Expired PAR-08-020: Specialized Programs of Research Excellence (SPOREs) in Human Cancer for the Year 2008 and 2009 (P50)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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.nci.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Title: Specialized Programs of Research Excellence (SPOREs) in Human Cancer for the Year 2008 and 2009 (P50)

Announcement Type
This funding opportunity announcement (FOA) is a reissuance of PAR-06-505, which was released on August 2, 2006.

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

October 2, 2009 - This PAR has been reissued as (PAR-10-003).

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 general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-020

Catalog of Federal Domestic Assistance Number(s)
93.397, 93.121, 93.853

Key Dates
Release Date: October 30, 2007
Letters of Intent Receipt Dates: December 22, 2007; April 22, 2008; August 22, 2008; December 23, 2008; April 21, 2009; August 21, 2009
Application Receipt Dates: January 23, 2008; May 23, 2008; September 23, 2008; January 23, 2009; May 22, 2009; September 22, 2009
Peer Review Dates: May/June 2008; September/October 2008; January/February 2009; May/June 2009; September/October 2009; January/February 2010
Council Review Dates: October 2008; January 2009; May 2009; October 2009; January 2010; May 2010.
Earliest Anticipated Start Dates: October 2008; March 2009; July 2009; October 2009; March 2010; July 2010
Additional Information: To Be Available Date (URL Activation Date): Not applicable
Expiration Date: September 23, 2009

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

The Organ Systems Branch of the Office of Centers, Training, and Resources, Office of the Director, National Cancer Institute, invites grant applications for Specialized Programs of Research Excellence (SPOREs) in organ-specific cancers. This Funding Opportunity Announcement (FOA) targets applicant institutions with demonstrated ability to conduct translational research in the prevention, etiology, screening, diagnosis, and/or treatment of human cancer. Applications may address cancer in any organ site, but each application must be organ site specific. Examples of organ sites include (but are not limited to) leukemias, lymphomas, myelomas, brain, breast, gastrointestinal (GI) system, genitourinary (GU) system, gynecologic (GYN) system, head & neck, lung, ovary, pancreas, prostate, skin, oral cavity & pharynx, bones, joints, soft tissue, eye & orbit, and endocrine system. Applicants are encouraged to consult with the NCI program staff members regarding the choice of cancer organ site. Translational research, as defined by the NCI, uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer.
Required components of a SPORE grant application include a minimum of four translational research projects, one or more cores, and developmental research and career development programs. A required core in a SPORE is a human cancer tissue core for the particular organ site that will benefit translational research.
SPOREs are designed to foster extended collaborations in critical areas of research among laboratory and clinical or applied scientists. Every SPORE is expected to have a robust research base in the respective cancer type, good access to patient populations, and substantial commitment from the applicant institution. Inter-SPORE collaborations and collaborations between SPOREs and other NIH programs are strongly encouraged. Each SPORE and the "network" of SPOREs are expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality of human cancer.
This FOA will use the NIH specialized center grant (P50) mechanism to fund up to approximately 18-20 SPORE awards per each of the 2 years of this FOA.
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. The total amount awarded and the number of awards will depend upon, quality, duration, and costs of the applications received.
Eligible organizations include: Public/State Controlled Institution of Higher Education; Private Institution of Higher Education; Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education); Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education); Small Business; For-Profit Organizations (Other than Small Business); State Governments; U.S. Territory or Possession; Regional Organization; and Eligible agencies of the Federal government. Foreign institutions and organizations are not eligible to apply for P50 SPORE grants.
Eligible Principal Investigators (PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.
Each applicant institution may submit multiple SPORE applications provided that they are scientifically different, proposed in a different cancer site and are led by different PIs.
For further assistance, contact GrantsInfo -- Telephone: (301) 710-0267; E-mail: [email protected].
Telecommunications for the hearing impaired is available at: TTY 301-451-5936.
Special Receipt Dates: January 23, 2008; May 23, 2008; September 23, 2008; January 23, 2009; May 22, 2009; September 22, 2009
Initial merit review convened by NCI

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(s) 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 and 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

As defined and supported by the National Cancer Institute (NCI), a Specialized Program of Research Excellence (SPORE) conducts state-of-the-art research that will contribute to improved screening, detection, diagnosis, treatment, and prevention of an organ-specific cancer (or related group of cancers). SPOREs are expected not only to conduct a wide spectrum of research activities, but should also contribute significantly to the development of specialized research cores, improved research model systems, and collaborative research projects with other institutions. The research supported through this program must be translational in nature. Translational research, as defined in the SPORE program, involves the use of knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans and/or to determine the biological basis for observations made in individuals with cancer or in populations at risk for cancer. Inherently, this process involves interdependence between investigators conducting basic and applied research. It should be noted that clinical and/or epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human cancer is not considered translational for the purposes of this program.

For the SPORE Guidelines and other information about this program, go to http://spores.nci.nih.gov/ and http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Final.pdf.

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

Section II. Award Information

1. Mechanism of Support

A SPORE is supported through the NIH specialized center (P50) grant mechanism. Applicants are solely responsible for planning, directing, and executing the proposed project. This mechanism provides funding for a broad range of research and developmental activities, from basic to human intervention studies. These grants are intended to promote multidisciplinary research focused upon a specific cancer (or related cancer) site(s). SPORE grants differ from traditional program project (P01) grants in that they also provide support for pilot research projects and a career development program, as well as enable investigators more flexibility to modify their research activities when new opportunities arise.

This funding opportunity uses just-in-time concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NCI policy for SPORE grants establishes the following limits to the requested budgets: new or competing renewal P50 SPORE applications may each request a maximum annual total cost of $2.5 million. The facilities and administrative (F&A) costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2.5 million. Applications can exceed this cap in subsequent years as a result of standard cost-of-living increases or special supplements approved by NCI.

A SPORE grant application may be submitted for up to 5 years of funding.

Up to approximately 18-20 SPORE awards per each of the 2 years of this FOA are anticipated.

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 and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Public/State Controlled Institution of Higher Education;
Private Institution of Higher Education;
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education);
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education);
Small Business;
For-Profit Organizations (Other than Small Business);
State Governments;
U.S. Territory or Possession;
Regional Organization; and
Eligible agencies of the Federal government.

Foreign institutions and organizations are not eligible to apply for P50 SPORE grants

Eligible institutions may include Foreign components as full research projects, or cores, or as part of a research project or core, but Foreign institutions and organizations are not eligible to submit SPORE applications. SPOREs may also use developmental funds to establish collaborative research efforts with foreign entities. Consortia agreements with Foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention and must be in compliance with NIH policies.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the NIH Grants Policy Statement. The most current Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or cost_sharing.

3. Other Special Criteria and Requirements

Not applicable.

Section IV. Application and Submission Information

1. Address to Request Application Information

The 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 application form and instructions. For further assistance, contact GrantsInfo -- Telephone: (301) 710-0267; E-mail: [email protected].

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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 on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review, and Anticipated Start Dates
Letters of Intent Receipt Dates: December 22, 2007; April 22, 2008; August 22, 2008; December 23, 2008; April 21, 2009; August 21, 2009
Application Receipt Dates: January 23, 2008; May 23, 2008; September 23, 2008; January 23, 2009; May 22, 2009; September 22, 2009
Peer Review Dates: May/June 2008; September/October 2008; January/February 2009; May/June 2009; September/October 2009; January/February 2010
Council Review Dates: October 2008; January 2009; May 2009; October 2009; January 2010; May 2010
Earliest Anticipated Start Dates: October 2008; March 2009; July 2009; October 2009; March 2010; July 2010

3.A.1. Letter of Intent

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

Descriptive title of proposed research;
Name, address, and telephone number of the PI;
Names of other key personnel (Project Co-Leaders, Co-Investigators, and Core Directors);
Participating institutions; and
Number and title of FOA.

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 NCI staff members to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to the NCI Program Director at the following address:

Rajeev K. Agarwal, Ph.D.
Program Director
Organ Systems Branch (OSB)
Office of Centers, Training and Resources (OCTR)
Office of the Director (OD)
National Cancer Institute, NIH
6116 Executive Boulevard, Suite 7006
Bethesda, MD 20892-8347 (regular mail)
Rockville, MD 20852 (courier mail)
Tel: 301-496-8528
Fax: 301-402-5319
mailto:[email protected]
http://spores.nci.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for non-USPS express/courier delivery)
Telephone: (301) 435-0715

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 paper copies of the application and one copy of the appendix material in paper or pdf format must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-mail: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt/submission 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 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 review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This rule does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the PI 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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 or competing continuation award if such costs: are necessary to conduct the project, and 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 or competing continuation 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 the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

SPORE applications must also have the following elements (i.e., sections):

(1) Institutional Support. A statement must be provided that addresses how the institutional commitment will be established and sustained, how the institution will maintain accountability for promoting scientific excellence, and how the SPORE research effort will be given a high priority within the institution (relative to other research efforts). The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the SPORE Director, assignment of specialized research space, cost sharing of resources, and/or other ways proposed by the applicant institution. The primary institution is strongly encouraged to demonstrate its commitment to SPORE by providing financial support to the Developmental Research and Career Development Programs on an awarded SPORE, as well as other programmatic needs identified as high priority on the application. Letters from a high-level institution official(s) (e.g., Dean of the School of Medicine, President, and Vice President for Research) and/or the Cancer Center Director should be attached confirming this commitment. In the case of a SPORE that involves a consortium arrangement between two or more institutions, the institution that submits the P50 application must receive a formal written agreement(s) from the other participant organization(s). This agreement should clearly delineate the institutional commitment of the participating organization(s) (in the ways outlined above) to the Program.

(2) Access to cancer patient population. Each SPORE must document access to a substantial patient population in the cancer-site focus of the application and provide reasonable assurance that the patients and human specimens needed for translational research are readily available. If the appropriate patient population is not available at the applicant institution, a consortium agreement may be established with a different institution to provide adequate access to clinical specimens (e.g., tissues, blood, and urine) and/or patients at another collaborative clinical site.

(3) Minimum Research Base. The minimum research base should include significant role/effort of at least a minimum of four independent investigators who are successful in obtaining peer-reviewed research support directly related to the cancer being investigated. To qualify, respective individuals must currently serve as PIs (or project leaders) on peer-reviewed research grants (e.g., NIH R01, R21, P01, U01, U10, American Cancer Society [ACS], U.S. Department of Defense [DOD], or equivalent) or serve as overall chairpersons or site chairpersons on active NCI cooperative group clinical trial(s) or committees directly related to the cancer(s) being investigated by the proposed SPORE. PIs supported by the NCI through NIH K05, K22, K24, and/or K25 career development grants can also be included in this research base requirement if the career award is directly relevant to the cancer being investigated on the SPORE. An investigator who is a PI on multiple qualified grants or clinical trials only counts once towards the research base and, in order to qualify, the investigator must be the PI (not co-investigator) on the highlighted activity. The qualifying investigators also must have a significant role on the SPORE (i.e., at least a 5 percent contributed effort as a project co-leader, co-investigator, or core director); they cannot just serve as mentors within the proposed Career Development Program or be the project leader of a proposed Developmental Research project. The funded activities of the investigators who fulfill the requirements of a minimal research base should be included in the Program Description part of the SPORE application as discussed in Section II below.

(4) Research Projects. A minimum of four research projects, which represents a balance and diversity of translational approaches.

Each proposed research project must meet the definition of translational research as described in Part II Section I.1 and the Executive Summary above. Investigators who are not certain about whether their project fits this definition are advised to consult with NCI program staff members in the Organ Systems Branch (http://spores.nci.nih.gov/osb/index_osb.html).
Each proposed research project must be designed to test the relevance and/or potential importance of the research to human cancer within the 5-year term of the grant (e.g., validation of a new screening mechanism or diagnostic test, early phase therapeutic trial, analysis of human tissues, such as tumor or blood samples). Basic research projects, such as those employing animal models or cell lines, qualify as translational only if a human application is included in the specific aims of the research. A project(s) proposed in a competitive renewal application may focus solely upon the human application or laboratory effort if it marks the final stage of an ongoing translational SPORE study. Applicants are encouraged to contact the Organ Systems Branch (see INQUIRIES above) if they have any questions concerning this essential requirement.
Each proposed research project must be led by two project co-leaders. One should be in basic biological sciences and one in applied/clinical sciences, who commit adequate percent efforts and can use their combined conceptual and experimental skills in designing and implementing the project. It should be evident from this collaboration that translational research objectives will be accelerated such that it will be possible to test the relevance of the underlying hypotheses or to generate new hypotheses relevant to human disease. It is not necessary that the co-leaders commit equal effort to the project. There are NO exceptions to this requirement.
For most organ sites, at least ONE research project must focus on early detection, screening, prevention (primary or secondary), and/or population science. See SPORE guidelines for a list of the organ sites supported by the SPORE program and which of these sites require a project focused on early detection, screening, prevention, or population science. If such a project is required, then at least one scored project in this category will be required for award (see REVIEW CONSIDERATIONS, Section V) and must be maintained throughout the entire term of the award.
Only early (including Phase I and Phase II) clinical trials and interventions may be supported by the SPORE mechanism. A plan for a clinical trial must include provisions for rigorous data management, quality assurance, and safety monitoring.

(5) Shared Cores. Shared cores designed to support the proposed translational objectives of the SPORE (including the required human cancer tissue/specimen core for the particular organ site).

Specimen Core (Required). Each SPORE must have a dedicated core for collecting and distributing human cancer site-specific and/or related specimens. Specimens include fixed tissue, frozen tissue, paraffin blocks, slides, preserved cells, serum, plasma, urine, sputum samples, and other body fluids. The specimen core should also include the essential pathological, clinical, and family history information needed for conducting a wide range of translational research activities. Appropriate informatics capability for tracking, as well as linkage to clinical and follow-up data sets, should be demonstrated.
Other Cores (Optional). Additional shared cores (e.g., administrative, clinical, biostatistical, animal, etc.) may also be proposed that are supportive of one or more of the research projects of the SPORE. These cores should provide essential services to at least one SPORE project and may also include other analytical or non-hypothesis driven research activities designed to enhance a service.

(6) A developmental research program. Every SPORE must allocate a significant effort (with a minimum required allocated budget of $50,000 in direct costs per year) to support pilot projects that take maximum advantage of new research opportunities. Such projects may be collaborative among scientists within one or more SPOREs, or with scientists outside the SPORE environment. In the application, the applicant SPORE application should propose an institutional review process for funding pilot projects that generate feasibility data and have the most promising translational research potential.

(7) A career development program (with a minimum required allocated budget of $50,000 in direct costs per year). The SPORE must demonstrate a consistent and significant commitment to a career development program (CDP) in translational cancer research. Funds from this program may be used to support advanced post-doctoral or clinical fellows (who will be independent investigators within the next year), junior faculty, or established investigators who wish to develop or refocus their careers on translational research. SPORE career development programs are not intended for predoctoral candidates or junior level post-doctoral and clinical fellows. Investigators supported by NCI career development awards (K series) may also be eligible for support through this program.

(8) Collaborative Arrangements (if applicable). Although an application can only be submitted by a single institution, subcontracted collaborative arrangements with scientists from other institutions may be included if these arrangements are clearly delineated and officially confirmed by signed statements from the responsible official at each institution. This circumstance, however, does not preclude the need for a full institutional commitment from the applicant organization.

(9) Budget documentation. Applications must contain documentation regarding the appropriateness of requested budgets to conduct proposed services. All proposed cores must include a budgetary request from SPORE funds. For example, the appropriateness of the budget with regard to the conduct of activities related to the banking, analysis, and distribution of specimens must be discussed in the application. For both the developmental research program and for the career development program, the appropriateness of the budget (whether derived entirely from the SPORE or a combination of sources) relative to the needs and demonstrated capabilities of the SPORE and to the proposed plans for sustaining a significant effort in career development, respectively, must be documented. SPORE application budget must also project the required attendance of SPORE lead investigators (i.e., principal investigators, project leaders, core directors, and other key personnel) at SPORE workshops and related meetings.

(10) Intellectual Property Rights (if applicable). An intellectual property management plan (IPMP) must be included in the application; the IPMP should discuss the plans for evaluation, protection, and commercialization of solely or jointly owned SPORE inventions, including any patenting and licensing strategies. This plan should be comprehensive for all proposed SPORE projects and be included in the Program Description as specified in Section II. The IPMP will not be evaluated during the peer review of applications, but it is an administrative requirement that will be evaluated carefully by the NCI program staff.

GUIDELINES OF THE SPORE PROGRAM: For additional details pertinent to application preparation, programmatic, review, and award issues, it is essential that all SPORE applicants consult SPORE GUIDELINES at http://spores.nci.nih.gov/ and http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Final.pdf.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly: (1) the expected schedule for data sharing; (2) the format of the final dataset; (3) the documentation to be provided; (4) whether or not any analytic tools will also be provided; (5) whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and (6) the mode of data sharing (e.g., under their own auspices by mailing a compact disk or posting data on their institutional or personal web site, through a data archive or enclave). Investigators who choose to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the peer reviewers. However, the reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Section V. Application Review Information

1. Criteria

(Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications:

Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review;
Availability of funds; and
Relevance to program priorities.

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Significance
Approach
Innovation
Investigator
Environment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Criteria for SPORE Research Projects

1. Significance.
Does this study address an important translational research goal or barrier? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Approach.
Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Specific for this PAR: Is there clear evidence of co-leadership between both a basic biological and applied or clinical scientist in the conception, design, and proposed implementation of the project? Do the project co-leaders acknowledge potential problem areas and consider alternative tactics? If the project is ongoing and has changed research direction, is there appropriate rationale for the new approach? Is it likely the study will be completed within the project period?

3. Innovation.
Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Specific for this PAR: Is the project original and innovative in the context of translational research? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this organ site?

4. Investigators.
Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?

5. Environment.
Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit form unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Specific for this PAR: If applicable, is there evidence of effective use of SPORE cores?

Additional Criterion Specific to this PAR

6. Progress (for competing continuation projects only). If a project is ongoing, did it achieve its goals within the previous funding period; is scientific progress adequate? Have the applicants addressed any difficulties in achieving the previously proposed specific aims? Are the new research goals logical extensions for the project? Is there clear evidence that such a project reached its anticipated human application(s) during the current funding period? Will the continuation of the project lead to new translational findings? Is there sufficient evidence provided that the investigative team, especially the project co-leaders, established a productive working relationship during the current performance period? Is their productivity documented by published or submitted manuscripts describing their previous findings?

Criteria for Cores

1. Specimen core (this human cancer tissue/specimen core for the particular organ site is a required component of a SPORE).

Does the proposed plan for this core adequately address the development, annotation, and maintenance of a human cancer site-specific specimen resource, including linkage of specimens with pre-analytical parameters and pathological, clinical, and family history data that maximize their potential use in translational research?
Does the proposed plan adequately address and prioritize the distribution of specimens within and outside the SPORE? (For competing renewal applications, there should be clear documentation of the use of specimens by SPORE investigators within full and developmental projects, as well as details, if applicable, about the distribution and use of SPORE collected specimens outside of the SPORE and/or institution.)
If applicable, does the proposed plan adequately address the performance of analyses on specimens (e.g., tissue microdissection, immunochemistry) and/or develop new technologies and methodologies that enhance or benefit activities of the SPORE? (For competing renewal applications, there should be clear documentation that demonstrates these analyses were critical to the success of certain projects and are worthy of continued support, if requested.)
Is sufficient evidence of experienced personnel dedicated to the activities of specimen collection, annotation, quality control, storage, distribution, and analysis; as well as overseeing the collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks presented? (For competing renewal applications, the performance and relative time commitments of these individuals should also be evaluated based on the past accomplishments of the core.)
Does the proposed plan give sufficient evidence that the activities of the core are well integrated with those of the projects and the investigators within the projects are working closely with those of the core to meet project objectives?
Does the proposed plan adequately augment and/or complement any existing specimen resource supported by a Cancer Center Support Grant (CCSG; P30 grant mechanism) or other funding mechanism(s) to avoid duplication and maximize productivity? Do investigators applying from institutions with a CCSG and multiple SPORE grants address how their core will benefit from already established infrastructure, databases, etc., that will enable this proposed specimen core to be more cost effective and efficient?
Does the proposed plan adequately address if and how the investigators will obtain written informed consent for all prospectively collected tissues/specimens in a manner that will protect patient confidentiality?

2. Other Cores

Does the proposed plan for each other core adequately indicate that it (will) effectively and efficiently support the research of the SPORE in a manner that cannot be supported through other available (institutional or outside) resources?
Does the proposed plan demonstrate that the activities of the core are essential to one or more SPORE projects? (For competing renewal applications, a demonstrated use of each core by SPORE projects during the previous funding period is critical and should be evaluated.)
Does the proposed plan demonstrate that the activities of the core are well integrated with those of the projects and the investigators within the projects are working closely with those of the core to meet project objectives?
If applicable, does the proposed plan demonstrate the activities of the core related to the performance of specialized analyses or development of technologies or methodologies that enhance and benefit the projects?
When appropriate, does the proposed plan address how the investigators will augment any existing shared resource supported by an NCI Cancer Center Support Grant (P30 grant mechanism) of other funding mechanism? (There should be adequate details within the core description to assure there is no duplication of services with pre-existing cores at the Cancer Center or institution.)
Does the proposed plan address the qualifications, past performance (if applicable), and time commitments of the Core Director(s)?

Criteria for Developmental Research Program (DRP)

1. Does the proposed plan for the DRP address attracting new ideas and pilot studies within and outside of the SPORE institution? The outreach capabilities of a SPORE are often demonstrated within this program.

2. Does the proposed plan address continuously reviewing and funding a spectrum of pilot projects with translational research potential? (For competing renewal applications, this program should also be evaluated by the SPORE's ability to promote outstanding translational pilot projects to full projects and/or demonstrate the successful competition of these projects for outside funds.)

Criteria for Career Development Program (CDP)

1. Does the proposed plan for the CDP describe how promising candidates for independent careers (academic, industrial, governmental) in translational cancer research will be selected? (For competing renewal applications, current status and research activities of individuals who have been supported by the career development program. This proposed plan for the CDP may include the promotion of outstanding career development projects to full projects within the SPOREs and involve the continuing support and integration of successful career development awardees as project co-leaders or co-investigators.)

2. Does the proposed plan address how the investigators will seek out and include qualified women and minorities for participation in the proposed program?

Criteria for Overall Program Organization, Interaction, and Capability

1. Leadership

Are the scientific qualifications and involvement of the principal investigator as well as his/her scientific and administrative leadership capabilities and time commitment sufficient for the requirements of the proposed SPORE?

2. Institutional Commitment

Is the institutional commitment for facilitating the research objectives of the SPORE (e.g., special facilities, recruitments, discretionary resources, such as dollars and space) documented and sufficient?

3. Integration within the SPORE and the Institution

Do the plans for integrating the activities of SPORE projects with proposed cores, as well as integrating SPORE research and cores with existing Cancer Center/institutional resources (e.g., use of clinical data and safety management systems, biostatistical cores, etc.), give confidence and sufficient evidence that such efforts are likely to be effective? (Note that SPORE projects are not required to interact with each other.)

4. Cancer Patient Population

Is the access to patients and populations for conducting current and projected therapeutic, prevention, detection, and control research adequate to ensure likely success of the program in achieving its goals? (For competing renewal applications, documentation of accomplished translational goals, including evidence of human subjects enrollment on clinical/population research studies during the past funding period should be provided.)

5. Planning and Evaluation of Activities

Are the plans and/or track records to evaluate the translational research productivity of existing projects and cores adequate for the requirements of the proposed SPORE? Are the plans (which may include but are not limited to: discontinuation of activities of low productivity; initiation of new activities in response to important translational research opportunities; establishment of collaborations; and utilization of the advice of internal and external advisors) presented and sufficient?

6. Collaborations

Is there evidence of tangible interactions with other SPOREs and/or NIH/NCI Networks? Are the abilities and availabilities of the investigators to interact with other SPOREs and with the NIH/NCI in sharing information, participating in committees, and collaborating on activities of mutual interest evident and sufficient? (For competing renewal applications, contributions and outcomes from annual SPORE Workshop and other related SPORE or NIH/NCI meetings during the term of the award.)

7. Data Management

Are the track records for the overall data management and/or bioinformatics capabilities of the SPORE as they related to the Cancer Center, institution, and/or activities of other NIH/NCI initiatives presented and sufficient for the requirements of the proposed SPORE?

8. Progress (for Competitive Renewal Applications)

Are the overall progress and achievements specific to the application and relevant to translational research since the previous competitive review? Are the justifications for adding new projects and/or cores and/or deleting previous components appropriate and acceptable?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398.)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

For SPOREs, this plan should be global in nature to include research data generated by projects and/or SPORE-supported cores. The plan should be presented in the Program Description.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. If applicable, this plan should also discuss how model organisms generated through the SPORE will be shared (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html).

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

See Section IV.3.A

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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 e-mail notification from the awarding component to the grantee business official (designated in Item 12 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the 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.

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).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. Also see SPORE Guidelines at http://spores.nci.nih.gov/ and at http://spores.nci.nih.gov/applicants/guidelines/SPORE_Guidelines_Final.pdf.

The NCI is developing a policy that will require Clinical Terms of Awards for clinical studies and trials when they are a component of the proposed research. The policy will require that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. The new policy will be posted in the NIH Guide within a few weeks. All funded applicants will be expected to adhere to the new policy.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jorge Gomez, M.D., Ph.D.
Branch Chief
Program Director (Endocrine, Bone, Soft Tissues, and any other organ sites not specified below)
E-mail: [email protected]

Rajeev K. Agarwal, Ph.D.
Program Director (Brain, Eye & Orbit, Ovarian, and Skin Cancer SPOREs)
E-mail: [email protected]

Ivan Ding, M.D.
Program Director (Gastrointestinal [GI], Head & Neck and Pancreas Cancer SPOREs)
E-mail: [email protected]

Andrew Hruszkewycz, M.D., Ph.D.
Program Director (Prostate and Genitourinary [GU] Cancer SPOREs)
E-mail: [email protected]

Igor Kuzmin, Ph.D.
Program Director (Breast and Gynecologic Cancer SPOREs)
E-mail: [email protected]

Peter Ujhazy M.D., Ph.D.
Program Director (Lymphoma, Leukemia, Myeloma, and Lung Cancer SPOREs)
E-mail: [email protected]

Organ Systems Branch
Office of Centers, Training, and Resources
Office of the Director
National Cancer Institute
National Institutes of Health
6116 Executive Boulevard, Suite 7013, MSC 8347
Bethesda, MD 20892-8347 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS express/courier delivery)
Telephone: (301) 496-8528
Fax: (301) 402-5319

Jane W Fountain, Ph.D.
Program Director
NINDS (National Institute of Neurological Disorders and Stroke)
6001 Executive Blvd
Rockville, MD 20892-9521
Telephone: 301-496-1431
FAX: 301-402-2060
Email: [email protected]

Yasaman Shirazi, Ph.D.
Program Director
NIDCR (National Institute of Dental and Craniofacial Research)
45 Center Drive, Room 4AN-18C
Bethesda, MD 20892-6402
Phone: 301-594-4812
FAX: 301-480-8319
Email: [email protected]

2. Peer Review Contacts:

3. Financial or Grants Management Contacts:

Ms. Judy Sint
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852-7150 (for non-USPS express/courier delivery)
Telephone: (301) 496-7240
E-mail: [email protected]

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); and 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 institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan, but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide 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.

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 at 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.

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-02-005.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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: (1) currently funded NIH research projects; or (2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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 website (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 U.S. 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 PAR 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 or Health Systems Agency review. 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. The NIH Grants Policy Statement can be found 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 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 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov/.