NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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

In 2012, the NIH in partnership with the Wellcome Trust, and with advice from the African Society of Human Genetics, initiated the Human Heredity and Health in Africa Program (H3Africa). At the NIH, H3Africa is a component of the NIH Common Fund's Global Health Initiative, and several Institutes and Centers have joined the Common Fund to support it. Recognizing that African researchers and populations have been, and still are, substantially underrepresented in genomics and environmental research and disproportionately affected by some environmental exposures, H3Africa is designed to provide new opportunities to African scientists to lead research on the genetic and environmental contributors to health and disease issues of importance to Africa through the use of genomics and other cutting-edge approaches. In this document, the term "genomics and other cutting-edge approaches" is used broadly and is intended to include approaches such as genetic epidemiology, phenotyping, biomarker development, pre-clinical research including the use of model organisms, and research on clinical utility, among others. The term "environmental contributors" is also used broadly and includes physical, chemical, biological, behavioral, and social environmental factors, among others. For further background on the origin and development of H3Africa, see the article "Research Capacity: Enabling the Genomic Revolution in Africa" Science (2014) 344: 1346-1348, and the H3Africa web site http://www.h3africa.org .

In order to enhance the capacity for genomics research, in Africa by African scientists, and to understand the genetic and environmental factors that determine disease susceptibility, H3Africa has three interrelated, interdependent objectives:

• To support human genomics and genetics research that will not only generate important findings and discoveries relevant to human health, but will also serve as a vehicle to improve the research capacity of African laboratories and provide research opportunities for young scientists at the institutions where the research is carried out.
• To expand expertise and experience in genomics-based biomedical research and environmental epidemiology in Africa through research experience, skills development, and enhanced collaborations with regional, national, and international partners.
• To improve infrastructure including bioinformatics and biorepository capacity needed to support genomics-based and environmental research and associated data and sample sharing.

These objectives have been addressed through a set of awards to African institutions from the two funding partners using several different funding mechanisms, awarded primarily in 2012 and 2013. In its initial five-year phase, the Wellcome Trust has supported collaborative research projects and NIH has supported H3Africa Collaborative Centers (U54), H3Africa individual research projects (U01; including studies in the area of the ethical, legal, and societal issues of genomics in Africa), H3Africa Biorepositories (UH3), and a bioinformatics network, H3ABioNet (U41). This Funding Opportunity Announcement (FOA) is being issued to solicit applications for H3Africa ELSI Collaborative Centers. A Collaborative Center should have multiple projects, based at three or more African institutions, and these projects should work collaboratively to address issues concerning genomics research that have ethical, legal, or societal implications for African communities. The solicitation for ELSI Research Projects (RFA-RM-17-021) is related to this FOA.

The H3Africa program is an initiative of the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. Investigators are invited to develop bold and innovative approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. Common Fund programs are limited to a maximum of 10 (ten) years in length. The NIH H3Africa program will complete its first five years in 2017; therefore, activities proposed in applications submitted in response to this FOA should (a) be framed in terms of what can realistically be accomplished in the remaining five years of the program (2017 2021) and (b) discuss how activities will be sustained after 2021, when Common Fund support for the program ends.

Investigators funded by the H3Africa program operate as a highly collaborative Research Consortium. The Research Consortium meets regularly in person and by teleconference. The H3Africa Consortium has developed a number of overall policies and guidelines (see http://www.h3africa.org/consortium/documents). These policies will be referred to at appropriate places in this document and all applicants are expected to recognize and adopt these policies (or else provide justification as to why a particular policy cannot be followed).

A. Scientific scope

The objective of this FOA is to solicit applications for support of H3Africa Ethical, Legal and Societal Issues (ELSI) Collaborative Centers (H3A ELSI CC) that will conduct research that will apply a multi-disciplinary or trans-disciplinary approach toward the understanding and identification of strategies to address high-priority ethical, legal, and societal issues relevant to genomics and environmental health research on the continent of Africa. Each H3A ELSI CC must consist of at least three collaborating projects, at least two of which will be led by investigators and performed by African institutions that are not a part of the applicant institution. International collaborations within Africa are encouraged but not required. It is expected that the projects will interact to provide the complete capacity needed to carry out the ELSI-based research effort proposed. The collaborative nature of the proposed H3A ELSI CC is a critical feature.

The primary responsibility of an H3A ELSI CC will be to conduct a well-defined, cohesive research program focused on an important ELSI research topic that is relevant to the study or application of genomics in Africa. The issue to be addressed may be one that has already been identified or one that has not yet been addressed on the continent. The Center must comprise at least three research projects that address the focal issue in a comprehensive, synergistic way. Research projects take trans-disciplinary approaches that use a range of expertise and methodologies, such as data-generating empirical (qualitative and quantitative) studies, legal and normative analyses, and other analytical or conceptual research methodologies.

The following list provides some examples of H3Africa ELSI research areas that might be addressed. Applicants should understand, however, that this list is meant only to provide guidance; it is not exhaustive and appropriate topics are not limited to the examples given here. Applicants are encouraged to identify and clearly articulate research studies on ethical, legal, and societal issues that are applicable to multiple communities throughout the continent.

• Genomic Research. The issues that arise in the design and conduct of genomic research on the continent of Africa, particularly as it involves the production, analysis and broad sharing of samples and individual genomic information frequently coupled with detailed health information, nationally as well as internationally.
• Genomic Health Care. Whether and how genomic research and technology and the availability of increasing amounts of genomic information may influence health care in countries in Africa. Do the advancing technology and the growth of genomic information increase or decrease the disparities of health between lower, middles and higher income countries in Africa?
• Broader Societal Issues. The normative underpinnings of beliefs, practices and policies regarding genomic information and technologies, as well as how genomics is conceptualized and understood in communities in Africa with regard to issues such as health, identity, disease, and individual responsibility.
• Legal, Regulatory and Public Policy Issues. The effects of genomic research, biobanking, and data and sample sharing on existing public policies, laws, and regulations in countries in Africa and the development of new policies, laws, and regulatory approaches.

In requiring that an H3A ELSI CC be comprised of multiple projects, the NIH does not intend to specify what those projects should be or how they are to be organized within the center. For example, the research endeavor could be comprised of three complementary projects each of which pursues a separate approach so that, when taken together, the different approaches integrate into a synergistic whole. Alternatively, an H3 ELSI CC could be organized so that each project pursues the same study in a different context, such as in different populations or different countries, i.e. a comparative study. These two examples are only intended to be illustrative; the roles and organization of the collaborative projects within an H3 ELSI CC will be determined by the applicant(s) to be those that will best achieve the proposed Center's research objectives.

The H3A ELSI CC should also include an effort to combine the output of the research activity with dissemination and outreach activities designed to inform the development of relevant policies or professional guidelines.

In addition to its primary research focus, an H3A ELSI CC should also include additional activities. An H3A ELSI CC is expected to contribute to developing the next generation of ELSI researchers in Africa by providing research opportunities for young scholars, scientists and investigators.

An H3A ELSI CC should also be a resource for the H3Africa Consortium. An H3A ELSI CC should be a knowledge base of multidisciplinary expertise in ethical, legal, and societal issues, and it should be available for consultation, both with individual projects in the H3Africa Consortium and, through the H3Africa Ethics and Regulatory Issues Working Group (http://h3africa.org/consortium/working-groups/24-working-group-external-pages/128-tor-ethics-wg-exp) with the H3Africa Steering Committee.

To ensure that its activities are well organized, integrated and managed, an H3A ELSI CC is expected to include a strong management component to provide the support and organizational structure for all the Center's activities.

The ultimate goal of this FOA is the establishment of one or more sustainable Centers of ELSI scholarship that have sufficient institutional and other research support to maintain the trans-disciplinary Center infrastructure and allow for the continuance of Center activities after the completion of H3Africa funding.

To further clarify the unique nature of an H3Africa ELSI Collaborative Center, the following list of attributes of a Center is provided.

A Center should:

• conduct research that cannot reasonably be addressed by a standard R01 research grant and that has the potential to lead to significant advances to address a well-defined critical topic area in ELSI research in Africa;
• promote intensive and sustainable interactions among investigators from different disciplines, such as the genomic sciences, clinical research, clinical and health policy, ethics, law, the humanities, and other social sciences;
• be highly innovative and develop new concepts, methods, analyses, or ways to consider ethical, legal, and social issues that will substantially advance the state of the science in ELSI research on the African continent;
• be familiar with H3Africa Consortium activities (see www.h3africa.org for current activities) including ethical, legal, and societal issues that have arisen while conducting genomic research;
• be prepared to be a resource for the H3Africa Consortium with regard to addressing ethical, legal, and social issues;
• develop and operate with a highly effective management strategy;
• develop plans for the timely dissemination of the results of the Center's ongoing activities to key stakeholders (including policy options as appropriate); and
• increase the pool of ELSI researchers in Africa, by offering innovative, substantive research opportunities across the career pipeline, including integrating the development of new investigators and broadening the mentoring of established investigators in ELSI research.

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 on the budget of a typical research study;
• be a collection of individual research projects.

B. Additional objectives of H3Africa.

As noted in the Purpose section, there are several specific objectives that the H3Africa Program is trying to achieve. Successful applicants will become members of the H3Africa Consortium, and will be expected to adhere to these policies, unless adequate justification can be provided.

H3Africa Consortium Participation: H3Africa will be organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The H3Africa Consortium consists of members from the Welcome Trust, the NIH, and all participants of research and infrastructure projects funded through H3Africa. Groups funded under this initiative will be expected to participate in the H3Africa Research Consortium and to collaborate effectively with each other to maximize the chances of overall success of the program. Each funded applicant is expected to participate directly or via proxy in consortium Working Groups that establish rules, guidelines, and resources for the Consortium (a list of H3Africa Working Groups can be found at www.h3africa.org). Each project is expected to comply with applicable consortium policies and procedures (also found at www.h3Africa.org). In addition, the PD/PI(s) will be active members of the H3Africa Steering Committee, which meets regularly by teleconference. The H3Africa Consortium generally holds two meetings per year, usually in Africa.

H3Africa Data Sharing Policies: H3Africa funds a Bioinformatics Network (http://h3abionet.org /). The research projects and any other H3Africa-funded activity will be required to interact with the H3Africa Bioinformatics Network, and all genetic and genomic data as well as selected associated phenotypes must be submitted to the Network, as well as eventually being submitted to the European Genome-Phenome Archive (EGA) as outlined in the H3Africa Consortium Data Sharing, Access, and Release Policy (found at http://h3africa.org/consortium/documents).

Community Engagement: H3Africa recognizes ongoing community engagement and the building of trusting relationships with research participants and the community as an essential feature of ethical biomedical and population based genomics research involving human subjects (www.h3africa.org/consortium/documents). Community engagement can include a variety of activities, such as broad consent for sharing of samples and data, recontact of research participants, return of results to individual participants, or other relevant topics.

Collaborations: One of the major goals of the H3Africa Initiative is to facilitate opportunities for collaboration between and among investigators within Africa, in order to help build a larger African scientific community, which will in turn lead to more research opportunities and cutting-edge science on the continent. Intra-continental collaborations will also contribute to sustainability of African genomics programs. Each H3Africa ELSI CC is expected to include at least three collaborating projects based in African institutions that will interact to provide the complete capacity needed to carry out the proposed research effort. At least two of the collaborators, in addition to the PD/PI(s) should be based in African institutions outside of the applicant institution. International collaborations within Africa are encouraged, but not required.

Providing the next generation of African researchers with opportunities in genomics: Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a primary objective of the H3Africa program. H3Africa projects provide a variety of career enhancement opportunities for students, postdoctoral researchers, and young investigators, such as attending seminars and scientific meetings, writing papers, and giving talks. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the H3Africa program.

All applicants are strongly encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed work with the goals of this FOA, and with the H3Africa Project. Technical Assistance Sessions and teleconferences will be held for potential applicants to this FOA and companion FOAs. NIH staff will be available to answer questions related to this FOA. Location, time, date, and dial in information will be announced in an NIH Guide Notice and will be posted on the H3Africa website: http://www.h3africa.org. During the Information Sessions, NIH staff will present an overview of these FOAs and answer questions from prospective applicants. The Information Sessions are open to all prospective applicants, but participation is not a prerequisite to applying.

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 in response to this FOA.

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Specifically the following African organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

• Only non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

The PD/PI should be an established investigator in their field and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have research experience in Africa, particularly in the country where the proposed research program will be established. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the program and appointing members of an Advisory Committee, as appropriate, and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.

The contact PD/PI must be affiliated with the low and middle income (LMIC) African institution submitting the application where the proposed research program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa, U.S. or other high income country (HIC) institutions may be proposed. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program.

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).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Ebony Madden, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Project	12
Core (use for ELSI Consultation/Services Core)	6
Admin Core (use for Administrative Core)	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Project: required, minimum of three, maximum of five
• ELSI Consultation/Services Core: optional, maximum of one
• Administrative Core: required, maximum of one

When preparing your application in ASSIST, use Component Type 'Overall'.

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: A concise set of specific aims is required that explains the overall goals and expected outcomes of the research.

Research Strategy:

Describe the H3A ELSI CC's overall research strategy. The discussion should address:

• the vision and goal(s) of the H3A ELSI CC, and its organization;
• the research strategy from the perspective of the center itself and how the specific research to be carried out by each project will contribute to the success of the center;
• the center-level analyses;
• additional activities that will be included in the center and how the center will be prepared to respond to emerging issues;
• the research education and career enhancement activities that will be included in the center;
• how the overall center will be managed, particularly with respect to collaborations that are not located at the PD/PI(s) home institution; and
• how the center will move towards sustainability during and beyond the period of funding requested.

The methods and technologies that will be used should be briefly presented; more detailed descriptions can be provided in the individual project sections. Innovative approaches that will be employed by the H3A ELSI CC should be identified and the impact of those methods/technologies on the future of African science and/or medicine should be described.

Unless otherwise justified, the proposed H3A ELSI CC will be expected to adopt current H3Africa policies with respect to community engagement, informed consent, data and biospecimen access, data sharing and release, and publications; the current policies can be found at www.h3africa.org/consortium/documents. In light of these policies, the Center's approach to informed consent and protection of research subjects (if applicable), research animal welfare (if applicable), and sample storage and delivery to a biorepository should be summarized.

Letters of Support: Applications should include letters of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from all collaborating institutions to substantiate the institutions' commitment to the proposed plan. Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. Where applicable, the letter should address institutional commitment to new faculty and any faculty who participate in associated skill-building programs. It should also address commitment to collaborating and sharing data as appropriate. The letter should also briefly discuss the institution's plans for sustaining an active program of ELSI related research subsequent to the end of the funding period.

As the programmatic activities of this initiative will support national and international collaborations, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component should be provided with the application if possible; if letters are not provided with the application, they may be requested from the applicant at a later date. The letter should briefly describe the national policy concerning the development of a national scientific research program and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development (R&D).

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data and Resource Sharing Plan. Applicants are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the H3A ELSI CC and its respective research projects. The applicants should also state whether they will abide by the H3Africa Consortium data sharing policy or provide a strong justification for why the policy cannot be followed. The policy can be found at: http://h3africa.org/images/DataSARWG_folders/FinalDocsDSAR/H3Africa%20Consortium%20Data%20Access%20%20Release%20Policy%20Aug%202014.pdf

Appendix:

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

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

An H3Africa ELSI Collaborative Center must comprise at least three collaborating research projects in Africa that together address one or more research areas of interest to the applicant. Each Project should be described as a distinct component and identified as a major-theme component.

When preparing your application in ASSIST, use Component Type 'Project.'

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The Project Lead investigators' experiences with conducting research and employing the proposed methods, technologies and strategies should be documented.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: A set of specific aims to be accomplished by the collaborating project is required.

Research Strategy:

The section should begin with a discussion of the significance of the project, including the specific contribution that the project will make to the overall success of the H3A ELSI CC and how it will interact with the other projects and other components of the Center.

The research strategy that will be pursued in the project should then be described. The experimental plan that will be employed should be discussed in detail, including methods, technologies, and analytical strategies.

The approaches to meeting the bioinformatics needs of the project, if any, should also be described.

Identify any aspects of the application that the applicant considers to be particularly innovative. Identify potential major challenges or problems that might be encountered in conducting the proposed research, and discuss how these will be addressed should they arise.

Each project should also describe how it will interact with the other projects in the center, either in pursuit of the major theme or, if appropriate, as part of the resource-development effort.

Engagement of Research Participants: If the proposed research project involves human research participants, the method(s) of recruitment should be described carefully. The research strategy must include a community engagement plan and a detailed plan for participant recruitment, and if applicable sample acquisition, storage, preparation of material needed etc. The community engagement plan should describe initial, ongoing, and future community engagement activities and should specifically address the benefit to the community. If the proposed research project involves the collection of samples from participants, the samples to be analyzed should be identified and the research strategy must include a detailed plan for sample acquisition (where applicable), storage, preparation of material needed etc

When recruiting participants or collecting new samples, investigators are required to obtain consent for the broad sharing of samples and data; detailed justification must be provided if archived samples and data cannot be shared or only shared in a limited manner. A document entitled "H3Africa Guidelines for Informed Consent" may be helpful to applicants in writing their informed consent documents; this can be found at http://h3africa.org/consortium/documents. A timeline for developing and implementing an informed consent process, including obtaining IRB approval, must be included in the application.

Sustainability: One of the major goals of the H3Africa program is to enable African investigators to become more productive and develop skills that will lead them to becoming internationally competitive for support in the future, increase the number of high quality publications, and become leaders in genomics, genetics and ELSI research. It is hoped that this will in turn lead to increased investment in research by African governments and private sources. Applicants should discuss the issue of future sustainability of their ELSI research program beyond the H3Africa program.

Letters of Support Applications should include letters of support from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent) from all collaborating institutions to substantiate the institutions' commitment to the proposed plan. Each institution should also state its commitment to overcoming any administrative obstacles to the implementation of the application. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. Where applicable, the letter should address institutional commitment to any faculty who participate in associated skill-building programs. It should also address commitment to collaborating and sharing data as appropriate. The letter should also briefly discuss the institution's plans for sustaining an active program of genomics related research subsequent to the end of the funding period.

As the programmatic activities of this initiative will support national and international collaborations, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component should be provided with the application if possible; if letters are not provided with the application, they may be requested from the applicant at a later date. The letter should briefly describe the national policy concerning the development of a national scientific research program and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development (R&D).

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:

This plan is necessary if biological materials will be collected as part of the research plan, consistent with achieving the goals of h3Africa. The resource sharing plan must be consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators will abide by the Consortium's sample sharing policies.

Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should also address a Data Sharing Plan, consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators will abide by the Consortium's data sharing policies.

Appendix:

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

PHS Inclusion Enrollment Report (Research Project)

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

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Core Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The H3A ELSI CC PD/PI (contact PD/PI for applications with multiple PDs/PIs) must serve as the Administrative Core Lead.
• If the multi-PD/PI model is not used, applicants must designate an appropriate senior investigator as an overall scientific research lead.
• The Administrative Core is expected to have a qualified Center Administrator to manage the day-to-day operations with responsibility for the administrative, budgetary, and operational aspects of the Center. For the Center Administrator, in the additional Senior/Key Profiles section, use Project Role of 'Other (Specify)' and provide the role under 'Other Project Role Category' as 'Center Administrator'.

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The Research Center contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-month of effort. The required levels of effort may reflect an aggregate of the effort for the entire H3Africa Collaborative Center (listed here under Administrative Core) and the efforts for other components, as applicable.

Center Administrator: Applicants are expected to propose and budget for a full-time or part-time Center Administrator to manage day-to-day operations, based on the complexity of the H3Africa Collaborative Center.

Travel Funds: The budget should include funds to support travel for Center and Consortium activities, including but not limited to supporting the participation of PD(s)/PI(s) and additional staff members at the Consortium meetings.

Other: Funds (including travel if appropriate) may be allocated for expenses related to the formation of a Scientific Advisory Board.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Outline Specific Aims for the Administrative Core.

Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to provide administrative support for ELSI research, and research opportunities and career enhancement for early stage scientists. It is also expected to foster synergy and integration of the H3A ELSI CC; and support any planning and evaluation activities that the Applicant chooses to include. Applications must describe the structure of the Administrative Core utilizing the following subsections (instead of the standard sub-sections):

Sub-section A. Administration and Management. The organizational structure of the H3A ELSI CC, and the plans for administering, managing, tracking, and coordinating the activities of the Center and its individual components should be described. The Administrative Core section should also include a description of the applicant institution's current capacity for administration of research grants, including information about the placement of the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) within the institution and its line of authority, the institutional provision of resources such as office space, administrator salary, office equipment and other in-kind activities, and the applicant institution's plans to support and sustain the research office.

Sub-section B. Scientific Advisory Board (optional): Each awarded H3A ELSI CC will, at the discretion of the PD/PI(s) be able to recruit external experts (i.e., from outside of the Center) to serve as scientific advisors to the Center leadership. If a Scientific Advisory Board (SAB) is included in the H3A ELSI CC application, describe its general composition, the range of expertise to be sought, and how the panel will be expected to contribute to the Center's activities. However, to facilitate the review process, DO NOT name specific individuals in the application and DO NOT contact any potential candidates.

Sub-section C. Travel: A plan for travel of Center members to H3Africa Consortium meeting, internal Center meetings, and other scientific meetings should be included.

Sub-section D. Research and Career Enhancement opportunities for early stage scientists including students, post-docs, and early stage investigators. Research and career enhancement opportunities for early stage scientists including students, post-docs, and early stage investigators should be described. Describe plans for opportunities for involvement of scientists at all stages of the career pipeline in this research project. If early stage scientists will be conducting aspects of their research outside of Africa, the issues involved in ensuring that the individuals involved will be able to apply what they have learned abroad in the African research setting must be discussed.

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: A plan for data and resource sharing and release is expected for all NIH applications (https://grants.nih.gov/grants/policy/data_sharing/). Applicants are, therefore, expected to provide a well thought-out plan for widely sharing data and resources generated by the H3Africa Collaborative Center, which should be consistent with the H3Africa Consortium's Data Release Policy (http://h3africa.org/consortium/documents).

Data Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The data sharing plan must be consistent with H3Africa Consortium policies (found at www.h3africa.org), and the application must include a statement that the investigators will abide by the Consortium's data sharing policies

Appendix:

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

PHS Inclusion Enrollment Report (Administrative Core)

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

An H3A ELSI CC should be a resource for the H3Africa Consortium. An H3A ELSI CC should be a knowledge base of multidisciplinary expertise in ethical, legal, and societal issues, and it should be available for consultation, both with individual projects in the H3Africa Consortium and, through the H3Africa Ethics and Regulatory Issues Working Group (http://h3africa.org/consortium/working-groups/24-working-group-external-pages/128-tor-ethics-wg-exp) with the H3Africa Steering Committee.

When preparing your application in ASSIST, use Component Type 'Core.'

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

SF424 (R&R) Cover (ELSI Consultation/Services Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (ELSI Consultation/Services Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (ELSI Consultation/Services Core)

Human Subjects: Answer only the 'Are Human Subjects Involved?' and 'Is the Project Exempt from Federal regulations?' questions.

Vertebrate Animals: Answer only the 'Are Vertebrate Animals Used?' question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (ELSI Consultation/Services Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (ELSI Consultation/Services Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of 'Other' with Category of 'Project Lead' and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (ELSI Consultation/Services Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (ELSI Consultation/Services Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Outline Specific Aims for the ELSI Consultation/Services Core.

Research Strategy: Describe the additional activities that will be accomplished by the H3A ELSI CC and how these activities will contribute to the Center's ability to act as an ELSI resource for H3Africa.

Describe plans and procedures for establishing and managing the Core. Describe the role of the Core Leader and each of the key participants. Present a clear picture of the facilities, expertise, and skills that the core will provide. Describe plans and procedures for communicating the Core's activities to the H3Africa Steering Committee, the H3Africa Ethics and Regulatory Issues Working Group, the H3Africa Coordination Center, and to other interested African investigators. Discuss how the Core plans to work with them when necessary to help prioritize and address ethical, legal, and societal issues that may arise within the H3Africa Consortium or elsewhere on the continent. Describe how, if necessary, the ELSI CC would adapt to deal with such circumstances and describe the approaches that it will take to prepare for such possibilities. Examples of such approaches that are appropriate to include in the ELSI Consultation/Services Core include, but are not limited to workshops, surveys, and/or meetings that address stakeholder perspectives and/or policies around genomics research in Africa. Propose any other approach that is designed to fulfill the resource role. Where applicable, include sections on plans for data management and data analysis. Describe the process(es) that will be in place to facilitate coordination, distribution and accessibility to the activities and resources that the Core proposes to provide.

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for the Core component of this FOA.

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

PHS Inclusion Enrollment Report (ELSI Consultation/Services Core)

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

If Foreign Institutions are not allowed, delete heading and description below. Otherwise do not edit

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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 the National Human Genome Research Institute(NHGRI), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. H3Africa projects are also encouraged to consult the H3Africa Phenotype Harmonization documents (found at http://h3africa.org/consortium/documents) and describe efforts to ensure CDEs with other H3Africa projects.

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the ELSI Collaborative Center t 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 ELSI Collaborative Center 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 ELSI Collaborative Center that by its nature is not innovative may be essential to advance a field.

Does the ELSI Collaborative Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the ELSI Collaborative Center 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? How will the goals of the proposed ELSI CC address the goals of H3Africa?

Is the proposed collaborative nature of the ELSI CC conducive to achieving the Center's goals?

Does the application provide adequate evidence of the advantages of conducting the proposed research as a collaborative program rather than through separate research efforts? Will the research efforts taken together have more impact on the field than each separate project conducted in isolation?

Do the collaborations among the institutions suggest viable long-term partnerships? How does the Center plan to ensure future sustainability? What additional collaborations will be pursued to further its research program?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the ELSI Collaborative Center? 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? Are the ELSI Collaborative Center investigators familiar with the past and current ethical, legal, and societal issues in the H3Africa Consortium? Are the proposed collaborators likely to work together synergistically? Is there appropriate expertise to provide ELSI consultation services to the Consortium?

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? Does the program propose ethical, legal, and/or societal issues research that will strengthen and sustain genomics research in Africa? How does the program promote and support "innovation" that will strengthen and sustain genomic and environmental research in Africa?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the ELSI Collaborative Center? 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 the ELSI Collaborative Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

How will the program proposed address the H3Africa goal of enhancing the competitiveness of African genomics investigators? Will the Center support the capacity building objectives of H3Africa? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project? Has the issue of future sustainability been adequately addressed?

Are there adequate plans to evaluate whether the strategies to engage the community are successful and the objectives achieved?

Are the proposed timelines appropriate and adequate for the project? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the Center take advantage of resources available at the collaborating institutions? Does the application identify and plan to take advantage of other resources at the participants' institutions, countries or other countries where necessary? Do the letters of collaboration and institutional support show strong commitment to the project and to the PD(s)/PI(s)? Is there a commitment at the institution to providing quality research education and career development for early stage scientists? Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained research enterprise?

As applicable for the ELSI Collaborative Center 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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not applicable.

Not applicable.

As applicable for the ELSI Collaborative Center 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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 .

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.

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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? How do the goals of the project contribute to the ELSI CC overall? How will the research proposed be enhanced by being part of the ELSI Collaborative Center?

Investigator(s)

Are the Lead(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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

Innovation

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

Approach

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

Does the project describe a strategy for community engagement with clear objectives of what they expect to achieve? Are there adequate plans to evaluate whether the strategies to engage the community are successful and the objectives achieved? Are the evaluation plans, milestones and timelines proposed appropriate and adequate for the project?

Are the proposed timelines appropriate and adequate for the project? Has the issue of future sustainability been adequately addressed? How will the activities initiated under this award be sustained at the conclusion of the five-year award period?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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, an Administrative Core that by its nature is not innovative may be essential to advance a field.

Significance

If the aims of the Admin Core are achieved, will the Core support the ELSI Collaborative Center so that scientific knowledge, technical capability, and/or clinical practice will be improved? How will successful completion of the aims of the Core support the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the Lead(s), collaborators, and other researchers well suited to the Administrative Core? 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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Admin Core? 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 the Administrative Core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are adequate mechanisms proposed for regular communication and coordination among investigators in the Collaborative Center? Are adequate administrative structures in place for the day-to-day management of the center, including arrangements for internal quality control of ongoing research?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Administrative Core? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the Administrative Core 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 Admin Core 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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, an ELSI Consultation/Services Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the ELSI Consultation/Services Core address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Core 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?

Investigator(s)

Are the Lead(s), collaborators, and other researchers well suited to the ELSI Consultation/Services Core? 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 there is more than one Lead, do the investigators have complementary and integrated expertise? Do the investigators have a track record of success in carrying out human genomic research programs? Do the investigators demonstrate significant experience with coordinating collaborative basic or clinical research? Do the investigators have the experience and ability to handle diverse data types and to present an integrated view of these data?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Shared Core? 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 the ELSI Consultation/Services Core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the ELSI Consultation/Services Core 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 ELSI Consultation/Services Core 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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.
• Commitment to compliance with H3Africa policies and procedures.
• Potential for establishing a sustainable research program.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.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 http://www.hhs.gov/ocr/civilrights/understanding/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 http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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:

• All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms.
• Awardee(s) will provide goals and progress toward those goals at regular intervals as requested by H3Africa staff and ensure that the data produced meets the quality standards agreed to at the beginning of the project by the H3Africa Consortium
• Awardee(s) will ensure that the data are submitted to the H3Africa Bioinformatics Network, that samples are deposited in the H3Africa Biorepositories, that resources developed as part of this project are made publicly available according to H3Africa policies, and that results are published in a timely manner
• Awardee(s) will agree to accept close coordination, cooperation, and participation of H3Africa staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Awardees agree to the governance of the Consortium through the Steering Committee
• PD(s)/PI(s) will serve as active members of the H3Africa Steering Committee and will participate directly or by proxy on relevant H3Africa Working Groups
• Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

• The Project Scientists will negotiate goals with the awardees as needed, serve as a liaison between the awardees and the appropriate NIH Institute and Center National Advisory Councils, the NIH H3Africa Working Group made up of program staff that collectively manage the program, and the larger international scientific community.
• The Project Scientists will participate (with H3Africa investigators) in the group process of deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
• Project Scientists will attend Steering Committee meetings as non-voting members, serve on H3Africa Working Groups, and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
• 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.

Areas of Joint Responsibility include:

Participation on the H3Africa Steering Committee. On voting matters, each funded project will have one vote and each funding agency will have a single vote. The Steering Committee will: (1) discuss progress in meeting the goals of various H3Africa projects and of H3Africa as a whole; (2) develop recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, for example for data quality measures and assessment, conventions for data deposition; (3) endorse and oversee progress and products of Working Groups within the Consortium; (4) meet twice a year in person in conjunction with network meetings and conduct intermittent conference calls.

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. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

R Ebony Madden, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-503-5620
Email: [email protected]

Rudy Pozzatti, Ph.D.
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 amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.