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 Institutes on Aging (NIA) (http://www.nia.nih.gov)

Title: Consortium for Clinical Trials on Anemia in Older Persons (U01)

Announcement Type
New

Request for Applications (RFA) Number: RFA-AG-09-003

Catalog of Federal Domestic Assistance Number
93.866

Key Dates  
Release Date: April 25, 2008
Letters of Intent Receipt Date: October 7, 2008
Application Receipt Date: November 7, 2008
Peer Review Date(s): February / March 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: November 8, 2008

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

Background

Anemia is a common clinical finding among the elderly, and its prevalence increases with age. About 11% of men and 10% of women ages 65 years and older and about 20% of those older than 85 years were found to have anemia in the NHANES-III survey. Causes of anemia in the elderly are divided into three broad groups: nutritional deficiency/blood loss (34% of all cases), anemia of chronic disease (32% of all cases), and unexplained anemia (34% of all cases).

Adverse physiologic consequences of anemia/low normal hemoglobin levels in the elderly include, but are not limited to decreased oxygen-carrying capacity and resulting compensatory cardiac and vascular effects and the possibility for deleterious organ function resulting from tissue hypoxia. Anemia and “low normal” levels of hemoglobin in the elderly are associated with substantial increases in risk for a variety of adverse clinical outcomes in older persons, including fall-related fractures, cognitive impairment, hospitalizations, and mortality. However, these associations do not prove a causal relationship.

In view of the potential adverse effects of anemia and low hemoglobin levels in older persons implied by epidemiologic data, and the availability of a variety of potentially efficacious treatments for differing types of anemia, there is reason to believe that clinical trials of the clinical and functional effects of treating different types of anemia or low hemoglobin could identify interventions with substantial public health benefits. In addition, since the efficacy of existing and newly developed treatments in raising hemoglobin levels is not clear for some types of anemia in older persons, there is also value in clinical trials to evaluate the hematologic effects of these interventions in specific populations of older persons.

The need for clinical trials in anemia in the elderly is further emphasized by the results of a recent meta-analysis of nine randomized controlled trials in 5,143 anemic chronic kidney disease patients aged 50 to 65 years [Phrommintikul A, Haas SJ, Elsik M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. Lancet 2007; 369: 381–88.] In these trials, participants were treated with recombinant human erythropoietin for 12 to 48 months to raise hemoglobin concentrations to normal levels as defined by the WHO criteria. Compared to those with hemoglobin levels maintained in the low-normal/mild anemia range (10.4 to 11.7 g/dl), there was a 17% increase in all-cause mortality in patients whose hemoglobin concentrations were raised to normal levels (12.0 to 16.0 g/dl), which is the range associated with lowest mortality in epidemiologic studies of older persons.

The implications of these findings in younger kidney disease patients regarding efficacy and safety of raising hemoglobin levels in the anemic elderly (most of whom do not have kidney disease) are unknown. In addition, it is unknown whether the increase in mortality seen in the younger chronic kidney disease patients is due to the increase in hemoglobin level or to some aspect of anemia therapy itself, the amount of erythropoiesis-stimulating agents (ESA) used and/or iron treatment that may play a causative role in increased mortality risk. The latter issue could be addressed by assessing the benefit-to-risk profiles of other available and emerging treatments for anemia in older persons. Thus, current evidence suggests that there could be substantial benefits, and/or serious risks, resulting from treating anemia or low normal hemoglobin levels in older patients. Currently, decision by practitioners on whether or not older patients with anemia or low normal hemoglobin should be treated must be made without  convincing evidence about the benefits and risks that only clinical trials can provide, thus leaving it highly uncertain whether treatment (or failure to treat) does substantial good or substantial harm.

An Advisory Panel convened by NIA reviewed issues regarding the need for clinical trials in regard to a variety of types of anemia in older persons, outcomes, populations, and interventions. The panel recommended that trials be conducted on safety and efficacy of interventions for unexplained anemia in the elderly, particularly a trial in moderately frail community-dwelling persons over age 70 with mild to moderate anemia, that measures of function should be principal outcomes, and that intervention effects be measured for up to one year. Secondary outcomes could include quality of life, mortality, hospitalizations and nursing home admissions, and other. The panel indicated that several potential agents might be suitable for trials including epoietin alpha, darbepoietin, hematide, and others. After reviewing recent results from clinical trials in patients with chronic kidney disease treated with ESA, the panel confirmed the need for clinical trials on anemia in the elderly and suggested that trials could set a relatively safe upper limit for target hemoglobin levels.

Noting that the implementation of a shared outcome measures and methods is of paramount importance, the panel recommended that such trials be conducted by a consortium, which would allow research algorithms to be developed and data generated in an organized, cohesive, efficient, logical and productive manner. Each member of the consortium would participate in intergroup studies and conduct coordinated trials within the scope of the consortium. An interdisciplinary team with expertise in hematology, geriatrics, clinical trials, biostatistics, functional assessment and other fields would be the best suited to accomplish these tasks.

Objectives and Scope

This FOA seeks applications for a clinical trials consortium to design and implement several phase II clinical trials on anemia in older persons consistent with the recommendations of the NIA Advisory Panel. The consortium should include at least three clinical sites, a coordinating center (CC), and other structural components (e.g., central laboratory).  During the project period, awardees can also develop and implement pilot translational and exploratory studies and perform additional analyses of data from existing databases informing designs of the future trials. NIA will issue one six year award (a Cooperative Agreement) in response to this FOA.

Applicants should propose a research plan that includes a protocol for a randomized, placebo-controlled, masked phase II intervention study that will be the first trial implemented in the consortium environment. The protocol should demonstrate knowledge of current issues in the treatment of anemia. Applicants must propose the relevant outcome(s), and number and type of participants required for proposed study based on recommendations of the NIA Advisory Panel. Applicants must provide evidence of their ability to recruit and retain adequate numbers of the elderly with anemia for clinical trials to be conducted by the consortium.  Applicants are expected to describe the nature of the available participant population including race/ethnicity and the type of anemia in their geographic area and to describe strategies that would be used to recruit these participants for the proposed trials.

First year of the award will provide funds to finalize consortium operations and refine protocol, recruitment and screening strategies, data collection forms, and manual of procedures for the first trial. The awardee should develop processes and procedures for planning and protocol development for clinical trials that will be conducted by the consortium after initiating the first trial.  The awardee may also conduct pilot studies e.g., to test recruitment strategies or validate screening and/or outcome measurement instruments for the proposed trial. In addition to the above activities for the proposed trial, the awardee should also develop plans for organizational mechanisms that Consortium would use for evaluating and conducting possible small translational exploratory studies informing designs of the future possible trials.

It is not the intent of the consortium to provide support for one or two large protocols that run for six years. It is expected that several clinical trials will be conducted over the six year project period, and that studies with different protocols will run concurrently at a given clinical site. The topics of these protocols will be decided and prioritized cooperatively by the Consortium Steering Committee (SC) and implemented after review and approval by the Data and Safety Monitoring Board and NIA.

Applicants are encouraged to include personnel with expertise in the wide range of scientific areas pertinent to this research including hematology, geriatrics, biostatistics, clinical trials design and implementation, data management, central laboratory procedures, psychology, functional assessment methodology, and others.

Project Organization

Consortium will be funded as a cooperative agreement consisting of a coordinating center, at least 3 clinical sites, and the NIA. Applicants should propose other structural components (e.g., central laboratory) for the consortium. 

I. NIA

The NIA will assist the Coordinating Center in coordinating the organization of the consortium and NIA’s Project Scientist will have significant scientific involvement with the awardee.  The NIA Program Official will have administrative duties, monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NIH and NIA policies. Applicants are encouraged to nominate Consortium Chair in their application. The NIH and Consortium Chair will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of consortium activities and operations.

II. Coordinating Center (CC):

The CC will coordinate, administer, and support all clinical research activities of the Consortium. It will provide administrative support for the DSMB, Consortium Chair, scientific leadership and committees, organization of investigator meetings, and will acquire and distribute medications to the sites. The CC will participate in protocol development, provide statistical expertise, and prepare operational timetables. The CC will develop a data collection system and manuals of operations, randomization schemes, perform sample size calculations and data analyses.

The CC will develop quality control procedures, oversee data collection and manage the studies.  It will monitor the quality and quantity of data received from clinical sites, provide relevant reports to the NIA, Consortium Chair, sites, and SC, and serve as a central repository for study data. The CC will be responsible for sites monitoring, staff training, study management, and at a minimum will visit each site at least three times in the course of the study period. The CC will prepare protocols and reports for submission to the DSMB, Institutional Review Boards, and government agencies as required. The CC will support manuscript preparation through data analysis, statistical consultation, editorial support, and meeting coordination.

III. Clinical Sites:

Clinical sites will propose and participate in the development and implementation of common protocols, recruit participants, monitor participant safety, collect and transfer study data to the CC and disseminate research findings. All individual sites are expected to participate in a cooperative and interactive manner with one another and with the CC in all aspects of the consortium. 

IV. Steering Committee:

The Steering Committee (SC) will be the main governing body of the consortium. Voting members of the SC will include the Consortium Chair, the principal investigators (PIs) of clinical sites and CC, and the NIA Project Scientist. The Consortium Chair will plan consortium activities, oversee its functions, conduct SC meetings, and cast a tie-breaking vote. The SC will develop and ensure compliance with consortium policies and procedures, and develop common study protocols for submission to the DSMB and NIA for approval. The SC will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner. The SC may meet in-person as often as three to four times in the first 12 months of the study, and two to three times per year thereafter. All major scientific decisions will be determined by majority vote of the SC.

V. Data and Safety Monitoring Board:

NIA will establish a Data and Safety Monitoring board (DSMB) in accordance with NIH policies to ensure data quality and participant safety and to provide independent advice to the NIA regarding progress and the appropriateness of continuing each study.  The DSMB members will be selected by NIA, and the Board will be advisory to the Director, NIA.   

All study protocols developed by the consortium must be recommended by the DSMB and approved by the NIA before initiation. The recommendation of the DSMB will be based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the consortium and consistency with NIA missions and policies. The DSMB will provide a written report of each proposal and a final recommendation to the NIA. APPLICANTS SHOULD NOT NOMINATE PROSPECTIVE DSMB MEMBERS IN THEIR APPLICATIONS.

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

Section II. Award Information


Mechanism of Support

This funding opportunity will use the National Institutes of Health (NIH) U01, 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".

This FOA is a one-time solicitation.  At this time, it is not known if this FOA will be reissued. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2009.

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

2. Funds Available
 
The estimated amount of funds available is $800,000 total costs (direct plus indirect) for fiscal year 2009 and approximately $3,000,000 per year in total costs in fiscal years 2010 through 2014 to fund one six-year award submitted in response to this FOA. Future year amounts will depend on annual appropriations.

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

Applicants are not permitted to submit a resubmission application in response to this FOA. 

Renewal applications are not permitted in response to this FOA

Applicants may not submit more than one application

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.

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: October 7, 2008
Application Receipt Date: November 7, 2008
Peer Review Date(s): February/March 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.

A copy of the letter of intent should be sent to:

Judy Hannah, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 3C307
Bethesda, MD 20892, (Courier/Express Mail ZIP 20814)
Telephone: (301) 435-0044
FAX: (301) 402-1784
Email: hannahj@nia.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:

Ramesh Vemuri, Ph.D.
Chief Scientific Review Office
National Institute on Aging 
7201 Wisconsin Avenue, Suite 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
Email: vemuri@nia.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 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 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.)

For the first trial, recruitment for this award will be restricted until an NIA-approved DSMB has met and approved the study’s IRB-approved protocol and consent from. Before the start of recruitment, the PI will provide to the NIA Program Official a timeline of projected participant accrual, randomization, retention, and completion of intervention. Beginning three months after the start of recruitment, the PI will also, on a quarterly basis, provide updates of this timeline, indicating actual participant accrual, randomization, retention, and completion of intervention, in relationship to projected numbers.

6. Other Submission Requirements and Information

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

Supplementary Instructions

1.  Each application for the consortium should propose at least three clinical sites, a coordinating center (CC), and other structural components (e.g., central laboratory, reading centers, etc.).  Applications proposing select structural components of the Consortium (e.g., coordinating center without clinical sites and / or other structural components) will be considered unresponsive to this FOA.

2.  The proposed applicant team should include personnel from multiple institutions. 

3.  Consortium will be a collaborative effort that will require the coordinating center, clinical sites and other structural components to participate in a cooperative and interactive manner with each other and with the NIA. Applicants should explicitly state their willingness to: participate in Steering Committee meetings, site visits, and regular telephone conference calls; serve as both members and chairpersons on subcommittees within the consortium; cooperate in the development and design of research protocols; abide by study policies and common definitions, protocols, procedures, and quality assurance measures as chosen by majority vote of the SC.  Applicants should agree to actively implement each protocol recommended by the DSMB and approved by the NIA. They should explicitly state their acceptance of the Cooperative Agreement Terms and Conditions of Award which are found in Section VI, Award Administration Information.

4. Applicants should propose a research plan that includes a protocol for a randomized, placebo-controlled, masked phase II intervention study that will be the first trial implemented in the consortium environment. Applications requesting support for one or two large protocols that run for the entire six years will be considered unresponsive to this FOA.

5. Applicants should present a table of organization for the consortium and describe the processes and procedures for planning and protocol development for clinical trials that will be conducted by the consortium after initiating the first trial. The applicants should provide a time line indicating key milestones for the project.

6.  The Coordinating Center should have significant prior experience with multicenter clinical trials, including protocol and data collection systems development, study management, quality assurance and data analysis. The CC must have demonstrated ability and expertise to provide quality logistical and information support to the consortium.  In order to ensure that data analysis is done independently of data acquisition, the CC cannot have the same PI as any of the clinical sites. In addition, there should be no overlap in personnel between the CC and the clinical sites.

7.  The PI and research team at each clinical site must have demonstrated prior experience with clinical intervention research, including IRB submissions, DSMB participation, participant recruitment and retention, and human subject protection. Documentation of institutional support for the clinical trials should be provided in the form of letters of support from the appropriate institution officials.

8. The application must reflect adequate time commitment of personnel. The commitment for the Consortium Chair should be no less than 2.4 months.

9. Budget Information: In first year of the award, applicants should budget for at least four in-person meetings of the major investigators in Bethesda, MD / metropolitan Washington, DC area and for costs associated with organizing these meetings. In years 2 through 6, applicants should budget for at least two in-person meetings of the major investigators in Bethesda, MD / metropolitan Washington, DC area and for costs associated with organizing these meetings.

10. Clinical Trial Agreement (CTA): When a pharmaceutical or device collaborator (third party) provides a study agent/device to the Consortium, a CTA will be negotiated describing respective responsibilities and rights. The agreement will include, but is not limited to, Investigational New Drug/Investigational Device Exemption (IND/IDE) sponsorship, safety and data monitoring, and access to data. Third party agreements must be developed and implemented by the DCC with approval from the NIA.

Research Plan Page Limitations

Research plan shall not exceed 35 pages

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (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: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

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 NIA 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?

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?  Is a protocol for a phase II trial proposed in the application? Does the application include structural components such as a CC, clinical sites, central laboratory, etc.?  Is a table of organization for the planning/protocol development and a time line for the key project milestones provided? Does the application describe the processes and procedures for planning and protocol development for clinical trials that will be conducted by the consortium after initiating the first trial?    

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)?  Does the application reflect adequate time commitment for the Consortium Chair of at least 20%?

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?  Does the CC have the experience to coordinate, administer, and support all clinical research activities of the Consortium?  How adequate are the facilities, equipment, and organizational structure of the CC to effectively support the coordination of Consortium activities and provide assistance to clinical sites in developing and implementing protocols, and collecting and managing high-quality data? Does the environment at clinical sites provide good access to potential study populations? Do investigators indicate that they understand the U01 mechanism and agree to participate with NIA in the development and completion of these studies? 

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 and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), 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). 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 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 identifying priority areas for research with input from the Steering Committee, the DSMB and NIA and developing and implementing protocols. The awardee will have lead responsibilities in all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee.  Investigators are expected to:  participate in Steering Committee (SC) meetings, site visits, and regular telephone conference calls; serve as both members and chairpersons on subcommittees within the Consortium; cooperate with other sites in the design and development of research protocols; abide by common definitions, common methods for participant selection and enrollment, and common protocols, procedures, tests, and reporting forms as chosen by majority vote of the SC.  The awardee will actively implement each protocol approved by the Data and Safety Monitoring Board (DSMB) and the NIA; comply with study policies and quality assurance measures approved by the SC; agree to oversight of studies by the DSMB; and report all adverse events in accordance with procedures and policies established by the SC, the DSMB and the NIH/NIA.

The collaborative protocols and governance policies will call for the continued submission of data to the coordinating center for a collaborative database; procedures for data analysis, reporting and publication; procedures to protect and ensure the privacy of medical information and records of individuals. The NIA Project Scientist, on behalf of the NIA, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.

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. Specifically, the NIA Project Scientist will:

The NIA will appoint a Program Official, who apart from the Project Scientist, will be responsible for normal program stewardship of the award, monitoring of patient recruitment and study progress, and ensuring disclosure of conflicts of interest, and adherence to NIA policies.  Specifically the Program Officer will:

Perform other duties required for normal program stewardship of grants. 

2.A.3. Collaborative Responsibilities

The management of the Consortium for Clinical Trials on Anemia in Older Persons includes committees with the following functions:

Steering Committee

 The Steering Committee will consist of the Consortium Chair, principal investigators (PIs) of the clinical sites and CC, and the NIA Project Scientist. The Consortium Chair will plan consortium activities, oversee its functions, conduct SC meetings, and cast a tie-breaking vote. The SC will be the main governing body of the Consortium for Clinical Trials on Anemia in Older Persons and will establish and implement policies and procedures that govern Consortium operations. The SC will have primary responsibility for developing research protocols, supervising the conduct of the studies, and reporting results.  It will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner. The SC will develop and ensure compliance with Consortium policies and procedures, identify and prioritize topics for investigation, evaluate protocols proposed by the investigators, and develop consensus protocols for submission to the DSMB for approval.  Each full SC member will have one vote. All major scientific decisions will be determined by majority vote of the SC. The SC may meet in person as often as three to four times in the first 12 months of the study, and two to three times per year thereafter.  In-person meetings of the Steering Committee will be held in the Bethesda MD/ metropolitan Washington DC area.

A member of the NIA Grants and Contracts Management Office and/or the NIA Program Official advises the Steering Committee on funding matters.

Data and Safety Monitoring Board (DSMB) 

NIA will establish a DSMB in accordance with NIH policies to ensure data quality and participant safety and to provide independent advice to the NIA and the SC regarding progress and the appropriateness of continuing each study.   The DSMB, in collaboration with the investigators, will develop stopping rules as necessary for each protocol.  When appropriate, the DSMB will review interim data analyses regarding the potential need to terminate studies, and make recommendations to the Director of the NIA and the Steering Committee.  In addition, the DSMB will evaluate planned Consortium protocols, with an emphasis on participant safety, and with additional ad hoc scientific and/or clinical experts as needed.   Members of the DSMB will be appointed by the Director of the NIA who will be provided a list of nominees identified by the Steering Committee. Each member of the DSMB will have one vote. The Principal Investigator of the CC and the NIA Project Scientist will attend open sessions of DSMB meetings as non-voting members.  Meetings of the DSMB will ordinarily be held in the Bethesda MD/ metropolitan Washington DC area.  Because the Board serves as an independent group advisory to the NIA, study investigators will not directly communicate with Board members regarding any issues relevant to the Consortium.  All study protocols developed by the consortium must be recommended by the DSMB and approved by the NIA before initiation. The recommendation of the DSMB will be based on the importance of the question to be addressed, scientific merit of the experimental design and approach, feasibility, appropriateness for the consortium and consistency with NIA missions and policies. The DSMB will provide a written report of each proposal and a final recommendation to the NIA.

Additional Provisions

Support or other involvement of the pharmaceutical industry or any other third party in the study; involvement of study resources or citing the name of the study or NIH support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NIA.

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 NIA may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have a designee of the Steering Committee chosen without NIA staff voting, one NIA 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:

Judy Hannah, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue
Suite 3C307
Bethesda, MD 20892
Telephone: (301) 435-0044
FAX: (301) 402-1784
Email:hannahj@nia.nih.gov

2. Peer Review Contacts:

Ramesh Vemuri, Ph.D., Chief
Scientific Review Office
National Institute on Aging 
7201 Wisconsin Avenue
Suite 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
Email:vemuri@nia.nih.gov

3. Financial or Grants Management Contacts:

Joe Ellis Jr.
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue
Suite 2N212
Bethesda, MD 20892
Telephone: (301) 402-7731
Email:ellisjoel@nia.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.

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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