Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Human Genome Research Institute (NHGRI/NIH), (http://genome.gov) on behalf of NIH.

Participating Institutes:

Office of Strategic Coordination (Common Fund)

Funding Opportunity Title

Human Heredity and Health in Africa (H3Africa): Ethical, Legal, and Societal Issues (ELSI) Research Program (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

NOT-RM-12-021

  • January 25, 2013 - This RFA has been reissued as RFA-RM-13-005.
  • January 4, 2013 - See Notice NOT-RM-13-006. The NIH Common Fund, with the NHGRI, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for research on Ethical, Legal and Societal Issues of Genomic Research in Africa.
  • October 26, 2012 - See Notice NOT-OD-13-005. Notice of Change in Due Date.
  • August 22, 2012 - See Issuance of RFA-RM-12-006, Human Heredity and Health in Africa (H3Africa): Collaborative Centers (U54) .
Funding Opportunity Announcement (FOA) Number

RFA-RM-12-005

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.310

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications to study the ethical, legal and societal issues (ELSI) of human genome research in African populations.  Of particular interest are projects that propose focused bioethical, legal, and social science analyses of new or emerging issues.  These applications should be for small, self-contained research projects.

This FOA is complementary to the H3Africa: Collaborative Centers (RFA-RM-11-008), the H3Africa: the Research Projects (RFA-RM-12-004), and H3Africa: Biorepository Grants (RFA-RM-12-003) FOAs that were released previously.

Key Dates
Posted Date

June 13, 2012

Open Date (Earliest Submission Date)

September 29, 2012

Letter of Intent Due Date

September 29, 2012

Application Due Date(s)

(Extended to October 31, 2012 per NOT-OD-13-005), Originally October 29, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

February/March 2013

Advisory Council Review

May, 2013

Earliest Start Date(s)

August 1, 2013

Expiration Date

(Extended to November 1, 2012 per NOT-OD-13-005), Originally October 30, 2012

Due Dates for E.O. 12372

Not Applicable.  

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Low- and middle-income nations suffer over ninety percent of the world’s burden of premature mortality, as measured in lost years of life.  These countries, constituting three-quarters of the world’s population, now must deal with a triple burden:  the persistent cluster of infectious diseases, malnutrition, and a growing incidence of chronic disease and disabilities due to increased life spans and new risk exposures that accompany it. The NIH has a long-standing commitment to address both communicable and non-communicable diseases around the world through health research and training, and one of NIH’s stated priorities is enhancing efforts in global health.  Genomics and other large-scale biological studies provide cutting-edge approaches to research on the genetic and environmental contributors to health and disease, the understanding of which will lead to unimagined advances in medical science and powerful new ways for improving human health. To maximize the impact on the health of people globally, advances in the fields of genetics/genomics/environmental studies must be integrated into the research conducted in developing countries, as well as into their medical education and health services.  However, African researchers and populations are substantially underrepresented in genomics and environmental research endeavors.  As documented in a recent review of studies across the world, about 75% of the thousands of genetic studies completed to date were conducted exclusively in populations of European descent and only a fraction of the studies done with non-European populations came from Africa (Rosenberg NA, Huang L, et al. (2010). Nat Rev Genet 11(5):356-366).  The paradox of limited genomics research conducted in Africa and the centrality of contemporary African populations for our understanding of human evolution and population genetics has been widely noted. 

While there are pockets of research excellence in genetics and environmental studies on the African continent done by African and other scientists, a limited number of individuals have the expertise to engage in this work compared to the overall population size and burden of disease there.  It is the objective of the H3Africa Initiative to enhance the capability of African scientists and research institutions to use genomics and other powerful new approaches to address problems of African health and disease.  Increasing African research capacity by building infrastructure, expanding the genomic proficiency of researchers, and increasing the number of well-trained individuals is essential to promote sustainable efforts to address the challenges to advancing health and combating disease in Africa.  While focused on benefitting the people of Africa, such research may also be relevant to the health of individuals in the U.S. and other countries worldwide, particularly those of African descent.  For example, many scientists believe that different environmental exposures for a population whose genetic architecture evolved in environments with a scarcity of available resources are an underlying contributor to disease in the U.S. 

H3Africa is a partnership among the National Institutes of Health (NIH, USA), the Wellcome Trust (WT, UK), and the African Society of Human Genetics (AfSHG).  A set of recommendations for H3Africa was developed by a pair of working groups, composed primarily of African scientific experts, who addressed the major scientific, ethical and practical issues in the development of a large-scale genomics research program in Africa.  The working groups formulated a detailed proposal (which can be found in a white paper at http://www.h3africa.org/whitepaper.cfm ) to address the goal of creating and sustaining a network of African Centers that could carry out training and research based on state-of-the-art genomics approaches. Through support for infrastructure development, training, and specific research projects, the working group recommendations were designed to catalyze genomics and environmental research concerning human diversity, health, and disease biology of particular relevance and benefit to African populations and societies and to explore ethical, legal, and societal issues regarding genomic research in Africa.   The proposal was discussed at a public meeting held in Cape Town, South Africa in March 2011 and the attendees ratified the white paper’s recommendations.  Subsequently, the NIH and the Wellcome Trust each published solicitations, that were based largely on the outcome of the Cape Town meeting, for H3Africa projects (http://commonfund.nih.gov/globalhealth/index.aspx).  Funding for the first set of H3Africa projects is expected by September 2012. 

At NIH, H3Africa is funded predominantly through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact.  All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Accordingly, H3Africa has three interrelated, interdependent objectives.  The first is to increase the human resources for conducting cutting-edge, genomics-based research in Africa through training and enhanced collaborations with national and international partners, particularly with investigators in other countries within Africa, as well as countries outside of the continent.  The second is to support cutting-edge research that will not only generate important findings and discoveries, but will serve as a vehicle for research training and for the improvement of the research capacity of African laboratories where the research is carried out.  The third is to support the improvement of specific types of infrastructure, i.e., bioinformatics and biorepository capacity, which are needed to do genomics-based and environmental research. 

In pursuit of these objectives, the H3Africa program at NIH includes: (a) Infrastructure improvement, addressed by support for an H3Africa Bioinformatics Network and planning grants for biorepositories in Africa; and (b) Research activities of three types: H3Africa Collaborative Centers , H3Africa Research Projects and the H3Africa ELSI program, which is the subject of this FOA.

The application of genomic technologies and the availability and use of genomic information has the potential to transform how research and medicine are practiced in African countries.  As with all genomic research, performing genomic studies in communities with diverse social, cultural and religious beliefs, such as those found in the urban and rural communities of countries in Africa, raises ethical, legal, and societal issues, and will ultimately influence how a wide range of social practices and norms are understood and shaped.  Thus, a research program is needed to investigate important ethical, legal, and societal issues surrounding the conduct of genomic research and the application of genomic findings in communities throughout Africa.  It is hoped that information from such ELSI research may help to minimize potential harm and maximize the capacity of African communities to partake of the expected benefits of improved prevention, diagnosis, and treatment of disease that are expected from genomic research. 

Information on the current knowledge of genetics/genomics in Africa and ELSI research needs surrounding cultural, religious, and community beliefs regarding genomic research was collected through the Ethics and Genomics Research in Africa (EAGER-Africa) conference held in Abuja, Nigeria on November 28-29, 2011 (http://eager-africa.com/ea/) and an NIH Request for Information (NOT-RM-12-014), as well as in discussions with many experts.  

The H3Africa ELSI Research Program aims to promote the study of ethical, legal, and societal issues related to genomics research in Africa.  It is envisioned that this research will help to inform the scientific community about ways to understand and address the diversity of cultural, community, and religious beliefs when carrying out genetic and/or genomics research in Africa.

Objectives of this Research Program

This FOA solicits applications for research projects that identify, examine and address the ethical, legal and societal issues raised by genomic research and technology that pertain to individuals, families, communities and societies throughout the African continent. These applications should be for small, self-contained research projects.  Of particular interest are projects that propose focused bioethical, legal, and social science analyses of new or emerging issues.  Examples of possible research questions to be addressed in studies proposed in response to this FOA include, but are not limited to, the following: 

As noted in the Background section, there are several specific objectives that the H3Africa Program is trying to achieve.  Applications submitted in response to this RFA must address the following:

Research Plan: The application should describe a well-conceived plan for the investigation of one or more ELSI topics related to genomic research. The applicant should clearly state the research objectives, describe the research plan in adequate detail, and give timelines and milestones, where applicable.  The applicant should also explain how the research proposed will lead to an improved understanding of the ELSI questions considered in the African context.  It is important that applicants follow the format outlined in the SF424 Application Guide (http://grants.nih.gov/grants/funding/424/index.htm#inst).

Informed Consent:  Evidence of appropriate informed consent and/or IRB approval or a plan for obtaining appropriate consent should be provided at the time of application submission, if required for the research activity.  Applicants should describe protection of participants’ privacy and confidentiality.

Collaborations: Applicants may propose collaboration with other researchers if it is logical, beneficial and necessary to complete the research goals proposed in the application.  Collaborations may be within Africa or outside the continent.  If proposing collaborations outside of the continent, please note that more than 51% of the grant's funds must be spent within the continent of Africa.

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.  If possible, letters of Institutional support and National commitments to provide evidence of long term sustainability are encouraged.

The NIH plans to have an H3Africa Bioinformatics Network (see expired RFA-RM-11-010) to provide virtual connectivity among the H3Africa participants, and eventually beyond H3Africa.  The bioinformatics network will provide ELSI research grantees with an opportunity to interact with each other and other H3Africa grantees who are involved in genomic research through in-person meetings and social networking websites.  Applicants should indicate their willingness to cooperate with the funded H3Africa Bioinformatics Network and other H3Africa participants.

Also, all awardees will be members of the H3Africa Consortium to further enhance the collaborative nature of this Initiative.  Awardees will meet in conjunction with the H3Africa Consortium and potentially with other related ELSI programs to participate in training workshops; share research plans; and identify commonalities in approaches, barriers, and solutions.  Travel funds should be included for the PI to attend two meetings per year.  It is expected that one meeting each year will be held in a city to be named in Africa and the other meeting will be held in London.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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

NIH intends to fund 3 to 4 awards for 3 years each, corresponding to a total of approximately $162,000 total costs per year for each of three years, depending upon availability of funds.

Award Budget

Application budgets are limited to $50,000 direct costs per year, and must reflect actual needs of the proposed project.

Award Project Period

August 1, 2013-July 31, 2016

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Specifically:

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 eligible to apply.

Foreign components, as defined in the  NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

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

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

The letter of intent should be sent to:

Ebony Bookman, Ph.D.
National Human Genome Research Institute (NHGRI)
National Institutes of Health
530 Davis Drive, Room 3130
Morrisville, NC 27560
Telephone: 919-541-0367
Email: ebony.bookman@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How does the proposed research strengthen the understanding of ethical, legal and societal issues of genomic research in African populations? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.   

Applications from Foreign Organizations

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.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans are reasonable: 1) Data Sharing Plan; 2) Questionnaires and Surveys; and 3) Research protocols.

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Human Genome Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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.

Definitions

Steering Committee (SC):

The Steering Committee is the primary governing body of the H3Africa Research Network.  PI(s)/PD(s) of grants, and NIH Program Directors serve on the committee.  See further details about the Steering Committee under "Joint Responsibilities". 

Panel of Scientific Consultants (PSC):

The PSC will be composed of four to six senior scientists with relevant expertise who are not P.I.s of a cooperative agreement involved in the H3Africa Research Network. It will be responsible for reviewing and evaluating the progress of the H3Africa Research Network.  See more about the PSC below under this topic.

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

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

Areas of Joint Responsibility include:

The Steering Committee will:

The Panel of Scientific Consultants:

The NIH will convene an expert committee, termed the Panel of Scientific Consultants (PSC), to provide advice to the Directors of DPCPSI and participating Institutes about the progress and achievements of the H3Africa Research Program.  The PSC members will be experts in genomics-based research and research in Africa, who are not associated with any of the funded H3Africa projects.

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.  The three members will be: 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Ebony Bookman, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 919-541-0367
Email: ebony.bookman@nih.gov

Jean McEwen, J.D., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: jean.mcewen@nih.hhs.gov

Jane Peterson, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: jane_peterson@nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone:  301-402-8739
Email: rudy.pozzatti@nih.hhs.gov

Financial/Grants Management Contact(s)

Vicki Bishton
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
Email: bishtonv@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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