Planning Grant for Minority Institution/Cancer Center Collaboration

RFA Number: RFA-CA-05-020

Part I Overview Information

Department of Health and Human Services (DHHS)

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

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

Announcement Type:
This is a reissue of RFA-CA-03-009 which was previously released on March 28, 2002

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

Catalog of Federal Domestic Assistance Number(s): 93.939, 93.394, 93.396, 93.398, 93.399

Key Dates
Release Date: September 30, 2004
Letters Of Intent Receipt Date(s): January 22, 2005
Application Receipt Dates(s): February 22, 2005
Peer Review Date(s): June-July 2005
Council Review Date(s) : September 2005
Earliest Anticipated Start Date: December 1, 2005
Additional Information To Be Available Date (URL Activation Date): not applicable
Expiration Date: February 23, 2005

Executive Summary

The National Cancer Institute (NCI) invites planning grant applications (P20s) to help researchers and faculty at Minority-Serving Institutions (MSIs) in collaboration with the researchers and faculty of NCI-designated Cancer Centers (or other institutions with highly-organized, integrated research efforts focused on cancer) plan and implement focused collaborations in cancer research, cancer research training, or cancer education. The sole intent of this planning grant is to provide support for cancer projects and programs for a limited duration of time to perform feasibility studies and obtain preliminary data that will lead to the submission of specific competitive grant applications traditionally supported by the NCI and others.

The NCI intends to commit approximately 2.5 million dollars total costs in FY 05 to fund up to six (three pairs) 3-year and six (three pairs) 4-year new grants in response to this RFA. This funding opportunity will use the NIH planning grant (P20) award mechanism.

Applications will only be accepted from MSIs [e.g., Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs) and Tribal Institutions (e.g., Colleges)] either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop comprehensive partnerships.

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 programs.

The Principal Investigators (PIs) must be U.S. citizens, U.S. nationals, or permanent residents of the United States.

An applicant may submit one application.

Application materials are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo Telephone: (301) 435-0714; Email: GrantsInfo@nih.gov.

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

For more information about this RFA contact 301-496-7344 at the Comprehensive Minority Biomedical Branch, Office of Centers, Training, and Resources.

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
    3. Other - Special Eligibility Criteria

  Section IV. Application and Submission and Instructions
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilites
        4. Arbitration Process
    3. Award Criteria
    4. 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

The National Cancer Institute (NCI) invites planning grant applications (P20s) to help researchers and faculty at Minority-Serving Institutions (MSIs) in collaboration with the researchers and faculty of NCI-designated Cancer Centers (or other institutions with highly-organized, integrated research efforts focused on cancer) plan and implement focused collaborations in cancer research, cancer research training, or cancer education. The sole intent of this planning grant is to provide support for cancer projects and programs for a limited duration of time to perform feasibility studies and obtain preliminary data that will lead to the submission of specific competitive grant applications traditionally supported by the NCI and others.

MSIs are defined as institutions at which students of minority groups that are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders), comprise a significant proportion of the enrollments AND at which there have been documented records of commitment to the special encouragement of minority faculty, students, and investigators.

Planning grants must be focused on two of the targeted areas that work toward the following objectives:

  1. Collaborative research project(s) between the MSI and the Cancer Center;
  2. Collaborative training, career development program(s) between MSIs and Cancer Centers designed to train students and scientists; and
  3. Collaborative education programs designed to motivate students (e.g., high school, undergraduate, and/or graduate) to pursue cancer research careers.

The final objective of the P20 must be the submission of specific competitive research grant applications (e.g., R03s, R01s, projects on P01s, projects on P50s); training and career development grant applications (e.g., K01, K08, K23, K22, T32s, K12s, R25Ts); individual predoctoral fellowship applications (F31); and/or cancer education grant applications (e.g., R25Es) funded by the NIH, NCI and other research funding organizations (e.g., American Cancer Society).

The submission of a P20 application is not a requirement for either a Cooperative Planning Grant for Comprehensive MI/CCP (U56) or a Comprehensive MI/CCP (U54) offered through the NCI.

1. Research Objectives

Since the War on Cancer was initiated in 1971, the disparities in cancer incidence, morbidity, and mortality in underserved racial and ethnic minority populations and among the socio-economically disadvantaged have continued to rise. For example, the incidences of colon and lung cancers in Alaska Native and African-American men and women are higher than that of other ethnic groups; 5-year survival rates in the Native American, African American, Hawaiian, and Hispanic American populations are lower than those in the Japanese and White American populations; and patterns of prostate cancer among African American males compared with White males, seen in the Southeastern U.S., particularly in rural areas, still remain higher (http://www.nci.nih.gov/atlasplus/). Clearly, more research is needed that specifically addresses these and other disparities if they are to be eliminated by 2010 (President's Initiative on Race and Health Disparities, http://raceandhealth.hhs.gov/sidebars/sbinitOver.htm ). This initiative is also in line with the priority recommendations for DHHS to lead the Nation in eliminating cancer health disparities (Making Cancer Health Disparities History, http://www.chdprg.omhrc.gov/pdf/chdprg.pdf).

MSIs conduct high-quality programs for educating minorities and they represent a rich source of talent with the appropriate cultural sensitivities and perspectives needed in cancer research. However, the MSIs have had difficulties developing and sustaining independent programs in biomedical research, and there is a paucity of underrepresented minority scientists who are pursuing successful cancer research careers. Despite various initiatives, progress in realizing a significant increase in the number of underrepresented minority scientists who are competitive for NIH research grants has been slow. More specifically, there remains a serious shortage of well-trained underrepresented minority scientists who can conduct independent cancer research, who can focus research efforts on the disproportionate burden of cancer in minority populations, and whose cultural perspectives are essential to the successful conduct of many forms of research involving minority patients and populations.

The NCI-designated Cancer Centers are geographically dispersed, research-intensive organizations with well-organized programs for training cancer scientists. They are the only organized units supported by the NCI that conduct research; sponsor research training in the basic, clinical, and population sciences; provide information services; and develop and sustain educational and outreach programs that benefit their communities. Yet, the progress of Cancer Centers in focusing on research issues of particular importance to cancer in minorities, in training underrepresented minority scientists, in reaching out to and partnering with different racial and ethnic minority populations in their communities, and in bringing the benefits of cancer research to these populations has been slow and often disappointing.

Objectives and Scope

The P20 MI/CCP planning grant offers three broad areas to target for focused planning, development, and implementation:

1. Cancer Research: Joint pilot research projects may be in any area of basic, clinical, prevention, control, behavioral, or population research. Research projects conducted primarily at the MSI may be in any area of cancer research, but research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in minority and underserved populations. Joint cancer research projects at MSIs might focus, for example, on general areas of environmental carcinogenesis, molecular epidemiology, and behavioral issues related to cancer prevention, treatment, and control. The expectation is that successful pilot research projects will become competitively funded grants (e.g., R03, R01, project on a P01, project on a P50).

2. Cancer Training: Joint training programs that link the faculty and students of the MSI and the Cancer Center are the most productive ways to sustain each long-term effective partnership. These programs must place an emphasis on the training of minority scientists and on educating majority trainees to appreciate the issues and problems associated with cancer disparities in minority populations. The NCI particularly encourages training of underrepresented minority scientists in clinical, behavioral, and population research; there is a huge deficit of underrepresented minority scientists engaged in these research areas, areas which are highly dependent for their success on the cultural sensitivity of the researchers. These training programs must represent true collaborations that function seamlessly across the institutional boundaries of the MSI and the Cancer Center. For example, new training programs might provide graduate students in MSIs opportunities to fulfill their research requirements in Cancer Center laboratories using state-of-the-art equipment and mentoring by Cancer Center investigators; or masters programs in an MSI might be linked formally to doctoral training programs in Cancer Centers. Clinical research training programs at MSIs might also include rotations for medical students and residents in Cancer Center laboratories. Other training programs may deal with minority cultural issues for majority trainees and clinical training programs at the Cancer Center might offer the use of current methodologies for national and international electronic communication on diagnosis and treatment of cancer for minority trainees. Successful activities in this area may lead to the submission of a competitive training grant application (e.g. T32, K12, R25T) as well as individual predoctoral fellowships (F31), career development awards (K01, K08, K23, K22), and research supplements for trainees.

3. Cancer Education: Cancer education programs could focus on any effort to augment existing or create new curricula in the MSI and/or the Cancer Center that would apprise and culturally sensitize graduate and postdoctoral students in research, medicine, and public health of the need to reduce the disproportionate cancer burden in minority populations. A successful effort may result in the submission of a competitive NCI education grant application (R25E) and that later should yield to institutional commitments to make these curricula an inherent component of their educational systems.

Depending on prior experience, interactions and progress in planning, applicants may apply for 3-year or 4-year P20 Minority Institution/Cancer Center Partnership (MI/CCP) awards. Applicants requesting 4 years of support must clearly describe a planning stage, a priority setting stage, and an implementation stage. Applicants requesting 3 years of support who have already identified areas of potential collaboration through planning, must document prior planning activities and clearly describe a priority-setting stage and an implementation stage.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH planning grant (P20) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. This funding opportunity uses just-in-time concepts.

2. Funds Available

The National Cancer Institute intends to commit approximately 2.5 million dollars total costs in FY 05 to fund up to six (three pairs) 3-year- and six (three pairs) 4-year new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to 3 or 4 years and a budget for direct costs up to $275,000 dollars (per pair) per year, depending upon prior progress in planning and setting priorities. Third-party contractual Facilities and Administrative costs will not be counted toward the maximum combined direct costs of $275,000. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html) Future years' direct costs support cannot exceed 3 percent of the maximum direct cost for each partner. 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 RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The total project period for applications submitted in response to this RFA may not exceed 4 years. The anticipated award date is July 1, 2005.

Allowable Costs

The P20 will provide support for:

1. Administrative costs (which may be higher in the early stage of development and lower in the late stages) for managing the planning effort, such as salaries for key personnel, travel for key personnel, equipment, and supplies to support an administrative structure.

2. Developmental costs for:

a. Initial Planning Stage, which should be focused on developing and organizing workshops, seminars, retreats, and other forms of communication to explore potential opportunities in cancer research, cancer training, and career development or cancer education;

b. Priority-Setting Stage, which should be focused on selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application. Pilot projects/programs cannot exceed $120,000 in direct costs per year, and may not exceed 3 years; and

c. Implementation Stage; which should be focused on implementing pilot research projects or pilot programs in training and career development or education for the explicit purpose of obtaining preliminary data for the submission of a specific grant application(s).

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:

Applications will only be accepted from MSIs (e.g., Historically Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs] and Tribal Institutions [e.g., Colleges]) either in the United States or in territories under U.S. jurisdiction, and from institutions that are NCI-designated Cancer Centers (or groups of centers) that wish to develop comprehensive partnerships.

MSIs are defined as institutions at which students of minority groups that are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders), comprise a significant proportion of the enrollments AND at which there have been documented records of commitment to the special encouragement of minority faculty, students, and investigators. A list of MSIs is available at http://www.ed.gov/about/offices/list/ocr/edlite-minorityinst.html. Both MSIs with medical schools and MSIs with more focused education and research programs (e.g., Masters and Ph.D. programs) are invited to participate in this initiative. MSIs that offer only baccalaureate degrees and Tribal Colleges are also invited to participate in this initiative as full collaborators, especially in the development of educational programs aimed at motivating students to enter careers in cancer research.

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 programs.

The Principal Investigators (PIs) must be U.S. citizens, U.S. nationals, or permanent residents of the United States.

2. Cost Sharing

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

There are a number of Special Requirements and Provisions with which each Minority Institution/Cancer Center Collaboration planning grant application must comply:

1. Planning grants must include two of the following targeted areas:

  1. cancer research;
  2. cancer research training; or
  3. cancer education.

2. There must be written "Letters-of-Commitment" from the MSI leadership and the Cancer Center leadership that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources would include:

a. A specific statement detailing the percent effort of release/protected time (up to 25 percent for MSI and 10 percent for the Cancer Center) as well as the activities from which each faculty member involved is being released (e.g., teaching, clinical, administrative duties).

b. Provisions for space and facilities for new projects/programs, capital improvements, recruitment of new faculty, and other resources that will ensure the success of the partnership.

Note: When the institutional leadership changes during the course of the award, new letters-of-commitment must be sent addressing the issues stated above. This letter must be received by NCI no later than 90 days after the change.

3. Each collaborative planning grant must be submitted as a clear partnership between the MSI and Cancer Center. This must be done by submitting two separate planning grant applications, one from the MSI and one from the Cancer Center. The PI of the MSI grant application must be the Co-Principal Investigator (Co-PI) of the Cancer Center grant application and vice versa. The overall objectives of the two applications must be the same, but the actual activities and budgets of the two applications should demonstrate how the MSI and the Cancer Center requests both differ and complement each other in achieving their common objectives. When the Principal Investigator from the MSI or Cancer Center is a less experienced scientist, there must be a written "Letter-of-Support" from a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the MSI or Cancer Center that identifies a mentor who will be responsible for career and professional development of the individual.

4. Depending upon prior experience, interactions, and progress in planning, the two applications must clearly describe a collaborative planning process that includes all of the following components:

a) Initial Planning Stage (for those applicants requesting 4 years of support) in which the participants must describe appropriate means of communicating and identifying areas of potential collaborations. The participation and specific roles of the Internal Advisory Committee (IAC) must be clearly explained.

b) Priority-Setting Stage for selecting the areas of greatest promise for implementation as specific types of pilot projects or programs based on merit and potential to result in a successful grant application. The Co-PIs should describe the process used by the IAC to evaluate new and ongoing pilot project/programs.

c) Implementation Stage of pilot project/programs in which preliminary data is acquired for the purpose of submitting a specific competitive grant application in one or two of the target areas mentioned above to the NCI or other funding agencies.

5. The direct costs of the two applications together cannot exceed $275,000 per year. The amount requested should be appropriate to the stage of development, because the planning and priority-setting stages are not as costly as the implementation stage, budget requests would be expected to escalate progressively from year 1 to year 4. If there are third party subcontract costs, only the direct costs of the subcontract will count against this cap.

6. The Co-PIs will convene an Internal Advisory Committee (IAC) that will be made up of the Co-PIs and equal representations from the MSI and the Cancer Center. The expertise of the IAC members should be relevant to the objectives and goals of the collaboration/partnership. If the committee lacks the scientific expertise to evaluate a specific application, ad hoc reviewers either from within or outside the partnering institutions may be added to the IAC. When a project/program co-leader is identified as a junior investigator, the application must be evaluated for the appropriateness of the career development and mentorship plan. In addition to reviewing and prioritizing new pilot projects/programs, the IAC will also evaluate ongoing pilot projects/programs and advise the Co-PIs as to the general activities of the partnership and how they may contribute effectively to achieving high priority goals and objectives.

7. The use of funds to support pilot projects and pilot programs must be for totally new activities that do not overlap in purpose or intent with existing funded grants (e.g., P30, P50, P01, R01, National Center for Research Resources' Research Infrastructure Grants, National Institute of General Medical Sciences' Minority Biomedical Research Support Grants, other peer-reviewed funded programs).

8. All recipients of P20 MI/CCP awards will be expected to participate in a biennial MI/CCP Workshop for the purpose of sharing information and strategies. Travel expenses for this purpose must be included in the grant applications from the MSI and the Cancer Center.

9. Any investigator turnover (replacement of a Co-Principal Investigator, Co-Leader of project and/or program) must be fully documented and approved by the NCI. Documentation should include institutional support letters, rationale for replacement in ensuring that they fall within the bounds of the areas prioritized for development and stabilization and the goals and objectives of the partnership, biographical sketches, and transition plans (when appropriate).

10. The NCI Program Director may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative. The NCI Program Director will also:

a. Work closely with individual investigators and partners to facilitate collaborations;

b. Assist the partnership efforts by facilitating access to fiscal and intellectual resources provided by NCI, NIH, industry, private foundations, and federal funding agencies;

c. Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by Cancer Center Support Grants, Research Centers at Minority Institutions, Infrastructure Grants, Minority Biomedical Research Support Grants, or other peer reviewed funding mechanisms;

d. Coordinate activities with other ongoing studies supported by NCI to avoid duplication of efforts and encourage sharing and collaboration in the development of new clinically useful agents and methodologies;

e. Link the approaches developed from these partnerships to each other and to other NCI Cancer Centers and NCI-supported networks to ensure that information is shared and utilized on the widest basis possible; and

f. Monitor institutional commitments and resources to ensure that the partnership receives the maximum chance of stabilization and success.

11. If the application includes participation of Native American (American Indian) or similar populations, a formal letter of support for the study from the Tribal Nation Leader or equivalent authority must be included.

Section IV. Application Submission Instructions

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. 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

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (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/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See also Subsection VI.2. for additional information.

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 Date

Applications must be received on or before the receipt date listed below.

3.A. Receipt, Review and Anticipated Start Dates

Letter-of-Intent Receipt Date: January 22, 2005
Application Receipt Date(s): February 22, 2005
Peer Review Date: June-July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: December 1, 2005


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 IC staff 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:

Sanya A. Springfield, Ph.D.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7344
Fax (301) 402-4551
Email: springfs@mail.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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard
Room 8041
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and non-responsive 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Technical Assistance Workshop

The NCI strongly encourages all potential applicants to attend a pre-application Technical Assistance Workshop (TAW). Since this is a relatively new concept for the NCI and for the applicant population, it will give staff the opportunity to clarify any perceived ambiguities in the RFA. If one is unable to attend the technical assistance workshop, the results of the workshop can be accessed at http://minorityopportunities.nci.nih.gov.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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 (see also Section VI.3. Award Criteria).

6. Other Submission Requirements

1. Face Page: Use Form Page 1 as instructed in the Form PHS 398 (rev. 5/01). On line 1 provide a title that is representative of your collaboration or partnership. This title should be the same for both the MSI application and the Cancer Center institution's application. On line 2, enter the title "P20 MI/CCP" and the RFA number, RFA-CA-05-020.

2. Description, Performance Sites, and Key Personnel: Use Form Page 2 of the Form PHS 398 and list the Principal Investigator first and next the Co-Principal Investigator of the P20; then list all Key Personnel for the Administrative Core and all Pilot projects/program in this application in alphabetical order. Follow the instructions provided in the Form PHS 398.

3. Table of Contents: The Table of Contents and Research Plan of the PHS 398 application are not specifically tailored to the unique objectives of the MI/CCP application. Organize the Table of Contents exactly as described below:

a. Face Page

b. Description, Performance Sites, and Key Personnel

c. Table of Contents

d. Detailed Budget for Initial Budget Period

i. Total Initial Budget for all stages

ii Planning Stage (if applicable)

iii. Priority-Setting Stage (Pilot project/program, IAC members, etc.)

iv. Implementation Stage

e. Budget for Entire Proposed Period of Support

i. Total Entire Budget for all stages

ii. Planning Stage (if applicable)

iii. Priority-Setting Stage

iv. Implementation Stage

f. Budgets Pertaining to Consortium/Contractual Arrangements

g. List of participating members of the MSI or the Cancer Center

h. Biographical Sketch and Other Support of:

i. PI (not to exceed four pages)

ii. Co-Investigator (not to exceed four pages)

iii. All Key Personnel in alphabetical order including the members of the Internal Advisory Committee

i. Resources

j. . Collaborative Plan: (replaces Research Plan in PHS 398 application instructions)

k. Special Introduction to revised application, if applicable (not to exceed three pages)

i. Background and Objectives

ii. Letter of Support from the MSI/Cancer Center

iii. Chronological Estimate of each Stage

iv. Initial Planning Stage (as appropriate depending on prior experience)

v. Priority-Setting Stage

vi. Implementation Stage (as appropriate depending on prior experience)

vii. Human Subjects

viii. Vertebrate Animals

ix. Literature Cited

k. Consortium/Contractual Arrangements

l. Appendix

m. Checklist

n. Personal Data

4. Detailed Budget for Initial Budget Period as appropriate to the stage of development: Use Form Page 4 of the Form PHS 398 application kit. It is expected that requested costs in the first year will be less than costs in the second or third years because planning and priority-setting are not as expensive as the implementation of a project or a program. Separately break out the budget into sections using different Form Page 4 for each as follows:

a) Total Initial Budget for all Stages

b) Planning Stage (if applicable)

c) Priority-Setting Stage

d) Implementation Stage

5. Budget for Entire Proposed Period of Support: Using Form Page 5 of the Form PHS 398; follow the instructions in the Form PHS 398 application kit.

Provide specific justifications for costs for each year requested appropriate to the stage of development (e.g., total entire budget for all stages, planning, priority-setting, and implementation). Costs for each year would include administrative costs and developmental costs as needed within the $275,000 direct cost cap. A three percent cost-of-living escalation may be included in future years.

6. Budgets Pertaining to Consortium/Contractual Arrangements: Use this category if more than one MSI or Cancer Center is being linked in the partnership. In this case, one of the MSI/Cancer Center institutions would have to serve as the primary grantee and subcontract for the consortia involvement of the other MSI/Cancer Center.

7. List all participating faculty/members of the MSI or the Cancer Center alphabetically by last name. Include for each their degree, department affiliation or equivalent, and research or other interest (e.g., research area, training, or education).

8. Biographical Sketches and Other Support: Use Biographical Sketch Format

Page and follow the instructions in the Form PHS 398 application kit for:

a. PI

b. Co-PI

c. All key Personnel of the MSI or Cancer Center: This section should include all professional individuals who serve in leadership roles, members of the Internal Advisory Committee. The biographical sketches of those Co-Leaders of Pilot projects/programs should be provided in the appropriate sections of this application.

9. Resources: Using Resources Format Page, follow the instructions in the Form PHS 398 application kit.

10. Collaborative Plan:

The Research Plan of the PHS 398 (rev. 5/01) application is not specifically tailored to the unique objectives of the MI/CCP application. Therefore, applicants should follow the outline below:

A. Special Introductory Statement for Revised Application (if applicable):

This section should be the same for both applications of the MSI and Cancer Center and should be limited to three pages. Include a summary of the additions, deletions, and changes in the revised application, placing particular emphasis on responses to the criticisms and issues raised in the summary statement. Include a chronological description of activities that occurred since the original submission (meetings, research activities, etc.). The changes in the full text must be clearly marked by appropriate bracketing, indenting, or changing the type setting, unless the changes are so extensive as to include most of the text.

B. Background and Objectives:

This section should be the same for both the MSI and the Cancer Center P20 applications and must be limited to two to three pages. It should describe the characteristics of the MSI and the Cancer Center that will contribute to the planning effort. It should clearly denote the nature of the interactions and deliberations that occurred and the individuals involved between the MSI and the Cancer Center during the preparation of these applications. State the objectives of the collaboration.

When Cancer Centers are NOT NCI-designated Cancer Centers, there should be a clear summary of the qualities of the institution that demonstrate that it has a highly organized and integrated cancer research program comparable to an NCI-designated Cancer Center.

C. Letters-of-Commitment:

This section should be different for each application. Two to three pages are recommended. There must be written Letters-of-Commitment from the MSI leadership and the Cancer Center leadership that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. A complete and specific description of such resources would include the following:

a. A specific statement detailing the per cent effort of release/protected time of faculty (up to 25 percent for MSI faculty and 10 percent for the Cancer Center faculty) as well as the activities that each faculty involved are being released from (e.g., teaching, clinical, administrative duties).

b. Provisions for space and facilities for new projects/programs, capital improvements, recruitment of new faculty, and other resources that will ensure the success of the partnership. This is especially important in cases where the application will require significant institutional commitments to ensure its success, such as a training program or an education program. The commitments must come from both institutional leaders of the MSI (e.g., Dean, President) and the Cancer Center (e.g., Cancer Center Director).

c. If the Principal Investigators of the MSI or Cancer Center are less experienced individuals, this letter of support should be from a senior member of the MSI (e.g., Department Chair, Dean), or Cancer Center (e.g., Dean, Cancer Center Director), and should include a statement describing how the Principal Investigator will be provided with appropriate mentoring and the necessary support to ensure the success of this collaborative planning effort. This support could be in the form of protected time for junior faculty to participate in and focus on the objectives of this grant and discretionary resources that will be made available to the Principal and Co-Principal Investigators.

D. Chronological Estimates of Planning, Priority-Setting, and Implementation Stages:

This section should be the same for the MSI and the Cancer Center application and must be limited to five pages. Each application should include a chronological narrative or table listing the specific first year, second year, third year, and fourth year (as applicable) objectives that are expected to be achieved. Applicants who have had minimal interactions and progress in planning should apply for 4 years of support incorporating all three stages whereas those who have had significant opportunity to plan should apply for 3 years of support. For each objective, a brief statement should be made about the separate contributions of the MSI and the Cancer Center in order to achieve success. The final objective of the P20 must be the submission of a specific grant application (R03, R01, T32, K12, R25T, R25E, project on Program Project Research Grant [P01], or Spore Grant [P50]) to the NCI or other funding agencies.

E. Initial Planning Stage:

This section should be the same for each application and limited to five pages.

For 4-year applications, the applicants should clearly describe the kinds of planning activities that the MSI and the Cancer Center will conduct to ensure a highly interactive and integrated effort between their faculty and scientists. These applicants should also relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives above and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in nutrition, etc.) involved in each activity.

For 3-year applications, the applicants should document prior planning experience, interactions, and progress in this section.

F. Priority-Setting Stage:

Clearly describe how the specific projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success.

G. Implementation Stage:

Applicants for 4-year grants should use the general outline below:

Applicants for 3-year grants should clearly describe the specific pilot projects/programs to be supported. Pilots must have co-leadership by individuals from the MSI and the Cancer Center. Each pilot project/program should include the following specific information:

**NOTE: (1) All NIH-supported biomedical or behavioral research projects involving human subjects must consider appropriate inclusion of Gender and Minorities and Children as noted on pages 17 – 27 of the Form PHS 398 instructions; (2) Research dealing with Human Subjects and Vertebrate Animals must be accompanied by appropriate documentation as described on page 27 of the Form PHS 398 instructions; (3) Research components involving clinical trials must include provisions for rigorous data management, quality assurance, and auditing procedures. Funds should be budgeted for these activities and should be justified. The proposed provisions should not duplicate review and monitoring systems already in place at the institution.

For any cancer treatment protocol supported directly or indirectly by the P20 MI/CCP, informed consent forms, early stopping rules, and procedures to detect and monitor adverse drug reactions (ADR) must be provided in the application, or in the case of protocols subsequent to funding of a P20 MI/CCP, to the NCI program director.

H. Human Subjects:

Follow the directions and instructions provided in the Form PHS 398 application kit.

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 the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, 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 the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing 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 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.

Sharing Research Resources

NIH policy requires that grant awardees recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. The NIH Grants Policy Statement is available at http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 data sharing plan and the resources sharing plan 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). See Section VI.3. Award Criteria.

Section V. Application Review Information

1. Criteria

No additional review criteria apply to this RFA.


2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not to be reviewed.

Applications that are complete and responsive to the RFA 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 will:

3. Merit Review Criteria

Applications submitted in response to a funding opportunity will compete for available funds with all other recommended applications.

This initiative is quite broad in scope and equally emphasizes cancer research, cancer training, and cancer education objectives. Under these circumstances, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator, and Innovation typically used for NIH research grants. Reviewers will have to use considerable that are flexibility in determining the merit of a broad range of possibilities that can expand research, training, and career development opportunities for minority scientists and students.

Applicants can either apply for 3 or 4 years of support depending on their previous experience, interactions, and planning history; consequently, reviewers must evaluate the following:

1. Strength of the evidence that the researchers and faculty of the MSI and the Cancer Center worked closely together in the preparation of the application;

2. The degree to which the letters-of-support from senior faculty and/or institutional/center leaders address the need for mentoring of inexperienced PIs or for specific institutional/center commitments to ensure the success of the collaboration;

3. The adequacy of the Career Development and Mentorship Plan if one or both Co-PIs are junior investigators;

4. As applicable, the adequacy of provisions made for day-to-day oversight, coordination, support, and logistical services needed to make the collaboration successful;

5. Initial Planning Stage:

For 4-year applications:

a. The adequacy of the different planning methods proposed by the MSI and the Cancer Center to explore areas of research and training opportunities, that will ensure highly interactive and integrated efforts between individual scientists (e.g., research cancer project) and/or between faculty and scientists (e.g., training program, education program); and

b. The adequacy and duration of the initial planning stage needed to identify areas of potential collaboration;

For 3-year applications:

a. The quality of the documented planning process used for identifying areas ready for prioritization and/or for pilot testing; and

b. The appropriateness and adequacy of the specific faculty and scientists identified from the MSI and the Cancer Center to contribute effectively to each aspect of this planning effort.

6. Priority-Setting Stage:

a. The adequacy of the experience and qualifications of the individuals from the IAC who will take part in prioritizing and selecting specific pilot projects/programs for implementation; and

b. The adequacy of the proposed process for selecting pilot projects/programs for implementation based on their merit and their potential for successful acquisition of preliminary data during the period of requested grant support.

7. Evaluation Criteria for Pilot Research Projects

For 4-year applications:

a. The potential of the Co-Investigators and the collaborative plan to prioritize and implement specific pilot projects and the relevance to the goals and priorities of the collaboration;

b. The likelihood that potential pilot projects/programs will emerge from this collaboration that will be successful as specific grant applications; and

c. The adequacy of Career Development and Mentorship Plan, if needed;

For 3-year applications:

a. The qualifications of the Co-Leaders to implement the pilot project/program;

b. The merit of the project/program and its potential to acquire the necessary preliminary data to become competitive for specific grant support

(e.g., R03, R01, P01, P50, K12, T32, R25); and

c. The adequacy of Career Development and Mentorship Plan, if needed.

The options will be either to score according to the NIH scale and recommend support at the recommended budget levels or to Not Recommend for Further Consideration (NRFC) because it has either: (1) low merit; (2) low relevance to the objectives of the partnership; and/or (3) low potential to become funded through competitive peer review.

8. Evaluation Criteria for Pilot Programs (i.e. training and education):

a. The qualifications of the Co-Leaders from the MSI and the Cancer Center to develop the proposed program;

b. The appropriateness of the mentors as related to the level of education of the trainees;

c. The objectives, design, and direction of the program;

d. The merit of the proposed program and its relation to the goals and priorities of the partnership;

e. Quality of the institutional environment (access to institutional resources, mentors accessibility, etc);

f. The relationship of the program to other programs in the MSI and the Cancer Center;

g. Identification of the pool (high school, undergraduate, graduate, medical students, minority populations, etc).

h. Quality of the program evaluation and the tracking; and

i. Potential of the application to develop into a full program or fundable program in the NIH peer review system or other agency.

The options will be either to score according to the NIH scale and recommend support at the recommended budget levels or to Not Recommend for Further Consideration (NRFC) because it has either: (1) low merit; (2) low relevance to the objectives of the partnership; or (3) low potential to become funded through competitive peer review.

Other Review Criteria

The overall degree of merit for the collaboration between the MSI and the Cancer Center will be reflected by one priority score that will be assigned to the MSI and the Cancer Center applications.

For 4-year applications, the score will be based primarily on the potential to develop projects/programs that will compete successfully for specific grant support.

For 3-year applications, the score should be based on the merit of the specific programs proposed and their likelihood to compete successfully for grant support with appropriate preliminary data.

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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 also Section VIII - Other Information.

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 also Section VIII-Other Information.

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 398 research grant application instructions (rev. 5/2001) will be assessed.

3.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.

3.C. Sharing Research Data

1. 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).

3.D. Sharing Research Resources

NIH policy requires that grant awardees 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 and 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

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 Principal Investigator 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. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Grant Award (NGA) are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

The NGA will be sent via email to the administrative official whose name is listed in Block 12 on the Face Page of the Form PHS 398

2. Administrative and National Policy Requirements

All NIH Grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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.


3. Award Criteria

The following will be considered in making funding decisions:

4. 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.

For those applications that are funded, the NCI will provide special instructions for submitting the Non-Competing Grant Progress Report (PHS 2590) each year.

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:

Sanya A. Springfield, Ph.D.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028
Bethesda, MD 20892-8350
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: springfs@mail.nih.gov

Nelson Aguila, D.V.M.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028
Bethesda, MD 20892-8350
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: aguilah@mail.nih.gov

Peter O. Ogunbiyi, D.V.M., Ph.D.
Office of Centers, Training, and Resources
National Cancer Institute
6116 Executive Boulevard, Suite 7028
Bethesda, MD 20892-8350
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-7344
FAX: (301) 402-4551
Email: ogunbiyp@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 496-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Ms. Barbara Fisher
Grants Administration Branch
National Cancer Institute
1003 West 7 th Street, Suite 300
Frederick , MD 21701
Telephone: (301) 846-1015
FAX: (301) 496-8601
Email: fisherb@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); and 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. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at 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, 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.

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://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). 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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH grant 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 that is available at 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 (see 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.

Public 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 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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.


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