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 Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)

Title: Clinical Trials in Organ Transplantation (CTOT) (U01)

Announcement Type
This is a reissue of RFA-AI-04-003.

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

Request For Applications (RFA) Number: RFA-AI-08-015

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release Date: June 12, 2008
Letters of Intent Receipt Date: September 22, 2008
Application Receipt Date: October 21, 2008 - (New Date November 7, 2008 per NOT-AI-09-003)
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/  
Expiration Date: October 22, 2008 - (New Expiration Date November 8, 2008 per NOT-AI-09-003)

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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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 National Institute of Allergy and Infectious Diseases (NIAID) invites new or renewal applications from groups of two (2) or more institutions to participate in a clinical studies program to improve the long-term outcome of recipients of thoracic and abdominal organ transplants. The Clinical Trials in Organ Transplantation (CTOT) program will support a cooperative, multi-institutional consortium for the conduct of interventional trials (Phase 1, 2, or 3) or observational clinical studies in organ transplantation. Each clinical study must include associated mechanistic studies that focus on immune-mediated pathologic processes in organ transplantation. The goals of this research will be to further our understanding of and ultimately reduce immune-mediated morbidity and mortality in thoracic and abdominal organ transplant receipts.

Background

The benefits of organ transplantation, as evidenced by prolonged survival and/or improved quality of life, have been clearly demonstrated for children and adults suffering from a wide range of congenital and acquired diseases. However, normal life expectancy and health-related quality of life are rarely, if ever, restored by organ transplantation. Although 1-year survival after organ transplantation has improved markedly over the last 15 years, the prevalence of morbidities such as systemic hypertension, diabetes mellitus, renal insufficiency, and malignancy remain high in transplant recipients as compared with the general population. In addition, it is clear that there are substantial health disparities in transplant outcomes. The barriers to short- and long-term success of organ transplantation are predominantly due to immunologic incompatibility between donor and recipient that leads to acute and chronic rejection, and complications of long-term pharmacologic immune suppression.

The CTOT was established in 2003 to conduct clinical research into the immune-mediated morbidity associated with organ transplantation.  Information about the current CTOT investigative sites and studies can be found at http://www.CTOTstudies.org. Currently, there are 36 clinical sites and 14 immunologic laboratories supported by and participating in the CTOT. Studies underway have enrolled almost 1000 subjects. Current observational studies focus on enhancing understanding of the mechanisms and markers of immunologic quiescence or activation in recipients of heart, liver, lung, and kidney transplant recipients by linking detailed blood, urine and tissue assays with scrupulously recorded clinical events. An interventional study of the treatment of kidney transplant recipients who develop anti-HLA antibodies after transplantation is also underway. The CTOT research laboratories perform a wide variety of tests on blood, urine and tissue samples from study subjects, including cellular assays, assays of antibodies and gene expression, genomic and proteomic studies, and histopathology. All CTOT investigators collaborate with respect to clinical data collection and the timing of and methods used for mechanistic assays, thus creating a powerful data resource for exploratory and confirmatory analyses. Specific questions being addressed include validation of noninvasive diagnosis of renal allograft rejection; identification of recipient biomarkers for the assessment of alloreactivity; and identification of donor biomarkers that predict recipient outcomes.

Research Objectives and Scope

The objective of this FOA is to support multi-center interventional clinical trials and/or observational studies in pediatric and adult candidates for and recipients of organ transplantation. Studies involving children will be carried out in collaboration with the NIAID-funded Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium (see below). All clinical trials and studies must include associated studies of immunologic mechanisms performed on samples from study subjects and, if appropriate, human controls. These mechanistic studies may include cellular assays (elispot, flow cytometry, etc), antibody assays, gene expression studies, genomic studies, or any other immunologic assays that will contribute to the scientific goals of the proposed studies.

Examples of clinical trials, observational studies and associated mechanistic studies include, but are not limited to, the following:

This FOA will NOT support research involving;

Applications proposing such studies will be considered non-responsive and will not be reviewed.

The CTOT consortium will work collaboratively with the Clinical Trials in Organ Transplantation in Children (CTOT-C) consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-07-006.html), a similar clinical studies program in pediatric organ transplantation. CTOT-C investigators will provide pediatric expertise and help to identify pediatric subjects for clinical trials.

Data Coordination and Management and Clinical Trial Support

Data coordination and management, and clinical trial support will be carried out by a separately funded data and clinical coordinating center, the Statistical and Clinical Coordinating Center (SACCC) (see http://www.CTOTstudies.org).  Each participating institution will be responsible for providing primary study data to the SACCC for management, quality control and analysis using procedures and standards determined by the CTOT Steering Committee (see below) and the SACCC. The quality and integrity of CTOT studies requires that all analyses are performed on data from the central database, and that these analyses are performed or have oversight by the SACCC. The SACCC will provide technical assistance and data management services to CTOT participating institutions with respect to quality control, uniformity of data collection, management of the collective database and data analysis; centralized data collection and management; and quality assurance.  The SACCC will develop a statistical analysis plan for each approved study protocol that will be reviewed and approved by the CTOT Steering Committee.  The SACCC will also provide clinical site monitoring, regulatory support, and drug and specimen distribution. More information about SACCC responsibilities can be found at http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-046.html  

CTOT Steering Committee

A Steering Committee will be established to direct the collaborative work of the CTOT consortium.  All major scientific and budgetary decisions will be made by the majority of the voting members of the Steering Committee. Other voting members will include the NIH Project Scientist and one representative from the SACCC supporting the CTOT consortium. CTOT Steering Committee responsibilities are described further under Section VI.2.A.3. below.

Mechanistic Studies Subcommittee

The CTOT Steering Committee shall appoint a Mechanistic Studies Subcommittee to review proposed mechanistic studies and make recommendations to the Steering Committee.  Each PD/PI shall select one representative from his/her consortium as a voting member of the Mechanistic Studies Subcommittee; additional non-voting members may be nominated and approved by the Steering Committee. The NIH Project Scientist will serve as a voting member. Responsibilities of the Mechanistic Studies Subcommittee are described further under Section VI.2.A.3. below.

Publications Subcommittee

The Steering Committee will establish a Publications Subcommittee to develop publication policies and procedures for the CTOT consortium.  See Section VI.2.A.3. below.

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 NIH cooperative agreement (U01) award mechanism.
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. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Plans for this cooperative agreement program beyond the current funding opportunity are indefinite.

2. Funds Available

The estimated amount of funds available for support of 3-4 projects awarded as a result of this announcement is $7 million for fiscal year 2009.  An applicant may request a project period of up to 5 years and a budget for direct costs up to $1.5 million per year.  Future year amounts will depend on annual appropriations.

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.

3. Other-Special Eligibility Criteria

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 in item (box) 2 only 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: September 22, 2008
Application Receipt Date: October 21, 2008
Peer Review Date: February, 2009
Council Review Date: May, 2009
Earliest Anticipated Start Date: July, 2009

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:

Kenneth E. Santora, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 3146, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2605
FAX: (301) 480-2408
E-Mail: ksantora@niaid.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:

Kenneth E. Santora, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 3146, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2605
FAX: (301) 480-2408
E-Mail: ksantora@niaid.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 reviewing Institute 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. 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 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Applications must contain the following sections, in order, with page limits where indicated: (1) Documentation of Commitment to the Collaborative Group [1 page]; (2) Research Plan [Items 2-5 - 35 pages]; (3) Scientific Agenda [2 pages]; (4) Applicant Group Qualifications, Organization and Administration [10 pages]; and (5) Collaboration with the CTOT-C [1 page]. Each section is described below:

1.  Documentation of Commitment to the CTOT Collaborative Group (1 Page)

The application must include a written commitment, signed by the PD/PI and the applicant institution, to participate in the CTOT consortium, including serving on the Steering Committee, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIAID staff in accordance with the guidelines described in Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award:  “Collaborative Responsibilities.”

2.  Research Plan (Items 2-5 - 35 Pages)

a.   Concept proposals for clinical studies

The application must include a detailed concept proposal for one or more interventional or observational clinical studies, each of which will have associated mechanistic studies that meet the objectives and scope of this FOA. Proposed studies must address questions with broad relevance in the field of transplantation. Applicants may propose either (1) a single study with a target population that includes recipients of different organs (e.g., kidney transplant recipients AND liver transplant recipients), or (2) two studies, each of which targets recipients of a single organ (e.g., a study of heart transplant recipients, and another study of pancreas transplant recipients). The applicant must explain how the results will have a broad impact on the field of transplantation, and must address any relevant health disparity issues. The proposed study or studies must not exceed the clinical and scientific resources of the applicant’s team of institutions (e.g., the applicant group must be able to recruit the required number of study subjects from within their own institutions) and must not exceed 5 years in duration.

Whether the applicant proposes one study or two, concept proposals, including the clinical studies and associated mechanistic studies, must be presented within a single Research Plan section not to exceed 35 pages in length for items 2-5. The concept proposal must be organized as specific aims, background and significance, preliminary studies, and research design and methods. The concept proposal must include the following information about the clinical study or studies:

The concept proposal should be presented in sufficient detail to allow reviewers to judge significance, approach, innovation and environment.  Submission of a detailed, final clinical protocol is neither required nor encouraged.

The CTOT Steering Committee (see Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award:  “Collaborative Responsibilities”) will be responsible for determining which clinical studies will be undertaken by the CTOT consortium. Study protocols implemented by the CTOT consortium may differ from the concept proposals proposed by the awardees in response to this FOA.

b. Associated mechanistic studies

Each concept proposal must include investigations performed on biological samples from the study participants that address, at the tissue, cellular, or molecular level, the immunologic mechanisms underlying the observed clinical events.

Descriptions of proposed mechanistic studies must include:

Mechanistic studies will be weighed equally with the interventional or observational clinical studies in the review of the application.  

3.  Scientific Agenda (2 Pages)

Applicants must briefly present their views of the important questions facing the field of transplantation and explain how their proposed research addresses these questions.  These responses will assist the Steering Committee in creating a scientific agenda for the CTOT consortium.

4.  Applicant Group Qualifications, Organization and Administration (10 pages)

a. The applicant team must contain two or more participating institutions. Member institutions may be clinical participants, in which case they must provide documentation of a United Network for Organ Sharing (UNOS) certified program in organ transplantation (foreign clinical sites must provide equivalent documentation as appropriate), or they may be mechanistic study participants, in which case they must have demonstrated expertise in the research techniques necessary for the proposed mechanistic studies and research agenda. 

b. The applicant institution and each clinical site participating in the applicant’s team must document clinical experience, capacity to recruit and retain study participants, and provide an estimate (backed by data) of the study participants available at their sites for each proposed study. The number of organ transplants performed (by organ) at each clinical site for the last five years must also be provided. 

c. The applicant must document availability of personnel and facilities capable of performing and supporting administrative functions for the overall management of the applicant group.

d. The application must name a single PD/PI who will have scientific responsibility for the application as a whole, including all team-related research activities. The PD/PI must be a physician with substantial experience in the field of organ transplantation and in the design, implementation, and evaluation of clinical trials as evidenced by clinical experience and publication in peer-reviewed journals.

e. Applications must name a single Senior Investigator for each collaborating institution. The Senior Investigator(s) will be responsible for on-site clinical and scientific implementation, direction and management of the clinical protocols, and the coordination of requirements for mechanistic studies.  A letter from each Senior Investigator, indicating a commitment to participate in the CTOT consortium, including adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIAID staff in accordance with the guidelines described in Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award:  “Collaborative Responsibilities” must be included with the application.

f. The applicant must provide a clear and concise plan in narrative and/or diagrammatic form that depicts the interrelationships among the members of the team, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this FOA.

g. The applicant must provide a plan to ensure the maintenance of close cooperation and effective communication among members of the applicant’s group and evidence of the capability of the applicant organization and each institution in an applicant group to participate and interact effectively in cooperative, multi-center clinical trials.

5. Collaboration with the CTOT-C (1 Page)

The applicant must describe how the CTOT consortium will establish a productive collaboration with the CTOT-C. Issues to address include, but are not limited to, the following: What are the opportunities for sharing and optimizing resources? How can collaboration enhance the power of studies conducted in one or both consortia? What research questions can be addressed more completely or effectively as a result of collaboration? Information about the CTOT-C is available at (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-07-006.html).

6.  Additional submission requirements for the preparation of the Detailed Budget:

Study Costs

All costs required for the concept proposals and mechanistic studies must be included in the application and must be fully justified.  These include the costs of the proposed clinical research, costs for patient recruitment and follow-up, mechanistic studies, data collection, and participation in on-site quality assurance audits.

The budget must include: support for a clinical study coordinator at each clinical site, with effort proportional to the anticipated volume of patient enrollment at that site; a minimum of 20% effort for the applicant PD/PI; and a minimum of 10% effort for the Senior Investigator at each participating institution.

Mandatory Meetings

Requested budgets must also include funds for:  (1) travel to the Bethesda, Maryland area for two Steering Committee meetings during the first 12 months, and annually thereafter, for the PD/PI and one Senior Investigator from each participating institution, and (2) travel to the Bethesda, Maryland area for two Mechanistic Studies Subcommittee meetings per year for two investigators.

Foreign Institutions

If a study requiring an application to a non-U.S. health authority is proposed, the application must include the costs associated with maintaining a legal entity in the foreign country, submission to the foreign health authority, and required insurance coverage for clinical trials in the study budget.

All foreign sites conducting interventional studies must provide a plan for independent clinical site monitoring, and must include the costs of monitoring in their budget(for guidelines on conducting clinical trials, see http://www.niaid.nih.gov/ncn/sop/ctmonitoring.htm, and also the ICH Guidelines for Good Clinical Practice at http://www.ich.org/cache/compo/276-254-1.html) .

Applications lacking the information described above, as determined by NIAID staff, will be designated as non-responsive to the FOA and will be withdrawn from further consideration without peer review. The applicant will be informed of this action. 

Research Plan Page Limitations

Items 2-5 may not exceed 35 pages

Appendix Materials

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

Do not use the Appendix to circumvent the page limitations of the Research Plan component. 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 must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

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

(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

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 NIAID 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 following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. 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 meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the research results have broad immunologic relevance in the field of organ transplantation? How do the proposed studies address the issues and questions raised in the applicants submitted Scientific Agenda?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are there adequate and feasible plans for managing the proposed studies and for recruitment and retention of study participants?  Does the applicant adequately address potential obstacles, limitations and problem-solving strategies with respect to these activities?

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

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the PD/PI and Senior Investigators have adequate expertise in and a documented history of contributions (peer-reviewed publications, service, and teaching) to the field of organ transplantation?  Do the PD/PI and Senior Investigators have prior experience with multi-center clinical trials?  Does the PD/PI present evidence of the leadership ability and skills that will be necessary to achieve multi-site adherence in a clinical trial research protocol? Is there a history of prior successful collaboration among the PD/PI and the Senior Investigators?  Do the mechanistic study investigators have expertise and prior experience with the conduct of mechanistic studies pertaining to the immunologic areas under study using human specimens?  Is the relationship among the applicant group members clearly defined?  Are there adequate plans for cooperation and effective communication among applicant group members.

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Do the clinical sites possess expertise in clinical organ transplantation as evidenced by clinical experience, transplant outcomes, and peer-reviewed scientific publications?  Do the clinical sites have a UNOS-approved transplant program (or equivalent, if a non-U.S. site)?  Is there any evidence of successful experience in recruitment and retention of research subjects in single- or multi-center clinical studies of organ transplantation?  Is the documentation of center volume adequate to contribute substantial numbers of subjects, with adequate racial and ethnic diversity, to the proposed studies?  What clinical and scientific resources does the site bring to the applicant team?

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 rating:

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 on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from 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 on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan 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. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 (designated in item 12 on the Application Face Page).

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 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 Rights and Responsibilities


The Principal Investigator will have the primary responsibility for: (1) providing scientific leadership and subject matter expertise; (2) determining and coordinating the scientific and administrative project activities; (3) setting project goals and timelines to achieve the proposed goals, (4) attending Steering Committee meetings, serving as a voting member of the Steering Committee, and accepting and implementing policies and procedures developed by the Steering Committee; (5) providing primary study data to the CTOT SACCC for management, quality control, and analysis; (6) submitting data to NIH-supported and/or public databases in accordance with policies agreed upon and established by the Steering Committee and the NIH data sharing policy available at: http://grants.nih.gov/grants/policy/data_sharing/ ; (7) participating in the cooperative nature of the CTOT and (8) maintaining a level of productivity that justifies continued funding.  It is recognized that goals may require revision and re-negotiation during the course of the project period.  Release of each funding increment by NIAID will be based on a review of progress towards achieving the previously agreed upon research goals. The PI must commit a minimum of 20% effort to this consortium.

Monitoring Clinical Studies

NIAID policy requires that clinical studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study.  An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.  The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf

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 will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist, with assistance from other NIH program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance by: participating in the design of the research activities; advising in the selection of sources or resources; coordinating or participating in the collection and/or analysis of data; advising in management and technical performance; or participating in the preparation of publications.  However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and that the NIAID staff participate in this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator and the CTOT Steering Committee.

The NIH Project Scientist will serve as a voting member of the Steering Committee and the Mechanistic Studies Subcommittee, schedule the first meeting of the Steering Committee, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies. 

Collaborations with industry will require the assistance of the NIAID Division of Allergy, Immunology and Transplantation (DAIT) Clinical Research Program, and be conducted under a NIAID Clinical Trials Agreement.

The NIAID reserves the right to terminate or curtail a study or any individual award in the event of: (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol; (b) substantive changes in the consensus protocol to which the NIAID does not agree; (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance; or (d) human subjects ethical or safety issues that may dictate a premature termination.

The Chief of the DAIT Office of Regulatory Affairs or designee will be responsible for providing guidance and assistance in the development, assembly and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, devices or products, to the Food and Drug Administration or other Health Authorities. NIAID will act as the IND sponsor for multi-center studies carried out by the CTOT consortium, or will be responsible for delegating the sponsor responsibility to another qualified party (i.e. a pharmaceutical industry sponsor) subject to the Principal Investigator’s approval.

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. The program official will monitor program progress, and must approve changes involving key personnel, addition or deletion of clinical sites or mechanistic laboratories, and protocol changes that have resulted in a substantive change in scope, goals, or human subjects risk as compared with a previously approved protocol. The NIAID program official will have access to data generated under these awards and may use information obtained from the data for the preparation of internal reports on the activities of the group.

All protocols developed in the CTOT consortium will be reviewed by NIAID program staff and the NIAID Transplant Data Safety Monitoring Board.

2.A.3. Collaborative Responsibilities

Steering Committee

The Steering Committee is the governing body of the CTOT. All participants in the CTOT consortium are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote.

Membership of the Steering Committee will include, at a minimum: the CTOT PIs; the SACCC PI; one additional Senior Investigator from each awardee group, selected by the PI; and the NIH Project Scientist.  Each member will have one vote. Additional members may be added by majority vote of the Steering Committee. Steering Committee decisions are binding upon CTOT consortium participants. The first Steering Committee meeting will be scheduled by the NIH Project Scientist. A Steering Committee Chair will be elected by majority vote from among the CTOT PIs at the first Steering Committee meeting. The Steering Committee may choose to rotate the position of Steering Committee Chair among the CTOT PIs. The Steering Committee Chair will be responsible for scheduling and developing the agenda for subsequent Steering Committee meetings and for promoting collaborative productive research among the members of the CTOT consortium.

Steering Committee responsibilities will include: development of a scientific agenda for the CTOT consortium; approval of study protocols prior to their implementation (study protocols implemented by the consortium may differ from the clinical studies proposed by the awardees in response to this FOA); and development of policies and procedures governing the activities of the CTOT consortium, including but not limited to ongoing evaluation of site performance, presentation and publication of study findings, evaluation of new proposed studies, addition of new clinical sites, and management of conflicts of interest. The Steering Committee will meet at least twice in the first year and annually thereafter in Bethesda, MD.

Mechanistic Studies Subcommittee

The Steering Committee shall appoint a Mechanistic Studies Subcommittee to review proposed mechanistic studies and make recommendations to the Steering Committee.  Each Principal Investigator shall select one representative from his/her group as a voting member of the Mechanistic Studies Subcommittee; additional non-voting members may be nominated and approved by the Steering Committee. The NIH Project Scientist will serve as voting member.  The Mechanistic Studies Subcommittee may appoint ad hoc subcommittee members if additional expertise in specific areas is needed. The Mechanistic Studies Subcommittee shall elect a Chair from among non-Federal members.  The Mechanistic Studies Subcommittee will meet at least twice yearly and its members will be expected to participate in all meetings, conference calls and other subcommittee activities.

Publications Subcommittee

The Steering Committee will establish a Publications Subcommittee to develop publication policies and procedures for the CTOT consortium.

Data Coordination and Management, and Clinical Trial Support

Data coordination and management, and clinical trial support will be carried out by a separately funded data and clinical coordinating center, the Statistical and Clinical Coordinating Center (SACCC). Each participating institution will be responsible for providing primary study data to the SACCC for management, quality control and analysis using procedures and standards determined by the Steering Committee and the SACCC. The quality and integrity of CTOT studies requires that all analyses are performed on data from the central database, and that these analyses are performed or have oversight by the SACCC. The SACCC will provide technical assistance and data management services to the participating institutions with respect to quality control, uniformity of data collection, management of the collective database and data analysis; centralized data collection and management; and quality assurance. The SACCC will develop a statistical analysis plan for each approved study protocol that will be reviewed and approved by the Steering Committee.  In the event of a specific safety concern, the NIAID Transplant Data Safety Monitoring Board may also request specific analyses from the SACCC.  All participating sites will have access to all data originating from their sites. The awardees will retain custody of and have primary rights to their data developed under these awards subject to government rights of access consistent with HHS, PHS and NIH policies. The participating institutions will be closely involved with these centralized data collection and management services, and are responsible for on-site data collection and transmittal. The performance of participating institutions with respect to data submission, data quality, and protocol compliance will be monitored by the SACCC using criteria developed by the Steering Committee; these data will be provided to the PIs and evaluated by the Steering Committee at regular intervals.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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:

Nancy D. Bridges, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Disease
Room 3035, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-4406
FAX: (301)480-0693
Email: nbridges@niaid.nih.gov  

2. Peer Review Contacts:

Kenneth E. Santora, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 3146, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 451-2605
FAX: (301) 480-2408
E-Mail: ksantora@niaid.nih.gov

3. Financial or Grants Management Contacts:

Mildred J. Qualls
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2125, MSC 7614
Bethesda, MD 20892-7614
Telephone: (301) 402-6611
FAX: (301) 493-0597
Email: mq20b@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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy 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 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 two years to the research. For further information, please see: http://www.lrp.nih.gov.


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