Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

Center for ELSI Resources and Analysis (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • August 8, 2018 - Notice of Pre-Application Information Webinar and Frequently Asked Questions (FAQs) for NHGRI Center for ELSI Resources and Analysis (CERA): RFA-HG-18-008. See Notice NOT-HG-18-014.
Funding Opportunity Announcement (FOA) Number

RFA-HG-18-008

Companion Funding Opportunity

None

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

93.172

Funding Opportunity Purpose

The NHGRI Ethical, Legal and Social Implications (ELSI) Research Program solicits applications to develop and implement a Center for ELSI Resources and Analysis (CERA). The proposed Center will:  1) provide ELSI researchers with an established platform to share their research tools and products related to genomics; 2) serve as a resource that curates and synthesizes ELSI research on key topics in the field, highlights new findings and provides access to these works; and 3) convene ELSI researchers for both small and large scale transdisciplinary projects and meetings to develop a more synergistic and integrated ELSI research community.

Key Dates
Posted Date

July 25, 2018

Open Date (Earliest Submission Date)

October 8, 2018

Letter of Intent Due Date(s)

October 3, 2018

Application Due Date(s)

November 8, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

March 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

November 9, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Purpose              

The NHGRI Ethical, Legal and Social Implications (ELSI) Research Program solicits applications to develop and implement a Center for ELSI Resources and Analysis (CERA). The proposed Center will:  1) provide ELSI researchers with an established platform to share their research tools and products related to genomics; 2) serve as a resource that curates and synthesizes ELSI research on key topics in the field, highlights new findings and provides access to these works; and 3) convene ELSI researchers for both small and large scale transdisciplinary projects and meetings to develop a more synergistic and integrated ELSI research community.

Background

Over the last 28 years the ELSI Research Program has funded research that has broad applications to genetic and genome sciences. As the range of applications of genomic research and clinical genomics grow, ELSI research findings on topics such as informed consent, the return of research results and secondary findings to research participants, data stewardship and sharing, and the inclusion of diverse populations in genomic research and medicine may be relevant to audiences unfamiliar with the field. However, ELSI research is multi-disciplinary in nature and employs a wide variety of methods. For example, ELSI research from NHGRI grantees has been published in 400 different journals spanning dozens of disciplines and topics. There is no single society or regularly held conference that encapsulates the field. This diversity of disciplines and approaches is a strength, but can make it difficult for researchers, educators, practitioners, and policy makers to locate ELSI research studies and publications. Moreover, the breadth of methods used to address a question can make cross-study comparisons, analyses and summaries challenging. As genomic science, genomic medicine, and big data become prevalent across biomedicine, researchers from other fields may design ELSI studies, or try to address ELSI questions without being able to locate or draw upon prior work in these areas. To avoid having investigators “reinvent the wheel,” there would be great utility to create a resource that would ensure ELSI research is easily found, clearly summarized, and broadly available.

Currently, there is no established NIH-supported resource dedicated to curating and sharing the breadth of ELSI research tools and products. While there are some data repositories and resources which accept ELSI research instruments and the resulting data, they tend to specialize in particular data types or disciplines and are not federated or coordinated. Wider, coordinated sharing of the products of ELSI research would promote transparency, rigor and reproducibility, increase the use and utility of ELSI findings, reduce unnecessary duplication, provide materials for trainees to work with, and promote the use of common measures, facilitating cross-study comparisons as well as methodological assessment. 

In November 2017, ELSI Research Program staff discussed how to address these challenges with the Genomics and Society Working Group (GSWG) of the National Advisory Council for Human Genome Research.  The program then held two public webinars in March attended by approximately 80 participants including a broad sample of the ELSI research community with respect to discipline, career stage, and mechanism of NIH funding. Overall, participants urged ongoing and increased collaboration between ELSI research, genetics, genomics, and other fields of biomedical and clinical research to ensure that ELSI research findings are used and translated into meaningful outcomes. Most participants also supported the idea of broader sharing of survey and interview instruments, measures and tools utilized and produced in NHGRI-funded ELSI research. Such an effort was viewed as a means of increasing multidisciplinary research, rigor, reproducibility, and transparency.  General support was also voiced for efforts to summarize work on specific topic areas and conduct meta-analyses across ELSI research areas. Feedback gathered during the webinars was similar in tone and content to the prior input provided by the GSWG.

Research Scope and Objectives

The Center for ELSI Resources and Analysis (CERA) will provide ELSI researchers with a stable platform to share their research tools and products.  While ELSI research is relevant to many fields of clinical and biomedical research, the Center will focus on ELSI research related to genetics and genomics. The Center will, however, create an open access, user friendly, online portal that provides access to tools and products which could be useful to researchers outside of genomics.

The Center will collect, index, store, and make publicly available data collection instruments, data dictionaries, and study methods from NHGRI-funded ELSI research. Further, the Center will track and maintain a central database of ELSI scholarship and its products (e.g., resulting manuscripts; best practice or recommendations; scales; and tools developed for use in clinical genomics or genomic research).  However, the Center will not serve as a repository for primary ELSI research data as these are too heterogeneous to be effectively aggregated. Where appropriate, the Center will collect and coordinate information on how interested parties can access data from NHGRI-funded ELSI studies, including data shared through existing repositories or resources. The Center will collaborate with the NHGRI to identify research tools and products for inclusion in CERA, and to incentivize and facilitate the contribution of resources by prior, current and future grantees. The Center should develop a public online portal to facilitate the upload of, and access to these resources. The portal should include an intuitive interface which allows researchers with different backgrounds and levels of expertise to easily contribute, navigate and locate Center resources. The Center will conduct usability testing and assess the ongoing needs of actual and potential users. All resources and tools developed by the Center will be designed as non-proprietary and open source employing user interfaces that will allow the upload and download of resources. In addition, all resources and tools should be portable and easily transferred to other institutions as needed.

The Center will also serve analytical functions. Working with NHGRI, the Center will identify topics of importance to both genomic and ELSI researchers.  It will provide broad overviews of ELSI scholarship, using methods including but not limited to meta-analysis, literature review, and methods assessment.  The Center will integrate and synthesize current and existing ELSI research data across disciplines to identify areas of consensus and disagreement in the field, and important research gaps. The Center will conduct analyses focused on the evaluation and enhancement of ELSI research methods. CERA will partner with outside experts as needed to inform and complete these analytical functions. In support of NIH's Interest in Diversity (see NOT-OD-18-210), the Center will establish a diverse and inclusive environment, including input from groups traditionally underrepresented in research, in order to ensure a balanced resource and avoid the introduction of bias.

Finally, the Center will coordinate and support convening of ELSI researchers around common issues.  Examples could include special journal issues, regular topical webinars and discussions, and topic-centered meetings generating scholarship, bringing ELSI researchers together with the broadening genomics community and identifying emerging areas of work. The Center will collaborate with NHGRI and the grantee(s) organizing the biennial ELSI Congress Meeting, to funded separately through a U13 award (see NOT-HG-18-009). The Center will also facilitate expert responses to emerging ELSI topics.

To achieve these three main objectives, the Center will develop an outreach plan to help bring ELSI research and Center products to the widening set of potential users. This plan should include innovative strategies to (a) encourage and incentivize ELSI researchers to contribute materials to the Center and participate in other Center activities, (b) connect ELSI researchers more directly to one another and to a broader genetic and genomic audience, (c) ensure that genomic researchers, practitioners, trainees, funders, and policy makers are aware of NHGRI-funded work, past and present, that may inform both research and healthcare, (d) inform the ELSI community about the expanding genomic landscape and (e) train potential users on how to access and utilize Center resources.  The Center should include outreach and dissemination activities aimed at researchers across the career development pipeline.  Particular emphasis should be given to providing networking opportunities and other resources (e.g., web-based career development seminars, links to training opportunities etc.) to trainees and investigators new to ELSI research.

Sample Use Cases for CERA

CERA is intended to use innovative approaches to meet a variety of needs within the ELSI research community.  To further explicate the intended purpose and role of CERA, the following sample of use cases should be considered as possible, but not exclusive, examples of potential user scenarios. These use cases are intended to inform, but not dictate, possible designs and approaches to CERA.

  • Use Case 1: An ELSI researcher is preparing a new grant application that will use measures of genomic literacy. In preparing her grant, she would like to access and compare measures that have been utilized previously in genomic studies. Since her study will involve diverse populations, she would also like to easily understand if the measures have been validated and if so, in what populations. CERA could collect, annotate and provide access to instruments that would aid this investigator.
  • Use Case 2: A researcher is developing a study that will include genomic sequencing as one of many analyses. She is not an ELSI researcher. She is putting together her research protocol and would like to find information on strategies and considerations for the return of genomic results to inform the study design. As a non-expert, she is particularly interested in summaries of such work. CERA could provide this investigator access to the extant literature and analyses and identify ongoing scholarship. 
  • Use Case 3: A high-profile research publication on a new gene editing technology has created a great deal of media attention. The media coverage is of uneven scientific accuracy and does not consider prior ELSI research. A more nuanced assessment of the overall landscape that draws upon relevant current and prior work is needed in a timely fashion. CERA could identify and call on experts with a deep knowledge of the technologies and ELSI related publications in these areas to develop an appropriate and timely response.
  • Use Case 4. A professional clinical association is drafting guidelines for contacting relatives of deceased probands who might benefit from genetic testing.  The association is unaware of existing guidelines or scholarship on the matter, but has heard that other professional groups are discussing the issue. CERA would provide access to past and current scholarship on the topic, and consider whether and how it might contribute to guideline development.
  • Use Case 5: Many funders, basic scientists, and clinical researchers want to develop ethical broad consent language to facilitate widespread data sharing.  There is uncertainty about how to design an acceptable broad consent process, and what questions should be addressed in a policy governing wide data sharing.  Although considerable legal, normative and empirical ELSI scholarship has been done on these topics, a cross-disciplinary analysis could inform researchers about the state of the field, including areas where there is agreement about how to implement broad consent and data sharing, and areas where decisions are left to the discretion of researchers. CERA could select specific areas where such cross-disciplinary analyses are lacking and likely to be especially relevant. The CERA team could produce or commission scholarship in this or other select areas.
  • Use Case 6: A PhD candidate in medical anthropology is considering possible post-doctoral fellowship positions. She has heard about ELSI research at scientific conferences, but no one in her current institution is very familiar with the field. She would like to learn more about ELSI research including possible collaborators and training programs. As someone new to ELSI research, she may need help navigating CERA and its resources. CERA would organize and offer current information relevant to trainees and others searching for sources and centers of ELSI scholarship.

Participation in the ELSI Research Community

The ELSI Research Program supports research through investigator-initiated grants (R01, R21, R03), training mechanisms, the Centers of Excellence in ELSI Research (CEER) and collaboration with the NHGRI Division of Genomic Medicine on embedded research in clinical sequencing programs.  CERA will bring together the research tools and products from across NHGRI-funded ELSI research. In addition, the Center will add value by further synthesizing and summarizing research on key topics. The Center funded under this initiative will be expected to collaborate effectively with the diverse array of ELSI and genomic researchers to maximize the chances of overall success of the program.

While CERA will not replace existing NHGRI Coordinating Centers that meet the needs of specific programs or consortia, it will provide a central source of ELSI tools, products, and expertise that could be consulted by and coordinated with other NHGRI consortia. CERA will collaborate with relevant NIH programs as well as other US-based and international genomics efforts to serve as a key convener and source of expertise for the larger research and policy communities, as appropriate. 

All applicants are strongly encouraged to contact NHGRI Staff to discuss the alignment of their proposed research with the goals of this FOA. An Information Session teleconference will be held for potential applicants to this FOA.  NHGRI staff will be available to answer questions related to this FOA.  Time, date, and dial in information for the call will be announced in an NIH Guide Notice and will be posted on the ELSI website:  http://www.genome.gov/ELSI. During the Information Session, NHGRI staff will present an overview of the FOA and answer questions from prospective applicants.  The Information Session is open to all prospective applicants, but participation is not a prerequisite to apply.

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

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

NHGRI intends to commit a maximum of $1M direct costs in FY 2019 to fund 1 award.

Award Budget

Application budgets need to reflect the actual needs of the proposed project.

Annual budgets are limited to $1M direct costs per year with a total direct cost over the entire 5-year project period of no more than $4.5M. Initial annual budgets may be smaller and grow in later years as Center functions become fully developed. All increases in budget must be thoroughly justified and no escalation in costs will be provided.

Award Project Period

The project period is 5 years.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

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.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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.

2. Content and Form of Application Submission

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.

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

Letter of Intent

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

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

  • 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:

Nicole Lockhart, Ph.D.
Telephone: 301-480-2493
Email: lockhani@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Effective management will require a significant commitment by the Program Director(s)/Principal Investigator(s). For an application proposing a single PD/PI, that PD/PI is expected to make a minimum commitment of 4 calendar months.  If multiple PDs/PIs are proposed, at least one PD/PI must have a minimum commitment of 3 calendar months, and any individual serving as a PD/PI must commit at least 1 calendar month of their time.

Budgets should include support for a dedicated Project Manager who will devote a minimum of 4 calendar months to oversee the day-to-day activities of the project, coordinate across project sites, if applicable, and be responsible for promptly providing requested reporting information to NHGRI Program Staff.

Budgets should include, but are not limited to, support for 2-3 group members to attend relevant national meetings as part of their outreach and dissemination activities. Budgets should also include attendance for 3-5 members at the biennial ELSI Congress to begin in 2020 which will be planned and organized under a separate award, but coordinated with CERA activities. Budgets should also include travel for External Scientific Panel members to attend an annual in-person meeting.

Applicants need to demonstrate an understanding of costs and how to track them. Costs should include infrastructure and all personnel. Applicants should describe how these costs will change over the course of the project.  All cost analyses should include an explicit item for Direct Costs and then be presented in terms of Total Costs.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: Applicants should describe plans for a CERA that is capable of working with broad ranges of ELSI researchers, genomics researchers, and other relevant stakeholders. Applicants should address the following points in the application:

1) Public online platform to share ELSI research tools and products related to genomics

Applicants should describe their overall strategy and vision for a platform to share ELSI research tools and products, including:

  • Plan to develop a public online portal to facilitate the upload of, and access to ELSI research products.
  • Plans for how to identify, collect, index, store, and make publicly available materials for the portal, including data collection instruments, data dictionaries, and study methods from NHGRI-funded ELSI research
  • Strategies to track and maintain a central database of ELSI scholarship and its products
  • Detailed plan on how the structure of the portal, its specific elements and content, the backend infrastructure (e.g., the database schema, the software interfaces, the associated documentation, etc.) and any related data analysis tools, including both executables and source code, will be rendered easily transferable to third parties or other institutions at the completion of the grant period.
  • Plan for collecting and coordinating information from NHGRI-funded ELSI investigators on how to access data from NHGRI-funded ELSI studies, including data being shared through existing repositories or resources
  • Innovative strategies to encourage and incentivize past, current and future ELSI investigators to contribute resources to the Center, such as microattribution, usage or download statistics for contributors, provision of small “seed grants” to contributors etc.
  • Plans to conduct usability testing and assess the ongoing needs of actual and potential CERA users

2) Curating and synthesizing ELSI research on key topics in the field

Applicants should describe their overall strategy for systematically curating and synthesizing the diverse range of NHGRI-funded ELSI research on issues of interest, including:

  • Plan for identifying ELSI research topics that are ripe for Center collection, curation and synthesis
  • Strategies for collaborating with diverse experts in the field to ensure individuals with both diverse methodological expertise and opinions contribute to these curation-and-synthesis efforts
  • Strategies to systematically integrate and synthesize current and existing ELSI research data across disciplines on a given topic to identify areas of consensus, disagreement, and research gaps
  • Plan for analyses focused on the evaluation and enhancement of ELSI research methods.
  • Plan for the communication and dissemination of resources and products developed through these activities

3) Convening ELSI researchers and relevant stakeholders

Applicants should describe their experience and expertise in convening both large and small groups of researchers through a variety of mechanisms, including:

  • Approaches and relevant expertise that will be utilized to convene diverse groups of ELSI researchers, including meetings of various sizes and formats
  • Strategies to convene ELSI researchers outside of meetings or workshops, for example webinars, special journal issues, etc.
  • Strategies to facilitate timely expert responses to a wide variety of emerging ELSI topics
  • Methods through which these expert responses will be disseminated. This would include outlets other than the scientific literature.
  • Strategies to incentivize and facilitate involvement of ELSI researchers and other relevant stakeholders in Center activities, including genomic researchers, practitioners, trainees, funders, and policy makers
  • Strategies for collaboration with relevant NIH programs as well as other US-based and international genomics efforts to serve as a key convener and source of expertise for the larger research and policy communities, as appropriate

4) Outreach, dissemination and training

Applicants should describe a strategy for outreach activities that will help make the CERA resources as widely accessible and highly utilized as possible, including:

  • Plans to connect ELSI researchers to one another and to a broader genetic and genomic audience utilizing a variety of outreach and dissemination tactics including social media, scientific meetings, etc.
  • Plans to inform the ELSI community about the expanding genomic landscape, e.g. new genomic technologies; evolving research, clinical and societal applications; new policies impacting genomics in the research and/or clinical settings, etc.
  • Plans to ensure that potential users of ELSI research, including genomic researchers, practitioners, trainees, funders, and policy makers are aware of NHGRI-funded work, past and present, that may inform both research and healthcare
  • Plans and strategies to train potential users on how to access and utilize Center resources and provide ongoing user support
  • Strategies for outreach and dissemination across the career development pipeline, including trainees and investigators new to ELSI research

The following additional items must also be addressed in the application:

  • Evidence of Successful Past Performance.  Applicants should provide evidence of research productivity as part of a consortium or other collaborative research network.  Applicants should demonstrate the capacity to scale activities and maintain flexibility as the Center evolves.
  • Information Technology (IT).  Applicants should discuss all pertinent informatics issues involved in providing the IT infrastructure/system administration for the proposed project. 
  • Management Plan. The management plan should describe how the PD(s)/PI(s) will manage the proposed project, who will oversee the day-to-day activities (i.e., a project manager if not a PD/PI), and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed project; its management structure; key personnel; section leaders and reporting relationships; and the External Scientific Panel. The role of the External Scientific Panel should be described, including how often it will meet, types of expertise to be represented on the board, and what specific activities will be performed by the board members.  The External Scientific Panel will be assembled and given its charge in collaboration with NHGRI staff, therefore applicants should not contact potential advisors prior to the review of the application, nor should potential advisors be named in the application or provide letters of support. Recruitment and training of personnel may also be discussed. The plan should also describe how the various components of the proposed effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.
  • Timeline, milestones and goals. Applications should establish a timeline and define a clear set of goals for the Center. Applications should identify annual milestones with metrics that will document progress towards the achievement of these goals.  Examples include, but are not limited to, milestones that: 1) develop and test the Center portal;  2) document usage and usability of Center resources; 3) track the number of research tools and/or products available through CERA;  4) track grants that have contributed resources for sharing; 5) track the number and quality of analyses performed as part of the curation and synthesis activities; and 6) document the number and effectiveness of  outreach and training activities, the stakeholders reached to date and resulting plans for follow-up interactions and engagement.  Applications should include plans for critically evaluating and revising these milestones on a regular basis.  The number and duration of milestones will depend on the project being proposed and applicants should include these items for every year, as appropriate.  Milestones may be revised at the time of the award as described in the terms and conditions of a Cooperative Agreement in section VI.2.

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:

Unrestricted timely access to Center Resources. The NHGRI is committed to the principle of rapid release of publications and resources to the scientific community from projects of broad community interest.  This principle was initially implemented during the Human Genome Project and has been widely recognized as leading to one of the most effective ways of promoting the use of investigators’ work.  To maximize the value of ELSI resources to the research community and to enhance the reproducibility of ELSI research, applicants should propose a resource release policy in their applications that creates a rapid resource acquisition and sharing pipeline consistent with achieving the goals of the Center, and the needs of Center users and contributors. In addition, all resources and tools developed by the Center will be portable and easily transferred if needed.

After the initial review, NHGRI program staff will conduct an additional administrative review of the plan for sharing ELSI resources, and may negotiate modifications of this plan with the prospective awardee.  The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.

Facilitating access to data collected from NHGRI-funded ELSI grants: The Center will not collect, curate, store or disseminate primary data collected as part of funded NHGRI ELSI grants.  However, the Center will be responsible for directing Center portal users to other data repositories and ELSI researchers who are sharing their data outside the Center.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information

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

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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. 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 NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

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.

Section V. Application Review Information
1. Criteria

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

Overall Impact

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).

Scored Review Criteria

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.

Significance

Does the proposed Center address the needs of the research resource that it will administer? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

Will the proposed Center increase the use and value of existing and future ELSI resources to the expanding ELSI and genomics communities?

Will the proposed Center increase the transparency of ELSI scholarship and enhance the rigor and reproducibility of ELSI research?

Will the proposed Center increase interaction and collaboration within the ELSI community, with the genomics community and other key stakeholders?

Will the Center make ELSI resources as widely accessible and highly utilized as possible?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing ELSI research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?  

Do the PD(s)/PI(s) and other key personnel have demonstrated experience coordinating the management, dissemination, and assessment of web-based public resources?

Do the PD(s)/PI(s) have a demonstrated record of working cooperatively within and outside the ELSI field?

Has adequate leadership for the day-to-day project management activities, and sufficient PD(s)/PI(s) effort to serve the key proposed roles, been described?   

Does the application include a variety of perspectives and sufficient expertise from across the full spectrum of ELSI research methodologies?

Does the research team include demonstrated experience and expertise in working with communities traditionally underrepresented in research?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research resource the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?   

Is the overall strategy for the public online platform to share ELSI research tools and products related to genomics novel and innovative?

Does the application describe innovative strategies to encourage and incentivize past, current and future ELSI investigators to contribute resources to the Center?

Does the application describe novel approaches to the systematic cross-disciplinary summary and synthesis of ELSI research?

Does the application describe innovative strategies to facilitate timely expert responses to a wide variety of emerging ELSI topics?

Does the application describe innovative strategies to evaluate or enhance the use of different ELSI methods?

Does the application describe innovative strategies to convene diverse members of the ELSI community, including genomic researchers as appropriate?

Does the application describe innovative approaches to dissemination of Center resources and products?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Is the plan to develop and maintain a public online Platform to share ELSI research tools and products related to genomics well developed, reasonable and appropriate?

Is a sufficient description provided of how the Center will ensure balanced and unbiased resources are provided to the ELSI research community?

Does the Center have a plan for establishing a diverse and inclusive environment, including input from groups traditionally underrepresented in research?

Are the plans to identify, collect, index, store, and disseminate relevant ELSI research resources clearly described, reasonable and appropriate?

Are the plans for evaluating the use and usability of the Center’s work products clearly described, reasonable and appropriate?  Is it clear how the results of evaluations will be used to improve the Center?

Are plans to conduct systematic cross-disciplinary synthesis of ELSI research clearly described, reasonable and appropriate?

Are the plans for leading ELSI dissemination and outreach efforts clearly described, reasonable and appropriate?  Will the plans connect the ELSI research community to a broader audience? Do such strategies span the career development pipeline, including trainees and investigators new to ELSI research?

Are the plans to collaborate with other resource efforts in the U.S. and abroad clearly described, reasonable and appropriate?

Are plans to work with existing NIH and NHGRI Centers and Consortia involved in ELSI research clearly described, reasonable and appropriate?

Are the milestones, timelines, and goals proposed for the research project clearly described, reasonable and appropriate?

Should funding for this Center come to an end, is a plan for the transfer of Center resources (i.e. online portal, databases, software and other code) to NHGRI or another entity clearly described, reasonable and appropriate?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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.

Vertebrate Animals

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.

Biohazards

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

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable.

Additional Review Considerations

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.

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

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.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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  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.
  • A balanced approach to considering a diversity of stakeholders, disciplines, viewpoints and expertise to guide Center work
  • Potential to work effectively in large collaborative efforts.
  • Adequacy of resource development and resource sharing plans, as appropriate.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to 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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Defining the details for the project within the guidelines of RFA HG-18-008 and for performing the scientific activities.
  • Providing annual and overall project period milestones, to the NHGRI as requested (usually at the outset of the award and annually thereafter, but also at other times as requested by NHGRI program staff).
  • Fully participating in group activities, relevant national scientific meetings, and outreach and training activities as requested by NHGRI.
  • Sharing scientific results, analyses, and collected resources, and software, as appropriate and according to the release policies developed for and by this project.
  • Assisting in the development of policies for dealing with situations that require coordinated action.
  • Not disclosing confidential information obtained from other ELSI investigators
  • Adhering to NHGRI policies regarding intellectual property and other policies that might be established during the course of this activity.
  • Accepting and implementing the common guidelines and procedures approved by the External Scientific Panel and NHGRI
  • Data and software transition. At the end of the award, or if a new recipient has been selected prior to the end of the award, the awardee will work with NHGRI staff and the new award recipient to transition the data and software to the new service, or to the Government.

Data/software ownership and transition to another grantee:

  • A fundamental objective of this cooperative agreement is to ensure that the valuable data, tools, and resources collected and provided by the CERA remain available without interruption to the research community if the awardee withdraws or otherwise can no longer manage the resource of the award is terminated by the NIH.
  • Consistent with 45 C.F.R. 75.322, the awardee will own the resources and content generated by the awardee, and it will be able to continue to use these resources upon expiration or termination of the award. NIH will have unrestricted cost-free access and use of all such resources, including the right to transfer said resources to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.
  • Ownership of the data and software hosted or uploaded on the CERA platform remain with the data and software providers. The CERA has no possessor rights of the data and software provided or generated by its users, who will retain ownership and control of their own resources.
  • Open Source Technology: Capabilities and software built as part of the NHGRI CERA must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Program Directors are members of the NHGRI extramural staff who will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards. This includes, providing assistance, advice, and coordination for CERA. It is anticipated that consequential decisions about all activities will be reached by consensus and that NIH staff will be given the opportunity to offer input as part of the process. NIH staff will participate in the group process of setting research priorities, deciding optimal approaches and contributing to the adjustment of CERA processes as warranted.

NHGRI Program Director(s) will:

  • Assist and facilitate the group process and not direct it.
  • Participate with the other External Scientific Panel members in the group process of setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
  • Negotiate milestones, e.g., resource collection, portal operability and usage, outreach, investigator participation, evaluation, and cost goals, as necessary.
  • Serve as a liaison, helping to coordinate activities among and between CERA investigators and ELSI awardees, including acting as a liaison to the NHGRI, and as an information resource about extramural ELSI-related activities.
  • Attend regular CERA meetings and all External Scientific Panel meetings as a voting member and assist in developing operating guidelines, quality procedures, and consistent policies for dealing with recurrent situations that require coordinated action. 
  • Retain the option to recommend, with the advice of the External Scientific Panel, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed upon at the time of the award, fails to maintain the state of the art of the field or fails to comply with the Terms and Conditions of the Award.
  • Report periodically on the progress of the CERA to the Director, Division of Genomics and Society and Director, NHGRI.
  • Provide relevant expertise and overall knowledge of NIH-sponsored research to facilitate the selection of scientists not affiliated with the awardee institution[s] to serve on the External Scientific Panel.
  • Provide advice in the management, outreach and performance of the Center.
  • Assist in promoting the availability of CERA and related resources developed in the course of this project to the scientific community at large.
  • Participate in data analyses, interpretations, and, where contributions warrant, co-author publications describing the results of studies conducted through CERA.
  • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NHGRI Project Scientist.

Areas of Joint Responsibility include:

An External Scientific Panel will be established by NHGRI to provide regular input on Center activities and evaluate Center progress.  The Panel will include members with diverse expertise including normative, legal, quantitative and qualitative research methods; the use of social and traditional media; web resource development; training of ELSI scholars; outreach and stakeholder engagement strategies; program evaluation; and data management, analysis, and dissemination. The External Scientific Panel will help ensure that milestones are achieved and the interests, perspectives and needs of the ELSI and genomics communities are considered in an unbiased manner. 

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 processes and NIH grant resources)
Email: GrantsInfo@nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

Nicole Lockhart, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-4802493
Email: lockhani@mail.nih.gov

Peer Review Contact(s)

Ken Nakamura, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8823
Email: nakamurk@mail.nih.gov

Financial/Grants Management Contact(s)

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
Email: Deanna.ingersoll@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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