H3Africa: Ethical, Legal, and Societal Issues (ELSI) Collaborative Centers (U54)

H3Africa: Ethical, Legal, and Societal Issues (ELSI) Collaborative Centers (U54) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-RM-17-020: Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Collaborative Centers (U54) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative ( https://commonfund. nih. gov/ ) through the NIH Office of the NIH Director, Office of Strategic Coordination ( https://commonfund.

nih. gov/ ). All NIH Institutes and Centers participate in Common Fund initiatives.

The FOA will be administered by the National Human Genome Research Institute ( NHGRI ) (https://www. genome.

gov/) on Funding Opportunity Title Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Collaborative Centers U54 Specialized Center- Cooperative Agreements October 24, 2017 - Notice of Technical Assistance Webinar for Human Heredity and Health in Africa (H3Africa) RFAs: RFA-RM-17-020, RFA-RM-17-021. See Notice NOT-RM-18-001 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-RM-17-021 (U01) Research Project Cooperative Agreement Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) encourages applications to establish Collaborative Centers to study ethical, legal and societal issues (ELSI) of human genome and environmental health research across the African continent.

Of particular interest are projects that propose bioethical, legal, and social science analyses of new or emerging issues that affect multiple communities across the continent of Africa. These awards will support 3-5 collaborating research projects at three or more African institutions working together as a partnership to accomplish more than each project could accomplish on its own.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) December 6, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) December 6, 2017 by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

** ELECTRONIC APPLICATION SUBMISSION REQUIRED** 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 I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description 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 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 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).

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. 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 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? 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 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 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 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 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.

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 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 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 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.

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. 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.

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. 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). 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.

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 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 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. Information for award authorities and regulations. Section II.

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The NIH Common Fund intends to commit up to a total of $500,000 per year for up to 4 years. NIH intends to fund 1 award.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $500,000 total costs per year, and must reflect actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum project period is 4 years. 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) Only non-domestic (non-U.S.) Entities (Foreign Institutions) 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 Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 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 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 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. 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.

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 must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Program Director/Principal 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 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 . 3.

Additional Information on Eligibility 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 A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information 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. 2.

Content and Form of Application Submission It is critical that applicants follow the Multi-Project (M) Instructions (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 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: National Human Genome Research Institute (NHGRI) Types Available in ASSIST Strategy/Program Plan Page Limits Core (use for ELSI Consultation/Services Core) Admin Core (use for Administrative Core) Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component 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: 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 All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall Project Information (Overall) Follow standard instructions.

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 Senior/Key Person Profile (Overall) 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 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 PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

set of specific aims is required that explains the overall goals and expected outcomes of the research. 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