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 Human Genome Research Institute (NHGRI), (http://www.genome.gov/)
Fogarty International Center (FIC), (http://www.fic.nih.gov)

Title: Training in Genomics and Hemoglobinopathies

Announcement Type
New

Request For Applications (RFA) Number: RFA-HG-05-002

Catalog of Federal Domestic Assistance Number(s)
93.172, 93.989

Key Dates
Release Date: February 24, 2005
Letter of Intent Receipt Date: June 13, 2005
Application Receipt Date(s): July 12, 2005
Peer Review Date: October/November, 2005
Council Review Date: January/February, 2006
Earliest Anticipated Start Date: April 3, 2006
Expiration Date: July 13, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this RFA is to train the next generation of researchers who will utilize genomic and proteomic technologies to facilitate the understanding of the biology of hemoglobinopathies in order to prevent the disease and/or to develop effective therapeutic interventions.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

  Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

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

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

  Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

Background

Sickle Cell disease was the first disease whose genetic etiology was defined. That occurred more than half-a-century ago, and since then many excellent researchers have given the disorder much attention. This has produced major gains in both understanding the biology of the disorder, such as the pathophysiological importance of polymerization, and in developing better therapies, such as hydroxyurea. Despite such advances, sickle cell disease continues to be a significant cause of mortality, morbidity, and health disparities, both in the United States and globally. The completion of the sequence of the human genome in April 2003 opened up the possibility of applying genomic and other high throughput proteomic technologies to the study of this disease.

The National Institutes of Health hosted a conference, “New Directions for Sickle Cell DiseaseTherapy in the Genome Era,” in Bethesda, MD, in November 2003 to consider how the new tools and techniques of genomics might be applied both to understand more fully the biology of sickle cell disease and to develop more effective therapeutic and preventive strategies for the disease. The purpose of the conference was to discuss how to move the field of sickle research dramatically forward, and yet be mindful of the social and cultural history of this disease. Over 120 individuals from the United States and abroad, including from the Caribbean and west and east Africa, attended this conference. The conference report can be viewed at: http://www.genome.gov/11509561.

Following the conference , staff from eight NIH institutes and centers formed the Trans-NIH Sickle Cell Therapies Working Group. The Working Group developed a number of initiatives for consideration for implementation over the course of the next several years. This initiative is in response to one of the recommendations. The National Heart, Lung and Blood Institute recently published a RFA, “Sickle Cell Disease Clinical Research Network “ that is also related to this initiative. Information about this RFA can be found at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-05-006.html. A LISTSERV, SCDR-L, has also been established to keep the community apprised of these initiatives as they are developed as well as other fundingopportunities. To join SCDR-L, send an e-mail to listserv@list.nih.gov. Type as the body of the message: Subscribe SCDR-L Your Name (Example: subscribe SCDR-L Jane Doe).

Training and Research Objectives

The purpose of this initiative is to create a multidisciplinary, institutional postdoctoral research training initiative in hemoglobinopathies and genomics/proteomics. The training and research initiative must include five components:

(1) Didactic Training: Courses relevant to the proposed research might include sufficient courses to prepare the fellow for an independent research career, such as, understanding the biological basis of the disease; designing protocols; collecting, manipulating and interpreting large data sets; understanding the ethical, social and legal implications of human genetics research; and training in the responsible conduct of research.

(2) Laboratory Experience in Genomics/Proteomics: A laboratory rotation of sufficient length to ensure that the fellow has sufficient skills in and understands how genomics, proteomics, and bioinformatics tools and technologies are utilized in designing large-scale experiments and collecting, manipulating and interpreting large data sets.

(3) Research Training in Hemoglobinopathies: Fellows should work with established researchers to develop a research project that will maximize the knowledge and skills they learn from the didactic training and laboratory experience. Genomics/proteomics/bioinformatics tools and technologies should be used to develop the research project, and should enable the trainees to increase understanding of hemoglobinopathies. The eventual goal of an applicant institution's research program should be to develop prevention strategies and effective therapeutic interventions. Where appropriate, the design of projects should take into account potential sex and gender differences, and phenotypic variation that may affect the questions asked and the analyses performed. These differences might include different responses to treatments and impacts of health interventions, differences in pathophysiology, and different psychosocial and behavioral issues in health promotion/disease prevention strategies. It is expected that the results of the research experience will be the basis of the fellows' future research programs.

(4) Submission of Grant Application Prior to Completing the Program: Before the end of the two or three year program, it is expected that fellows will have sufficient preliminary data to submit a research grant application to a US federal or international agency.

(5) Plans for Future Collaboration Between Research Faculty and Fellows: One of the purposes of this program is to develop a new community of hemoglobinopathy researchers who will utilize genomics and proteomics technologies in their research. It is expected that mentors and fellows will develop significant research collaborations that extend beyond the two to three year training program. Such research collaborations are encouraged through research grants and/or program projects.

Program Design
Special attention should be paid to the design of the program. The following is provided as guidance: (1) Fellows should be appointed for a minimum of two years and a maximum of three years and have a strong interest in a career combining hemoglobinopathies and genomicsc/proteomics must be evident. (2) At least one-fourth of fellows appointed should be foreign and from low- and middle-income countries that have a significant population with one or more forms of hemoglobinopathy. As part of the application process to the US institution, foreign fellows must show evidence, for example by a letter of endorsement from the appropriate officials at their home institutions, that upon return to their home country, they will have sufficient institutional support (e.g. position and space) to carry out a research program in their area of training on this fellowship. (3) Each program should strive to appoint to the training program an equal number of individuals with clinical and research doctorates. (4) Fellows are required to pursue this program full-time. (5) Fellows who are also training as clinicians must devote at least 75% of their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. (6) It is expected that program enhancements, such as journal clubs, lab meetings, seminars, etc. will be developed in order to ensure that fellows and mentors will form a cohesive research group of mentors and trainees. (7) The program should provide opportunities for US citizens or permanent residents of the US who are women, or are from disadvantaged backgrounds, including racial and ethnic minorities, or who are underrepresented in biomedical and behavioral research in the United States in order to contribute to a diverse US research workforce in the future. (8) The application should address how the success of the program will be evaluated, including tracking of trainees who have completed their program for at least a decade.

Program Evaluation Plans.
Procedures for annual evaluation of the program should include plans to measure the impact of the program on the individual students and plans to measure the fellows' progress. The evaluation procedures should also describe plans to monitor the future career course of individual fellows, to evaluate the effectiveness of the overall program, and assess the impact of the training program on the institution. It should also include plans for assessing the effectiveness of the mentoring relationship and the training plan.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the T90 award mechanism, which combines research and NRSA authorities in a single mechanism. Applicants may request a project period of up to five years. As an applicant you will be responsible for planning, directing, and executing the proposed training program. This is a one time solicitation. At the end of the five year project period, acceptance of applications for competing renewals or for new programs will be at the discretion of individual NIH institutes and centers.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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

The initiative requires co-program directors—one from each of the relevant disciplines or research areas (hemoglobinopathies and large-scale genomics and proteomics). The co-directors would be required to have intensive research programs in the areas of interest and could either be within the same institution or from a different institution within the United States or a low- and middle-income country where a significant part of the population is affected with one or more forms of hemoglobinopathy.

Scientists interested in being co-directors of the program must be recognized as accomplished investigators in hemoglobinopathy research and/or genomics research and must have the skills, knowledge, and resources necessary to carry out the proposed research training program. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply as co-directors. The co-directors will be responsible for the selection and appointment of fellows to the program and for the overall direction, management, and administration of the program.

Foreign scientists from a low- or middle-income country, as defined in the paragraph below, may be considered as co-program directors. In such a case, the foreign scientist must either hold a full-time faculty research position or should have a full-time faculty position with a strong research commitment. The individual may be based at a public or private university, health professional school (including school of public health, dental school, nursing school or medical school) or research institution that will allow him or her adequate time and provide appropriate facilities and resources to participate in the proposed hemoglobinpathy training program. In naming a foreign co-program director, the applicant must demonstrate either an ongoing collaborative research relationship or high potential for development of collaborative research with the hemoglobinopathy researcher named as a co-program director. Co-Directors from foreign institutions may serve as in-country mentors for trainees who wish to have a clinical research experience outside of the US. In addition, foreign co-mentors may participate in collaborative research projects at their home institutions. For Foreign Institutions: Low- and middle-income institutions are not eligible to apply, but may be considered as mentors and research collaborators on the program. A listing of those countries categorized as low- and middle-income by the World Bank may be found at: http://www.worldbank.org/data/countryclass/classgroups.htm.

Fellows

This program is open to US citizens, non-citizen nationals of the United States (generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island), permanent residents of the United States (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status) and foreign nationals of low- and middle-income countries, as defined by the World Bank: http://www.worldbank.org/data/countryclass/classgroups.htm. Individuals on temporary or student visas are not eligible. Postdoctoral fellows must have received, as of the beginning date of the appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr. P. H., D.N.Sc., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable. Postdoctoral fellows appointed to the training program must have the opportunity to obtain the necessary didactic training and develop the appropriate genomics/proteomics research skills with the primary objective of developing or extending their research skills and knowledge in preparation for an independent research career in hemoglobinopathy research.

Foreign Post doctoral Fellows must show evidence of approval for collaborative research and training. This can be documented by providing a letter of endorsement from the appropriate officials at the collaborating institutions at the time of application. Evidence should be provided of substantive institutional commitment in the foreign country (this may include space, positions, matching funds, infrastructure support, access to data and systems, trainee support during their re-entry period, a commitment to establish a degree or certificate program, etc). Foreign fellows are expected to return to their home country upon completion of their training.

Applicants must address the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include an adequate representation of men, women and ethnic minorities or socially disadvantaged population groups among the developing country trainees. Programs are strongly encouraged to give special emphasis in selecting foreign trainees to include women and to ensure adequate representation of women and minorities in selecting U.S. trainees under this program.

2. Cost Sharing or Matching

No cost sharing or matching funds are required for this program.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Add Special Requirements

The NIH recognizes that individual institutions will be positioned to respond in different ways to the opportunities presented in this RFA. However, all programs are expected to provide comprehensive interdisciplinary research training experiences in genomics and SCD research for all trainees.

The following items should be addressed in the application:

Program self-evaluation – the program should set measurable clear goals for itself, and establish milestones and measures of success for achieving them.

Trainee and faculty attendance at annual meeting – trainees and associated faculty supported by the program will be expected to attend a one to two day annual meeting to be held in Bethesda or other suitable location each year. The meeting will highlight the breadth and interdisciplinary nature of the research being conducted and will be a networking node for trainees, associated faculty, and NIH staff.

Trainee reporting requirements – programs will be required to submit trainee appointment forms for all trainees supported by the program and to track trainees who are no longer supported by but are still associated with the program.

In addition, the application must address the program features:

Applicant pool – Postdoctoral fellows who have potential for participating in the training program should be clearly identified. The application should also include any recruitment and outreach plans to increase the depth and ethnic diversity of the US applicant pool. Institutions

that already have one or more NRSA pre-doctoral or postdoctoral training grants should address how the trainees for the proposed program is distinct from or relates to that for existing training grants.

Rotations and internships – are highly encouraged and should be of sufficient duration and rigor to ensure that the trainees produced by this program are at a minimum conversant in genomic/proteomic technologies and pressing problems in hemoglobinopathies.

Co-Mentoring – should be substantively shared by faculty members representing genomics/proteomics and hemoglobinopathies research; formal co-mentoring is strongly encouraged.

Trainee interactions – must be of sufficient quantity and quality to ensure that the trainees and associated faculty develop an internal sense of the identity of their interdisciplinary field and its rewards and challenges. Examples of mechanisms for fostering program cohesiveness include seminar series with presentations from trainees, faculty, and invited guests in the areas of genomics/proteomics and hemoglobinopathies research; retreats; and journal clubs.

Leadership and teambuilding skills – will be critical to the future success of the trainees produced by these programs. Plans should be developed and put in place to help trainees and interested faculty develop the leadership skills and understanding of the challenges of group dynamics necessary to establish and maintain a genuinely integrated research program.

Responsible conduct of research – plans for training in this area must be included.

Monitoring of trainees – should be an integral part of the program, with close attention paid to individual programs that will ultimately produce preliminary data for future grant applications to federal and non-federal organizations.

Academic and career advice – will be an important factor in the success of these training programs since they will be producing the first generation of hemoglobinopathies researcher skilled in genomics/proteomics. Trainees should be apprised of the broad range of career options as well as instructed in how to apply successfully for research funding. Moreover, graduates of the program should be able to submit an application to an organization using the data generated during the time of the traineeship.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Training in Genomics and Hemoglobinopathies; RFA-HG-04-002.

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: June 13, 2005
Application Receipt Date(s): July 12, 2005
Peer Review Date: October/November, 2005
Council Review Date: January/February, 2006
Earliest Anticipated Start Date: April 3, 2006

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 at the beginning of this document.

The letter of intent is to be sent by June 13, 2005.

The letter of intent should be sent to:

Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@nih.gov.

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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

Ken Nakamura, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5 635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0838
Email: ken_nakamura@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

3.C. Application Processing

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

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Supplementary Instructions:

Allowable costs:

Two budget pages (NRSA SUBSTITUTE FORM PAGE 4, in PHS 398) will be submitted to distinguish requested funds for NRSA-qualified and non-NRSA-qualified trainees. Please refer to NRSA Guidelines for eligibility (http://grants.nih.gov/training/nrsa.htm#policy). Briefly, NRSA-qualified trainees are post-doctoral fellows AND either U.S. citizens or U.S. permanent residents. Non-NRSA-qualified trainees are postdoctoral fellows who are neither U.S. citizens nor U.S. permanent residents. Funds for NRSA-qualified individuals will be for stipends and funds for non-NRSA-qualified individuals will be salaries.

PHS2271 (Statement of Activation) to initiate each fellow on the T90 program.

Support for postdoctoral trainees: Under the T90 mechanism, both foreign and domestic postdoctoral fellows at any level may be supported. However, no fellow may be supported by the program for more than three years. Postdoctoral fellows (both US citizens/ permanent residents of the US and foreign) will be supported up to NRSA levels in place at the time of award. To qualify for support by the program, a fellow must be in training full time.

Training related expenses:

Administrative Staff Support - up to $20,000 per year for program staff support.

Travel, supplies – up to $5,000 for postdoctoral students to help defray the cost of research supplies and attendance at the annual meeting.

Tuition, Fees, and Health Insurance: The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition, fees, and health insurance are allowable only if they are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812072.

Other Trainee Costs: Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual's research training, is an allowable trainee expense. In addition, foreign scientists may be provided with funds for one round trip to and from the US host institution during the course of their research experience. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.

Training Related Expenses: Institutional costs of $3,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years.

Facilities and Administrative Costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. Applications from state and local government agencies may request full indirect cost reimbursement. Information onFacilities and Administrative Costs is available in the Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_4.htm#_Toc504812080.

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

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

6. Other Submission Requirements
Not Applicable

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

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

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHGRI. Incomplete and/or non-responsive applications will not be reviewed.

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

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

The goals of NIH-supported research training and career development programs are to help ensure that adiverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the training program and then consider whether the requested number of trainee positions is appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted in the program.

Training Program: This criterion assesses the objectives, design and direction of the training program. Does the proposed training program provide broad-based, fundamental, early-stage training in genomics and hemoglobinopathies research? Are appropriate courses available to provide a curriculum that spans the breadth of genomics and hemoglobinopathies in terms of the level of analysis (genes to molecules to cells to integrated, functional systems), approaches (including translational research), etc? Are appropriate programmatic activities incorporated into the training program? Does the proposed training program address the five components- didactic training, genomics/proteomics laboratory experience, hemoglobinopathy research experience, plans for fellows to submit applications, and post training research collaborations, including adequacy of the program enhancements in developing a cohesive community of fellows and mentors, and plans for evaluating the success of the program?

Training Program Co- Directors: Do the Co-Directors have the scientific background, expertise, and experience or potential to coordinate and supervise a broad-based training program in the genomics of hemoglobinopathies? Have the Co-Directors committed adequate time to program administration? If there is a Co-Director from a foreign country, is there evidence of the potential for long-term collaborations? Is there evidence that the plans for collaborating and making this a seamless and transparent program are feasible? Are the plans for cooperative arrangements between the collaborating institutions adequate? Is there demonstrated commitment of the relevant faculty at the collaborating institutions?

Preceptors: Is there appropriate expertise available in the hemoglobinopathies and genomics research communities at the institution or in the consortium? What is the caliber of the preceptors as researchers, including the overall quality of their research, their publication record, and their successful competition for research support in areas directly related to the proposed training program? What is the record of the preceptors as mentors, especially as mentors of postdoctoral students?

Institutional Training Environment: Does the environment in which the training program will be conducted, i.e. the quality of the participating departments and the extent of their participation, contribute to the probability of success? Does the training program represent the breadth of the hemoglobinopathies and genomics research community at the institution or in the consortium? Is there evidence of adequate institutional commitment? Is there evidence of ongoing genomics and/or hemoglobinopathies research in areas relevant to the mission of one or more participating NIH Institutes? Is there evidence of adequate research support, equipment, and facilities?

Training Record: This criterion evaluates the past research training record of the co-program directors and the designated preceptors. What is the success of former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include successful completion of the PhD, receipt of fellowships or career development awards, additional training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors or awards, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. What is the track record of the preceptors in directing postdoctoral training or the potential of those preceptors lacking a track record?

Applicant Recruitment, Selection and Retention: What is the quality and size of the applicant pool? Are the recruiting procedures, trainee selection criteria, and retention strategies appropriate and well defined? Is the racial and ethnic diversity of the trainee pool in keeping with the availability of individuals from underrepresented groups within the relevant pool of applicants?.

Evaluation and Tracking Component: The application must describe a strong evaluation and tracking component that will review the effectiveness of all aspects of the program (including curriculum, training faculty, training program director) and a system for tracking trainees for a 10-year period following program completion to determine program outcomes. Provide plans for monitoring trainee progress and overall program evaluation. Describe the measures (e.g., publications, grant proposals and awards, career trajectory of trainees) that will be used to assess the success or failure of the program. Outcome measures may include relevant positions obtained, current research activities, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. Data for tracking should include annual application, enrollment and appointment information. While the Program Director and Advisory Committee (if present) will of necessity help provide information for evaluation and tracking, the application should provide a prospective evaluation plan for process and outcome measures. The evaluation report should be included as part of the Progress Report at the time the competing continuation is submitted or as part of the Final Report if no competing continuation is submitted.

Minority Recruitment and Retention Plan: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). In addition, all competing continuation applications must include a report on the recruitment and retention of underrepresented minorities during the previous award period. If an application is received without a plan or without a report on the previous award period (if appropriate), the application will be considered incomplete and will be returned to the applicant without review.

2.A. Additional Review Criteria:

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

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

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

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

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. Is the requested number of trainee positions appropriate for the number of high-quality, eligible first/second-year trainees likely to be accepted into the training program? Can the number of positions be accommodated by the program given the availability of preceptors, their funding, and the number of trainees already in the program?

Evaluation and Tracking Plan: The application must describe a prospective evaluation and tracking plan (see Special Programmatic Requirements in Section IV.6.). Is this plan adequate to help ensure the effectiveness of the training program? NIH initial review groups will assess the applicant's plan based on the adequacy of plans for monitoring trainee progress, process and outcome measures, and overall program evaluation. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Training In The Responsible Conduct Of Research: Every NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research (see http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must describe a program to provide formal and informal instruction on scientific integrity and ethical principles in research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.

NIH initial review groups will assess the applicant's plan on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The initial review groups will also evaluate the results of assessments of this instructional program, if available. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note of the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Minority Recruitment and Retention Plan: All competing applications for institutional research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program (see http://grants.nih.gov/grants/guide/notice-files/not93-188.html). The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included in the priority score. In addition, peer reviewers will separately evaluate the minority recruitment and retention plan and report (for competing continuation applications) after the overall determination of merit, so that the review panel's evaluation of this plan will not be a factor in the determination of the priority score. Here reviewers will assess the strategies to be used in the recruitment and retention of minorities. For competing continuation applications, reviewers will also assess whether the experience in recruitment during the previous award period has been incorporated into the plan formulated for the next award period. The plan will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note in the summary statement. Regardless of the priority score, applications with an unacceptable plan will not be funded until the applicant provides an acceptable revised plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

2.C. Sharing Research Data

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

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates

The following will be considered in making funding decisions:

Applicant institutions will be notified if an award will be made through the receipt of the Notice of Grant Award. The anticipated award date is April 3, 2006.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIH will request “just-in-time” information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

If the institution is e-mailed enabled, the Notice of Grant Award will be e-mailed to the institution. If the institution is not e-mailed enabled, the Notice of Grant Award will be mailed.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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 notice of grant award. 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).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Bettie J. Graham, Ph.D.
Division: Division of Extramural Research
Institute or Center: National Human Genome Research Institute
Street Address: 5635 Fishers Lane
Building Number, Room Number: Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 496-7531
Email: bettie_graham@nih.gov

Flora Katz, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: Katzf@mail.nih.gov

2. Peer Review Contacts:

Ken Nakamura, Ph.D.
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Twinbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0838
Email: ken_nakamura@nih.gov

3. Financial or Grants Management Contacts:

Ms. Cheryl Chick
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Tw inbrook Building; Room 4706
Rockville , MD 20852
Telephone: (301) 402-0733
Email: cheryl_chick@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 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.

Public 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 public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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