Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) 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. 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.

Part 1. Overview Information
Part 2. Full Text of the 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

Rapid advances in genomic technologies and the increasing availability and use of genomic information in a wide range of contexts both within and outside the biomedical setting - have the potential to transform how research and health care are practiced and to affect many aspects of society. As new genomic tests emerge, large amounts of detailed personal genomic information are becoming widely available and being used in a variety of ways in research, health care, commercial and other settings. These trends raise new ethical, legal, and social issues and create a need for new policies and practice guidance. It is essential that such policies and practice guidance be informed by reliable data and be based on sound theoretical models and rigorous research. New policies and practices must also 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 Ethical, Legal and Social Implications (ELSI) Research Program, has funded many studies involving investigators from single or multiple disciplines using a variety of methodologies. While considerable progress has been made, longstanding issues occasionally require fresh reconsideration, and new issues continue to arise. As the pace of genomic innovation increases, the development of research teams with the multi-disciplinary expertise and flexibility to anticipate and respond rapidly to these issues will become increasingly important. The establishment of Centers with the resources and expertise to design and implement trans-disciplinary investigations of complex, persistent or emerging ELSI issues is an important component of the overall NHGRI portfolio.

The Centers of Excellence in Ethical, Legal and Social Implications (ELSI) Research (CEER) Program is designed to support the establishment of sustainable trans-disciplinary research teams that can anticipate and investigate well-defined high priority ELSI research questions best approached through intensive and extended collaborations among investigators from multiple disciplines, using diverse methodologies. The investigators in a Center are encouraged to: consider new ways to explore such questions; design innovative research projects that utilize a range of research methodologies; and, where appropriate, propose and disseminate research, health, or social policy options based on the results of their research.

In order to enhance the focus and cohesiveness of the Centers and decrease the risk that the activities of a Center will become diffuse, each Center will be expected to identify a well-defined topic area that will serve as the focus or organizing theme for its activities, and to describe plans for research that will be conducted consistent with that focus or theme. It is critical that the topic area not be overly broad and that the planned research be articulated in sufficient detail to allow assessment of its scientific merit in the peer review process.

The following are broadly defined ELSI research priorities. Applicants are encouraged to identify and clearly articulate a targeted theme that falls within any of these areas.

• Genomic Research. The issues that arise in the design and conduct of genomic research, particularly as it involves the production, analysis and broad sharing of individual genomic information, frequently coupled with detailed health information.
• Genomic Health Care. How rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided and how it affects the health of individuals, families and communities.
• Broader Societal Issues. The normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as the implications of genomics for how we conceptualize and understand such issues as health, identity, disease, and individual responsibility.
• Legal, Regulatory and Public Policy Issues. The effects of existing genomic research, health and public policies, laws, and regulations and the development of new policies, laws, and regulatory approaches.

Although many important ELSI topics are appropriately addressed through Research Project (R01), Developmental/Exploratory Research (R21) or Small Research (R03) grants, the intent of the CEER Program is to allow researchers to propose more comprehensive, sustained, trans-disciplinary approaches to exploring and addressing existing issues and identifying new issues in a particular topic area. Each application will be expected to describe either a single research project or a number of tightly interwoven research projects focused on the central topic or theme. The project or projects should include comprehensive, sustained, trans-disciplinary approaches to address existing issues and identify new issues in the topic area. Applicants are encouraged to propose research that uses a wide range of methodologies, including data-generating empirical (qualitative and quantitative) studies, legal and normative analyses, and other analytical or conceptual research methodologies, which can be combined with dissemination and outreach activities designed to inform the development of appropriate policy options or professional guidelines.

To ensure that the Centers activities are well organized, integrated and managed, each Center is expected to establish a strong management component to provide the support and organizational structure for all the Center’s research, education and career advancement activities. Education and career advancement activities can span the career pipeline from undergraduate through junior faculty levels and should focus on developing the next generation of ELSI scholars.

The ultimate goal of this FOA is the establishment of sustainable Centers of ELSI scholarship that have sufficient institutional and other research support to maintain the trans-disciplinary Center infrastructure and allow for the continuance of Center activities after the completion of NHGRI funding. Although not required under the current FOA, which solicits new applications, applicants are encouraged to address ideas for how Center activities will be supported and sustained after the funding period has ended. When competitive renewals are submitted, applicants will be required to include a detailed sustainability plan.

To further clarify the unique nature of the CEER Program, the following list of attributes of a Center is provided.

A Center should:

• develop and operate with a highly effective management strategy;
• promote intensive and sustainable interactions among investigators from different disciplines, such as the genomic sciences, clinical research, clinical and health policy, ethics, law, the humanities, economics, political science, anthropology and other basic social sciences;
• be highly innovative and develop new concepts, methods, analyses, or ways to consider ELSI issues that will substantially advance the state of the science in ELSI research;
• propose potentially significant advances to address a well-defined critical topic area in ELSI research;
• propose research that cannot reasonably be addressed by a standard R01 research grant (as the Center’s primary research activities continue, additional funding may be sought through the ELSI research project (R01), small research (R03), and exploratory research (R21) grant programs to support other related research);
• add value beyond the genomics and ELSI research studies that are already ongoing at the applicant institution;
• include a strategy for the timely dissemination of the results of the Center's ongoing activities to key stakeholders (including policy options as appropriate); and
• increase the pool of ELSI researchers, by offering innovative, substantive educational and career advancement opportunities across multiple disciplines and across the career pipeline, including integrating the development of new investigators and broadening the mentoring of established investigators.
• A Center should NOT:
• simply continue a research track already being pursued by an institutional or an inter-institutional research team;
• serve as the obvious next step in a project or field of inquiry, which could be accomplished by assembling a sizeable research team and budget of a typical R01;
• be a collection of individual R01s or a program project; or
• provide infrastructure for an existing Program, Division, or Department.

All successful applicants are eligible to participate in NHGRI's diversity action plan by applying to PAR-13-063 Limited Competition: Initiative to Maximize Research Education in Genomics (R25): Diversity Action Plan, for the September 25, 2016, due date. Applicants are strongly encouraged to discuss the initial results of their RM1 application with staff before applying for the R25. (Updated February 25, 2015 per issuance of NOT-HG-15-022.)

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• For-Profit Organizations (Other than Small Businesses)

Governments

• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

Institutions that have previously received funding for a P50 Specialized Center through the CEER Program are not eligible to submit applications under this FOA. However, individual investigators at these institutions may participate in new applications in a limited fashion as consultants/collaborators.

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Joy Boyer
Telephone: 301-402-4997
Fax: 301-402-1950
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The Research Strategy must consist of the following subsections with the indicated page limits:

A. Research Activities: 30 pages

B. Research Management, Education and Career Advancement Plan: 6 pages

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI of a Center will be required to commit at least 4 person months effort to the implementation and leadership of the Center. If multiple PDs/PIs are listed, their combined effort must total 4 person months, with at least one PD/PI committing not less than 2 person months.

Annual meetings of investigators from funded Centers and Exploratory Research Center projects will be held. This will facilitate sharing of information about current and planned research, education, career advancement, and policy activities, communication of research findings and policy deliberations, and experiences in organizing and operating a Center. 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 PD/PI and three others) per year should be included in the requested budget. Funding also can be requested to support the participation of individuals involved in Center education and career advancement activities. In addition to these meetings, Center investigators will be expected to participate in and, where appropriate, lead trans-Center initiatives, such as networking activities, joint workshops and research projects, and trans-Center publications.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: These should address the specific aims of the Center as a whole. A description of the Center's high priority topic area and how it will serve as the focus for Center activities should be included.

Research Strategy: The Research Strategy section should consist of the following subsections, uploaded as a single pdf attachment.

A. Research Activities: This subsection will propose an interwoven set of research activities using a wide range of methodologies and approaches to address the high priority topic area identified as the theme for the proposed Center. The research activities described should integrate data-generating qualitative and quantitative studies, legal and normative analyses, and other analytical or conceptual research methodologies with activities that can facilitate the use of Center research findings and expertise to inform the development of research, health and public policies and practices regarding the use of genomic information and technologies. To maximize the utility and potential impact of these options or guidelines, the activities described should involve the appropriate stakeholders in the conceptualization, design and implementation of the research and the subsequent dissemination of research findings. The research should incorporate diverse points of view, including, as appropriate, communities that may be particularly vulnerable to or disproportionately affected by the issues being addressed. 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 addition, this subsection should describe the process that will be used to identify new issues coming out of the Center's research that may be targeted for expanded research activities. A description of how these new activities will be developed, reviewed, prioritized and supported should be included.

B. Research Management, Education and Career Advancement Plan: Centers proposed in response to the FOA will require a strong organizational structure to ensure the creation of an integrated, effective and sustainable trans-disciplinary Center. The description of the Research Management, Education and Career Advancement Plan should include the following:

• A description of the management structure, leadership roles, and mechanisms of communication. A description of the advisory structure and disciplinary expertise of project advisors, along with a clear description of the role that will be played by the advisors in guiding the Center s activities. (Note: to facilitate the review of applications and to avoid unnecessarily creating conflicts of interest, the actual individuals that will serve as advisors should NOT be listed in the application and should NOT be contacted until the review of the application is completed.)
• A description of the strategies and approaches that will be used to reach across institutional departmental boundaries to recruit and retain multi-disciplinary investigators--particularly those in fields that have not traditionally been involved in ELSI research and those primarily involved in genomic research--to participate in the Center's research, policy, and education and career advancement activities.
• A description of an effective education and career advancement program that will leverage the transdisciplinary nature of the Center and its investigators to develop the next generation of ELSI scholars. It should include a description of the recruitment, supervision, education, and career advancement activities that will be used by the Center. Education and career advancement activities may address the career pipeline from undergraduate students to junior faculty; however, applicants are not required to address the full pipeline and can focus on individuals at specific career levels, as appropriate.
• A description of how all the activities of the Center will be integrated to effectively address the topic area identified as the Center's theme.
• A timeline that shows how the Center aims will be met within the timeframe of the award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

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 review criteria and additional review criteria (as applicable for the project proposed).

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 project that by its nature is not innovative may be essential to advance a field.

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 research topic area related to genomic and genetic science? Is the topic area clearly defined and not overly broad 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 area be significantly advanced? Will the Center's activities have an impact on the field of ELSI research? Will they be relevant and useful to the larger research, health, and social policy communities?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PDs/PI(s) have the ability, expertise and experience to lead, coordinate, and manage all of the activities of the Center? Do the PDs/PI(s) have strong track records of working collaboratively across disciplines and across institutions? Are the other key personnel identified from multiple disciplines? 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 methodologies needed to achieve the goals of the Center? Are investigators from minority populations and/or those with disabilities included?

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?

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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 score, but will not give separate scores for these items.

Research Activities

Is the research clearly described and is it focused on the topic area identified as the Center's theme? 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 policy options or professional guidelines? Are diverse points of view incorporated, including, as appropriate, communities that may be particularly vulnerable or disproportionately affected by the issues being addressed? Are the proposed strategies for ensuring that the Center's research can be used, as appropriate, 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 findings?

Is the process used to identify, review, support and prioritize new issues that are emerging out of Center research clearly described and likely to be successful? Is there evidence that this process is well integrated with other Center activities?

Research Management, Education and Career Advancement Plan

Is the management plan, including the management structure, appropriate and adequate to support and sustain the Center? Is there an effective plan for use of fiscal resources, shared facilities and human resources to achieve the research aims and overall Center goals?

Is there an adequate plan for the organization, management and coordination of the Center 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 PDs/PI(s) and investigative team?

Is the role of project advisors clearly described? Is the expertise described appropriate to support planned Center aims and activities?

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?

Are education and career advancement plans adequate? Are a sufficient number of well-qualified and experienced potential supervisors identified? Is the research environment suitable? What is the quality of the proposed activities and what is their likely effectiveness in producing well-prepared ELSI researchers who can develop new approaches to ELSI questions and research?

Are the Center's components well integrated? Do the various research, education and career advancement activities of the Center work together synergistically to strengthen the Center's ability to accomplish its overall goals? Do the combined resources create capabilities that are more than the sum of the parts?

Can the proposed activities be accomplished within the timeframe of the award?

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 Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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 score.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

After the second year of funding, administrative site visits may be scheduled to assess progress being made in the Center. 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, a decision will be made about the disposition of the fourth year of funding of the Center. If the NHGRI decides to phase out the project before the fourth year, the budget for the third year may also be reduced..

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Joy Boyer
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-4997
Email: [email protected]

Rudy Pozzatti
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]

David Ruane
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0733
Email: [email protected]

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.

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 Part 75.