and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of
Participating Organizations
National Human Genome Research
Institute (NHGRI) (http://www.genome.gov)
Title: Initiative to Maximize Research Education in Genomics (R25)
Announcement Type
New
Program Announcement (PAR) Number: PAR-09-245
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.172
Key Dates
Release/Posted Date: August 6, 2009
Opening Date: August 25, 2009 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): Thirty (30) days before application due date.
NOTE:
On-time submission requires that applications be successfully submitted to
Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization)
Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration/Closing Date: September 26, 2012
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Education Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Education Objectives
The National Human Genome Research Institute
(NHGRI) invites R25 applications in response to two important initiatives: (1)
short, advanced level courses that are intended to disseminate new laboratory
techniques, methods, analyses related to the mission of the NHGRI and (2)
research education and training initiatives that are linked to specific NHGRI
research initiatives, such as Centers of Excellence in Genomic Science and
large-scale sequencing and database grants.
Courses. Genomics has stimulated and continues to stimulate the development of powerful new laboratory techniques, methods and analyses, and biomedical research would benefit from the rapid, widespread dissemination of these methods to the general research community. Short (a few days to two week) courses have been a very effective means of doing so.
Genomics has also addressed the many ethical, legal and social implications (ELSI) that have been raised by genomics research. Discussion and dissemination of new and emerging ELSI issues would keep the community updated and alerted to issues that should be anticipated in genomics research involving human participants.
Applications are encouraged for courses designed to address either of these needs. Courses designed to cross-train genomic researchers and ELSI scholars are particularly encouraged. Course offerings should be targeted to individuals in careers at the doctoral level and beyond; are expected to be hosted by academic or research institutions where the staff and faculty are experienced in training; include as faculty established investigators or scholars actively working in the area of instruction; and should typically be one to two weeks in length and offered annually, although other terms may be acceptable. Applicants may request up to three years of support.
Research Education and Training. The National Advisory Council for Human Genome Research and the National Human Genome Research Institute want to ensure that the next generation of genome scientists will have adequate representation from populations that are currently underrepresented in genomic science as researchers. Moreover, specific initiatives have been identified as preferred incubators for research education and training in genomics (http://www.genome.gov/10001707). Initiatives targeted to those at the undergraduate level and/or beyond, including the faculty level, are encouraged and will be given the highest priority. The main focus should be on ensuring that individuals: (a) successfully transition to the next career level; (b) remain in a science, technology, engineering, and mathematics (STEM) field; (c) pursue doctoral degrees or advanced training in fields relevant to genomics; and (d) pursue careers in genomics. Examples of how these objectives can be accomplished include, but are not limited to, academic enhancement programs, appropriate laboratory experience; mentoring adequate for the career level; career development activities; enhancements in writing scientific papers and fellowship/grant applications; and developing scientific presentation and interviewing skills. The duration of the research education and training program must coincide with that of the parent grant application.
The types of research experiences that can be supported under this award include, but are not limited to: (1) short-term research experiences for undergraduate and graduate students; (2) up to two years of post baccalaureate research and academic support with the objective of transitioning to a F31 support for graduate school; (3) up to 24 months of graduate school support with the objective of transitioning to a F31; (4) up to 24 months of postdoctoral fellowship support with the objective of transitioning to a F32; and (5) research experiences for faculty to provide preliminary data for research grant applications. Exceptions to accommodate research experiences for high school students will only be made for competing continuations of the parent grant that have in the past supported such students. In such cases, support of high school students must represent less than 10 percent of total support requested.
The proposed research education and training initiative may complement other ongoing research training and education programs at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support and provide added value. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1.
Mechanism of Support
This FOA will use the
NIH Research Education Grant (R25) award mechanism. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.
2.
Funds Available
Because the nature and
scope of the proposed research education program will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the NHGRI provide support for this program, awards pursuant to
this funding opportunity are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications.
For courses, the total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of the course, it is expected that applications will stay within the budgetary guidelines of annual direct costs limited to $ $50,000.
For research education and training initiatives that are linked to parent grant applications, the project duration must coincide with the initiation and termination dates of the parent grant, but in no case can exceed 5 years. Although the size of the award may vary with the scope of the research education and training program, it is expected that applications will stay within the budgetary guidelines of annual direct costs of $300,000. In rare exceptions will this limit be waived for research education and training initiatives submitted as part of competing renewal applications. In such cases, the applicant must receive prior approval to exceed the $300,000 direct cost limit.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
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
1.A.
Eligible Institutions
The following
organizations/institutions are eligible to apply:
Foreign institutions are not eligible to apply in response to this FOA.
In many cases, it is anticipated that the proposed research education and training component will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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 research education and training grant applications that are linked to specific NHGRI grants that require a research education component, the principal investigator of the parent grant initiative and the research education and training initiative must be the same.
The PD/PI should be an established investigator in the scientific area in which the application is targeted who is capable of providing both administrative and scientific leadership for the development and implementation of the proposed research education program.
2. Cost
Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Sponsoring Institution: The sponsoring institution must assure support for the proposed course or research education and training project. Appropriate institutional commitment to the project includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education project. The application should include a letter explaining the institutional commitment to the proposed research education program.
Participants: Describe who the intended participants are, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed program.
For courses, participants may be genome scientists or ELSI scholars who wish to learn the latest developments in their respective fields or wish to be cross-trained in another discipline.
For research education and training initiatives, NHGRI seeks to improve the diversity of the health-related research workforce by supporting participants from groups that have been shown to be underrepresented in research careers in genomics or ELSI. Such candidates include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.
Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6). This is not required for applications requesting support for courses.
Evaluation and/or Dissemination Plan: Applications must contain an evaluation plan and a dissemination plan. Applications submitted without Evaluation and/or Dissemination sections may be delayed in the review process or not reviewed.
Applications for courses must contain an evaluation plan and a dissemination plan.
Research education and training applications must have an evaluation plan.
Number of Applications. For courses, applicants may submit more than one course application, provided each application is scientifically distinct.
For research education and training initiatives linked to specific NHGRI research grants, applicants may submit only one application per parent grant application. If an institution has more than one NHGRI research grant in which a research education and training initiative is required, such as a training grant and a CEGS, only one application may be submitted to cover NHGRIs support of the research education and training initiative at that institution.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewal applications are allowed for course applications. Renewal applications for research education and training initiatives are allowed as long as they are submitted at the same time as the parent grant applications.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application
Package and SF424 (R&R) Application Guide for completing the SF424
(R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1.
Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to
a specific FOA can be used. You will not be able to use any other SF424
(R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one
FOA.
For further
assistance, contact GrantsInfo -- Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424
(R&R) (Cover component)
Research
& Related Project/Performance Site Locations
Research &
Related Other Project Information
Research &
Related Senior/Key Person
PHS398 Cover
Page Supplement
PHS398 Research
Plan
PHS398 Checklist
PHS398
Modular Budget or Research
& Related Budget, as appropriate (See Section IV.6., Special
Instructions,
regarding appropriate required budget component.)
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 14 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
NHGRI strongly encourages a single PI application for research education and training activities with large-scale sequencing applications, databases, Center of Excellence in Genomic Science, etc.
Research Education Program
While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.
If multiple sites are involved in the research education initaitive, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
Although course and research education and training initiatives are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives.
Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.
Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.
Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.
Applicants for research and training programs should request funding for the PIs and the training coordinators to attend the annual fall grantees meeting and for the training coordinators to attend the annual spring training coordinators meeting. The latter is usually held in the Washington metropolitan area.
Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.
For courses, there will be some funding available, but in general most of the participants will be expected to provide for their own travel, registration and per diem.
For research education and training initiatives, participants may be compensated in accordance to institutional policies which may include housing and per diem, as appropriate. In additional research costs may be requested and must be justified in the applications. Graduate students and postdoctoral fellows may be supported for up to 24 months on this award; during this period, they must apply for an individual National Research Service Award, within 12 months if they wish to continue in this program. To ensure that participants apply for NRSA fellowships, this information must be documented in the type 5 application.
Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.
Participants in the research education program may request funds to defray partial tuition, other education-related, and travel expenses. Expenses for foreign travel will not be allowed. Funds will not be provided for fringe benefits or health insurance for participants in any research education program. Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program. Graduate students and postdoctoral fellows should receive stipends that are comparable to NRSA stipends for similar levels of training.
Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants are not allowable. A full-time participant is defined for the research education program as an individual supported for 40 hours/week for a continuous, 12-month period.
Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.
A letter of institutional commitment may be attached at line Item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.
Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).
3. Submission Dates and
Times
See Section IV.3.A for details.
3.A. Application Due,
Review and Anticipated Start Dates
Opening Date:
August 25, 2009 (Earliest date an
application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Thirty (30) days before
application due date.
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The letter of
intent is to be sent by the date listed in Section IV.3.A.
The letter of
intent should be sent to:
Bettie J. Graham, Ph.D.
Division
of Extramural Research
Suite 4017
National
Human Genome Research Institute
5635
Fishers Lane
Rockville, MD 20852
Telephone:
(301) 496-7531
Email:
[email protected]
3.B. Submitting
an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In
order to expedite the review, applicants are requested to notify the National
Human Genome Research Institutes Referral Office by email
([email protected]) when the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application.
3.C. Application
Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time (of the applicant
institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is
not submitted by the due date(s) and time, the application may be delayed in
the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays to view the application image.
Upon receipt, applications will be evaluated for
completeness by the CSR. Incomplete applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
4.
Intergovernmental Review
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. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or renewal award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project. See the NIH
Grants Policy Statement.
6. Other Submission
Requirements
For research education and training grant applications, applicants
should include the cost of attendance at two annual meetings per year: (1) fall
meeting of principal investigators and training coordinators and (2) a spring
meeting of training coordinators that is held in the metropolitan Washington, DC area. The cost of travel should be included in the budget.
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS 398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:
Specific
Instructions for Applications Requesting $500,000 (direct costs) or More per
Year
Applicants requesting
$500,000 or more in direct costs for any year (excluding consortium F&A
costs) must carry out the following steps:
1) Contact the IC program staff at least 6 weeks
before submitting the application, i.e., as plans are being developed for the
study;
2) Obtain agreement
from the IC staff that the IC will accept the application for consideration for
award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004, October 16, 2001.
Appendix Materials
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
Supplementary Research Education Program Application Instructions
Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.
1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.
Not applicable.
2. SF 424 Research & Related Other Project Information, Item 7 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education and course programs. For the research education and training application, the training coordinator is considered key personnel.
4. Research & Related Budget: Complete for each budget period requested.
A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI and the training coordinator, if appropriate must be included here.
B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.
C. Equipment: self-explanatory.
D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the research education program. For research education and training applications, the cost of two meetings per year for the purpose of program coordination should be requested.
E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. See Section IV.2 for this information.
F. Other Direct Costs: itemize as appropriate and allowed for the research education program.
K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.
5. PHS 398 Research Plan Attachments:
Preliminary Studies for New Applications and Progress Reports for Renewal and Revision Applications should be contained in the Research Education Program Plan. Applications should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal (noncompeting continuation) applications.
For courses, information should include: (1) demographics, such as-- participant pool such as number applying, number accepted, including the number of women and individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged background; (2) any changes to the course curriculum; (3) any information to justify the need for the course based on evaluations; (4) how information about the course materials were disseminated; (5) information about how the course influenced the research programs of the participants.
For research education and training programs, information should include. (1) the number and demographics of applicants who participated, (2) number who transitioned to the next career phase and in what scientific areas; (3) outcomes data, such as publications, number applying for and receiving fellowships/awards, transition data such as employment or movement to the next career level, etc. (4) any information to demonstrate that the program goals have been met, etc.
The Research Strategy should be re-titled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.
Program Director/Principal Investigator(s): Describe arrangements for administration of the program, provide evidence that the Program Director(s) is actively engaged in research and/or teaching in an area related to the mission of the National Human Genome Research Institute, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.
Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the National Human Genome Research Institute.
Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).
For courses, applicants should ensure that the latest methods, tools and resources are deployed.
For research education and training programs, applicants should describe the goals of the program; career level(s) targeted; purpose and expected outcome of the program; plans for recruiting and retaining participants; measurable milestones; plans for evaluating the program in the short- and long-term; plans for assessing participants career development and progression etc. All responses should: (1) describe the demographics in the institution for the population(s) targeted in the Action Plan response; (2) describe ongoing programs at the institution to recruit individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged backgrounds into the sciences; (3) describe how this program collaborates with similar programs in the host institution and other participating similar NHGRI programs; and (4) address how the proposed activity will increase the number of scientists from these groups pursuing careers in genomics and ELSI research.
Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.
If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.
Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.
Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panels evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the National Human Genome Research Institute, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will not be reviewed. Applicants applying for research education and training activities must indicate their willingness to work with the NHGRI-supported Data Analysis and Coordinating Center to generate program-wide reports and analyses.
Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc. Applications that lack a dissemination plan will not be reviewed. Only applications for courses are required to have a dissemination plan.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
(d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Human Genome Research Institute and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nations biomedical, behavioral, and clinical research needs. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high impact/priority score. These criteria are not listed in any order of priority.
Research education
program grant applications submitted in response to this funding opportunity
announcement should be characterized by innovation, scholarship and
responsiveness to the priorities and/or changing needs of the Institute in
meeting its objectives. Applicants are strongly encouraged to contact the
Institute program staff for current information about targeted priorities and
policies before preparing an application (see Section VII).
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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 five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 proposed research education program address an important problem or critical question in scientific/education areas and/or topics outlined in this funding opportunity announcement (FOA)? How will implementation of the proposed program advance the objectives of this FOA? If the aims of the education program are achieved, will they (1) lead to the development of highly trained scientists in adequate numbers and in appropriate scientific areas as outlined in the FOA, and (2) will they provide public education and outreach on NIH-funded research to a variety of audiences?
For course applications: how significant and
timely are the topics and overall objectives of the course in furthering the
training goals of NHGRI? Does the course fill a need for investigators in
the field or the general biomedical community that is currently unmet?
For research education and training activities, the applicant must address: Will the activities facilitate the goals of the institute in increasing the number of individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged background in the fields of genomics or ethical, legal and social implications of research (ELSI)? Are the goals clearly stated and achievable? Are genomics or ELSI topics prominently integrated into planned activities?
Investigator(s): Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program? If Early Stage Investigator or New Investigator, does the PD/PI have appropriate experience to lead the program? 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? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?
For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?
For course applications: Is the training and research experience of the principal investigator suitable for organizing the course? Are the training and expertise of the faculty clearly described and appropriate?
For research education and training components, the applicant must address: Are individuals with the right expertise involved in the development and management of the program? Does the PI have sufficient involvement in the program? Does the program leverage ongoing activities designed and managed by others? Do the PI and key personnel maintain an appropriate level of involvement to ensure the substantial and unique added value critical to genomics and ELSI research? Does the training coordinator have the scientific expertise to implement activities that are essential for the success of the participants and their anticipated career?
Innovation: Is the proposed research education program characterized by innovation, scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.
For course applications: Are there any novel approaches, format, or methods planned that will help achieve the course goals? Are there plans in place for ensuring that the course will change as new methods, resources, analyses become available?
For research education and training initiatives that support undergraduates and post baccalaureates: Are there any unique activities that will increase the number of students pursuing doctoral degrees versus medical degrees? For postdoctoral individuals, are there sufficient plans and activities to ensure that the participant will transition successfully to employment by the number of publications, career development activities, such as grant application writing, etc. For faculty members, are there plans to ensure that the participant has appropriate preliminary data to pursue a research project in her/his home institution, etc?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? If the program 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?
For course applications: Are the scope and content of the course syllabus adequate to fulfill the course goals? Are there adequate plans/criteria for selecting participants? Are there adequate plans for publicizing and recruiting participants, in particular plans for recruitment of and acceptance of individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged background? Is the quality and timeliness of the course content and syllabus adequate? What criteria will be used for selecting participants? Are the plans for recruiting potential participants and publicizing the availability of courses to the appropriate community of scholars and scientists adequate? Are the plans for the recruitment of individuals from underrepresented racial/ethnic groups, disabled persons, and individuals from disadvantaged background, and women adequate?
For research education and training initiatives, the applicant must address: How will the activities facilitate participants moving to the next phase of their educational or career program? Are the measurable outcomes adequately described? Are the milestones appropriate? Is genomics or ELSI prominently integrated into planned activities?
Environment: Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
For course applications, are the facilities adequate and appropriate? Are the facilities accessible for persons with disabilities?
For research education and training initiatives, how does the plan take advantage of the research infrastructure of the applicant institution and other similar programs supported by NHGRI?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
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.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents 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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).Dissemination Plan: Is the dissemination plan for course applications strong and of high quality?
Evaluation Plan: For courses: How well has the course met the previously stated goals? How well has the course been received by former participants, including evidence that the course has had an impact on the participants research effort? How well attended has the course been and has attendance by URM participants been adequate? How well has the course adapted to meet the changing requirements in the field related to genomics? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the programs evaluation?
For research education and training initiatives, was the evaluation of the previous period used to make program changes and if so, were they adequate and appropriate. Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? For Renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the programs evaluation? Are there plan to obtain feedback from participants, to help identify weaknesses in the courses/programs and provide suggestions for improvements?
Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the impact/priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the impact/priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.
Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nations capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panels evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the Institute, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
3.
Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1.
Award Notices
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 NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
Notice of Award (NoA) are at the recipient's risk. These costs may be
reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding
Restrictions.
A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
National Human Genome Research Institute to the grantee business
official.
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
Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.
Change of Institution: The research education program may not be transferred from one institution to another, unless strongly justified.
Consultation with the Institute program staff is strongly encouraged when a change of institution is being considered. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the Institute may require peer review or may disapprove the request and, if appropriate, terminate the award.
The applicant must provide the following information to the National Human Genome Research Institute for review:
Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.
Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
3.
Reporting
Awards made in response to this FOA are not subject to
SNAP. Appointment and termination forms may be used to track participants who are appointed for periods greater than three months.
When multiple years are
involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.
Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research
Contacts:
Bettie J. Graham, Ph.D.
Division of Extramural Research
National Human Genome Research Institute, NIH
Telephone: (301) 496-7531
Email: [email protected]
2. Peer Review Contacts:
Keith Mc Kenney, Ph.D.
Scientific Review Branch
Division
of Extramural Research
National Human Genome Research Institute, NIH
Telephone:
(301) 594-4280
Email:
[email protected]
3. Financial or Grants
Management Contacts:
Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute, NIH
Telephone:
(301) 435-7858
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human
subjects should read the "NIH Policy and Guidelines" on the inclusion
of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject
Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is
described in the Catalog of Federal Domestic
Assistance at http://www.cfda.gov/ and is not subject to
the intergovernmental review requirements of Executive Order 12372. 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. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan
Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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