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: Community Clinical Oncology Program Groups (U10)

Announcement Type
This funding opportunity announcement (FOA) is a re-issue of RFA-CA-09-022.

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

Request For Applications (RFA) Number: RFA-CA-10-010

Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394, 93.395, 93.396, 93.397, 93.399, 93.398

Key Dates
Release Date: July 16, 2010
Letters of Intent Receipt Date: August 16, 2010
Application Receipt Date: September 16, 2010
Peer Review Date: November-December 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: June 1, 2011
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 17, 2010

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(s) of Support
2. Funds Available

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The overall objective of the Community Clinical Oncology Program (CCOP) is to develop and conduct state-of-the-art cancer prevention clinical trials and control and treatment clinical trials with prominent involvement of community oncologists and the populations that they serve. The CCOP, established by the Division of Cancer Prevention, National Cancer Institute (NCI) in 1983, is a community-based clinical trials network that links community physicians, who accrue participants/patients to cancer clinical trials as part of their overall practice, with NCI Cooperative Groups and Cancer Centers that serve as their “CCOP Research Bases.”

The CCOP Network is designed to: (1) increase the involvement of community oncologists, other specialists (e.g., surgeons, family practitioners, gastroenterologists, urologists, gynecologists), and their patients in clinical trials designed by NCI Cooperative Groups and Cancer Centers; (2) involve a wider segment of the community in cancer clinical trials, including minorities, women, and other underserved (e.g., rural) populations; and (3) accelerate the transfer of knowledge gained from clinical trials to community oncology practices.

The CCOP Network consists of three types of components:

A CCOP Group is a consortium of community oncologists from one or more interacting community institutions that accrue patient/participants to clinical trials designed and conducted by the CCOP Research Bases. Each CCOP Group must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to prevention and control clinical trials. Equally important to accrual, CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A Minority Based CCOP Group is a consortium of oncologists from one or more interacting community institutions with at least 40% minority cancer patients that accrue patients/participants to clinical trials that are designed and conducted by the CCOP Research Bases. Each MB-CCOP must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to cancer prevention and control clinical trials. Equally important to accrual, MB-CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A CCOP Research Base designs clinical trials for use in the CCOP Network. It also conducts the trials, manages and analyses the data, and reports the results. CCOP Research Bases must either be: (i) a NCI-funded Clinical Cooperative Group (ii) NCI-designated Cancer Center; or (iii) an existing (i.e., currently funded). Cooperative Group CCOP Research Bases design and conduct both cancer treatment and cancer prevention and control clinical trials. Cancer Center CCOP Research Bases design and conduct only cancer prevention and control clinical trials.

This Funding Opportunity Announcement (FOA) solicits new and renewal applications for CCOP Groups.

Definition: Cancer prevention/control clinical trials include the clinical evaluations of: the effectiveness of interventions for the purpose of reducing the risk for developing cancer (including, but not limited to chemo-preventive agents; surgical interventions, and lifestyle modifications); methods for early detection of cancer and precancerous lesions; interventions to improve patients’ quality of life or to treat symptoms arising from cancer or toxicities arising from cancer therapy; and ways to improve continuing, palliative, and end-of-life care.

Background

The CCOP Network was initiated in 1983 as a mechanism for including community oncologists and their patients in treatment clinical trials designed by NCI Cooperative Groups and Cancer Centers. In 1986, the Network’s focus expanded to include cancer prevention/control clinical trials research aimed at reducing cancer incidence, morbidity, and mortality through the evaluation of interventions in controlled clinical trials. Prevention and control research in the CCOP Network has increased steadily since funding began in 1987.

The CCOP Network is a vital resource for conducting NCI cancer prevention/control clinical trials because the Network provides access to: (1) cancer prevention trials; (2) large populations of cancer patients for symptom management, supportive care, and quality-of-life interventions; (3) large populations of former cancer patients and survivors who may benefit through participation in chemoprevention clinical trials; (4) cancer patients' family members and other classes of individuals who may be at increased risk of developing cancer and thus be candidates for cancer prevention and/or detection studies; and (5) geographic areas inhabited by diverse populations not always available in university or urban settings. Several large chemo-prevention trials have been implemented through the CCOP Network, among them the prostate cancer prevention trial with finasteride (PCPT), the study of tamoxifen and raloxifene in the prevention of breast cancer (STAR), and the selenium and vitamin E trial in the prevention of prostate cancer (SELECT).

In 2009, the CCOP Network consisted of 47 CCOP Groups, located in 28 states and comprising more than 340 hospitals and more than 3,000 physicians. The CCOPs enrolled approximately 10,800 patients to treatment and prevention and control trials in 2009. The Network also included 12 CCOP Research Bases, which conducted several hundred treatment/prevention/control trials. The MBCCOP Program consisted of 14 MBCCOP Groups, located in 11 states and Puerto Rico with more than 50 hospitals and 470 physicians. MBCCOP Groups enrolled over 1,275 patients to NCI-approved cancer clinical trials.

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 will use the U10 cooperative agreement award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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

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

2. Funds Available

The estimated amount of funds available for support of approximately 3 CCOP Group awards as a result of this announcement is $1.8 million for fiscal year 2011. Future year amounts will depend on annual appropriations.

For CCOP Group applications, the total project period proposed may not exceed 3 years for new applications and 5 years for renewal applications.

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1. A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1. B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

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

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

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

For new and renewal CCOP Group applications, the following provisos apply:

Institutions not eligible to apply for the CCOP Group awards include:

Number of Applications: Applicants may submit only one application in response to this FOA.

Resubmissions: Resubmission applications are not allowed except from those that were submitted in response to RFA-CA-09-022 and were not selected for funding. These applications must include an Introduction addressing the previous peer review critiques (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals: Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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

The exceptions from the PHS398 instructions and detailed information on the application structure and components are provided in Section IV.6. - Other Submission Requirements. All applicants must follow the specific instructions in that section.

Applications with Multiple PDs/PIs

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

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

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

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

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

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

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: August 16, 2010
Application Receipt Date: September 16, 2010
Peer Review Date: November-December 2010
Council Review Date: January 2011
Earliest Anticipated Start Date: June 1, 2011

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 in Section IV.3.A.

The letter of intent should be sent to:

Lori Minasian, MD
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 2017, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email:minasilo@mail.nih.gov

3. B. Sending an Application to the NIH

Applications must be prepared using the 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

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

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

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

3. C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NCI.  Incomplete and/or 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.

Resubmission applications are not allowed except for those CCOP Group applications that were submitted in response to RFA-CA-09-022 and were not selected for funding.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

Specific Restrictions for CCOP Applications:

Budget requests may include the following allowable items:

The following items are NOT allowed in the budget requests:

6. Other Submission Requirements

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

NOTE: The applicant should review the terms and conditions of award prior to preparing the application as these terms include information and clarifications needed by the applicant to understanding the complete requirements of a CCOP award.

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

For CCOP Group applications submitted in response to this FOA, the standard PHS 398 Research instructions are altered as follows:

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

A. Program Overview

B. Research Program

C. Leadership

D. Administrative/Data Management Core

Standardized table templates are available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Applicants are strongly encouraged to use templates for Table 1, 2, 3A, 3B, 4 and 5 and 8 for the inclusion as part of the Resources section.

RESEARCH PLAN: The standard PHS398 Research Plan is altered as follows:

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

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

Other sections of the PHS 398 Research Plan remain unmodified and should be completed following standard instructions.

NOTE: An application from a currently funded CCOP Group (renewal application) must include a progress report under Section 3. Research Strategy, sub-section A –Program Overview.

A.    Program Overview (up to 12 pages)

The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization (Note: Include letters of institutional commitment under 14. Letters of Support (e.g., Consultants)) and/or documentation of consortium arrangements must be provided (Note: Include Letters of Intent to Establish a Consortium under Section 14 of Research Plan "Letters of Support". Applicants, whose applications are considered for funding, will have to provide fully executed consortium agreements as a Just-in-Time requirement). In addition, each application must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. The description of this space may be included under the Resources section or under Organizational Structure.

B.    Research Program (up to 12 pages)

Research Plans. The application should describe the group’s plans and approach to implementing and conducting NCI-approved cancer clinical trials in the practice setting(s) of the community it serves. The plans should cover the next 3 years (for new applications) and 5 years (for renewal applications). The plans should include a description of how the CCOP Group will access an adequate selection of cancer prevention/control/treatment clinical trials to meet or exceed accrual requirements and/or planned accrual goals, as well as provide appropriate trials to the participants/patients in the CCOP Group’s catchment area. Applications should describe in narrative form the type of treatment trials the CCOP Group expects to active as well as a detailed listing of the projected cancer prevention/control trials (Table 9 is available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Trial access must be documented through formal affiliations with Research Bases. The conditions of affiliation must be provided in the CCOP Research Base affiliation agreement(s).

The process the CCOP group uses to select trials and the recruitment and retention plans for the selected trials should be described. The CCOP Groups outreach efforts and methods for engaging the community its serves should be described as well. The CCOP Group’s plan for recruiting women and minority populations must be described and may be included under Section 5.5.7 Inclusion of Women and Minorities.

The application should describe the CCOP Group’s interactions with its Institutional Review Board(s) and the processes it has for ensuring compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46) related research involving human subjects. The description may be included under Section 5.5.6 Protection of Human Subjects of the application and cross referenced to this section of the Research Plan.

The research base(s) affiliations should be described in the application. Table 8 is available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply and may be included in the Resources section of the application. Copies of affiliation agreements should be included under Section 14. Letters of Support. The rationale for choosing these research base affiliations should be discussed. In addition, the application should outline its plans for contributing to the scientific agenda as well as the infrastructure of its affiliated research bases over the next project period. Examples of contributions might include such activities as: participation/membership in research base committees; serving as chair(s) on cancer clinical trials; authorship of joint publications, etc. Information coming from the community via the CCOP Group that informs the research base scientific agenda should also be described.

The application should describe the type of cancer prevention/control trials the CCOP Group plans on implementing during the next project period. In addition, the application must describe implementation plans for at least two NCI-approved cancer prevention/control clinical trials that use an intervention, such as a trial of a chemo-preventive agent or a trial to study an intervention/agent for the treatment of a cancer symptom. The application should include specifics on patient/participant recruitment, compliance and follow-up, etc. The clinical trials selected must come from CCOP Research Bases with which the CCOP Group is or proposes to affiliate.

C.    Leadership (up to 6 pages)

Key/Senior Personnel. A designated PD/PI is required. A substitute PD/PI candidate should be identified to assure continuity in the event of resignation of the PD/PI. The qualifications and experience of both persons must be described, specifically documenting their respective abilities to organize and manage a community oncology program that includes cancer prevention/control/ treatment clinical trials and related activities, as well as experience in accruing patients/participants to clinical trials. In addition, the application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility with respect to the trials selected for activation by the CCOP Group and how the responsibility is delegated among key/senior individuals.

A mentoring plan or program for leadership succession within the CCOP Group is recommended to ensure a smooth transition of leadership if and when necessary. If such a plan exists or is under development it should be described in the application.

The application should propose a committed group of multidisciplinary professionals appropriate for its expected clinical trials participation. This team should include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, gastroenterology, pediatrics, internal medicine, family practice), as appropriate. A description of the team, how they operate and interact and how they lend their expertise to achieve the goals of the CCOP Group should be provided.

D.    Administrative/Data Management Core (up to 12 pages)

The summary audit report(s) of CCOP Group performance by affiliated CCOP Research Base(s) should be provided. These reports may be included under Section 5.5.6 Protection of Human Subjects. A brief description of the overall summary audit(s) results should be included in this Administrative & Data Management sub-section of the Research Plan and cross referenced to the actual summary audits reports.

Budget

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

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

Overall Impact

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

Scored Review Criteria

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

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

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?

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

Additional Review Criteria

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

A. Program Overview

Relevant Accomplishments (New Applications). How relevant are the group’s accomplishments in implementing cancer clinical trials in the group’s practice setting(s) to the goals and requirements for CCOP Groups?

B. Research Program

Does the existing CCOP Group (or new Group applicants) have in place an appropriate process for selecting clinical trials that fits their structure? Does the process include appropriate CCOP Group team members?

Are the recruitment/retention plans and outreach plans described likely to be effective?

How effective is the existing CCOP Group (or new Group applicants) in engaging the community served? How relevant are these activities to the goals and roles of CCOP Groups?

Are the affiliations of the CCOP Group with Research Base(s) appropriate and consistent with the rationale provided in the application?

C. Leadership

Has the PD/PI demonstrated effective leadership abilities in the community served by the CCOP Group and/or to the affiliated research bases of the Group? Have other Key/Senior personnel taken on leadership roles that contribute to the success of the CCOP Group and/or the research agenda of the affiliated research bases?

D. Administrative/Data Management

Operations. Are the management structure, standard operating procedures, and workflow processes for conducting clinical trials clear and adequate for the proposed project goals? Are the personnel and their duties appropriately matched?

Is the quality assurance plan/program for data management and investigational drug monitoring described with sufficient detail to assess it completeness? Does the plan/program appear to be robust enough to accomplish its objectives?

Do the audit report evaluations reflect that the CCOP Group (new or renewal) is in good standing overall or do they reflect problems that are of concern?

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.

Revisions are not allowed for this FOA.

Additional Review Considerations

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

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

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

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

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

2. A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator and CCOP Awardee Rights and Responsibilities

Throughout these Terms and Conditions of Award, “CCOP awardee” refers to the organizational structure which is composed of the key personnel (including the designated accruing physicians) and the institutions/organizations of the performance sites, including those designated as affiliates and CCOP components, all of whom agree to collaborate on research goals of the NCI Community Clinical Oncology Program.

The following three documents (and any subsequent modification to them) are hereby incorporated by reference as terms of award. These documents describe the programmatic responsibilities for the conduct of the research supported by this cooperative agreement. The documents are as follows:

Specific Responsibilities of the CCOP PD/PI

Appropriate Clinical Trials for Accrual Requirements

To receive credit for accruals the CCOP awardee must access NCI-approved treatment and prevention/control clinical trials through the CCOP Research Bases with which CCOP awardee has affiliation agreements. The CCOP awardee also may access treatment trials from Research Bases with which it is not affiliated through the NCI’s Cancer Trials Support Unit (CTSU). Accruals by CCOP awardees to CTSU protocols will receive credits (towards the required accrual quotas) and not per case reimbursement.

All clinical trials originating at the CCOP Research Bases must be reviewed and approved by the Protocol Review Committee of the Division of Cancer Prevention (DCP) or the Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation.

Research Base Affiliations

Each CCOP awardee must affiliate with one national multi-specialty cooperative group having a spectrum of cancer treatment and prevention/control clinical trials. As an exception, CCOP awardees may be granted permission to affiliate with more than one multi-specialty group, if the CCOP awardee participates in NCI-sponsored “pilot” projects. In addition, each CCOP awardee may affiliate with as many other Research Bases (exclusive of the multi-specialty groups) as the CCOP deems appropriate.

Typically, an established CCOP Group is expected to affiliate with approximately four to six CCOP Research Bases (in addition to its affiliation with multi-specialty cooperative group). Through these affiliations, the CCOP awardee must ensure an access to an adequate selection of clinical trials for its patient population and to meet/or exceed the minimum accrual requirements.

If participation of the CCOP awardee in the clinical trials of one CCOP Research Base competes with that of another CCOP Research Base with which the CCOP awardee is affiliated, the CCOP must prioritize the protocols to avoid bias in the allocation of participants/patients to competing protocols.

Note: A list of eligible Research Bases may be obtained from the CCOP Web pages at http://prevention.cancer.gov/programs-resources/programs/ccop/rbccop or by contacting the Community Oncology and Prevention Trials Research Group (COPTRG), DCP, NCI, at (301) 496-8541.

When circumstances require changes in Research Base affiliations, prior written approval from the DCP Program Director is required. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

Accrual Requirements

Each CCOP awardee must accrue a minimum of 50 participants/patients per year to cancer prevention/control clinical trials.

Each CCOP awardee must accrue a minimum of 50 participants/patients per year to treatment clinical trials. The minimum of 50 treatment participants/patients may be waived in case of:

Quality Control Guidelines

In accordance with CCOP Research Base guidelines and NCI policies, the CCOP awardee must establish and follow procedures for the assurance of data quality and for the prevention and/or identification of false or otherwise unreliable data. The CCOP awardee must follow policies developed by the CCOP Research Bases with which they are affiliated. Any data irregularities identified through quality control procedures or through the audit program that raise the suspicion of intentional misrepresentation of data must be reported to the NCI DCP Program Director within 24 hours. COPTRG must be notified by telephone (301-496-8541) of any findings suspicious or suggestive of intentional misrepresentation of data and/or disregard of regulatory safeguards for any of the three components (regulatory, pharmacy, and patient care) within an audit. It should be emphasized that a reasonable level of suspicion is sufficient to warrant notification to NCI of irregularity and/or misrepresentation.

Data Management

The CCOP awardee must provide the NCI DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data.

Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all CCOP investigators accruing participants/patients must have an active FDA Form 1572 on file with the Pharmaceutical Management Branch, Clinical Trials Evaluation Program (CTEP), DCTD, NCI.

Monitoring Activity Requirements

Each CCOP awardee must agree to periodic on-site audits by representatives of its CCOP Research Base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following:

The performance sites designated as affiliates and CCOP components and the individual accruing investigators participating or collaborating with the CCOP awardee must be in compliance with the monitoring standards established by the CCOP Research Base(s) and stated in the NCI GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) (http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm).

Sites found not to be in compliance with the NCI monitoring guidelines may be suspended from participating in Research Base trials until compliance can be confirmed by NCI/CTMB.

Specifically, the institutions/organizations representing performance sites must adhere to the following standards:

CCOP Radiotherapy Equipment

Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in clinical trials requiring radiation therapy, as required by the affiliated Research Base(s).

Organizational Changes in a CCOP

Certain organizational changes in the structure of a CCOP awardee must have the prior written approval of the DCP Program Director. These changes include the addition/deletion of a participating physician, a health professional other than a physician (who is active in enrolling participants/patients to cancer treatment, prevention and control trials), an affiliate, a component, or a Research Base affiliation. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

CCOP Network Participation

CCOPs are part of a national network for conducting cancer prevention/control and treatment clinical trials. As such, each CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community.

Logging Patients/Participants

Each CCOP awardee may be asked to maintain a new patient/participant log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the CCOP investigators.

Federally Mandated Requirements

Each CCOP awardee must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. Appropriate documentation must be available for review. At a minimum, these requirements include the following:

For other Federally mandated requirements see the following Federal citations:

Publications

Timely publication of major findings is encouraged. Publications or oral presentations of work conducted under this cooperative agreement require proper acknowledgment of NCI support. See the NIH Public Access Policy for specific requirements.

2. A.2. NIH Responsibilities

A National Cancer Institute (NCI) Division of Cancer Prevention (DCP) Program staff member(s) acting as a Project Scientist(s) or Project Coordinator(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators). The NCI Project Scientist(s)/Coordinator(s) will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI program director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

The main NCI responsibilities pertinent to CCOP awards include the following activities.

Review of Clinical Trials in CCOP Network

Monitoring, Investigational Drug and Data Management

Approval of CCOP Organizational Changes

The NCI Program staff members will review organizational change request and provide a written response. Organizational changes requiring NCI approval are outlined in “Guidelines for Approval of CCOP Organizational Changes,” available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

Program Review and Federally Mandated Requirements

2. A. 3. Collaborative Responsibilities

Execution of this program will require collaboration among the PD/PIs of the CCOP Groups and CCOP Research Bases, the DCP Project Scientists(s) and staff as well as NCI DCTD CTEP Program officials and staff, and/or its designees/contractors as described above.
 
2. A. 4. Dispute Resolution Process

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

3. Reporting

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.

Reporting by CCOP Group awardees

CCOP group awardees will report their cumulative accrual to NCI-approved clinical trials at 6 months, 9 months (included in the annual progress report), and 12 months for each budget period.

A suggested format for CCOP-specific information relative to the progress summary section of the PHS Form 2590 will be provided. The format is available at https://ccop.nci.nih.gov/.

Adverse Event Reporting Procedures

To be in compliance with FDA regulations, all recipients of NCI support for clinical trials, including Research Bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsor(s) according to NCI Guidelines. For treatment trials utilizing CTEP investigational agents, guidelines are listed at http://ctep.cancer.gov/reporting/adeers.html. For cancer prevention and control trials utilizing DCP investigational agents, guidelines are listed at http://prevention.cancer.gov/clinicaltrials/management/pio

The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol.

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:

Lori Minasian, MD
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 2017, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8541
FAX: (301) 496-8667
Email: minasilo@mail.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Sean Hine
Office of Grants Administration
National Cancer Institute, NIH
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-2182
FAX: (301) 496-8601
(email) hines@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/.

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

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

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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