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/)  

Title:  Centers for Excellence in Ethical, Legal and Social Implications (ELSI) Research (CEERs) (P50)

Announcement Type
This is a reissue of RFA-HG-03-005, which was previously released August 13, 2003.

Request For Applications (RFA) Number: RFA-HG-06-025

Catalog of Federal Domestic Assistance Number(s)
93.172

Key Dates
Release Date:  September 14, 2006
Letters of Intent Receipt Date(s): December 20, 2006
Application Receipt Date(s): January 16, 2007
Peer Review Date(s): June-July 2007
Council Review Date(s): September 10-11, 2007 
Earliest Anticipated Start Date(s): September 28, 2007
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: January 17, 2007

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 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
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

In April 2003, the last of the original goals of the Human Genome Project, the sequencing of the human genome, was completed, marking the culmination of this historic biomedical research enterprise.  The attention of the biomedical research community has now turned to understanding and interpreting this fundamental source of knowledge about human biology and to the development of approaches for applying genomics to improving human health and preventing disease.  With this changing focus, new ELSI issues will inevitably arise, with regard to both accomplishing the necessary research and applying the new knowledge to diagnosing, treating, and preventing disease.  Thus, a vigorous program of ELSI research, the results of which will inform policy development deliberations, will continue to be an essential component of genomics research.

The NHGRI ELSI Research Program has funded a large number of research grants from investigators in a wide range of disciplines.  Many of these projects have used interdisciplinary approaches to investigate important ELSI questions. While considerable progress has been made on ELSI issues, much remains to be done.  In addition, as the pace of genomic and genetic research increases, the development of research teams that have the expertise and flexibility to anticipate and respond rapidly to the large number of emerging and evolving ELSI issues is critical.  All of these factors contribute to a need for new and more innovative approaches, including new organizational structures and funding mechanisms, to carry out ELSI research.  The creation of research centers with the resources and expertise to design and implement multi-faceted and multi-disciplinary investigations of particularly complex, persistent or rapidly emerging ELSI issues will be an important addition to ongoing genetic, genomic and ELSI research efforts.

Scope of Research

The CEER program is designed to support the development of a research group that will identify and investigate ELSI research questions that can best be approached through intensive and extended collaboration among investigators from multiple disciplines, using diverse methodologies.  The investigators in a CEER will be encouraged to consider new ways to explore these questions, design innovative and efficient research projects, propose and disseminate health or social policy options based on Center research and, when feasible, facilitate policy development pertinent to a specific issue.  Center applicants are particularly encouraged to identify cutting edge research topics and approaches that have the possibility of leading to high payoff solutions to important ELSI problems. 

A CEER must identify a theme around which it will be organized.  The research agenda should be focused on a single issue or set of related issues. CEER themes could be related o one or more of the Grand Challenges identified in the NHGRI vision document, "A Vision for the Future of Genomics Research" (Nature (2003) 422: 835-847), also available at: http://www.genome.gov/11006873.  Applicants also can suggest other significant ELSI challenges that extend beyond those identified in the document above.

Although aspects of each of these issues could be addressed through regular (R01) or small (R03) research grants, the CEER program will allow researchers to propose truly trans-disciplinary, innovative and comprehensive approaches to exploring and addressing these issues.  To further clarify the unique nature of the CEER program, the following list of attributes of a successful CEER application is provided.

A successful CEER will:

A CEER will NOT:

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 P50 Specialized Center award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

The requested budget for a CEER may be up to $750,000 in direct costs for the first year for continuing operations (e.g., personnel, standard office equipment, supplies, travel and other expenses). Future year budgets may exceed $750,000 for inflationary adjustments. Under this cap, it is anticipated that the size of the awards will vary because the nature and scope of research programs will vary. To accommodate collaborations that extend beyond single institutions, Facilities & Administrative (F&A) charges on the subcontracts, which are formally direct costs to the parent institution, will be excluded in considering the $750,000 operating costs limit.


The NHGRI intends to commit approximately $3,300,000 dollars in FY 2007 to fund up to three new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $750,000 dollars per year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

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:

Foreign institutions are not eligible to apply. However, subcontracts to foreign institutions will be considered.

Investigators from majority institutions are encouraged to consider partnering with minority-serving institutions.

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

2. Cost Sharing or Matching

Cost sharing is not required.

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

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): December 20, 2006
Application Receipt Date(s): January 16, 2007
Peer Review Date(s): June-July, 2007
Council Review Date(s): September 10-11, 2007
Earliest Anticipated Start Date(s): September 28, 2007

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 should be sent to:

Dr. Elizabeth J. Thomson
ELSI Research Program, Division of Extramural Research
National Human Genome Research Institute, NIH
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892
Telephone: (301) 402-4997
FAX: (301) 402-1950  
Email: et22s@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier 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:

Dr. Rudy Pozzatti
Co-Director, Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305

Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: rp7s@nih.gov

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

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the 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.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

Minority Training: The NHGRI is committed to increasing the number of underrepresented minorities trained to conduct genomics and ELSI research. As part of their training component, each Center PI is required to submit a specific plan for engaging the talents of individuals from underrepresented minority groups as outlined in the NHGRI Action Plan. The initiatives included in this plan will be conducted as stated in the application. Funds allotted to these efforts may not be rebudgeted. As part of the annual review of this grant, the principal investigator must submit specific information detailing these activities. This information should include a description of ongoing activities, budgetary expenditures on each activity, number and demographic characteristics of individual participants and future plans.

6. Other Submission Requirements

Page Limits:   An expanded page limit of up to 40 pages will be allowed for a description of the research plan (PHS 398 items 2-5: specific aims, background and significance, preliminary studies, research design and methods).  This description should include the overall theme and aims of the center, the elements that will comprise the center and how they will be integrated, as well as specific research aims, design and methodologies, data analysis and dissemination plans. Up to 15 pages will be allowed to describe the organizational structure of the center, management plans and plans for training activities.  Each individual section should be clearly labeled.

Consortium participation:  Annual meetings of investigators from funded Centers will be held. This will facilitate sharing of information about current and planned activities, communication of research findings and policy deliberations, and experiences in organizing and operating a CEER. Such meetings will encourage collaboration among Centers, reduce duplication of effort, and promote more rapid dissemination of knowledge and information.  The initial meeting will take place shortly after the Center grants are funded. Funds for travel to these meetings for up to four investigators (the PI and three others) per year should be included in the requested budget.

Multidisciplinary and diverse research teams:  The CEER program is intended to facilitate the formation of multidisciplinary teams of investigators who will develop new ways to anticipate, frame, and investigate ELSI research questions.  These research teams may include basic genomic and genetic scientists, clinical and social scientists, and researchers from law, bioethics and the humanities. However, it is essential that the theme be well anchored in genomic and genetic sciences.  NHGRI particularly encourages the involvement of minority serving institutions and investigators from minority populations and those with disabilities. 

Management and organization: A CEER will include a well-integrated project plan.  The application should describe the specific organizational structure that will be used to support the research, and the synergism that will result because of this arrangement.  A well thought out and carefully described organization is required.  The application should explain how different components of the CEER will interact and why they are essential to accomplishing the overall goals of the research.  How the combined resources create capabilities that are more than the sum of the parts should be described.  The PI will be responsible for ensuring that the scientific goals are met and for developing and managing a decision-making structure and process that will allow resources to be allocated to meet the Center's goals. 

Therefore, the PI will be required to commit at least 30% effort to the implementation and leadership of the Center.  A timeline for the project should be included in the application that shows how the Center's goals can be met within the timeframe of the CEER grant.  This timeline will be used to help assess progress toward the Center's goals.

Training:  In addition to a strong research component, a Center is required to have a highly effective training component that will leverage the strengths of the multidisciplinary nature of the Center and its investigators to train the next generation of ELSI scholars, genome/genetics researchers, clinical and social scientists, and researchers in law, bioethics and the humanities to be able to develop independent research programs that address important ELSI problems.  The training component of the Center must include a specific plan for engaging the talents of individuals from underrepresented minority groups as outlined in the NHGRI Action Plan (http://www.genome.gov/10001707 ).  Specific funds may be requested for training activities to include up to two post-doctoral trainees per year.  Further, it is expected after one year of support on this training grant, the post-doctoral fellow will have applied for a National Research Service Award (NRSA-F32).  For more information regarding this program announcement, see:  http://grants.nih.gov/grants/guide/pa-files/PA-99-122.html.  Given this training path, CEER trainees must eligible for an NRSA award.  As such, they must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status).  Non-citizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island).  Individuals on temporary or student visas are not eligible.  For other ELSI funding opportunities, visit: http://www.genome.gov/10000930.    

Site visits:  After the first year of funding, annual administrative site visits will be scheduled to assess progress being made in the Centers.  Most will likely be held at the funded institution.  Occasionally it may be necessary to hold reverse site visits, in which investigators travel to Bethesda to report on progress.

Plan for Sharing Research Data

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

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources

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

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 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 high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance:  Does this study address an important emerging or particularly persistent ELSI problem related to genomic and genetic science? If the aims of the application are achieved, will our understanding or ability to address these issues be advanced? Will these studies have an effect on the field of ELSI research?  Will they be relevant and useful to the larger scientific and public policy communities?

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? For proposed multi-component centers, is there a demonstrated scientific gain from the interrelatedness and synergy among the components? If any individual component were removed, would the ability of the CEER to accomplish its overall aims be impaired?

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 PI have the ability, expertise and experience to lead, coordinate, and manage all of the activities of the CEER?  Does the PI have sufficient leadership qualities and experience to develop and implement the CEER plans for the entire project?  Are the other key personnel identified from multiple disciplines?  To what degree will the individual and combined expertise of the key personnel contribute to the accomplishment of the overall goals of the proposed research?  Is the level of effort for the key personnel adequate? Is there evidence of effective collaboration among key personnel?  Is there evidence that the team has sufficient expertise in both ELSI and genomic/genetic science? Are investigators from minority populations and/or those with disabilities included?

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, including improvement of infrastructure and relief from other academic duties where necessary? Is the environment adequate for proposed training activities?

Management: Is the management plan, including the management structure, appropriate and adequate to support the CEER? Is there an effective plan for use of fiscal resources, shared facilities and human resources to attain the research aims and overall CEER goals?  Is there an adequate plan for the organization and coordination of the CEER personnel?  Is there a high quality plan for making critical decisions or choices about the overall research direction for the CEER? Where appropriate, are the approaches used or under development to implement the research plan cost effective?

Training: What is the quality of the proposed training plan and its likely effectiveness in producing well-trained researchers who can develop new approaches to ELSI questions and research?  Are there plans to develop new training opportunities and to integrate them with other on-going or planned training?  Plans to achieve effective training of underrepresented minorities receive particular attention.

2.A. Additional Review Criteria:

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

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and

http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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

3. Anticipated Announcement and Award Dates

N/A

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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

Site Visits: The period of award for this grant is five years.  Each Center will have annual administrative site (or reverse site) visits to assess progress being made in the Center. After the site visit of the third year, a decision will be made about whether a fifth year of funding will be provided to the Center.  If the NHGRI decides to phase out the project before the fifth year, the budget for the fourth year may also be reduced.  Further, after that review, the Principal Investigator (P.I.) will receive guidance from the NHGRI program director concerning the NHGRI's interest in accepting a competing renewal application to extend the initial award.

Annual Investigator Meetings:  Annual meetings of investigators from funded Centers and Exploratory Centers will be held. The initial meeting will take place shortly after the Center grants are funded.  The Center PI is required to attend and is expected to use Center grant funds to cover travel expenses for his or herself and up to 3 co-investigators.

3. Reporting

Minority Training Plan Reporting Requirement: The NHGRI is committed to increasing the number of underrepresented minorities trained to conduct genomics and ELSI research. As part of their training component, each Center PI was required to submit a specific plan for engaging the talents of individuals from underrepresented minority groups as outlined in the NHGRI Action Plan. The initiatives included in this plan will be conducted as stated in the application. Funds allotted to these efforts may not be rebudgeted. As part of the annual review of this grant, the principal investigator must submit specific information detailing these activities. This information should include a description of ongoing activities, budgetary expenditures on each activity, number and demographic characteristics of individual participants and future plans.

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:

Dr. Elizabeth J. Thomson
ELSI Research Program
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892
Telephone: (301) 402-4997
FAX: (301) 402-2950
Email: et22s@nih.gov


2. Peer Review Contacts:

Dr. Rudy Pozzatti
Co-Director, Scientific Review Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076

Bethesda, MD 20892-9305
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: rp7s@nih.gov

3. Financial or Grants Management Contacts:

Ms. Cheryl Chick
Chief, Grants Administration Branch
National Human Genome Research Institute
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9305
Telephone: (301) 402-0733
Fax: (301) 402-1951
Email: cc149o@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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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