Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title

Genomic Medicine Pilot Demonstration Projects (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • April 1, 2013 - This RFA has been reissued as RFA-HG-13-004.
  • June 20, 2012 - Frequently Asked Question (FAQs) for RFA-HG-12-006. See Notice NOT-HG-12-018.
Funding Opportunity Announcement (FOA) Number

RFA-HG-12-006

Companion Funding Opportunity

RFA-HG-12-007,  U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.172

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support a consortium of collaborative genomic medicine pilot Demonstration Projects designed to demonstrate the feasibility of, and develop methods for, incorporating an individual patient’s genomic findings into his or her clinical care.

Key Dates
Posted Date

April 3, 2012

Open Date (Earliest Submission Date)

May 1, 2012

Letter of Intent Due Date

June 19, 2012

Application Due Date(s)

July 19, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November/December 2012

Advisory Council Review

January, 2013

Earliest Start Date(s)

April, 2013

Expiration Date

July 20, 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

Nature of the Research Opportunity

The purpose of this funding opportunity announcement (FOA) is to support a consortium of collaborative Genomic Medicine Pilot Demonstration Projects designed to develop methods for, and evaluate the feasibility of, incorporating an individual patient’s genomic findings into his or her clinical care.  Specific goals are to expand and link existing genomic medicine efforts, and develop new collaborative projects and methods, in diverse settings and populations; contribute to the evidence base regarding outcomes of incorporating genomic information into clinical care; and define and share the processes of genomic medicine implementation, diffusion, and sustainability in diverse settings.

For the purposes of this FOA, "genomic medicine" is defined as incorporation of an individual patient's genomic information (as reflected by their own genotypic, sequencing, family history, etc., data) into decision-making about his or her clinical care.

Background

Although the potential for genomics to contribute to clinical care has long been anticipated, the pace of incorporating genomic findings into medical practice has been relatively slow.  NIH currently supports a limited number of such programs, such as the National Institute of General Medical Sciences (NIGMS)-led Pharmacogenomic Research Network and the National Cancer Institute’s Comparative Effectiveness Research for Genomics and Personalized Medicine program. 

Several medical centers have recently begun institutionally funded programs to use an individual patient’s genomic information in his or her clinical care, encountering many of the same obstacles and developing the same solutions, often quite independently.  Evaluating the impact of such programs and ensuring access to them in diverse settings and populations are high priorities in NHGRI’s genomic medicine research agenda, as described in its 2011 strategic plan [PMID: 21307933]. In an effort to identify the opportunities for rapid implementation and evaluation of genomic medicine projects, as well as the obstacles that might be addressed by a coordinated effort in this area, NHGRI convened two meetings in June and December, 2011, of genomic medicine centers identified as such through Internet searches and knowledgeable Institute advisors [http://www.genome.gov/27546373].

Ongoing exemplar projects include screening for highly penetrant germline mutations (such as Lynch syndrome or hypertrophic cardiomyopathy) to identify genetically at-risk individuals; using web-based computerized tools to integrate patient-reported family history information into the electronic medical record (EMR) and provide appropriate clinical decision support (CDS); assaying pharmacogenetically important variants and integrating results into a decision support-enabled EMR for medication selection and dosing; and conducting genomic sequencing to solve diagnostic dilemmas and/or identify potential avenues for treatment.  Much of this work, supported largely by institutional rather than NIH funds, is being done in relative isolation and would benefit from more structured collaboration and sharing of approaches. 

Skepticism, resistance, and/or inertia from institutions and clinicians present major barriers to implementation of pilot genomic medicine projects, which is often as much a cultural and political exercise within a given institution as a scientific one.  Collaborative projects among experienced, early adopter genomic medicine centers or among experienced genomic medicine centers joined with interested but less experienced sites could implement and evaluate genomic medicine interventions and develop best practices for integrating genomic medicine in diverse settings, thus increasing their reach as well as their generalizability.  Such projects could help develop best practices for complex tasks such as integrating with laboratory workflows and EMR systems, defining and collecting outcomes of implementation, and delivering complicated genomic information to clinicians and patients.  They could also play a key role in collecting evidence of the effects of incorporating this information into clinical care.  A consortium of such collaborative projects could become a valuable clearinghouse of successful implementation projects, collecting and disseminating detailed protocols that outline steps needed for patients, clinicians, laboratories, departments, and institutions.  Indeed, critical questions to be examined are whether and how approaches developed at highly specialized and resourced tertiary care centers can be adopted in less resource-intensive settings.

Potential limitations of initial approaches, and/or drawbacks of genotype-driven strategies, should also be assessed objectively in multiple settings.  Such data will provide a needed evidence base for identifying effective interventions suitable for widespread implementation and reimbursement. 

For the purposes of this FOA, "early adopter sites" are those with at least one ongoing program that is incorporating an individual patient's genomic information into his or her clinical care.  "Less experienced groups" are those without such programs, or with programs in related areas that would benefit from collaboration. 

Scientific Knowledge to be Achieved

This funding opportunity will define barriers to implementing genomic medicine projects in general, and as they relate to diverse clinical settings and populations; develop and disseminate solutions to these barriers as well as the processes of genomic medicine implementation; assess outcomes of such implementation projects; and identify outcomes most important to ensuring rapid and sustained adoption.  Although early outcomes of Pilot Demonstration Projects will likely be limited to process measures such as timeliness and validity of assays, patient/clinician satisfaction, acceptance of recommendations, and behavior change, projects that can assess more compelling outcomes within the project period such as reductions in cost, hospitalizations, or morbidity will be preferred.

Objectives of this Research Program

This FOA will support Pilot Demonstration Projects to adapt ongoing successful genomic medicine projects, or initiate new ones, to expand the implementation of genomic medicine.  Demonstration Projects will be expected to incorporate a patient's resulting genomic information into their electronic medical record (EMR), to the extent compatible with informed consent and relevant regulations and guidelines, and provide clinical decision support (CDS) for implementation of appropriate interventions or clinical advice.  Examples of such Demonstration Projects include, but are not limited to:  1) Implementing screening for inherited conditions or highly penetrant germline mutations that commonly pose diagnostic or therapeutic dilemmas; 2) Collecting, validating, and assessing risk information provided by patient-entered family history information to make clinical decisions; and 3) Surveying patients' available genotype or sequencing data, previously generated through clinical or research testing for known risk variants and using these genomic findings in their clinical care. 

Examples of Demonstration Projects that would not be responsive to this FOA include: 1) Implementing Mendelian disease variants that are already regularly used in clinical genetic settings; 2) Incorporating family history into the medical record, but not using the family information to influence clinical decisions; and 3) Incorporating genetic or genomic data into the medical record, but not using the information for clinical care decision-making.  Although research funded through this FOA may uncover novel alleles or variants during the course of the work, proposals that focus primarily on discovery rather than clinical application will not be considered to be responsive

For settings without suitable EMR systems, approaches for providing appropriate information to clinicians in an efficient and effective manner should be described. 

Proposed pilot demonstration projects are not required, but may choose, to partner with less experienced group(s) to expand sample size and generalizability and evaluate their proposed intervention(s) in different settings.  Inclusion of diverse settings such as community hospitals, primary care practices, specialty groups, and military or Veterans’ Administration hospitals, and under-served populations such as disadvantaged or non-European ancestry groups, is particularly encouraged, though feasibility and advantages of such expansions should be clearly described.  Similarly, expansion to multiple different medical or hospital systems, rather than within current members of an existing system, is also encouraged.  

Optimal Demonstration Projects are expected to include: 1) strong supporting evidence for the importance and appropriateness of the particular genomic medicine intervention to be implemented, 2) evidence of (or a plan for obtaining) institutional endorsement, practitioner involvement, and patient participation; 3) an identified group of clinicians willing to learn about, receive, and act upon genotyping results on their patients; 4) a CLIA-certified genotyping environment and efficient workflow for collecting, assaying, and reporting results; 5) a process for integrating genotype results into patients’ EMRs, including working within each institution's relevant regulations and guidelines;  6) a process for providing clinical decision support in settings with such capabilities, and alternative non-computerized processes for those without EMRs; 7) defined outcomes of implementation such as patient and clinician satisfaction and uptake of recommended interventions, cost, or morbidity, and approaches for collecting and assessing them; and 8) a plan for sustaining, and possibly expanding, successful implementation projects once NIH funding support ends.  Leveraging available institutional support and other resources and identifying a clear path to sustainability of the implementation project are strongly encouraged.  Wider-ranging projects that go beyond analysis of a single or small number of genes or variants, such as those that integrate a large panel of pharmacogenomic variants or evaluate large-scale genomic data from a variety of technologies for actionable results, to be used prospectively to guide care, are also encouraged.  Projects designed to contribute objective evidence most likely to influence uptake and reimbursement of genomic medicine interventions are also particularly encouraged.

Each application should clearly describe the above aspects, as well as the ongoing projects at each site upon which the project will build but not duplicate or overlap.  Applications proposing multi-site collaborations should also describe the characteristics of the lead site that make it suitable to lead (including available resources and tools to be shared with and/or adapted to partner sites) and those of the partner sites that make them appropriate to expand the implementation of genomic medicine and assess its impact.  Each application should also describe the proposed study sample(s) and base population, eligibility criteria, consent processes, participant recruitment methods, return of results, EMR interface, clinical workflow, and CLIA/CAP certification requirements.  The clinical decision intended to be influenced, hypotheses to be tested, expected change in outcome, data to be collected, sample size and characteristics (particularly age and race/ethnicity) and CDS tools to be developed/adapted and implemented should also be clearly described.  Criteria for success and next steps for the project if successful, and for re-design and re-assessment if not, should be provided.  Each application should clearly define the patient care costs and aspects considered or not considered to be research by the institution and its IRB. 

Short-term (1 year) as well as longer term (2-3 year) implementation and assessment projects are expected to be conducted throughout the 4-year duration of the award, so that definitive early results will be available for incorporation in later stages of this consortium as well as in other projects.

Program Formation and Governance

The awards funded under this FOA will be cooperative agreements (see Section VI.2.A. Cooperative Agreement Terms and Conditions of Award).  Close interaction among awardees and the NIH will be required to develop appropriate strategies and tools to carry out this program.

Shortly after award, the awardees will meet as a consortium to share research plans; identify commonalities in approaches, barriers, and solutions; and develop common resources such as educational, reporting, and evaluative tools.  A Coordinating Center (CC) will be funded through related RFA-HG-12-007 to collect and disseminate detailed protocols that outline steps needed for successful implementation at the levels of patients, clinicians, laboratories, departments, and institutions.  The CC will also organize broader, open meetings of the genomic medicine community, similar to NHGRI’s recent and planned genomic medicine meetings and likely in conjunction with thrice-yearly meetings of the consortium, to further expand the reach and implementation of genomic medicine.  Interaction and coordination with related NHGRI projects such as the Return of Results Consortium (RFAs HG-11-003 and HG-11-004), Clinical Exploratory Sequencing Centers (RFA-HG-10-017), Electronic Medical Records and Genomics Network (RFAs HG-10-009, HG-10-010, and HG-11-022), and NIGMS’s Pharmacogenomics Research Network, will also be led by the Coordinating Center. 

Given the expected commonalities in infrastructural and institutional needs across collaborative Demonstration Projects, the potential to expand specific projects to other members of the consortium and beyond will be actively explored and encouraged.  Creating a cadre of institutions implementing and evaluating the use of genomic results in clinical care, and collecting and disseminating successful approaches, is expected to lead to more rapid development and adoption of effective genomic medicine programs.

It is expected that the Genomic Medicine Pilot Demonstration Projects Consortium will have subcommittees and/or working groups in areas of interest to the awardees and the funding Institute(s).  The tasks of the subcommittees/working groups will include, among other responsibilities: identifying common scientific areas and adjusting projects to accommodate shared interests, identifying novel projects that may result from synergy among the awarded groups, and identifying ways to interact with external ongoing networks and initiatives.  Working groups may propose new research collaborations with non-network investigators and organizations not funded under this FOA, as long as most or all of the Demonstration Projects as well as the CC have the opportunity to participate, according to criteria established by the Genomic Medicine Pilot Demonstration Projects Steering Committee.   

External Input to the Consortium

The Genomic Medicine Pilot Demonstration Projects Consortium will have an External Scientific Panel (ESP) appointed by NHGRI.  The ESP will be convened to advise NHGRI and the consortium on how best to incorporate genomic research into clinical care and evaluate its impact.  The Genomic Medicine Pilot Demonstrations Steering Committee members will meet with members of the ESP once a year in-person and once a year through teleconference, will receive and consider a report of the ESP’s comments, and will respond with a written letter each time through NHGRI.

Data Sharing under this Initiative

Data from this FOA are expected to be handled so as to increase the value of the significant public investment in implementing genomic medicine projects.  Consistent with achieving the goals of this program, NHGRI expects that Project Datasets (including phenotypic, environmental, covariate, process, and other relevant data) and associated genotyping data from the participating projects be widely shared with the scientific community for research.  Information such as study protocols, descriptions, CDS and bioinformatic tools, and publications are expected to be made available through an open access section of a database such as dbGaP, other public web sites, and/or publication in the scientific literature. 

Applicants should indicate their willingness to cooperate with other awardees in the development and design of research and consultation methods, procedures, policies and strategies to be applied in this program. Applicants should also describe prior experience in working as part of a research consortium or other collaborative activities to meet individual study and collaborative goals.

This initiative will not support studies using animal models.  Applications using animal models will be considered non-responsive and returned to the applicant.

Evidence of appropriate informed consent and/or IRB approval for using the EMR for implementation of genomic medicine projects, or of approval for prior similar projects, or a plan for re-consent, should be provided at the time of application submission.  Only applications describing protection of patients’ privacy and confidentiality will be considered.

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.

NHGRI intends to fund an estimate of 3-5 awards, corresponding to a total of $2.6M, for fiscal year 2013. Future year amounts will depend on annual appropriations.

Award Budget

$750K total costs in FY13, $1M total costs per year in FY14-FY16.

Award Project Period

The maximum period is 4 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not 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.
Office of Population Genomics, NHGRI
KEYSTN/3130
530 Davis Dr., MSC K3-02
Durham, NC 27713
Telephone: 919-541-0367
Email: bookmane@mail.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:

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.

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 components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at kn24c@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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 clinically significant, in terms of potential benefits or risks, are the proposed interventions, clinical decisions to be influenced, and outcomes to be assessed?  How likely is the project to improve the assessment and expand the implementation of genomic medicine?

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? How suitable is the research team to expand the implementation of genomic medicine and assess its impact? 

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?  How likely is the proposed project to contribute valuable new information to the evidence base on genomic medicine?

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? For settings without suitable EMR systems, are the proposed alternative approaches likely to provide the appropriate information to clinicians in an efficient and effective manner?  Are criteria for success and next steps for the project clearly defined?  Are definitive early results likely to be available from short-term (1 year) projects as well as longer term (2-3 year) projects?

 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?  Are institutional endorsement, practitioner involvement, patient willingness, EMR and CDS availability, and CLIA requirements sufficient to ensure success of the project?  Are institutional resources and infrastructure being committed or leveraged?  Are arrangements for a CLIA-certified genotyping environment and efficient workflow sufficient? 

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

Not Applicable.

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; and 3) Genome Wide Association Studies (GWAS).

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 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.

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

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The Project Scientist is a scientist of the NHGRI staff who will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination.  However, the role of NIH staff will be to facilitate and not to direct the activities.  It is anticipated that decisions in all activities will be reached by consensus of the program and that NIH staff will be given the opportunity to offer input to this process.  The Project Scientist will participate as a member of the Steering Committee and will have one vote.  The Project Scientist will have the following substantial involvement

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to develop appropriate strategies and tools to incorporate genomic results into clinical care. The awardees and the Project Scientist will meet as the program Steering Committee three times per year and monthly on conference calls as needed to share information on data resources, methodologies, analytical tools, as well as data and preliminary results.  Key co-investigators and pre- and postdoctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, in addition to the PIs, are eligible to attend these meetings.

The Steering Committee will serve as the main scientific body of the program.  The Steering Committee will be responsible for coordinating the activities being conducted by the program.  The Steering Committee membership will include one NHGRI Project Scientist and the PI from each awarded cooperative agreement.  The Steering Committee may add additional members, and other government staff may attend the Steering Committee meetings as desired.  It is anticipated that additional coordination mechanisms may be set up with other U.S. and international groups that may collaborate with the program.

To address particular issues, the Steering Committee may establish working groups as needed, which will include representatives from the program and the NIH and possibly other experts. Awardees agree to work collaboratively to:

External Scientific Panel

An External Scientific Panel (ESP) will evaluate the progress of the program. The ESP will provide recommendations to the National Advisory Council for Human Genome Research about the progress and scientific direction of all components of the program.

The ESP will be composed of 5-8 senior scientists with relevant expertise, although the membership may be enlarged permanently or on an ad hoc basis as needed.  The ESP will meet at least twice a year, one in-person meetings and one telephone conference.  At least once a year, there will be a joint meeting with the Steering Committee to allow the members of the both the ESP and the Steering Committee to interact directly.  Twice a year the ESP will make recommendations regarding progress of the program to the National Advisory Council for Human Genome Research about changes, if any, which may be necessary in the program.

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.

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.  
Office of Population Genomics, NHGRI
KEYSTN/3130
530 Davis Dr., MSC K3-02
Durham, NC 27713
Telephone: 919-541-0367
Email: bookmane@mail.nih.gov

Peer Review Contact(s)

Ken Nakamura, Ph.D.
Scientific Review Branch
National Human Genome Research Institute, NIH
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service, non-USPS service)
Telephone:  (301) 402-0838
E-mail:  kn24c@nih.gov

Financial/Grants Management Contact(s)

Ms. Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute (NHGRI)
5635 Fishers Lane, Suite 4076
Bethesda, MD 20892-9306 (U.S Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-0733
Email: chickc@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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