Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

Specialized Centers of Excellence in ELSI Research (CEER) (P50)

Activity Code

P50 Specialized Center

Announcement Type

Reissue of RFA-HG-09-003

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HG-12-005

Companion Funding Opportunity

RFA-HG-12-012, P20 Exploratory Grants

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.172

Funding Opportunity Purpose

The National Human Genome Research Institute (NHGRI) is soliciting grant applications for the support of Specialized Centers (P50) of Excellence in Ethical, Legal and Social Implications (ELSI) Research (CEERs).  The CEER program is designed to develop and support trans-disciplinary research teams that have the expertise and flexibility to anticipate, conduct research on, and respond quickly to a range of ELSI issues related to the rapidly increasing availability and use of genomic approaches and information.  CEERs are intended to provide an opportunity to cross disciplinary boundaries and create new research opportunities between and among investigators such as those in the basic genomic and social sciences, clinical and health policy research, ethics, law, the humanities, and various stakeholder communities.  In addition, CEERs will play a role in ensuring that relevant ELSI research findings and deliberations are made available to policy makers as appropriate.  Finally, CEERs will be responsible for contributing to training the next generation of ELSI researchers, with particular emphasis on training researchers from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

Key Dates
Posted Date

April 12, 2012

Letter of Intent Due Date

June 19, 2012

Application Due Date(s)

July 19, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November, 2012

Advisory Council Review

Janauary2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

July 20, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The rapid evolution of genomic technologies and the increasing availability and use of genomic information have the potential to transform how research and medicine are practiced and to reshape the conceptualization of various social norms.  New genetic tests and large amounts of detailed personal genomic information are now widely available in research, health care and 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 and practice guidance is increasing.  To ensure the usefulness and applicability of these policies, it is essential that they: 1) are informed by reliable data, based on sound theoretical models and rigorous research, and 2) incorporate the perspectives of individuals from diverse racial, ethnic and socioeconomic backgrounds, as well as children, older adults and people with disabilities.

The NHGRI, through its ELSI Research Program, has funded many research projects involving 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 continues to increase, the development of research teams that have the multi-disciplinary expertise and flexibility to anticipate and respond rapidly to the large number of emerging and evolving ELSI issues will become increasingly important.  The creation and maintenance of research centers with the resources and expertise to design and implement multi-faceted and trans-disciplinary 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 can anticipate and investigate clearly defined high priority 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 research projects that utilize the full range of ELSI research approaches, 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.  NHGRI welcomes the involvement of minority-serving institutions and investigators from under-represented minority populations and those with disabilities.

To ensure that the CEERs’ activities are well organized, integrated and managed, each CEER will be expected to establish a strong and effective operational core to provide the support and organizational structure for all the Center’s activities.  In order to enhance the focus and cohesiveness of the CEERs and decrease the risk that activities of a CEER will become diffuse, each Center will be expected to identify a well-defined, highly significant current research topic, or set of closely related research questions, that are well anchored in genomic and genetic sciences and that will serve as the focus or organizing theme of its research, policy and training activities.  Examples of possible high priority topics are described on the ELSI Research Program’s website (http://www.genome.gov/27543732).  These topics are based on the broad priority areas identified in the Genomics & Society section of NHGRI’s 2011 strategic plan for the future of human genome research ("Charting a course for genomic medicine: from base pairs to bedside”  Nature 10 Feb 2011:470;204-13.).  They are meant as examples only and should not be considered an exhaustive listing of all possible research areas of focus. 

Although aspects of each of these issues can be and are being addressed through Regular (R01), Developmental/Exploratory (R21) or Small (R03) research grants, the intent of the CEER program is to allow researchers to propose more comprehensive, trans-disciplinary approaches to exploring and addressing existing issues and identifying new issues.  To accomplish this, each CEER will be expected to propose a focused research project that will use the full spectrum of ELSI research and policy methodologies and approaches to explore and address the high priority topic they have identified as the theme for their CEER.  The research project should integrate data-generating qualitative and quantitative studies, legal and normative analyses, and other analytical or conceptual research methodologies with translational activities that use these conceptual tools and empirical data to inform the development of appropriate public-policy options or professional guidelines.

In addition to the operational core and the comprehensive research project, the CEER application should include: 1) a trans-disciplinary component that describes trans-disciplinary outreach and support activities; 2) a translation and emerging issues component that describes how the CEER will facilitate the translation of its research to inform the development of policies and practices.  This component also should describe mechanisms the CEER will use to identify new and emerging issues that are ripe for policy development or need further research; and 3) a training component that describes CEER recruitment, mentoring and training activities.

In addition, each CEER should propose a trans-CEER coordination component, that will provide support for joint CEER activities such as monthly conference calls, shared web resources, and coordination of the annual investigators meeting.  (Note: each P50 applicant is required to include this component in their application; however, only one CEER's trans-CEER coordination component will be funded.)

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:

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, demonstrating effective collaborations, exploring organizational concepts, developing courses or curricula, collecting preliminary data, or refining and fully developing their vision for a proposed P50 CEER project. For these groups, the Exploratory Grant (P20) mechanism should be used.  Individuals interested in applying for a P20 Exploratory Grant should respond to RFA-HG-12-012.

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.

CEER grantees submitting applications for competitive continuations will be required to include a brief progress report and list of CEER publications and to present a plan describing how the CEER will sustain its activities after it has completed its second, and final, five years of NHGRI funding.  This sustainability plan should be included in the description of the overall Center operational core.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal.  A P50 Center grant will be renewable one time, for a total project period not to exceed ten years.

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NHGRI intends to commit $ 2,100,000 in FY 2013 to fund 2 P50 grants.

Award Budget

Application budgets for the P50 Center grants are limited to $750,000 direct costs per year for up to five years.   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 cost limit.  In addition, up to $75,000 in direct costs can be proposed for the budget for the trans-CEER coordinating component.  This will be in addition to the $750,000 limit on direct costs.

Award Project Period

The maximum period of support for a P50 Center grant application is 5 years.

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

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Joy T. Boyer
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: jb40m@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and 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)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Dr. Rudy Pozzatti
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: rp7s@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:

For the P50 Center applications:

Detailed Budget for Initial Budget Period

A separate detailed Budget for the initial budget period should be provided for the Trans-CEER Coordination component.

Budget for Entire Proposed Period of Support

A separate detailed Budget for the Entire Proposed Period of Support should be provided for the Trans-CEER Coordination component.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Center grant (P50) Applications to this FOA will include: 1) an operational core; 2) a comprehensive research project component; 3) a trans-disciplinary research component; 4) a training component; 5) a translation and emerging issues component; and 6) a trans-CEER coordination component.

1. Operational Core. (12 pages)  CEERs proposed in response to the FOA will require a strong organizational structure to ensure the creation of an integrated and effective Center.  The description of the Center Core should include:

2.  Comprehensive Research Project Component. (12 pages)  This component will propose a focused research project that will use the full spectrum of ELSI research and policy methodologies and approaches to explore and address the high priority issue identified as the theme for the proposed CEER. The research project should integrate data-generating qualitative and quantitative studies, legal and normative analyses, and other analytical or conceptual research methodologies with translational activities that use these conceptual tools and empirical data to inform the development of appropriate public-policy options or professional guidelines. To maximize the utility and potential impact of these options or guidelines, the project should involve the appropriate stakeholders in the conceptualization, design and implementation of the research and the subsequent translation and dissemination of the products of the research. The research should incorporate diverse points of view, including, as appropriate, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed.

This component should follow the instructions in the PHS 398 Application Guide, Section 5.5.3 Research Strategy, with the exception of the overall CEER progress report for CEERs that are submitting renewal applications.  The CEER progress report should be included in the Center operational core section, as described above.

3.  Transdisciplinary Support Component. (6 pages)  This component is designed to facilitate the creation of a strong and sustainable transdisciplinary research team. These research teams must include, as appropriate, basic genomic and genetic scientists, clinical and social scientists, and researchers from law, bioethics and the humanities.  This component should include a description of the strategies and approaches that will be used to reach across institutional departmental boundaries  and recruit multi-disciplinary investigators--particularly those that are not traditionally involved in ELSI research and those primarily involved in genomic research--to participate in the Center's research, policy translation and training activities; a discussion of how this involvement will be sustained should also be included.  Institutional support for these efforts should be discussed. 

4.  Translation and Emerging Issues Component. (6 pages)  This component will support the CEER's efforts to ensure that Center research and expertise is used to inform the development of research, health and public policies and practices.  It should include a description of the resources, strategies and approaches that will help facilitate the utilization of the CEER's expertise and the translation of the CEER's research into formats that can be used to inform policies and practices; a discussion of how these activities will be integrated throughout the research process—from conceptualization to dissemination--should be included, along with a concrete strategy for ensuring the involvement of the appropriate stakeholders in the design and implementation of the research and the subsequent translation and dissemination of the research products.  This component also should include a description of the process that will be used to continuously identify, review and prioritize new issues that are emerging out of the Center's research that may be ripe for policy development activities, or targeted for expanded research efforts.  A description of how these new policy and research activities will be developed, reviewed, prioritized and supported should be included.

5. Training component. (6 pages)  This component will support the establishment of an effective training program that will leverage the strengths of the transdisciplinary nature of the CEER and its investigators to train the next generation of ELSI scholars to be able to develop independent research programs that address important ELSI problems.  It should include a description of the recruitment, mentoring and training activities that will be used by the CEER.  A clear plan for engaging the talents of individuals from underrepresented minority groups and a plan to provide the necessary support and mentoring as outlined in the NHGRI Action Plan (http://www.genome.gov/10001707) should be included.  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--see http://grants.nih.gov/grants/guide/pa-files/PA-09-210.html) or a Pathway to Independence Award (K99/R00--see http://grants.nih.gov/grants/guide/pa-files/PA-09-210.html) which will allow funds for additional trainees.  Given this training path, CEER trainees must be 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. 

6.  Trans-CEER coordination Component. (6 pages)  This component will provide support for trans-CEER activities.  It should include a detailed plan and budget (no more than $75,000 direct costs per year, except as noted below) to support trans-CEER activities, including:

Applicants are encouraged to proposed additional trans-CEER coordination activities and new and innovative ways of coordinating the activities listed above.

Each P50 CEER applicant is required to propose a trans-CEER coordination component; however, only one CEER's component will be selected for funding, based on the peer review of the application.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Consortium participation and collaboration.  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 CEERs, 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.  In addition to these meetings, CEER investigators will be expected to participate in and, where appropriate, lead trans-CEER initiatives, such as trainee networking activities, joint workshops and research projects, and trans-CEER publications.   

PD/PI commitment and timeline.  The PD/PI of a P50 Center will be required to commit at least 4 person months effort to the implementation and leadership of the CEER.  The PD/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 CEER's goals.  A timeline should be included in the application that shows how the goals can be met within the timeframe of the P50 CEER grant.  This timeline will be used to help assess progress toward the project's goals.

Site visits.  After the first or second year of funding, administrative site visits may 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. 

Centers applying for a competitive renewal.  Those applicants who have already had an initial five years of Center funding (competitive renewals) should include a brief progress report summarizing the accomplishments of the Center to date at the end of the Center Operational Core section of the application.  Applicants should include information about the placement and structure of the CEER within the institution, a summary of trans-disciplinary research activities including the disciplines involved, information about any translational activities, and a summary of training accomplishments.  Plans for securing support for the Center’s continuing activities once CEER funding is over also should be included.

The 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, and 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).    

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

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

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific 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 CEER that by its nature is not innovative may be essential to advance a field.

Significance

Does the application address an important problem or a critical barrier to progress in the field? If the aims of the CEER 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 ELSI research question related to genomic and genetic science?  Is the research topic clearly defined and is it the primary focus of the Center's activities?  If the aims of the application are achieved, will our understanding or ability to address the issues surrounding this topic be significantly advanced? Will the Center's activities 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 topic identified require investigation by a Center team?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the application? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have the ability, expertise and experience to lead, coordinate, and manage all of the activities of the CEER?  Do the PI(s) have sufficient leadership qualities and experience to develop and implement the CEER plans for the entire project?  Do the PD(s)/PI(s) have strong track records of working collaboratively across disciplines and across institutions? 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 the full spectrum of ELSI research and policy methodologies, as well as genomic/genetic science?  

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 CEER? 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 CEER 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?

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? Does the proposed CEER build on the multi-disciplinary resources available at the institution?  Is the environment adequate for the proposed training activities?  

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Operational Core

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 achieve the research aims and overall CEER goals?  Is there an adequate plan for the organization, management 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 PD(s)/PI(s) and investigative team?  Are the components of the project well integrated?  Do the transdisciplinary, translation, training and emerging issues components work together synergistically to strengthen the CEER's ability to accomplish its overall goals?  Are they effectively integrated into the proposed comprehensive research project? Do the combined resources create capabilities that are more than the sum of the parts? 

Comprehensive Research Project

Does the project address a well-defined and high priority research issue?  Does it incorporate and effectively integrate 'basic' analytical investigations that develop conceptual tools and shared vocabularies, data-generating qualitative and quantitative studies, legal and normative analyses, and more 'applied', 'translational' approaches?  Are the proposed conceptual tools, empirical data and analyses used to explore and define appropriate public-policy options or professional guidelines?  Are the appropriate stakeholders involved in the planning, implementation and dissemination of the research findings? Are diverse points of view incorporated, including, as appropriate, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed?

Transdisciplinary Support

Are there concrete, effective and sustainable plans for reaching across disciplinary boundaries and recruiting individuals with appropriately diverse experience and expertise?  Are strategies outlined that will effectively retain these individuals and support productive  and continuing collaborations? Is there evidence of institutional support for these efforts?

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? Is there a sufficient number of well-qualified and experienced 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 well-detailed plans laid out to recruit trainees from under-represented populations?

Translation and Emerging Issues

Are the proposed strategies for translating the CEER's research into formats that can be used to inform policies and practices well described and likely to succeed?  Is the plan for integrating these activities throughout the research process—from conceptualization to dissemination--well thought-out and realistic?  Are appropriate stakeholders involved in the design, implementation and dissemination of the research?  Is the process used to identify, review and prioritize new issues that are emerging out of CEER research clearly described and likely to be successful?  Is there evidence that this process is well integrated with the comprehensive research project, the training component and the translational efforts?  Is the process for developing, reviewing and supporting new research and policy activities clearly described and realistic?

Trans-CEER Coordination

Will the proposed plan provide adequate support for trans-CEER activities, such as regular CEER investigators conference calls, shared web-based resources, the annual investigators meeting and the annual trainee workshop? Is the plan cost-effective?  Does it take advantage of existing institutional resources and new information technologies?

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the NHGRI,  in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Ms. Joy T. Boyer
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: jb40m@nih.gov

Peer Review Contact(s)

Dr. Rudy Pozzatti
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: rp7s@nih.gov
Financial/Grants Management Contact(s)

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: chickc@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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