This Funding Opportunity Announcement (FOA) is a Common Fund initiative (http://commonfund.nih.gov) through the NIH Office of the Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by National Human Genome Research Institute (NHGRI) (https://www.genome.gov/) on behalf of the NIH.
The purpose of this FOA is to call for U24 cooperative agreement applications that will request funding to further develop and sustain up to three H3Africa Biorepositories, building upon existing infrastructure. The H3Africa Biorepositories will continue to have the responsibility of maintaining state of the art methods and technologies for DNA collection, processing, quality control, handling, management, and storage and of providing support services needed for bio-specimen collection and dissemination in Africa. They may also propose collection and handling of specimen types including but not limited to PBMCs, plasma, serum etc. Biorepositories will coordinate closely with H3Africa research projects and the H3Africa Bioinformatics network (H3ABioNet) to ensure responsible stewardship of high quality biological specimens linked to well-curated phenotypic and genomic data.
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.
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.
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 and environmental health research, in Africa by African scientists, and to understand the genetic and environmental factors that determine disease susceptibility, H3Africa has three interrelated, interdependent objectives:
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 end in 2021; 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 three years of the program (2019 – 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 why a particular policy cannot be followed).
Purpose and Objectives
This Funding Opportunity Announcement (FOA) is soliciting applications for continued operations and capacity building of currently funded biobanks that are part of the H3Africa Biorepository Program (U24). It is expected that applicants will leverage and build upon their existing infrastructure to support multiple aspects of the scientific research outlined above. The H3Africa Biorepositories will continue to maintain state of the art methods and technologies for DNA and other specimen collection. They will provide processing, quality control, handling, management, storage, and support services needed for bio-specimen collection and dissemination in Africa. They must also coordinate closely with H3Africa research projects and the H3Africa Bioinformatics network (H3ABioNet) to ensure responsible stewardship of high quality biological specimens linked to well curated phenotypic and genomic data. The applicants should propose plans to establish new partnerships and capabilities, expand to serve entities beyond H3Africa, and transition to a self-sustaining model of operations by the end of the three-year period of funding provided by this FOA.
Applicants should propose a plan that clearly outlines how they will address:
1. The DNA sample storage and dissemination needs of the H3Africa consortium.
2. Capacity for other sample processing, storage and dissemination.
3. Shipping, storage, and quality control.
4. Responsible stewardship of additional samples types including samples for both genomic and environmental measures.
5. The biorepository needs of the local scientific community.
6. The specific challenges facing biobanking in Africa.
7. A business plan for continued operation beyond H3Africa support including the monitoring of local and regional research priorities and potential for development of services and capacity to support them.
Responsible stewardship, tracking, and storage of samples are the primary responsibility of all Biorepositories and all practices and procedures of the H3Africa Biorepositories must meet International Society for Biological and Environmental Repositories (ISBER) standards. While all H3Africa Biorepositories are required to have and maintain expertise in the storage and handling of DNA samples, successful long-term planning will include moving beyond DNA storage. Biorepositories may propose to establish additional nucleic acid capabilities including extraction, genotyping, handling and storage of RNA, etc. H3Africa Biorepositories should also consider expanding to include storage of additional samples types such as blood or blood spots, serum, and urine; in storage of these types of samples, consideration should be given to downstream applications including analyses of environmental exposures. Finally, repositories should describe any specialized services they plan to offer. These could include, but are not limited to, plans to support:
In all cases, applications to expand capacity should engage co-funders interested in that area of work. All applicants are encouraged to contact NIH Staff early in the application process to discuss the alignment of their proposed work with the goals of this FOA, with the H3Africa Consortium, and with NIH Institutes and Centers.
As noted in the Purpose section, there are several specific objectives that the H3Africa Program is trying to achieve. Successful applicants will become members of the H3Africa Consortium, and will be expected to adhere to these policies, unless adequate justification can be provided.
H3Africa Consortium Participation: H3Africa is organized as a research consortium that brings participants together in a highly collaborative and synergistic effort. The H3Africa Consortium includes all participants of research and infrastructure projects funded through H3Africa, as well as responsible Wellcome Trust and NIH staff. 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. H3Africa Biorepositories are full consortium members, and are expected to work with H3Africa research projects and centers, with the H3Africa Bioinformatics Network, and with each other. 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 (found at www.h3africa.org). In addition, the PD/PI(s) will be active members of the H3Africa Steering Committee, which meets regularly by teleconference. The H3Africa Consortium generally holds two meetings per year, usually in Africa.
H3Africa Data Sharing Policies: Data sharing is an increasingly important aspect of contemporary biomedical research, and the Consortium has developed a Data Sharing, Access, and Release Policy (www.h3africa.org/consortium/documents). One of the roles of the H3Africa Informatics Network (currently: http://h3abionet.org) is to facilitate data sharing, by providing a data repository in Africa for all genetic and genomic data, as well as selected associated phenotypes. Members of the H3Africa Consortium submit data to the Informatics Network according to that policy, and thereby facilitate transfer of those data to the European Genome-Phenome Archive (EGA). An H3Africa Biorepository is expected to share data in the agreed-upon format with the H3Africa Bioinformatics Network and work together to establish a consortium-wide catalog of linked samples and data.
H3Africa Sample Sharing Policies: H3Africa funds a Biorepository Program consisting of three Biorepositories, located in Eastern, Western, and Southern Africa. All DNA samples must be deposited in one of the H3Africa Biorepositories according to H3Africa policies (www.h3africa.org/consortium/documents) so that they can be distributed and shared for further research consistent with achieving the goals of this funding initiative. Other biological samples may also be banked for future use. H3Africa Biorepositories are expected to work with each other, and with H3Africa research projects and centers, to ensure integrity of sample quality and responsible stewardship of biological materials.
Community Engagement: H3Africa recognizes ongoing community engagement and the building of trust and strong relationships with research participants 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, re-contact of research participants, return of results to individual participants, or other relevant topics. H3Africa should consider participating in Community Engagement activities as appropriate.
Collaborations: One of the major goals of the H3Africa Initiative is to facilitate opportunities for collaboration between and among investigators within Africa, 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. H3Africa Biorepositories are expected to collaborate with each other and with the Consortium and may also propose additional collaborations that will strengthen their capacity and potential for sustainability.Providing the next generation of African researchers with opportunities in genomics: Establishing the next generation of African researchers to take advantage of genomic approaches to health research is a primary objective of the H3Africa program. Operation of an H3Africa Biorepository should provide a variety of career enhancement opportunities to students, postdoctoral researchers, and young investigators, such as training in laboratory techniques, writing policies and SOPs, attending appropriate scientific meetings, and giving presentations to disseminate research findings. Long-term sustainability and institutional/governmental commitments to research education programs and independent career opportunities are objectives of the H3Africa program.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The NIH Common Fund intends to commit up to a total of $2,200,000 and NHGRI $300,000 in FY 2019 contingent upon receiving scientifically meritorious applications.The Common Fund and NHGRI intend to commit an estimated total of $6,900,000 over 3 years to fund up to three awards.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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 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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The PD/PI should be an established investigator in their field and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI should have research experience in Africa, particularly in the country where the proposed research program will be established. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the program and appointing members of an Advisory Committee, as appropriate, and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.The contact PD/PI must be affiliated with the low and middle income (LMIC) African institution submitting the application where the proposed research program will be established and must have citizenship in an LMIC African country. Other Multiple PDs/PIs with relevant expertise from partner institutions in Africa, U.S. or other high-income country (HIC) institutions may be proposed. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed program.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: Organize the Research Strategy in the subsections identified below.
1) Background and Significance
Provide a compelling justification for the resources proposed for development in the context of the H3Africa Consortium and sample sharing plans and the ultimate potential impact on human health.
2) Progress Report and Preliminary Data
Applicants should present any preliminary studies along with demonstrations of feasibility, pitfalls, and alternative approaches including, but not limited to, the following:
Applicants should also describe their current capacity, usage, projected future usage for H3Africa consortium DNA samples, and projected capacity that is available for other sample types and use by other projects.
Describe the plans, procedures, and processes to sustain and develop the H3Africa Biorepositories:
Proposed plans should describe how valuable biosamples will be received, processed, stored, and distributed by the H3Africa Biorepositories. Plans should address how the proposed procedures and processes will ensure efficient, cost-effective, standardized biobanking, and distribution of verified and high-quality samples that will advance biomedical research.
Address each of the following key areas:
Receipt of samples – Describe the general procedures that will be used to provide to participants or sites with training, instructions, and, if necessary, materials needed to ensure shipping processes that are in accordance with standard industry practice. The application should also describe planned systems to document the handling and archiving of all shipments, including documenting exceptions and corrective measures.
Shipments – Describe the approach to establishing arrangements with commercial vendors to provide timely and cost-effective shipping of biosamples among multiple sites, the Biorepository, end-users and/or analytic laboratories.
Sample processing – If applicable for services and sustainability plans, the applicant should describe any plans to process saliva, blood, or urine biospecimens using established protocols to produce high-quality materials, including plasma, serum, red blood cells, buffy coats, and DNA, and other potential biospecimens or cell derivatives for subsequent analysis. The plans should take into account the future use of Biobank automation and use barcoded tubes and racks. Consideration should be given to special processing needs for samples to be used for measures of environmental exposures (i.e. metal-free tubes).
Storage – Describe the facilities and plans to store biosamples under optimal conditions to minimize loss, damage, or contamination. The application should include information about the suitability of the facility to perform the proposed work and, if applicable for sustainability plans, achieve biohazard containment, complying with all safety guidelines and regulations, as well as federal and local laws.
QA and QC systems – Describe the quality control (QC) and quality assurance (QA) programs that will be implemented for all aspects of H3Africa Biorepository operations, including but not limited to:
Security and back-up – Describe the proposed security and back-up systems and a plan for disaster recovery following a natural or man-made disaster. The plan should include provisions to maintain an adequate number of empty, functional storage units to serve as back-up units in the event of freezer failures, and to create a back-up facility located at a second site, in case of catastrophic loss. The application should describe the fire, smoke, and mechanical failure alarms, and fire control equipment, as well as the plan to alert key personnel at any time in the event of fire, mechanical failure of one or more freezers, or other emergency.
In addition, describe the proposed emergency back-up generator system that is capable of handling the complete power supply, in the case of electrical power failure, with a minimum of 72 hours of fuel available for the generator(s), and the plans for maintaining the back-up system to ensure proper operation.
Describe plans to prevent access to samples and data by unauthorized individuals.
Information systems - Describe the proposed robust information systems that will allow detailed tracking of sample receipt, processing, storage and distribution, rapid retrieval of samples, and metadata associated with the sample, and that permit efficient, rapid, and flexible reporting. Include information about the ability to rapidly and efficiently download and upload information, to readily transfer information to researchers or other entities submitting or receiving samples, and to efficiently handle sample and data destruction per participant revocation of consent. Describe plans to ensure state-of-the-art security for all electronic databases. Describe how the information systems will interface with other H3Africa Biorepositories, H3ABioNet, and H3Africa projects.
Sustainability – Describe additional capabilities to be developed, outreach to stakeholders, users, and customers, and a business plan for attracting funds to increase the Biorepository capacity and services and sustaining an active Biorepository after H3Africa core funding ends.
Succession plan – Describe plans to arrange transfer of samples for storage, or appropriate elimination of samples if required.
Additional Application Elements:
Applicants must also address each of the following key elements:
Milestones: Specific milestones should be presented that will be met to accomplish the aims. Annual milestones must be provided in the context of a study timeline. These milestones will provide clear indicators of a project’s continued success or emergent difficulties. Milestones are goals that include clear and quantitative criteria for success. Milestones should include timely receipt, processing of sample submissions, and distribution; accuracy of inventory; quality of processed samples; quality and yield of extracted DNA; and clear communication and data transfer timelines with H3ABioNet and the H3Africa consortium. Achievement of milestones will be evaluated by NIH, and funding of non-competing award years will depend on milestone accomplishment, among other considerations.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Letter of Support Indicating Institutional and National Commitments: Applications should include letters from the appropriate institutional official (University or Medical School President, Dean or Director, or the head research administrator or equivalent from the institution) stating its commitment to the proposed project and its sustainability. The institution should also indicate its commitment to overcoming any administrative obstacles to the implementation of the proposed UH2 Phase I study activities and the Phase II activities. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program. The letter should also briefly state its commitment to participate as a member of the H3Africa Consortium and discuss the institution's plans for sustaining the Biorepository.As the programmatic activities of this initiative will support an important international resource if the applicant is successful in competing for the full-scale repository, letters of support from the relevant national ministries, for example the Ministry of Science, Ministry of Health and/or Ministry of Education; Medical Council; or appropriate government official for the host country will be required. The letter should briefly describe the national policy concerning the development of national scientific resources and how the country is addressing the target that the African Union set in 2006 for each nation to spend 1% of its gross domestic product (GDP) on research and development (R&D). Letters should also describe their commitment toward sustaining this international resource. It is highly recommended that these letters of support be included with the application
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.
Does the proposed biorepository address the needs of the research consortium that it will serve? Is the scope of activities proposed for the biorepository appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the biorepository? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the biorepository? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the biorepository will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the biorepository will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Resource Sharing Plan
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Will the institutional environment in which the biorepository will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the biorepository proposed? Will the biorepository benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Does the application include adequate plans to ensure future sustainability? Are the plans appropriate, adequate, and sufficient to ensure future sustainability? How will the activities initiated under this award be sustained at the conclusion of the award period? Do the letters of Institutional and National commitment suggest that the environment is conducive to a sustained research enterprise? Does the application include adequate plans to ensure future sustainability?
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Renewals, the committee will consider the progress made in the last funding period.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below
The PD(s)/PI(s) will have the primary responsibility for:
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 on the H3Africa Steering Committee. On voting matters, each funded project will have one vote and each funding agency will have a single vote. The Steering Committee will: (1) discuss progress in meeting the goals of various H3Africa projects and of H3Africa as a whole; (2) develop recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, for example for data quality measures and assessment, conventions for data deposition; (3) endorse and oversee progress and products of Working Groups within the Consortium; (4) meet twice a year in person in conjunction with network meetings and conduct intermittent conference calls.
Dispute Resolution:Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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Dr. Jennifer Troyer
National Human Genome Research Institute (NHGRI)
Dr. Bonnie Joubert
National Institute of Environmental Health Services (NIEHS)
Dr. Sudha Srinivasan
National Institute of Allergy and Infectious Disease (NIAID)
Dr. Rudy Pozzatti
National Human Genome Research Institute (NHGRI)
Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
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