and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
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), (http://www.genome.gov) on behalf of the NIH. |
|
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 |
Reissue of RFA-RM-12-005 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-RM-13-005 |
Companion Funding Opportunity |
None |
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. |
Posted Date |
January 25, 2013 |
Open Date (Earliest Submission Date) |
May 19, 2013 |
Letter of Intent Due Date(s) |
March 7, 2013 and December 19, 2013 |
Application Due Date(s) |
June 19, 2013 and March 19, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October/November 2013 and June/July 2014 |
Advisory Council Review |
January/February 2014 and September 2014 |
Earliest Start Date |
April 1, 2014 and October 1, 2015 |
Expiration Date |
March 20, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
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. 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). The first set of H3Africa projects were funded in 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 have 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.
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:
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the SF424 (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 an estimate of 3 to 4 awards, corresponding to a total of $162,000 total costs, for fiscal year 2014. Future year amounts will depend on annual appropriations. |
Award Budget |
Application budgets are limited to $50,000 direct costs per year, and must reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum period is 3 years. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum period is 3 years. |
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) 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.
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.
Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational signing official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
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.
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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, letters of intent are strongly encouraged as 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: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Applicants may propose collaborations 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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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.
Cooperation with the H3Africa Bioinformatics Network: The NIH has funded an H3Africa Bioinformatics Network, the H3ABioNet (see http://www.h3abionet.org/), 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 H3Africa Bioinformatics Network and other H3Africa participants. All awardees will be members of the H3Africa Consortium to further enhance the collaborative nature of this Initiative.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed. With the following additional instructions:
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 PD/PI to attend two meetings per year.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: 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.
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: If possible, letters of Institutional support and National commitments to provide evidence of long term sustainability are encouraged.
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:
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 (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.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications long before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
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 before the deadline in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit 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
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III
of this FOA for information on registration requirements.
The applicant organization
must ensure that the DUNS number it provides on the application is the same
number used in the organization’s profile in the eRA Commons and for the System
for Award Management (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 by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed
In order to expedite review, applicants are requested to notify the Program Director, Ebony Bookman, 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.
Program Staff will have a teleconference with potential applicants at 9:00 am EST on Monday, March 18, 2013. Teleconference information will be posted on the H3Africa website (www.h3africa.org). The date and time of the teleconference for the March 14, 2014 receipt date will be posted in another notice as well as the H3Africa website.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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 project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
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/PI, 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?
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 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
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
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
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, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; 3) Genome Wide Association Studies (GWAS); 4) Questionnaires and Surveys; and 5) 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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:
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:
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.
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 the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants 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.
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. PD(s)/PI(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 PD(s)/PI(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:
Participation in the Steering Committee. A Steering Committee will serve as the main governing board of the H3Africa Research Network. The Steering Committee membership will include the NIH Project Scientists and the P.I. of each awarded cooperative agreement. The Steering Committee Chair will not be an NIH staff member but will be appointed by H3Africa staff. Additional members may be added by action of the Steering Committee. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions. Because the Research Network will include investigators funded by this FOA and other FOA's for H3Africa, it is possible that H3Africa staff will create appropriate subcommittees to handle interests that may be specific to a set of awardees under a specific FOA.
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.
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. The application submission contacts provide support that may be needed for timely and error free submission of applications in response to this funding opportunity.
Having a problem completing the electronic submission
process? Suspect a system
issue? Make sure to refer to the NIH
Late Policy and contact the eRA Help
Desk before 5 p.m. (local
time) on the due date to report the issue.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Web ticketing system: https://public.era.nih.gov/commonshelp
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726
Email: [email protected]
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Phone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Ebony Bookman, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 919-541-0367
Email: [email protected]
Jean McEwen, J.D., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: [email protected]
Jane Peterson, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: [email protected]
Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]
Vicki Bishton
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
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 Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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