Part I Overview Information


Department of Health and Human Services

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

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

Title: Advanced Technology Radiation Therapy Clinical Trials Support (ATC) (Limited Competition U24)

Announcement Type
This limited competition RFA is a reissue of RFA-CA-02-505, released in October of 2001

Request For Applications (RFA) Number: RFA-CA-07-503

Catalog of Federal Domestic Assistance Number(s)
93.395

Key Dates

Release Date:  October 16, 2006
Letters of Intent Receipt Date(s): Not Applicable.
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 1, 2007
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: December 1, 2006

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The overall purpose of this Funding Opportunity Announcement (FOA) is to facilitate and support clinical trials that employ advanced technology radiotherapy methods, particularly those requiring digital data submission. To further this goal, the National Cancer Institute (NCI) intends to continue funding for the “Advanced Technology Radiation Therapy Clinical Trials Support (ATC)” consortium, which was created as a result of RFA-CA-98-006 and continued under RFA-CA-02-505.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration 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 this Funding Opportunity Announcement (FOA) is to continue support for the NCI’s Advanced Technology Radiation Therapy Clinical Trials Support (ATC) initiative. The use of direct image-based radiation therapy treatment planning and delivery continues to grow substantially. The remarkable growth in computer processing power and concomitant decrease in cost for computation-intensive technological solutions has made direct image based radiation treatment practical. This ability has led to a progression of new complex conformal radiation delivery techniques (CCRT): from three-dimensional conformal radiation therapy (3D-CRT) to intensity-modulated radiation therapy (IMRT) to image-guided radiation therapy (IGRT) and stereo-tactic body radiotherapy (SBRT). In addition, interstitial and intracavitary treatment approaches have been developed, such as high dose-rate brachytherapy (HDR), that are also driven by image guidance and computer-aided planning and radiation delivery.  The planning and delivery of radiation with conformal techniques is not as straightforward as with conventional two-dimensional techniques. Rather, more precise definition of tumor and normal tissue is necessary, as is the need to evaluate many aspects of the treatment plan in all three spatial dimensions as well as over the time-course of the treatment, which adds a fourth dimension.

These techniques make substantial use of multi-functional imaging, such as Computerized Tomography (CT) and Positron Emission Tomography (PET), in the planning and treatment process. Also inherent to these methods is the need for technologically advanced precise patient positioning and immobilization.  All of these new processes require increased multi-institutional credentialing and result in very large data-sets that must be archived and available for rapid reviewing through remote access.

Although technologically and logistically challenging, the new CCRT-based approaches allow the radiation oncologist to more precisely deliver the desired radiation dose to the tumor, while minimizing the exposure of normal tissues. It is hypothesized that these approaches have the potential to considerably raise the levels of tumor control probability (TCP) while keeping normal tissue complication probabilities (NTCP) within acceptable ranges. Further development and implementation of the CCRT-based radiotherapeutic methods in the clinic are thus of high priority to the mission of the NCI. Accordingly, the ATC program has been designed to provide the necessary resources to facilitate and support clinical trials that employ advanced technology radiotherapy methods, particularly those involving massive digital data, and to facilitate assuring and assessing the effectiveness of these approaches in clinical settings.

Background

One of the main programmatic goals for the Radiation Research Program (RRP) of the Division of Cancer Treatment and Diagnosis (DCTD), NCI, is to insure meaningful outcomes of clinical trials with the technically demanding conformal radiotherapeutic approaches. Therefore, in 1998, the NCI initiated a program designed to generate a resource that would use state-of-the-art methods to develop quality assurance criteria for NCI-sponsored advanced technology radiation therapy clinical trials and to implement those criteria for selected clinical  protocols when applicable, including credentialing of participating institutions and treatment plan review. It was also expected that the resource would develop and maintain a database of treatment parameters for correlating with clinical outcomes. In response to the RFA (CA-98-006), two grants were funded, which created the ATC as a consortium of subcontracts for development efforts and protocol support and integration efforts.

After the initial 3-year funding period, the original two awardees successfully re-competed for the continuation of this initiative under a Limited Competition (Letter) RFA-CA-02-505. However, the NCI and its scientific advisors felt at that time that the main thrust of ATC program should emphasize more the need for integration of existing technologies into the quality assurance (QA) infrastructure (activities conducted largely under CA-U24081647) and de-emphasize software developmental work. Accordingly, most of the software integration effort was funded by means of a subcontract under the ATC CA-U24081647, while the second U24 component of the ATC (CA-U24081636) was reduced to a relatively small infrastructure developmental project.

Consolidation, coordination and service infrastructure continues to be the priority of the ATC Program. It is intended that only one award will be made to continue integrating these service and developmental efforts into the various clinical trials through the ATC. Since the conformal radiotherapeutic technologies are still not fully assimilated into routine clinical use, many issues pertinent to quality assurance, data transfer and database remain to be addressed. Several NCI-sponsored clinical trials groups are in the process of activating clinical trials that will utilize advanced radiotherapeutic technologies that require the on-going support and participation of the ATC program. Specifically there is continuing need for:

Objectives

The goals of the ATC Program will be accomplished through the following coordination, service, and developmental efforts.

Objective1. Eliminate duplication of infrastructure developmental efforts and facilitate sharing of QA resources among cooperative groups.

Objective 2. Help to insure that appropriate and uniform QA procedures and criteria for advanced technology trials are developed across all cooperative groups.

Objective 3. Facilitate and help manage the uniform credentialing of institutions for advanced radiotherapy trial protocols.

Objective 4. Facilitate and manage digital data protocol submission.

Objective 5. Facilitate and manage the QA review of submitted data.

Objective 6. Further the development of methods for rapid analysis of volumetric treatment planning data. 

Ojective 7. Assist clinical trial cooperative groups in the development of clinical trials protocols including:

(a)     Credentialing requirements;

(b)     Target volume definitions;

(c)     Quality assurance procedures; and

(d)     Data submission instructions.

Objective 8. Develop, implement and maintain innovative methods for electronic exchange of digital planning data between institutions participating in clinical trialsand between QA Centers.

Objective 9. Develop, implement and maintain innovative web-based software tools to facilitate protocol digital data reviews by Study Chairs, Dosimetry Groups, the Radiological Physics Center (RPC), and the Quality Assurance Review Center (QARC).

Objective 10.  Develop, implement and maintain archival treatment planning and  QA databases that can be linked with the cooperative groups’ clinical outcomes databases.

Objective 11. Demonstrate understanding of and ability to achive compatibality with existing software and electronic health record standards, including the Cancer Bioinformatics Grid (caBIG) and DICOM RT.

In the realization of these objectives, the ATC will be advised by a Steering Committee (SC) described in detail in Section VI.2.A.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the NIH U24 award mechanism.  The NIH U24 is a cooperative agreement award mechanism.  In the cooperative agreement mechanism, the Principal Investigator (PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NCI staff being substantially involved as a partner with the PI, as described under the Section VI.  2.  Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."

After consideration of the continuing need and the advice of the evaluation committee (EC), the NCI may reissue this announcement at the conclusion of the current award period.

This funding opportunity uses just-in-time budget concepts.  It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The NCI intends to commit approximately $ 8.75 M (total cost) in FY 2007-2012 to fund one competing continuation grant in response to this RFA.  An applicant may request a project period of up to 5 years and a budget for total costs up to $1.75 M dollars per year award. Although the budget plans of the NCI anticipate support for this ATC program, awards pursuant to this funding opportunity are contingent upon availability of funds and receipt of a meritorious application.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Eligible institutions will be restricted to current ATC awardees due to the necessity to preserve and extend the existing infrastructure.The initial 8-year award period has seen the development of an infrastructure which could not be transferred to a different awardee without significant loss of resources and interruption of support for existing and proposed clinical trials protocols. These resources include hardware, software, staff and processes.While the NCI recognizes and endorses the need for full and open competition and, by preference, utilizes open competition for most initiatives, this instance is an exception. It is clear to the Institute that the transfer of the high technology quality assurance program to a new awardee would hamper the ongoing efforts of several of the clinical trials groups as they attempt to utilize more aggressive, high-technology radiation methods in single and combined modality trials.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Not applicable.

3. Other-Special Eligibility Criteria

Each investigator and institution may submit only one application for this funding opportunity.

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

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

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(s): Not Applicable.

Application Receipt Date(s): November 30, 2006
Peer Review Date(s): February/March 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 1, 2007

3.A.1. Letter of Intent

Not Applicable.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications 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 delivery; 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 the appendix materials in pdf format must be sent to:

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

Fax:  ( 301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

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

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NCI. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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 http://grants.nih.gov/grants/policy/policy.htm.

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

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

6. Other Submission Requirements

Content and order of information to be provided in applications (presented within page limits indicated)) is described below. Failure to comply with these instructions will result in return of the application without review.

For the application submitted in response to this RFA, the standard PHS398 Research Plan (Sections A-D) is altered as follows:

The following new sections must be included:

Section 1. PROGRESS REPORT.  The application must include a progress report, which at a minimum addresses the following elements:

Section 2. TEAM QUALIFICATIONS. The applicant should describe the current and proposed structure of the team that will comprise the ATC consortium, including at least the following:

Section 3. FACILITIES AND INFRASTRUCTURE. The applicant must provide at a minimum:

Section 4. APPROACH. The applicant must describe the structure, methods, proposed facilities, equipment and personnel that will be used to advance the goals of the ATC to:

SECTION 5. COMPATIBILITY. The applicant must describe plans to harmonize the ATC activities with the Clinical Trials Working Group (CTWG) coordination initiative to “Create a comprehensive database containing information on all NCI-funded clinical trials to facilitate better planning and management across clinical trial venues” (http://www.cancer.gov/dctd/recommendationsaccepted.htm).  This plan must include the following elements:

SECTION 6. EVALUATION MILESTONES. The applicant must acknowledge in this section that if the ATC award is made, an independent Evaluation Committee (EC) will be formed to conduct at least two reviews of the effectiveness of the funding initiative described in this RFA during the projected 5-year award period. This panel will be selected from experts in the field who are knowledgeable about the needs of the clinical trials cooperative groups and the scientific infrastructure of the ATC. EC will form a separate body from the Steering Committee (SC, described in Section VI.2.A. Cooperative Agreement Terms and Conditions of Award).  As a part of this anticipated evaluation process, the applicant must propose appropriate metrics/milestones to address each of the following issues.

Budget Note: The application budget must not include funds for the participation of the PI and/or designated scientists in the meetings of Steering Committee. These activities will be directly funded by the NCI.

Plan for Sharing Research Data

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

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

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

Sharing Research Resources

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

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

Section V. Application Review Information


1. Criteria

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

ATC applications will be reviewed using criteria in Section 2 (Review and Selection Process) below.

The following will be considered in making funding decisions:

2. Review and Selection Process

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

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the Consortium will be able to meet its responsibilities described in Section VI.2.A.1 and will be successful in meeting the goals of the ATC Program through the coordination, service, and developmental efforts as defined in Section 1.1 and specified in Section IV.6... Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Progress:

Investigators/Team Qualifications:

Facilities and Infrastructure:

Approach:

Compatibility:

Evaluation Milestones:

2.A. Additional Review Criteria

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

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

3. Anticipated Announcement and Award Dates

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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.

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 (U24), 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

Throughout these Terms and Conditions of Award, “Consortium” refers to the organizational structure which is composed of the Consortium PI, other key personnel, and participating organizations, all of whom agree to collaborate on research goals of the ATC program.

The Principal Investigator (PI) will have the primary responsibility for all ATC activities including the planning, organization, administration, allocation of responsibilities to subcontractors, and the development of resources and relationships.

Other specific responsibilities of the PI include the following:

  1. The PI, working with the NCI Project Scientist, will form the Steering Committee (SC) and will participate in its activities (as described in Section 2.A.3. Collaborative Responsibilities).
  2. The PI will oversee Consortium key personnel from each of the sub-contractors to ensure that the planning, organization and administration of activities and personnel within the individual subcontracted entity is well aligned with the overall goals and priorities of the ATC.
  3. The PI, working with the Consortium key personnel, will be responsible for anticipating the quality-assurance data-analysis needs of radiotherapy clinical trials as they employ advanced technologies and providing for these needs in an efficient and timely manner. This responsibility will include the development and implementation of the hardware, software and personnel that are needed to archive and remotely review the clinical trial data.
  4. Where appropriate, the PI will establish collaborations with existing private or public organizations and work toward seamless integration of efforts rather than competition or redundancy of efforts.
  5. The PI will be responsible for organizing meetings of the ATC members in a timely manner and with a frequency adequate for accomplishing the goals of the ATC. These meeting will be coordinated with the NCI Project Scientist to allow for review and approval of all major programmatic initiatives by the NCI prior to their implementation.
  6. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities
 
An NIH Project Scientist (PS) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH PS and other NCI staff members will engage in frequent and regular communication with the ATC and other interacting entities, such as cooperative groups, researchers, and vendors to ensure proper coordination of research efforts, to facilitate collaborations, to consult with intra-ATC and external experts, and to provide oversight of the entire program.

Specific responsibilities of the NCI Project Scientist related to the research efforts of ATC include the following:

1.       Serving on the Steering Committee (SC) (as described in Section 2.A.3. Collaborative Responsibilities);

2.       Substantial involvement in coordinating the activities of the awardee with the non-ATC researchers and other NCI-sponsored research networks, as necessary;

3.       Participation in the SC and any subcommittee meetings that may be called;

4.       Serving as a resource with respect to other ongoing NCI/NIH activities that may be relevant to this effort and providing expert advice to the awardee on specific scientific and/or analytic issues;

5.       Assisting, with the agreement of the PI, in the design, development, and coordination of the ATC studies;

6.       Forming the Evaluation Committee (EC) consisting of members who are expert in bio-informatics and digital data transfer technology as well as knowledgeable about the needs of the clinical trials groups and the scientific infrastructure of the ATC; and

7.       Empanelling the EC at least twice during the projected 5 year period of the award to gather an appraisal of the productivity and usefulness of the ATC efforts relative to the goals of the RFA.


Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities


The PI will work with the NCI Project Scientist to form the Steering Committee (SC), which will be the main advisory body to the ATC.

SC will be composed of no more than 10 voting members consisting of representatives from at least five clinical trials groups as well as representatives from scientific societies that have a demonstrable interest in radiotherapy clinical trials. Both the PI and PS will also be members of the SC. SC will meet at least annually and will give a written report to the NCI PS summarizing the progress made during the past year as well as the areas that the SC feels that need further attention. A summary of this report will be shared with the PI and subcontractors for their review and written reply.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee and the Institute.

2.A.4. Arbitration Process
 
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration 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 arbitration procedure in no way affects 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 PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

James A. Deye, Ph.D.
Clinical Radiation Oncology Branch
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN Room 6018, MSC 7440
Bethesda, MD 20892-7440 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-6111

Fax: (301) 480 5785
Email: deyej@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 express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone:  (301) 496-3428

Fax:  ( 301) 402-0275
Email:  ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contacts:

Eileen M. Natoli

Office of Grants Administration
National Cancer Institute
6120 Executive Boulevard, EPS, Room 243, MSC 7150.
Bethesda, MD 20892 (for U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier delivery; non-USPS service)
Telephone: (301) 496-8791
Fax: (301) 496-8601
Email: natolie@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State, and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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.

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

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

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

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

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

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

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

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

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

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 2 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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