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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 (P50) and Exploratory Grants for Centers (P20) for Excellence in Ethical, Legal and Social Implications (ELSI) Research (CEERs)

Announcement Type
This is a reissue of RFA-HG-03-005.

Request For Applications (RFA) Number: RFA-HG-09-003

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

Catalog of Federal Domestic Assistance Number(s)
93.172

Key Dates
Release Date: January 8, 2009
Letters of Intent Receipt Date: April 14, 2009
Application Receipt Date: May 14, 2009
Peer Review Date(s): October-November 2009
Council Review Date: January 2010.
Earliest Anticipated Start Date(s): March-April, 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: May 15, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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 sequencing of the human genome was essentially completed, marking the culmination of the Human Genome Project. The attention of the biomedical research community has now turned to understanding and interpreting this fundamental source of knowledge about human biology and to developing approaches for applying genomics to improving human health and preventing disease. Some of the products of this research are already being used in health care and other settings.

New genetic tests and large amounts of detailed personal genomic information are becoming widely available in research, health care and more recently commercial settings and are being used in a variety of ways. New ethical, legal and social questions are being raised by the availability and use of such information, and the need for coherent and effective policies to address them is increasing. Without reliable data, provided by sound theoretical models and rigorous research, on which to base such policies and guide decision-making, there is a risk that research, health, and public policies may be ill-informed and consequently ineffective, inappropriate, or even counter-productive. In addressing the questions raised, it is critical that the perspectives of individuals from diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities be taken into consideration.

The NHGRI, through its ELSI Research Program, has funded many research projects that have been carried out by investigators from a wide range of disciplines and backgrounds. These projects have involved investigators from single or multiple disciplines, using a wide variety of methodologies. While considerable progress has been made on ELSI issues, new issues continue to arise and much remains to be done. As the pace of genomic and genetic breakthroughs 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 increasingly important. The creation and maintenance of research centers with the resources and expertise to design and implement multi-faceted and transdisciplinary investigations of complex, persistent or rapidly emerging ELSI issues is an important component of the overall NHGRI portfolio in ELSI and genomic research.

Scope of Research

The CEER program is designed to support the development of research groups that will identify and investigate those ELSI research questions that can best be approached through intensive and extended collaborations among investigators from multiple disciplines, using diverse methodologies. The investigators in a CEER are encouraged to consider new ways to explore such questions, design innovative and efficient research projects, propose and disseminate research, health, or social policy options based on the results of Center research and, where feasible, facilitate policy development pertinent to specific issues. 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 to 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. Alternatively, the theme could be related to issues raised by one or more of the large-scale projects/types of studies currently supported by NHGRI, which include:

The Medical Sequencing Projects (MSP) http://www.genome.gov/15014882 ;

The Cancer Genome Atlas (TCGA) http://cancergenome.nih.gov/ ;

The Human Microbiome Project (HMP) http://nihroadmap.nih.gov/hmp/ ;

The Genotype-Tissue Expression Project (GTex) http://nihroadmap.nih.gov/GTEx/ ;

The 1000 Genomes Project http://www.1000genomes.org/page.php ;

The Genetic Association Information Network (GAIN) http://www.genome.gov/19518664 ;

The Genes and Environment Initiative (GEI) http://www.genome.gov/19518663 ; and

The electronic MEdical Records and GEnomics (eMERGE) https://www.mc.vanderbilt.edu/victr/dcc/projects/acc/index.php/Main_Page .

Genome-Wide Association Studies (GWAS) http://grants.nih.gov/grants/gwas/ ;

Each of theses projects has raised new high priority ELSI issues. As the nature and topics of genomic and ELSI research are evolving rapidly, applicants are also encouraged to visit the ELSI Research website to view other emerging high priority research areas. http://www.genome.gov/page.cfm?pageID=10001618#Priorities. Applicants also can suggest other significant ELSI topics and challenges that extend beyond those identified above.

Although aspects of each of these issues can and are being addressed through regular (R01) or small (R03) research grants, the intent of the CEER program is to allow researchers to propose larger-scale, transdisciplinary, and innovative approaches to exploring and addressing them. To further clarify the unique nature of the CEER program, the following list of attributes of a CEER is provided.

A CEER will:

A CEER will NOT:

The P20 grant mechanism will be used to support planning for a new CEER, expansion or modification of existing resources at an institution for the purpose of developing a P50 CEER application, or feasibility studies to explore various approaches to the development of an interdisciplinary program that offers potential solutions to ELSI problems of special significance to the mission of the NHGRI. The application for support of such exploratory studies must explicitly discuss how the proposed planning activities will lead to such a P50 application. It should describe in substantial detail a vision of the research to be conducted under the subsequent P50 grant. P20 applications should not propose a training component; however, they should include a description of the types of training activities, particularly for training of investigators from under-represented minority populations that would be appropriate for the subsequent P50 Center.

An exploratory grant is not required as a precursor to a P50 Center application. In addition, NHGRI’s funding of an exploratory grant does not obligate NHGRI to fund a subsequent P50 Center grant.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use both the P50 Specialized Center and P20 Exploratory Research award mechanisms. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

A high priority under this program is the establishment or continuation of strong academic Centers in which state-of-the-art ELSI research can be or is being conducted. At some institutions, the nucleus of a well-functioning collaborative research group that could conduct the research described in this FOA may already exist, and such groups will be able to submit suitable P50 applications for this program directly.

However, some groups of investigators may require an opportunity to enhance their collaborative network by establishing or strengthening new multi-investigator or interdisciplinary relationships, demonstrate effective collaborations, explore organizational concepts, develop courses or curricula, collect preliminary data, or refine and fully develop their vision for a proposed P50 CEER project. For these groups, the Exploratory Grant (P20) mechanism should be used.

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

2. Funds Available

The requested budget for P50 CEERs may be up to $750,000 in direct costs for the first year for continuing operations (e.g., personnel, standard office equipment, supplies, travel, training, and other expenses). The requested budget for a P20 Exploratory Research project may be up to $150,000 in direct costs for the first year (e.g., partial salary of key investigators, travel, and certain supplies and equipment).

Future year budgets may exceed these caps for inflationary adjustments. Under these caps, 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 and Administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

An applicant may request a project period of up to five years for a P50 application and up to three years for a P20 application. A P50 Center grant will be renewable one time, for a total project period not to exceed ten years. A P20 Exploratory Center grant will not be renewable.

The NHGRI intends to commit approximately $3,900,000 dollars in FY 2010 to fund up to three new or renewed P50 Center grants and up to three new P20 Exploratory Research grants in response to this FOA.

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.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

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

Renewals. Renewal applications will be permitted for this FOA.

Number of Applications. 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) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: April 14, 2009
Application Receipt Date: May14, 2009
Peer Review Date: October-November, 2009
Council Review Date(s): January 2010
Earliest Anticipated Start Date(s): March-April, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

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: [email protected]

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material are requested to 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 (for US Postal Service)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-Award Costs: Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

Minority Training: The NHGRI is committed to increasing the number of underrepresented minorities trained to conduct genomics and ELSI research. As part of the training component, the principal investigator of each P50 Center must submit 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). 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. The PI of a P20 Exploratory Research grant need not submit a plan, but should describe in the application how he/she will lay the groundwork for developing a training initiative that will engage trainees and researchers from underrepresented minority groups.

6. Other Submission Requirements and Information

Research Plan page limitations: For the P50 Center applications 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, and plans for data analysis and dissemination. Up to 15 additional pages total will be allowed to describe the organizational structure and management plans for the Center, and a description of training plans and activities. Each individual section should be clearly labeled. For the P20 applications, the regular PHS 398 instructions should be followed (with a page limit of 25 pages total for items 2-5).

Consortium participation: Annual meetings of investigators from funded Centers and Exploratory Research projects will be held. This will facilitate sharing of information about current and planned research, training, and policy 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 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 Exploratory grants can budget for fewer participants if desired. Trainees are welcome to attend.

Transdisciplinary and diverse research teams: The CEER program is intended to facilitate the formation of transdisciplinary teams of investigators who will develop new ways to anticipate, frame, and investigate ELSI research questions. These research teams must include, as appropriate, basic genomic and genetic scientists, clinical and social scientists, and researchers from law, bioethics and the humanities; however, it is essential that the theme selected for the CEER be well-anchored in genomic and genetic sciences. NHGRI particularly encourages the involvement of minority-serving institutions and investigators from under-represented minority populations and those with disabilities.

Management and organization: The PI of a P50 Center will be required to commit at least 30% effort to the implementation and leadership of the Center. 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. There is no specific time commitment required of the PI of a P20 project however; the PI should devote sufficient time to demonstrate that he/she will be able to do the organizational groundwork and planning to develop a successful P50 center proposal. A timeline for both Center and exploratory research projects should be included in the application that shows how the goals can be met within the timeframe of the CEER grant. This timeline will be used to help assess progress toward the project's goals. A CEER will include a well thought out and well-integrated project plan. The application should carefully describe the specific organizational structure that will be used to support the research, and the synergism that will result because of this arrangement. 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.

Training: In addition to a strong research component, a P50 Center is required to have a highly effective training component that will leverage the strengths of the transdisciplinary nature of the Center and its investigators to train the next generation of ELSI scholars 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 by this training component, the post-doctoral fellow will have applied for a National Research Service Award (NRSA-F32) which will allow funds for additional trainees. 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. While P20 exploratory projects should not propose a training component in their application, they should describe the types of training activities, particularly for training of investigators from under-represented minority populations that may be appropriate for the subsequent P50 Center.

Site visits: After the first year of funding, it is expected that annual administrative site visits will be scheduled to assess progress being made in the P50 Centers. Most site visits will be held at the funded institution. Occasionally it may be necessary to hold reverse site visits, in which investigators travel to NHGRI to report on progress. After the site visit of the third year, a decision will be made about the disposition of the fifth year of funding of 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. After that review, the P50 Center Principal Investigator will receive guidance from the NHGRI program director concerning the NHGRI's interest in accepting a competing renewal application to extend the initial award. This would not apply to those Centers that have already been competitively renewed.

Centers applying for a competitive renewal: Those applicants who have already had Center funding (competitive renewals) should begin their application with a 3-5 page progress report summarizing the accomplishments of the Center to date. Applicants should include information about the placement and structure of the Center within the institution, a summary of transdisciplinary research activities including the disciplines involved, information about any translational activities, and a summary of training accomplishments. More detailed information can be included in the preliminary studies section of the application. Plans for continuing the Center’s activities once CEER funding is over should be included in the research design and methods section.

Progress Report Publication List should include the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project. When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the Pubmed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate PMC Journal In Process. A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference (note that copies of these publications are not accepted as appendix material).

Appendix Materials

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

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Not applicable.

Genome-Wide Association Studies (GWAS): 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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHGRI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does this application address an important emerging or previously unresolved 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 significantly advanced? Will these studies have an effect on the field of ELSI research? Will they be relevant and useful to the larger research, health, and social policy communities? Does the research problem addressed require investigation by a Center team?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 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?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? For proposed multi-component centers, is there a high likelihood for scientific gain from the collaborations, interrelatedness and synergy among the various components? If any individual component were removed, would the ability of the CEER to accomplish its overall aims be impaired?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 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 the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of the PI and investigative team? 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: Does the Training Program Director have experience in managing career development programs and success in preparing investigators for independent research careers? Are there high quality potential candidates (plans for recruiting and selecting candidates, particularly minorities)? Are academic and research career development plans adequate? Are sufficient and high quality potential Mentors identified? Will trainees receive instruction in the Responsible Conduct of Research and Human Subjects Protections? Is the Research Environment suitable for trainees? What is the quality of the proposed training plan and its likely effectiveness in producing well-trained ELSI 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? Are there well-detailed plans laid out to recruit trainees from under-represented populations?

NIH considers the following in evaluating Center grant applications:

2.A. Additional Review Criteria:

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

2.B. Additional Review Considerations

Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html). Items 2 and 3 are not applicable to this FOA.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

3. Reporting

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

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 the training component, each Center PI will be required to submit 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 ). 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.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

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: [email protected]

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 (for US Postal Service)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 402-0838
Fax: (301) 435-1580
Email: [email protected]

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 20892-9306
Telephone: (301) 435-7858
Fax: (301) 451-5434
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

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

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

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

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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

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

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

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

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

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

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

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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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