It is critical that applicants follow the Research (R) 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

Continuing advances in genomic technology, coupled with lower sequencing costs, are rapidly increasing the numbers of people being sequenced and transforming biomedical research. As knowledge of the relationship between genetic variation and human diseases and traits proliferates, the distinctions between basic and clinical genomic research are beginning to blur, and new findings are altering the practice of medicine. Meanwhile, information technologies - including personal mobile devices, patient health portals, electronic health records, and cloud storage are influencing how individuals genomic data are stored, analyzed, shared, and used in commercial, biomedical and non-medical settings. Taken together, these developments may have profound effects on many long-standing societal beliefs and norms and create a need for new policies and practice guidance. It is essential that such policies and guidance be informed by reliable data 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. Supporting this research through the existing ELSI research project (R01), small research (R03) grant, and exploratory research (R21) grant Program Announcements is a critical component of the ELSI Program and will continue to be a high priority as the program moves into the future. While considerable progress has been made in many areas, longstanding issues periodically require reconsideration, and new issues continue to arise. As the pace of genomic innovation continues, the development of research teams with the multi-disciplinary expertise and flexibility to anticipate and respond rapidly to these issues is critical. The support 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 supports the establishment of sustainable trans-disciplinary research teams that will anticipate and investigate well-defined high priority ELSI research questions requiring intensive, extended, multi-disciplinary collaborations that employ diverse methods. 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 or theme that will serve as the focal point for its activities, and to describe plans to conduct research that will be consistent with that theme. It is critical that the theme not be overly broad and that the approaches to achieve the planned research be articulated in sufficient detail to allow assessment of scientific rigor and merit in the peer review process.

The following are broadly defined ELSI research domains. More detailed descriptions are available on the ELSI Research Program website. Renewal applicants are encouraged to identify and clearly articulate a targeted theme that falls within any of these areas and which builds on the research currently being funded by the Center.

Genetic and Genomic Research. These projects may examine and address the ethical, legal, and social issues that arise in connection with the design and conduct of genetic and genomic research. Research areas of particular interest include the following (order of topic areas is unrelated to relative priority):

• Inclusion of Diverse Populations in Research
• Participant Rights and Engagement
• Informed Consent
• Re-identification, Security and Data Privacy
• Data Stewardship and Sharing
• Return of Research Results and Secondary Findings
• Boundaries Between Research and Clinical Care
• Legal and Regulatory Research Issues

Genetic and Genomic Health Care. These projects may examine and address the ethical, legal, and social issues that arise in connection with the translation of genetic and genomic research into clinical practice and health care. Research areas of particular interest include the following (order of topic areas is unrelated to relative priority):

• Clinical and Personal Utility of Genomic Health Information
• Rights and Responsibilities of Patients and Providers
• Return, Communication and Use of Clinical Genomic Results and Secondary Findings
• Genomic Medicine in Diverse Healthcare Settings
• Genomics and Public Health
• Precision Medicine and Genomics
• Genomic Medicine and Health Disparities
• Economics of Genomic Medicine
• Legal and Regulatory Health Care Issues

Broader Legal, Policy and Societal Issues. These projects may examine and address a range of broader legal, policy and societal issues raised by the use of genomic technologies and information in research, clinical or non-medical settings. Research areas of particular interest include the following (order of topic areas is unrelated to relative priority):

• Genomic Equity and Social Justice
• Citizen Science & Consumer Genetics
• Non-Medical Uses of Genomics
• Downstream Implications of Emerging Genomic Technologies
• Genomics and Shifting Societal Definitions and Norms
• Genomics and Conceptions of Human Identity and Origins
• The Effect of Genetic Determinism on Attitudes, Behaviors and Policy
• The Role of Genetic Exceptionalism in Policy Development

Although many important ELSI topics can appropriately be 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, trans-disciplinary approaches to explore and address existing issues and identify new issues relevant to a particular topic area or theme. Each application will be expected to describe either a single research project or a number of smaller, well-integrated research projects that are clearly related to the Center’s theme. The project or projects should include comprehensive, trans-disciplinary methods and approaches to address existing issues and to identify new issues. Applicants are encouraged to propose and justify research approaches that make use of a wide range of methodologies, including data-generating empirical (qualitative and quantitative) studies, legal and normative analyses, and other analytical or conceptual research methodologies. Research should be combined with dissemination and outreach activities designed to inform the development of appropriate policy options or professional guidelines.

Another important aspect of the CEER Program is the support of activities designed to help develop and nurture a strong and diverse cadre of new ELSI researchers. Applicants should propose a clearly described plan to develop the next generation of ELSI researchers that emphasizes experiences in the full range of multidisciplinary ELSI activities. This plan can focus on one or multiple career levels from undergraduates to junior faculty. Activities focused on K-12 or the general public are not permitted. The plan to provide ELSI Research Career Experiences should be clearly integrated with all Center activities. Applicants are strongly encouraged to propose activities that leverage existing institutional and other resources to realize the goals of this plan and to enhance the involvement of participants from diverse backgrounds.

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, coordination and organizational structure for all the Center’s activities.

The ultimate goal of this FOA is the support of self-sustaining Centers of ELSI scholarship whose expertise and accomplishments garner sufficient institutional and other research support to maintain the trans-disciplinary Center and its work after the completion of NHGRI funding. Applicants are encouraged to consider how they anticipate that Center activities will be supported and sustained after the funding period has ended. This concept of sustainability is particularly relevant for applicants applying for the final four year renewal of their existing Center. As the Center’s primary research activities continue, additional funding should be sought through other funding opportunities such as the ELSI research project (R01), small research (R03), and exploratory research (R21) grant programs to support related research.

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 and research collaborations 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 social sciences;
• be highly innovative and develop new concepts, methods, analyses, or ways to consider ELSI issues or use ELSI findings that will substantially advance the state of the science in ELSI research;
• propose an integrated set of activities to address a well-defined highly significant topic area or theme in ELSI research;
• propose research that cannot reasonably be addressed by other NIH research grants
• 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);
• increase the pool of ELSI researchers, by offering innovative, substantive experiences in ELSI research that encompass the full range of multidisciplinary ELSI activities; and
• propose a clear strategy to promote the development of new investigators, particularly investigators from diverse backgrounds.

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 research team and budget of a typical R01;
• be a collection of individual R01s or a program project; or
• provide infrastructure for an existing Center, Program, Division, or Department.

All successful applicants are eligible to participate in NHGRI's diversity action plan by applying to PAR-16-345, Initiative to Maximize Research Education in Genomics (R25): Diversity Action Plan (R25). Applicants are strongly encouraged to discuss the initial results of their RM1 application with staff before applying for the R25.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)

Only grantees previously funded under RFA-HG-15-021 and currently eligible to submit an application for a four year renewal are eligible to apply.

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 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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. ELSI Research Career Experiences: 6 pages

C. Research Management 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 at least 4 person months, with at least one PD/PI committing not less than 2 person months.

Annual meetings of investigators from funded Centers will be held. This will facilitate sharing of information about current and planned CEER 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. 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 research career experiences and 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 or theme 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: For Renewal applications, this section should begin with a progress report on the activities and accomplishments of the currently funded CEER. The Progress Report should:

• Summarize the specific aims of the previous project period and discuss the importance of the transdisciplinary research efforts and research findings, the translation and dissemination of research findings to support the development of informed policy and practice, and the success of the center in supporting the development of diverse and accomplished young researchers.
• Discuss efforts to help ensure the sustainability of Center activities beyond the final funding period.
• Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
• Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research.

Use the progress report to discuss, but not duplicate information collected elsewhere in the application. (NOTE: the submission of a progress report in the application does not supersede the requirement for submission of the I-RPPR and will not serve in lieu of the I-RPPR. See Guide Notice https://grants.nih.gov/grants/guide/notice-files/not-od-17-037.html )

Do not include a list of publications, patents, or other printed materials as part of the progress report in this section. That information will be included in the "Progress Report Publication List" attachment.

The progress report should be followed by a description of an integrated set of research activities that build on the previous work of the Center. These activities should use a range of clearly justified 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 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 impact of Center work, the activities described should involve the appropriate stakeholders in the design and implementation of the research and the subsequent dissemination of research findings. Where appropriate the research should incorporate or consider diverse points of view, including, communities that may be particularly vulnerable to or disproportionately affected by the issues being addressed. A discussion of how stakeholder input will be integrated throughout the research process should be included, along with a concrete strategy to ensure stakeholder participation.

Applicants should succinctly describe and justify their methodological approaches for each research activity, and provide enough detail so that reviewers can assess the value, feasibility, and rigor of the proposed research. The expertise of the Center's researchers to carry out the proposed research as a synergistic team should be clearly described, but should not duplicate information provided on individual biosketches. 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. ELSI Research Career Experiences: This section should provide a clear description of an effective program to provide experiences in ELSI scholarship that will use the transdisciplinary nature of the Center and its investigators to develop the next generation of ELSI researchers. These experiences may encompass the full range of multidisciplinary CEER activities, such as normative, legal, qualitative and quantitative data collection and analysis, preparing publications, presenting findings to a variety of audiences, using research data to help inform the development of ethical and effective policies and practices, and developing successful multidisciplinary ELSI research grant applications. The qualifications of the senior researchers who will be overseeing these experiences should be discussed. Experiences may be focused on participants across the career pipeline from undergraduate students to junior faculty, or on individuals at specific career levels, as appropriate. Activities focused on K-12 or the general public are not permitted. Information on the identification and selection of candidates for these experiences should be included. In addition, applicants are strongly encouraged to describe how they will leverage existing programs at their institution and at the NIH (e.g. the Research Supplements to Promote Diversity and the NRSA Predoctoral Fellowship to Promote Diversity programs) to ensure that they can effectively recruit and retain diverse scholars. A brief description of how the CEER may apply for and will incorporate a possible R25 Diversity Action Plan into their Center activities should be included. If the CEER already is supporting an R25 DAP, the integration of this program into ongoing CEER activities should be described.

Plans for assessing the effectiveness of these activities in contributing to the development of a diverse and well-prepared cadre of new ELSI researchers should be described.

C. Research Management 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 Plan should include the following:

• a description of the management structure, leadership roles, and mechanisms of communication;
• 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 description of the disciplinary expertise of any planned project advisors, along with a clear description of the role that will be played by these advisors in guiding the Center’s activities. For renewal applications, the names of members of existing advisory groups should be identified;
• a description of the strategies and approaches to reach across institutional departmental boundaries to recruit and retain multi-disciplinary investigators to participate in the Center's research, policy, and career advancement activities. Particular attention should be given to recruitment and retention of investigators from fields that have not traditionally been involved in ELSI research and those primarily involved in genetic and genomic research;
• a description of institutional support for Center activities and how this will contribute to long-term sustainability of the Center; and
• a timeline that shows how the Center’s 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, with the following modification:

The NHGRI is committed to the principle of rapid release of publications and resources to the scientific community from projects of broad community interest. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applicants should justify the design and extent of resource sharing based on the nature of the research proposed. Applicants should describe whether and/or under what conditions the following may be shared: primary research data; tools, instruments and study methods; and publications and best practices.

Applicants should describe how they will collaborate with ongoing NHGRI efforts to ensure sharing of ELSI research resources, such as the Center for ELSI Resources and Analysis (CERA). CERA will be funded in the summer of 2019 to establish a platform to share ELSI research tools and products and curate and synthesize ELSI research on key topics in the field.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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? Is the prior research that serves as the key support for the proposed project rigorous? 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 unresolved ELSI research topic area related to genomic and genetic science? Is the topic area or theme clearly defined and not overly broad? 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 related to this theme be significantly advanced? Will they be relevant and useful to the broader research, health, and social policy communities?

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 the activities of the Center? Do the PDs/PI(s) have strong track records of working collaboratively across disciplines and across institutions? Is the level of effort for the PDs/PIs and other 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? Is the role played by each investigator clearly described and integrated with proposed CEER activities?

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?

In addition, for applications involving clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If multiple projects are proposed, are the approaches and methodology for each project described succinctly but with sufficient detail to determine the feasibility of the proposed research?

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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials:

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of institutional support for Center activities and infrastructure, and for the likelihood of sustaining Center activities beyond the proposed period of NIH funding?

In addition, for applications involving clinical trials:

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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, does it build on the previous work of the Center, and is it focused on the topic area identified as the Center's theme? If multiple projects are proposed, are they well integrated and do they clearly contribute to the Center’s overall goals? Does the proposed research 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, as appropriate, to inform the development of policy options or professional guidelines?

Where appropriate, are diverse points of view incorporated, including, 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?

ELSI Research Career Experiences

Are the ELSI research experiences and activities described of high quality? Will they contribute to the development of well-prepared ELSI researchers? Have a sufficient number of well-qualified and experienced senior researchers been identified to support these activities? Is the research environment suitable? Are the plans to identify and select participants, particularly those from diverse populations, clear and well justified? Are efforts to leverage existing institutional programs clearly described and feasible? Are plans to assess the effectiveness of the activities described?

Research Management 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?

Are the Center's components well integrated? Do the various research, policy 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?

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 investigators 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?

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

Study Timeline

Specific to applications involving clinical trials:

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

For research that involves human subjects but does not involve one of the 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 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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

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

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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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:

• 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 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 National Advisory Council for Human Genome Research. 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Joy Boyer
National Human Genome Research Institute (NHGRI))
Telephone: 301-480-2247
Email:[email protected]

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

Anneliese Galczynski
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4935
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 mended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.