Part I Overview Information


Department of Health and Human Services  

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

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

Title: Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30)

Announcement Type

New

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

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

Program Announcement (PA) Number: PAR-11-005

Catalog of Federal Domestic Assistance Number(s)
93.397

Key Dates
Release Date:  October 12, 2010
Letter of Intent Receipt Date(s): Not applicable
Application Receipt Dates: November 9, 2010, after which Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Dates: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 8, 2013

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

  1. Research Objectives

Section II. Award Information

  1. Mechanism of Support
  2. Funds Available

Section III. Eligibility Information

  1. Eligible Applicants
    1. Eligible Institutions
    2. Eligible Individuals
  1. Cost Sharing or Matching
  2. 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
    1. Submission, Review, and Anticipated Start Dates
               1. Letter of Intent
    2. Sending an Application to the NIH
    3. Application Processing
  1. Intergovernmental Review
  2. Funding Restrictions
  3. Other Submission Requirements

Section V. Application Review Information

  1. Criteria
  2. Review and Selection Process
    1. Additional Review Criteria
    2. Additional Review Considerations
    3. Resource Sharing Plan(s)
    4. Selection Process
  1. 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

Purpose

This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), invites new, renewal, and resubmission applications for P30 Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers. NCI-designated Cancer Centers serve as major sources of discovery into the nature of cancer and of the development of more effective approaches to prevention, diagnosis, and therapy. They contribute significantly to the development of shared resources that support cancer relevant research and they collaborate and coordinate their research efforts with other NCI-funded programs and investigators. The objectives of the NCI Centers Program  are to foster highly interactive cancer research through support of the following:

NCI support to cancer centers is intended to foster excellence in research across a broad spectrum of scientific and medical concerns relevant to cancer. To facilitate discovery and its translation into direct benefit to patients and the general public, the NCI awards Cancer Center Support Grants (CCSGs) to institutions that have a critical mass of excellent cancer-relevant scientific research. The CCSG focus on research derives from the belief that a culture of discovery, scientific excellence, transdisciplinary research, and collaboration yields tangible benefits extending far beyond the generation of new knowledge.

Background

The NCI-designated Cancer Centers are the centerpiece of the Nation’s effort to reduce morbidity and mortality from cancer. The NCI Cancer Centers Program was formally established by the 1971 National Cancer Act to create a centralized platform for sharing concepts and resources and the management structure necessary to cure cancer. The Act authorized the establishment of cancer centers, created an administrative and organizational home for the Program, implemented a standing funding mechanism, i.e., the P30 Cancer Center Support Grant or CCSG, and established programmatic guidelines.

Over time, NCI-designated Cancer Centers have developed in many different organizational settings, reflecting considerable diversity in the size and complexity of their research emphases. Whether freestanding, matrixed within an academic institution, or comprised of a consortium of separate but partnering scientific institutions that work together to develop and actualize a cancer research agenda, Cancer Centers are expected to capitalize on all institutional cancer research capabilities, integrating meritorious programs in laboratory, clinical, and population research into a single transdisciplinary research enterprise across all institutional boundaries. The NCI’s support to cancer centers is focused on fostering excellence across this cancer research spectrum. Today, NCI-designated Cancer Centers are a major platform for advancement of NCI’s scientific agenda. They garner more than half of the extramural research funding on a yearly basis and serve as home to the NCI’s most significant initiatives. Additionally, they serve as a primary test bed for new research and technological approaches, and play a leadership role in the formation of national cancer policy and programs.

The NCI recognizes two types of Cancer Centers:

The Six Essential Characteristics of an NCI-designated Cancer Center: Despite great institutional variety, the one common denominator of all successful NCI-designated Cancer Centers is excellence in research. Successful cancer centers have scientifically strong research bases that are funded by peer-reviewed grants from the NIH and other sources, and organized into formal, collaborative, cancer-focused, scientific Programs. In addition to excellence in research, a successful center is organized and administered to maximize the potential of its research base so that the whole is greater than the sum of its parts. There are six essential characteristics of an NCI-designated Cancer Center:

1.     Facilities: Physical facilities dedicated to the conduct of cancer focused research, and to the center’s shared resources, administration, and research dissemination efforts, should be appropriate and adequate to the task.

Organizational Capabilities: The center should be organized to take maximum advantage of institutional capabilities in cancer research, and to appropriately plan and evaluate center strategies and activities.

3.     Transdisciplinary Collaboration and Coordination: Substantial coordination, interaction, and collaboration among center members from a variety of disciplines should enhance and add value to the productivity and quality of research in the center.

4.     Cancer Focus: A defined scientific focus on cancer research should be clear from the center members’ grants and contracts, and from the structure and objectives of its formal Programs.

5.     Institutional Commitment: The center should be recognized as a formal organizational component with sufficient space, positions, and discretionary resources to insure its stability and fulfill the center’s objectives.

Center Director: The director should be a highly qualified scientist and administrator with leadership experience and institutional authority appropriate to manage the center and further its scientific mission and objectives.

Please refer to the Cancer Center Support Grant Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf and to the Guidelines Clarifications documents at http://cancercenters.cancer.gov/grants_funding/index.html for additional information.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity uses the NIH P30 center grant award mechanism.  The applicant will be solely responsible for planning, directing, and executing the proposed project.

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

2. Funds Available

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

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

NIH grants policies as described in the

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions and organizations are not eligible to apply for Cancer Center Support Grants.

Only one CCSG application is allowed per institution. Institutions must have a funding base of at least $4M in annual direct costs of peer-reviewed, cancer-related funding. For the definition of funding base used for this FOA, please refer to the CCSG Guidelines at http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf .

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her 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.

Additionally, PDs/PIs must be compliant with the requirements included in the CCSG Guidelines. Only one Project Director/Principal Investigator (PD/PI) may be designated on the application http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf .

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Only one application per institution is allowed.

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

Renewals. Applicants may submit a renewal application.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

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

2. Content and Form of Application Submission

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

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

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

Applicants should consult with NCI staff concerning the technical aspects of preparing the application.

CCSG applications have additional submission requirements, which are described in more detail in the Policies and Guidelines Relating to the Cancer Center Support Grant; these NCI CCSG Guidelines, http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf , must be used in conjunction with this Funding Opportunity Announcement when preparing applications.  Submission requirements are detailed here: http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Letter of Intent Receipt Dates: Not applicable
Application Receipt Dates: November 9, 2010, after which Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and 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 delivery)

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

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

Referral Officer
Division of Extramural Activities
National Cancer Institute
9609 Medical Center Drive, Room 7W412
Bethesda, MD 20892-9750 (for Express mail, use Rockville, MD 20850)
Telephone: 240-276-6390
Fax: 240-276-7682
E-mail: ncirefof@dea.nci.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
 
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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

Acceptance of the Application: Upon receipt of an application, the NCI Scientific Review Officer (SRO) conducts an administrative review of the submitted materials with attention to the following elements:

1.     Format: Applications should be prepared in conformity with the PHS Form 398 (rev. 6/09) instructions to facilitate review of the submission. It is very much in the applicant’s interest that review of these complex applications be as trouble-free as possible for peer reviewers.

2.     Completeness of Required Information: To facilitate the quality and consistency of the review, the applicant should ensure that all essential information is presented completely and unambiguously.

If an application is deficient in the elements above, depending upon the magnitude of the problem, the NCI Staff may:

1.     Defer the application to a later review cycle; or

2.     Return the application to the applicant without review.

Modifications After Submission: Minor, unavoidable modifications of the application [as defined by NIH revised policy on submission of late grant application materials prior to initial peer review (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html)] can be accepted up to 30 days prior to the site visit.

Inquiries about the application after submission:

1.     Before completion of NCI initial review group (IRG) Subcommittee A (NCI – A) review: Direct inquiries to the SRO.

2.     After completion of the NCI – A review: Direct scientific and programmatic questions to the responsible Program Director in the Office of Cancer Centers or to the Director of the Office of Cancer Centers. Direct fiscal questions to the responsible Grants Specialist in the NCI Office of Grants Management.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project; and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal 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/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission Requirements

PHS398 Research Plan Component Sections

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

Budget Component

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

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

Applicants requesting $1,000,000 or more in direct costs for any year (excluding consortium  F&A costs)  must carry out the following steps:

  1. Contact the NIH institute or center (IC) program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;  
  2. Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and
  3. Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, and/or resubmission applications. See NOT-OD-02-004, October 16, 2001

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations or add components that were not in the original submission.  An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

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

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

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

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by  an

appropriate scientific review group convened by the NCI in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. 

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

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

The NCI Initial Review Group (IRG), NCI IRG Subcommittee A (NCI – A), reviews CCSG P30 applications.  CCSG applications undergo peer review in a three-step process involving the following:

1.     Site visit review, which may be full or limited;

2.     NCI – A review; and

3.     National Cancer Advisory Board (NCAB) review and decision-making, the final level of review for all grant applications referred to the NCI.

For additional information about the review process, please see: http://cancercenters.cancer.gov/documents/CCSG_Guidelines.pdf  and to the Guidelines Clarifications documents at http://cancercenters.cancer.gov/grants_funding/index.html for additional information.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  What is the overall quality of the cancer relevant science in the center?  What has the center contributed to the development of more effective prevention, diagnosis, and treatment for cancer (where appropriate)?

(Note: in the context of a P30 Cancer Center Support Grant review, the  term ‘project’ refers to the Center application and ‘project aims’ refers to the Center’s strategic goals.)

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

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Does the cancer center add value over and above the separately funded research efforts themselves?  Have thoughtful, coherent scientific Programs been assembled and Program members selected  to maximize the cancer-related interactive science in the parent institution as a whole?  How do the different cancer-related scientific themes in the parent institution fit together in the center? What is the overall strength of the other components of the application?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  What impact has the center itself had (or is likely to have) on the quality of the science, the productivity of the scientists, and the transdisciplinary activities of the institution relating to cancer?  Have the choices for center membership made by its leaders resulted in a group of excellent cancer-focused scientists who are also committed to productive interactions with one another? What is the extent of value added by the CCSG to the center?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Essential Characteristics of the Center:

1.     Facilities: (merit descriptor)

a.     Adequacy and appropriateness of the center’s space and physical facilities in relation to its identify, objectives, and activities

2.     Organizational Capability: (merit descriptor)

a.     Effectiveness of the Center’s organization in taking full advantage of institutional capabilities in cancer research and in fostering scientific interactions and joint initiatives among programmatic elements

b.    Adequacy and appropriateness of membership criteria: documented processes for evaluation of members, including non-aligned members, on a periodic basis, and compliance with these policies and procedures

c.     Effectiveness of the center in the use of external and internal cancer center advisory bodies (e.g. executive committee) for strategic planning, decision making, and priority setting

d.    For Consortium Centers; adequacy of mechanisms in place to ensure that

                                        i.    Differences can be resolved among consortium institutions

                                       ii.    Benefits of clinical research are uniformly available across consortium institutions to the population within the catchment area

                                      iii.    Strategic goals of the center are being met through an integrated recruitment process

                                      iv.    The center Director has authority over all shared resources in CCSG-supported shared resources in collaborating institutions and to integrate scientists from all partner institutions into the scientific Programs of the Center

                                       v.    All members have appropriate access to shared resources, participate in scientific Programs, and may assume leadership positions in the center, even if partner institutions are geographically dispersed

3.     Transdisciplinary Collaboration: (merit descriptor)

a.     Level of effective transdisciplinary and translational collaborations among laboratory, clinical, and population science Cancer Center members and adequacy of mechanisms used by center to promote them

b.    Extent to which collaborative activities within and among (inter- and intra- programmatic) Programs have added value to cancer related scientific activities

c.     For Consortium Centers, adequacy of mechanisms in place to ensure that:

                                        i.    Research is integrated across partner institutions as evinced by programmatic structure and objectives, joint publications and grants and other transdisciplinary, cross institutional activities

                                       ii.    The partnership is stable, as evidenced by a history of research integration (see above) and the provisions of formalized legal agreements

4.     Cancer Focus: (merit descriptor)

a.     Breadth, depth, and significance of the cancer research base, as judged by the structure and objectives of the Programs, research support, and collaborative publications of center members

5.     Institutional Commitment: (merit descriptor)

a.     Extent to which the institution has met prior commitments and provided (or plans to provide) resources to insure that the center reaches its full potential

b.    For matrix centers, evidence that cancer center status is at least equivalent to that of that of an academic department.

c.     Adequacy of:

                                        i.    Space, positions, and discretionary funds controlled by the center director

                                       ii.    Cancer Center access to clinical inpatient and outpatient facilities for the conduct of clinical trials

                                      iii.    Oversight of faculty and staff critical to clinical research

                                      iv.    The institution’s plan to deal with a change in the directorship of the center

d.    For Consortium Centers, adequacy of mechanisms in place to ensure that:

                                        i.    The partnership is stable, as evidenced by a history or research integration (see above) and the provisions of formalized legal agreements

                                       ii.    The Center Director has authority over all shared resources in CCSG-supported shared resources in collaborating institutions and to integrate scientists from all partner institutions into the scientific Programs of the center.

6.     Center Director: (merit descriptor)

a.     Appropriateness of the scientific and administrative qualifications and experience of the director in relation to the center’s research activities and objectives

b.    Appropriateness of the director’s position within the institution (at least that of a department chair) and his/ her presentation on decision making committee relevant to center objectives

c.     Appropriateness of the director’s time commitment to the center’s research activities

d.    Adequacy of the director’s formally codified authority over (and effectiveness in management of the center’s space and research resources, including: )

                                        i.    Appointment of new members and discontinuation of existing members

                                       ii.     Appointments of faculty necessary to enhance the research objectives of the center

                                      iii.    Inpatient and outpatient facilities necessary to achieve the center’s clinical research objectives (in centers with clinical research activities)

                                      iv.    Philanthropy, clinical revenues, or other funding streams

e.     For consortium centers, adequacy of mechanisms in place to ensure that the center director has authority over all shared resources in CCSG-supported shared resources in collaborating institutions and to integrated scientists from all partner institutions into the scientific  Programs of the center

7.     Senior Leadership – Guidelines Section Part II, 7.1 (merit descriptor)

a.     Appropriateness of the qualifications and effectiveness of each senior leader in relation to his/ her role in the research activities of the center

b.    Appropriateness of the time commitment of each leader in relation to the needs and objectives and to the difficulty and complexity of his/ her responsibilities

c.     Effectiveness of the team in working together as a group in addressing cancer center issues and planning strategies

8.     Planning and Evaluation– Guidelines Section Part II, 7.4 (merit descriptor)

a.     Effectiveness of external and internal advisory and evaluation activities on the development of the center’s scientific activities

b.    Appropriateness of External Advisory Committee relative to the center’s needs

c.     Effectiveness in using the External Advisory Committee as a group, based on:

                                        i.    Annual meetings of the committee as a whole

                                       ii.    Production of a committee report with recommendations to the center director

                                      iii.    Response to committee recommendations by center and institutional leadership

9.     Developmental Funds – Guidelines Section Part II, 7.5 (merit descriptor)

a.     Effectiveness in (or potential for) strengthening the center’s identified strategic needs, including use of funds in the prior project period, where applicable

b.    Effectiveness in (or potential for) assessing scientific merit of research opportunities proposed by center members

c.      Effectiveness of the center in the use of internal and external advisory bodies to assist in identifying scientific opportunities and needs appropriate for the investment of developmental funds (development of new shared resources and areas of recruitment)

10.  Center Administration – Guidelines Section Part II, 7.6 (merit descriptor)

a.     Appropriateness of the qualifications of administrative staff

b.    Appropriateness of policies regarding use of cancer center space

c.     Effectiveness of administration:

                                        i.    In providing centralized administrative services important to the research activities of the center in center decision-making processes

                                       ii.    In oversight of shared resources

                                      iii.    In budget, purchasing, and accounting processes

                                      iv.    In support of faculty recruitment, payment, and review; membership application policies and process; arranging and documenting meetings organized by the center; and management of pilot projects review and awards

                                       v.    In representing the center within the institution, including the central grants office (e.g. level of support, assignment of applications and grants for center members, and overlap of functions), and clinical (e.g. in-patient, out-patient, and networks) and other pertinent entities

d.    For consortium centers, adequacy of mechanisms to ensure smooth administration of CCSG functions across institutions

11.  Staff Investigators – Guidelines Section Part II, 7.3 (approval/disapproval)

a.     For Research Staff Investigators:

                                        i.    Service as Principal or Co-Investigator on at least one NCI-approved peer-reviewed and funded research project

                                       ii.    Special, clearly definable role in helping the center achieve its scientific objectives (above and beyond own research support and those duties encompassed in another CCSG role, such as senior or program leader).

                                      iii.    Extent to which the investigator’s proven record or scientific productivity and accomplishments, as well as current peer-reviewed support, justify the request for support

b.    For Clinical Staff Investigators:

                                        i.    Special, clearly definable role in helping the center achieve its clinical objectives (above and beyond own clinical research activities and those duties encompassed in another CCSG role, such as senior or program leader)

                                       ii.    Extent to which participation in the development and implementation of the center’s clinical activities (e.g. authorship of clinical trials, accrual of patients on intervention trials, or leadership roles in cooperative group studies promotes the center’s clinical and translational goals and therefore justifies  the request for support

12.  Scientific Quality of Each Program – Guidelines Section Part II, 8.0 (merit descriptor for each program)

a.     Overall scientific quality of the Program

b.    Extent of cancer focus

c.      Extent to which the relevant scientific disciplines that enhance Program breadth and depth and maximize productivity are represented

d.    Extent of value added by the Program in promoting transdisciplinary and translational research among its members and with members of other Programs

e.     Judicious and justifiable selection of members of the Program, based upon evidence of participation

f.     Effectiveness of Program Leaders

g.    Appropriateness of the percent effort requested for the Program Leader in relation to the difficulty and complexities of his/ her research responsibilities

h.     Extent of value added by the program to the Center

i.      Interactivity of the Program as documented by agendas of Program meetings (minutes not required) and inter- and intra- programmatic publications.  Of total publications, 10% inter- and 10% intra- programmatic publications constitute general benchmarks for a reasonably interactive Program Publications should represent the broad diversity of Program members

j.      For clinical and translational Programs, effectiveness in accrual of patients to all types of trials in relation to the patient population.  This includes investigator initiated institutional trials; those that demonstrate leadership, interaction, and collaboration in other NCI-funded clinical programs, such as Cooperative Groups, SPOREs, and other multi-site clinical trial networks; and collaborative trials with industry. A total of 10% accrual to therapeutic and prevention trials constitutes a general benchmark for a reasonable level of protocol accrual.

k.     For consortium centers:

                                        i.    All members participate in scientific Programs and may assume leadership positions in the center, even if partner institutions are geographically dispersed.

                                       ii.    Research is integrated across partner institutions as evidenced by programmatic structure and objectives, joint publications and grants, and other transdisciplinary, cross institutional activities

13.  Overall Quality of the Program (merit descriptor)

a.     Overall scientific quality of the Program

b.    Value added by the Program to the center

14.  Shared Resources and Services – Guidelines Section Part II, 9.0 (Merit descriptor for each resource

a.     Extent to which resource provides services to multiple investigators in the center

b.    Extent to which the resource is strategically important to the science of the center

c.     Quality of the science the resource supports

d.    Quality of the product and cost-efficiency of the service (e.g. whether quality and costs compare favorably with equivalent services provided by an outside source)

e.     Appropriateness of the qualifications of the staff

f.     Appropriateness of the budget request in relation to the amount and quality of the service provided

g.    For high throughput shared resources, breadth of use by and benefit to, center members, for low and equitable prioritization system

h.     Where relevant, extent of compliance with NCI, national or international standards

i.      If an institutional shared resource

                                        i.    Adequacy of CCSG member access to the facility’s services

                                       ii.    Benefits center members receive as a result of CCSG support

                                      iii.    Participation of the center in facility planning and oversight

j.      For consortium centers, adequacy of mechanisms in place to ensure that all members have appropriate access to shared resources

15.  Protocol Review and Monitoring System (PRMS) – Guidelines Section Part II, 9.2 (approve, conditionally approve, or disapprove)

a.     Appropriateness of the composition of the committee and the qualifications of its members, for ensuring sufficient size and breadth of expertise to conduct a critical, fair scientific review of all clinical research protocols involving cancer patients in the institution or institutions comprising the center

b.    Authority and process for initiating, monitoring and termination all cancer clinical research protocols in the institution or institutions comprising the center

c.     Appropriateness of criteria and process for scientific review, taking into account the specific rationale, study design, duplication of studies already in progress elsewhere, adequacy of biostatistical input, and feasibility for completion within a reasonable time frame.

d.    Appropriateness of mechanisms for overseeing the prioritization of competing protocols from all sources (including cooperative group trials and industry trials) and thus, for ensuring optimal use of a center’s clinical resources for scientific purposes

e.     Adequacy of criteria and process for monitoring trials to ensure ongoing research is making sufficient scientific progress, including adequate patient accrual rates and for terminating trials that do not meet scientific goals

f.     For consortium centers, a single Protocol Review and Monitoring System governing all cancer clinical trial protocols across all the partner institutions

16.  Protocol Specific Research Support – Guidelines Section Part II, 9.3 (Merit descriptor)

a.     Proposed studies comply with criteria for support, as outlined in Part II, Section 9.3

b.    Scientific quality and innovation of proposed studies

c.      Appropriateness of the number and percent effort of research nurses and data managers involved in the direct conduct of institutional, investigator-initiated, feasibility (pilot or pre-phase I) or phase I studies that are not funded via other peer reviewed mechanisms

d.    Adequacy of the process for setting priorities in the assignment of these research nurses and/ or data managers and for overseeing the progress of the research

17.  Data, Safety, and Monitoring Plan:  Guidelines Section 12 (acceptable, unacceptable)

a.     General adequacy of the Plan itself in defining the general structure of the monitoring entity and mechanisms for reporting adverse events

b.    For centers requesting funds for implementation of DSM functions (Note that budgets for DSM functions must be presented and justified separately from other components):

                                        i.    General advocacy of DSM functions for the different kinds of studies (e.g. therapeutic trial, behavioral intervention, gene therapy trials that require evaluation, auditing, and monitoring) – NOT the specific evaluation of any particular study or the audit of that study

                                       ii.    Adequacy of the expertise of individuals serving on key committees that perform DSM functions

c.     For consortium centers, a single Data Safety Monitoring Plan governing all cancer clinical trial protocols across partner institutions

18.  Minority and Gender Representation - Guidelines Section Part II, 10 (approval, disapproval)

a.     Appropriateness of the accrual of women and minorities to both therapeutic and non-therapeutic clinical trials in proportion to the center’s catchment area based on demographic and accrual data provided

b.    When accrual is inadequate, adequacy of the center’s plan to improve performance

The following criteria apply to the comprehensiveness review only and are not factored into the overall impact/priority score.

Stage I Comprehensiveness: (approval, disapproval)

a.     Adequacy of the depth, and breadth of each of the three major areas of laboratory, clinical, and prevention, control, and population sciences

b.    Evidence of strong transdisciplinary research bridging these scientific areas

                                  i.    Note: The Comprehensiveness of consortium centers is based on the strengths of all collaborating institutions

Stage II, Education and Training of Biomedical Researchers and Health Care Professionals: (approval, disapproval)

Training of basic, clinical, and prevention and control cancer researchers as evidenced by a list of competitive training grants awarded to center investigators

a.     Recruitment of under-represented minorities and special populations to research training pro­grams as evidenced by data on total trainees and minority trainees and a narrative discussion of recruitment accomplishments and hurdles

b.    Continuing education and training of health care professionals, in a spectrum of state-of-the-art cancer care and services, with a particular focus on prevention and on accrual of patients to can­cer clinical trials, as evidenced by a list of training activities, seminars, and continuing education opportunities

Stage II, Community Service, Outreach and Dissemination: (approval, disapproval)

a.      The knowledge of the cancer problem in the community served by the center, as evidenced by demographic data, narrative discussion of special or underserved populations and pertinent cancer incidence and mortality data

b.    Process for priority setting and use of available expertise and resources to serve the community in ways that will reduce cancer incidence and mortality

c.     Outreach activities, including those that address the special problems of the community, as evi­denced by a listing and discussion of such activities and any other supporting documentation

d.    Collaborations with not for profit or for profit outreach programs; and with other centers, commu­nity hospitals, and private oncology practices when service regions are overlapping, to develop complementary outreach efforts to maximally benefit the community, as evidenced by a listing and discussion of such collaborative efforts

e.     Process for evaluation of the impact of outreach and dissemination activities on clinical and pub­lic health systems within the center’s catchment area

Additional Review Criteria

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

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

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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

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

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

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations 

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

Applications from Foreign Organizations. Foreign are not applicable for this FOA.

Select Agents Research. Not Applicable.

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

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

If after evaluating all individual budget requests, the total budget seems excessive relative to the overall quality of the cancer focused science in the center, or in relationship to their NCI funding base, reviewers may recommend a single cut in the overall budget without identifying specific areas for reduction.

Selection Process

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

NIH considers the following in evaluating Center grant applications:

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

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/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. Reporting

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

See also Policies and Guidelines Related to the Cancer Center Support Grant, Instructions for Non-Competing Continuation Applications (go to http://cancercenters.cancer.gov/grants_funding/index.html).

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

Section VII. Agency Contacts


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:

Office of Cancer Centers
National Cancer Institute
9609 Medical Center Drive, Room 2W212
Bethesda, MD 20892-9708 (for regular mail)
Rockville, MD 20850 (for express delivery and campus visits)
Telephone: 240-276-5600
Fax: 240-276-5625
E-mail: ncicenters-r@mail.nih.gov

2. Peer Review Contacts:

Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: 240-276-6390
E-mail: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Rebecca Brightful
Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150
Telephone: 301-846-6703
Fax: 301-496-8601
Email: brightfr@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

Access to Research Data through the Freedom of Information Act:
The 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.

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

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

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

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

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

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

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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