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)

National Cancer Institute (NCI)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Funding Opportunity Title

Development of a Preliminary Evidence Base to Inform Decision-making about Returning Research Results to Participants in Genomic Studies (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • January 3, 2011 - See Notice NOT-CA-11-005 National Cancer Institute (NCI) will participate in Request for Application.
  • December 21, 2010 - See Notice NOT-HG-11-007 Information Teleconference and Webinar for Applications to NHGRI Sequencing and Ethical, Legal, and Social Implications (ELSI) FOAs.

Funding Opportunity Announcement (FOA) Number

RFA-HG-11-003

Companion FOA

RFA-HG-11-004, R21
RFA-HG-10-017, U01

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.172, 93.173

FOA Purpose

The purpose of this FOA is to stimulate empirical research to develop a preliminary evidence base to inform decision-making about whether, when, and how to offer to return individual research results to participants in genomic research studies (especially whole exome or whole genome sequencing studies) or to individuals who have provided samples or data for genomic repositories (such as biobanks or databases such as dbGaP).  This FOA is aimed primarily at investigators who propose behavioral or social science research projects in which there is likely to be direct interaction with research participants or other stakeholders involved in current, ongoing genomics projects (especially whole exome or whole genome sequencing projects) or in genomic sample or data repositories.   

This FOA is complementary to FOA HG-11-004 (R21), which invites applications that propose to analyze the normative and legal issues involved in decision-making about returning research results.  It is also complementary to FOA HG-10-017 (U01), which invites applications for projects designed to generate, process, filter, and interpret data from whole exome or whole genome sequencing in the specific context of an active clinical setting, and to return--and investigate the psychosocial and behavioral implications of returning--genomic results in the clinical setting (as distinct from the traditional research setting).  A consortium of investigators will be organized that includes the principal investigators and relevant key personnel funded under all three FOAs; this consortium will address common issues, explore opportunities for synergy among studies, and identify areas of possible consensus that can form the basis for policy recommendations in this area.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

Februrary 10, 2011

Letter of Intent Due Date

February 10, 2011

Application Due Date(s)

March 10, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2011

Advisory Council Review

August, 2011

Earliest Start Date(s)

September 30, 2011

Expiration Date

March 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/Research Objectives

Defining the circumstances, if any, under which individual research results can, should, or should not be offered to participants in genomics research studies (especially whole exome and whole genome sequencing studies) raises complex challenges for genomics researchers, managers of repositories of genomic samples and data, and members of institutional review boards (IRBs).  While issues related to the return of results are neither new nor unique to genomics research, several unique characteristics of genomics research make their resolution in this field especially daunting.

First, genomics studies involve the generation of information which will, by definition, be voluminous in quantity and comprehensive in scope.  This is particularly the case in whole exome and whole genome sequencing studies, which are becoming increasingly feasible--and thus more common--as sequencing costs continue to decline.   In such studies, researchers may or may not uncover the particular variants or variants they were originally looking for (related to the disease or trait of initial interest).  However, they will inevitably uncover a large number of incidental findings--findings that are apparently unrelated to the original research questions.  Such incidental findings will include variants of both known and unknown significance, information about carrier status, and information about risk for late-onset disorders.  Deciding what to do with these findings will present researchers with significant ethical challenges.

Second, the trajectory of genomics research is typically very uncertain and open-ended; samples provided for one study—or data generated in the course of one study-- may subsequently be made available (such as through a biobank or a database such as dbGaP) to secondary investigators in far-flung places who have no direct relationship to the participant.   These secondary investigators may mine the samples or the data for purposes very different from those contemplated as part of the original study.  These studies likewise may uncover new information--not only about risk factors for the disease or trait that was the stated subject of the original study, but about risks for other diseases and traits as well. 

Finally, for several reasons, the meaning of much genomic information—especially for low penetrance variants and for variants related to common, complex diseases--is likely to be highly indeterminate and hard to interpret.  The rapid pace of development of genomic technologies (especially the new sequencing technologies), makes the quality of the data hard to evaluate.  Studying many individuals in the context of a research project--and interrogating perhaps tens of thousands of genes in search of variants that are individually relatively rare--will inevitably lead to technical errors and give rise to the potential for “analytic false positives.”  Searching for even well-known disease-associated variants in a research participant without a relevant family history raises the potential for finding “clinical false positives.”  This will particularly be the case with respect to variants that genome-wide-association studies have found are associated with only moderately increased risk for common, complex disease, which may be very hard to interpret on the level of an individual research participant.  In addition, sequencing will invariably discover variants in genes known to be associated with disease but which have never before been seen (i.e., “private” mutations); the significance of these will similarly be hard to discern.  Compounding all these problems is the fact that the significance of the information uncovered through genomic analysis may evolve over time as additional knowledge is gained. 

All of these factors--coupled with the limited resources typically available to researchers--can make the prospect of offering to return all or even most individual results to the participants in genomics studies unwieldy, and in some cases frankly unrealistic.  As a practical matter, some researchers, and some institutions that maintain biobanks, will simply find it beyond their capability to promise to return any individual results and may default to the traditional approach of offering only aggregate study findings and no individual findings at all.  On the other hand, certain subsets of findings—such as findings of risk alleles for highly penetrant single gene disorders, variants with established pharmacogenomic relevance, and recessive carrier status--may not only have well-established validity, but in some cases, may also be clinically actionable.  Deciding the appropriate course of action with respect to findings in these categories raises difficult issues. 

There is general consensus among lawyers that if genomic research results are being offered to study participants at all, this should be done only when their analytic validity has been established in a laboratory certified under the Clinical Laboratory Improvements Amendments (CLIA).  Most ethicists also agree that results should be offered only in circumstances where they have actual utility.  However, considerable controversy exists about the precise threshold of utility that that is required before a result can or should be returned.  Some take the position that proven clinical utility is necessary (i.e., that some recognized preventive or therapeutic intervention must exist), while others believe that personal utility (e.g., the possibility that the information could be used for reproductive decision-making or general life planning) or even the mere recognition that the information may be useful in and of itself (e.g., by enhancing one’s sense of personal identity) may be sufficient. 

Given the lack consensus in this area, a pressing need exists to develop rational and workable criteria to help guide decision-making by researchers, managers of sample and data repositories, and IRBs about what types of information can, should, or should not be offered to participants in genomics studies.  Such criteria must be informed both by normative and legal considerations and by solid empirical (behavioral and social science) evidence.  This FOA is intended to stimulate research that will contribute to the preliminary behavioral and social science evidence base needed to inform the development of such criteria.  (A complementary FOA, RFA-HG-11-004, is intended to stimulate research on the relevant normative and legal issues.  A second complementary FOA, RFA-HG-10-017 (U01) is intended to stimulate behavioral and social science research on the relevant issues in the clinical (non-research) context.)

Specific Areas of Research Interest

So far, most studies that have examined the attitudes of the public and of potential research participants regarding the return of results--at least where the topic has been introduced in the abstract--suggest that people have an overwhelming preference for learning such information.  However, responses become more equivocal when people are asked to consider the uncertainties and nuances associated with incidental findings, findings of unknown or uncertain significance, or findings the significance of which may change over time.  In addition, it is well known from other contexts that people’s statements about what they would theoretically want are often quite different from what they actually want and expect in a "real life" research context.  This FOA thus particularly invites studies that will investigate how participants in ongoing or planned genomics research projects understand, react to, and use individual research results when they are offered and returned.  Studies that examine the actual psychosocial and behavioral impact of receiving (or not receiving) such results are especially invited.  Specifically, what is the emotional impact of receiving results with implications for reproductive decision-making, life expectancy, or anticipated severe disability?  Will participants be prepared to navigate the practical implications (e.g., follow-up testing and other health care utilization issues)?  How will the presentation of scientific uncertainty affect participants' trust in doctors, researchers, and the medical system, their willingness to participate in research studies, and their willingness to share results with family members who may also be at risk?

Given the complexities of the information that participants may receive, issues of informed consent are also of particular interest under this FOA.  For example, what does it mean to inform people adequately about the potential benefits and risks associated with the possible return of individual research results?  What are the measures and their thresholds?  Are there thresholds for numeracy, literacy, and health literacy, and if so, what are they?  Is it necessary to educate participants about genomics during the informed consent process? 

This FOA also invites studies that investigate the experiences of researchers (including both clinical and epidemiological researchers), managers of biobanks and data repositories, and institutional review boards who have already begun to grapple with issues related to the return of results.  For example, to what extent are the decisions of the relevant actors motivated by a normative sense of duty, versus concerns about the potential for legal liability (e.g., for failing to disclose a clinically actionable result for a serious disorder for which a preventive or therapeutic intervention exists, or for disclosing information that turns out to be unwanted, causing the participant undue psychological distress)?  What are the advantages and disadvantages of various institutional processes or shared decision-making processes for deciding which results can, should, or should not be returned?  How do researchers and other relevant decision-makers weigh such factors as the nature and size of the study, the characteristics of the study population (including whether the participants have alternate ways of accessing the information), and nature and the extent of the previous relationship with individual participants?  What are the implications of attempts to “mine” the data for potentially relevant information, versus limiting the focus to potentially relevant information merely “stumbled upon”?  What practical, logistical, and budgetary considerations enter into the calculus?  What are the implications of CLIA?  What practical difficulties do researchers encounter when attempting to discern participants' wishes and expectations regarding the return of results during the informed consent process, or when incorporating information about their plans to offer (or not offer) individual results into the development of mechanisms for research governance?  What practical and regulatory challenges do they encounter when considering whether or how to incorporate such information into participants' medical records?  Are there intellectual property impediments to returning certain types of results?  If the project is one that involves children or other potentially vulnerable research participants, or one in which the research participant is deceased, what additional complications may be involved?  For example, if the investigator offers genomic results to participants, parents likely would make the initial decision on behalf of the child whether or not to receive results.  However, as the child participant will age into adulthood, is the investigator obligated to offer anew the opportunity to obtain genomic results to the now-adult (current or past) participant?  How often and what variables predict that a near-adult participant will agree with their guardian/parent's choice regarding genomic results?  What are the chronological or "cognitive age" requisites to appropriately reason about the genomic disclosure and are there readily available feasible assessment tools to allow for this determination?

These questions are merely a few examples of the types of areas that are appropriate for investigation under this FOA.  However, applicants should understand that the primary goal of this FOA is to stimulate highly innovative empirical (e.g., behavioral or social science) research in which there is likely to be direct interaction with participants or other stakeholders in ongoing or planned genomics projects (or in existing or planned biobanks or data repositories), which are actually confronting (or plan soon to confront) these issues.  Priority will thus be given to research teams that involve active collaborations between researchers in the behavioral or social sciences and genomics researchers who are already conducting or have plans to conduct studies (especially whole exome or whole genome sequencing studies) that are likely to generate actual individual research results and incidental findings that are potentially clinically actionable. 

Applicants may choose to include in their applications a component aimed at the analysis of normative or legal issues related to the return of results, but are not required to do so.  Applicants proposing studies with a primary normative or legal focus should consider applying instead under RFA-HG-11-004 (R21).  Applicants proposing studies with a primarily clinical (non-research) focus should consider applying under RFA-HG-10-017 (U01). 

Additional Information for Applicants

A consortium will be organized that includes the principal investigators and relevant key personnel funded under this FOA; this consortium will also include other investigators who are already working on these issues, as well as the investigators to be funded under the two complementary FOAs referenced above.  The consortium of investigators will meet at least one time per year, and more frequently by conference call, to identify and address common issues, explore opportunities for synergy among studies, and identify areas of possible consensus that can form the basis for policy recommendations in this area.   Travel costs for the principal investigator and relevant key personnel to attend the annual meetings should be included in the proposed budget. 

This FOA will not support the recruitment of human subjects for genomic studies, the collection of genomic samples or data, or the collection of medical or phenotype data.  Applications that request support for these activities will be considered non-responsive and will be returned to the applicant.  This FOA will, however, support obtaining reconsent from human subjects, in cases where the applicant expects to offer results to some or all participants as a part of the study design and where the original informed consent did not clearly anticipate the sharing of this information.  This FOA will also support obtaining confirmatory testing of research results in a CLIA-certified laboratory, in cases where the applicant expects to offer results to participants as a part of the study design and where the research that generated the findings was not performed in a CLIA-certified laboratory.  If reconsent or the obtaining of confirmatory testing in a CLIA-certified laboratory will be necessary, specific budgets for reconsent and for obtaining confirmatory testing should be provided.

Applications are required to include a detailed description of how the genomics  research participants' rights and interests will be protected.  Where the study design anticipates returning individual results to some or all participants, the applicant must provide proof of appropriate informed consent (or of a plan to obtain reconsent with IRB approval) at the time of application submission. 

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

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 NIH intends to commit the approximately $2 million per year to this FOA.  It is anticipated that 3-4 grants will be awarded.

Award Budget

Application budgets are limited to $500,000 per year in direct costs for each project year.  It is anticipated that the budgets of many applications submitted in response to this FOA will be substantially less than this amount.

Award Project Period

The scope of the proposed project should determine the project period.  The project period generally should not exceed 3 years. 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations 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 Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the 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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Rockville, MD 20852 should be used for FedEx, UPS and other courier services
Telephone: 301-402-4997
Email: mcewenj@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 application submission. 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.

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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Review Office by email at rp7s@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?

Investigator(s)    

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

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 NIH national advisory council . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

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 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

Not Applicable.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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)

Jean E. McEwen, J.D., Ph.D.
Program Director
Ethical, Legal, and Social Implications Program
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD  20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD  20852 (express/courier service, non-USPS service)
Telephone:  (301) 402-4997
Email:  mcewenj@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
Scientific Review Officer
Division of Extramural Research
National Human Genome Research Institute
5635 Fishers Lane
Suite 4076, MSC 9306
Bethesda, MD  20892-9305 (U.S. Postal Service Express or regular mail)
Rockville, MD  20852 (express-courier service, non-USPS service)
Telephone:  (301) 496-7531
Email:  pozzattr@mail.nih.gov

Financial/Grants Management Contact(s)

Cheryl Chick
Grants Management Officer
Grants Administration Branch
Division of Extramural Research
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane
Suite 3058, MSC 9307
Bethesda, MD  20892 (U.S. Postal Service Express or regular mail
Rockville, MD  20852 (express courier service, non-USPS service)
Telephone:  (301) 435-7858
E-mail:  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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
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