones described in the application. Achievement of these milestones will be evaluated by NCI prior to releasing funding for each year of the award.

Respondents to this FOA will be required to provide and regularly update metadata about their cohort to NCI including cohort characteristics, study protocols, basic counts of study participants with various characteristics such as biospecimen availability and study variable definitions. Investigators will be expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/bestpractices) for collection, processing, and storage of future and past biospecimens.

NCI will compile metadata across cohorts and make the information available online to assist the research community in identifying potential cohorts to address specific research questions or evaluate the potential for cross-cohort studies.

Respondents to this FOA will be required to explore the feasibility of cross-CEC data harmonization with NCI staff and other awardees through participation in working groups.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Cooperative Agreement U01 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills, and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other - Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct (i.e., pertains to a different cohort).

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009, official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009, are permitted two amendments (A1 and A2). For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. 

Renewals. No renewal applications will be permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY (301) 451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the Web site at http://www.dnb.com/us. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic {non-U.S.} Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates - New (Per NOT-CA-11-002)
Letter of Intent Receipt Dates: February 8, 2011; June 6, 2011; October 10, 2011; February 6, 2012; June 6, 2012; October 8, 2012; February 8, 2013; June 10, 2013; October 8, 2013
Application Receipt Dates: March 8, 2011; July 6, 2011; November 10, 2011; March 6, 2012; July 6, 2012; November 8, 2012; March 8, 2013, July 10, 2013, November 8, 2013
Peer Review Dates: June/July 2011; October/November 2011; February/March 2012; June/July 2012; October/November 2012; February/March 2013; June/July 2013; October/November 2013; February/March 2014
Council Review Dates: October 2011; January 2012; May 2012; October 2012; January 2013; May 2013; October 2013; January 2014; May 2014
Earliest Anticipated Start Dates: December 2011; April 2012; July 2012; December 2012; April 2013; July 2013; December 2013; April 2014; July 2014

3.A. Submission, Review and Anticipated Start Dates - Old
Letter of Intent Receipt Date(s):, February 8, 2011, June 6, 2011, October 10, 2011, February 6, 2012, June 6, 2012, October 8, 2012, February 8, 2013, June 10, 2013, October 8, 2013..
Application Receipt Date(s):, March 8, 2011, July 6, 2011, November 10, 2011, March 6, 2012, July 6, 2012, November 8, 2012, March 8, 2013, July 10, 2013, November 8, 2013.
Peer Review Date(s): February/March 2011, June/July 2011, September/October 2011, February/March 2012, June/July 2012, September/October 2012, February/March 2013, June/July 2013, September/October 2013
Council Review Date(s): May 2011, October 2011, January 2012, May 2012, October 2012, January 2013, May 2013, October 2013, January 2014
Earliest Anticipated Start Date(s): April 2011, July 2011, December 2011, April 2012, July 2012, December 2012, April 2013, July 2013, April 2014

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH Institutes and Centers (IC)  staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

Deborah Winn, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute,  6130 Executive Boulevard, Room 5112
Bethesda, MD 20892 (For express delivery, use Rockville, MD 20852)
Telephone: (301) 594-9499
Fax: (301) 435-6609
Email: winnde@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and threesigned photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to:

Referral Officer
Division of Extramural Activities (DEA)
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefgrp@mail.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt/date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

PHS 398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

For CEC applications submitted in response to this FOA, the standard PHS 398  application instructions are altered as follows:

Table of Contents (PHS 398 Form Page 3): Modify Form Page 3 of the PHS 398 to include in Section 3 “Research Strategy” the following new sub-sections A – D:

A. Program (Cohort) Overview

B. Infrastructure Design and Methods

C. Leadership and Administrative Structure

D. Research Program: Methodologic Research (if Applicable) and Broad Research Agenda

RESEARCH PLAN: The standard PHS 398 Research Plan is altered as follows:

Standard sub-sections of Section 3. Research Strategy of the PHS 398 Research Plan are replaced by the new sub-sections A – D (see details below); and

The PHS 398 standard page limit for Research Plan is replaced by individual limits indicated below for the new sub-sections A – D.

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 Section 3. Research Strategy, sub-section A – Program Overview.

A. Cohort Overview (up to 12 pages)

1.    Background and Experience. Describe the group’s history and experience in       designing and implementing CECs.

2.    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.

B. Infrastructure Design and Methods (up to 12 pages)

1.     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.

2.     Core Infrastructure Activities. Describe the planned activities related to the core functions described in Section 1 of this FOA.

3.     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 14. 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 Section 14 of Research Plan "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.

  1. 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.
  2. 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.

C. Leadership and Administrative Core (up to 6 pages)

Key/Senior Personnel. A designated contact 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. 

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

All foreign applicants must complete and submit budget requests using the Research & Related Budget Component instructions found in the application package for this FOA. See NOT-OD-06-096.

Applicants may include in their proposed budgets the costs pertinent to the submission of metadata to NCI. Additionally, applicants may include costs expected for harmonizing data across cohorts and/or providing access to CEC data for studies requiring pooled data (these efforts will be conducted in cooperation with NCI).

Annual Meeting. Awardees under this FOA will be required to participate in an annual Investigators Meeting with NCI staff to maintain dialogue and communication and foster data sharing. This meeting may be concurrent with the NCI Cohort Consortium’s annual meeting to foster interaction between as many cohorts as possible, such as NCI’s intramurally funded CECs. Costs associated with key personnel attending  this meeting should be included in the application’s budget. Application for membership in the NCI Cohort Consortium is also strongly encouraged because this is the main NCI-sponsored consortium implementing cross-cohort collaborative projects (see http://epi.grants.cancer.gov/Consortia/cohort.html).

Cooperative Agreement

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs)  must carry out the following steps:

1. Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2. Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and

3. Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CD only, and include five identical CDs in the same package with the application (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in the Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Model Organism Sharing Policy and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A GWAS is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information, see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget Component instructions found in the application package for this FOA. See NOT-OD-06-096,

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

How likely it is that the PIs will be successful in achieving the overall scientific agenda that the cohort is intended to address? How will the proposed core functions implementation improve the capability to address the cohort scientific agenda?

In addition, specific to this FOA: Is there evidence of the success of the cohort in the past to support productive scientific projects (as measured by publications and related grants)? For the continuing CECs, are the follow-up rates and/or response rates (especially the first round of follow-up) adequate? Are the length of follow-up and age of the cohort appropriate and the number of outcome variables tracked appropriate to the related research scope? Is the CEC population representative or unique? Has the applicant been successful in completing previously proposed CEC’s aims and activities?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well-suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established investigators, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project? 

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategies, methodologies, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: Are the plans to optimize the continuation or establishment of activities in support of the CEC adequate? How realistic are these plans in terms of achieving a high-quality support infrastructure? Are there appropriate plans for the rigorous management and quality control of data and biospecimens collected by the CEC? Are the CEC design and methods adequate to achieve the stated objectives and to support the stated overall research agenda? Are the CEC objectives described likely to be completed during the requested period? How adequate are the administrative and communication structures in terms of efficiently supporting the CEC’s activities?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items:

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. Renewals are not allowed for this FOA.

Revision Applications. Revisions are not allowed for this FOA.

Additional Review Considerations 

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

In addition, specific to this FOA: Is there evidence in the data-sharing plan and past activities of the CEC that broad access to the CEC resource for research has been encouraged? Is there a plan for extensive data and biospecimen sharing?

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "Just-in-Time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (NOA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Awardee and Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for defining objectives and approaches, and to plan, conduct, analyze and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assumes(s) responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award in accordance with these terms and conditions of the award.

Specific rights and responsibilities of awardees will include the following:

Awardees will be expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources, for collection, processing, and storage of future and past biospecimens (http://biospecimens.cancer.gov/bestpractices).

Awardees will be required to explore with NCI staff and other awardees of this FOA the feasibility of pooling data across cohorts or providing access to the data from their cohort for studies requiring pooled data.

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.

2.A.2. NIH Responsibilities

A designated NCI Program Director acting as a Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The main NCI Project Scientist (s) responsibilities include the following activities:

Additional NCI staff members may be designated to have substantial involvement. The substantially involved NCI staff members will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waivers according to the NCI procedures for management of conflict of interest.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

2.A.3. Collaborative Responsibilities

The Steering Committee will serve as the main governing board for the CEC Core Functions and Methodological Research initiative.

The committee will consist of the following voting members:

The appointed voting CEC members will be required to attend all the CEC Steering Committee (SC) meetings and teleconferences or to appoint a substitute that will be fully briefed on the issues at hand. Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members. Steering Committee may also formed subcommittees as needed. The NCI Project Scientist may serve on such subcommittees as deemed appropriate.The Chair of the Steering Committee will be selected from the SC voting members.

The Steering Committee will meet one time per year in a face-to-face meeting. The Steering Committee chair will meet with NCI Project Scientists one-time per month by telephone conference.

The Steering Committee will have primary responsibility for:

CEC Core Functions and Methodological Research awardees will be required to accept and implement the policies approved by the SC.

2.A.4. Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

This progress report must include the following elements:

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts


Potential applicants are strongly encouraged to consult with the NCI to clarify the expectations, requirements, and limitations of infrastructure support by this FOA. In particular, applicants requesting support for a CEC whose infrastructure was not previously supported through a grant from EGRP, DCCPS, NCI, are encouraged to consult the NCI Program staff early enough so they could use the feedback in the preparation of the application.

Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact:

Deborah Winn, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute, NIH
6130 Executive Boulevard, EPN Room 5112, MSC 7395
Bethesda, MD 20892
Telephone: (301) 594-9499
Fax: (301) 435-6609
Email: winnde@mail.nih.gov

2. Peer Review Contact:

Referral Officer
Division of Extramural Activities
National Cancer Institute, NIH
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial/Grants Management Contact:

Lan Nguyen
Office of Grants Administration
National Cancer Institute, NIH
6120 Executive Boulevard, Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-9048
Fax: (301) 496-8601
Email: nguyenla@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness, and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a GWAS is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a GWAS are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time, the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004, receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The OMB Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site (http://www.hhs.gov/ocr) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The Loan Repayment Program (LRP) is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, see: http://www.lrp.nih.gov.


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