Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
NIH Basic Behavioral and Social Science Opportunity Network (OppNet http://oppnet.nih.gov/) and its member institutes, centers and offices:
Fogarty International Center (http://www.fic.nih.gov/)
National Cancer Institute (NCI) (http://www.cancer.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/ )
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Library of Medicine (NLM) (http://www.nlm.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)
Office of Disease Prevention (ODP) (http://prevention.nih.gov/)
Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/)
Title: NIH Basic Behavioral and Social Science Opportunity Network (OppNet) Short-term Interdisciplinary Research Education Program for New Investigators (R25)
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-NR-11-002
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)
93.989, 93.393, 93.213, 93.307, 93.389, 93.867, 93.837, 93.233, 93.172, 93.866, 93.273, 93.855, 93.846, 93.286, 93.865, 93.279, 93.173, 93.121, 93.847, 93.113, 93.859, 93.242, 93.853, 93.361, 93.879, 93.142, 93.143, 93.281, 93.282, 93.394, 93.395, 93.396, 93.399, 93.838, 93.856, 93.936
Release/Posted Date: September 14, 2010
Opening Date: December 6, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 6, 2010
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).
Application Due Date(s): January 6, 2011
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): June/July 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date(s): (New Date September 30, 2011 per NOT-NR-11-005), Original Date: December 30, 2011
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 7, 2011
Due Dates for E.O. 12372
Table of Contents
II. Award Information
1. Mechanism(s) 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. Receipt, 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
V. Application Review Information
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
Section VII. Agency Contacts
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
This funding opportunity announcement (FOA) issued by the National Institute of Nursing Research (NINR) as part of the NIH Basic Behavioral and Social Science Opportunity Network (OppNet) solicits short-term R25 Research Education Project applications that will focus on providing creative and innovative education research experiences for new scientists in basic behavioral and social science research (b-BSSR). The goal of this initiative is to support the growth of a cohort of scientists with research expertise in b-BSSR to further the understanding of fundamental mechanisms and patterns of behavioral and social functioning relevant to the health and well-being of individuals and populations. Overall goals include: 1) encourage new investigators to engage in the field of basic behavioral and social science while also facilitating their long-term career development as principal investigators within the field; and 2) support research on how to best transfer b-BSSR knowledge into biomedical and/or other fields of research (e.g., physical sciences, engineering, and mathematics). Educational partnerships between institutions including, research institutions and clinical and primary care organizations, are highly encouraged in order to broaden research educational opportunities and, ultimately, increase the number of basic biomedical and other health-related researchers trained in the basic behavioral and social sciences field at large.
This FOA uses the R25 Research Education grant mechanism, which supports only educational activities focused on basic behavioral and social sciences research, and may not be used for support of non-research clinical training. However, this mechanism may be used to provide basic behavioral and social science research education to scientists in clinical training or in a clinical research track within a clinical training program or from biomedical or other fields of research (including but not limited to physical sciences, engineering, and mathematics). Formats for the research education programs may vary to include single or multiple short courses, seminars, workshops, or structured short-term research experiences; or curriculum development, design, implementation and evaluation.
OppNet is a trans-NIH initiative that funds activities that build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and lifecourse-related research. Applicants should understand that the NIH IC that made this FOA available to the public is not necessarily the NIH Institute or Center that ultimately will manage a funded OppNet project. For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov.
OppNet uses the NIH definition of basic behavioral and social science research (b-BSSR, http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx) to determine application responsiveness. Consequently, OppNet strongly encourages prospective investigators to consult this definition, OppNet’s answers to frequently asked questions about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and answers to frequently asked questions regarding this specific RFA (use this segment and insert website, if applicable). See this FOA’s Scientific Contacts section for individuals with expertise in the research subject matter and the OppNet initiative.
Broad and fundamental research education in the basic behavioral and social sciences (b-BSSR) is needed to develop qualified individuals and ensure viability of the workforce, with core competencies in the theoretical underpinnings and methodologies for careers in b-BSSR. While the NIH has supported other programs targeted toward established, mid-career and senior investigators, to support their development of research capability in b-BSSR, published research has indicated the value of cross-disciplinary research opportunities for graduate and medical students that later shaped their career interests and research productivity. Among the benefits to participants were improved confidence in designing and conducting research in newly exposed research areas as well as increased rates of interest to pursue new projects in the new areas or research.
A recent inquiry of the health care research community indicated that improvement of the quality of research education in b-BSSR is strongly needed. This community recognized that highly trained investigators operating in multidisciplinary teams are critical for effective utilization of the many profound developments and discoveries from the basic sciences to explore successfully the interconnections of brain, body and environmental stimuli. In order to accelerate the availability of a competent workforce, OppNet offers an opportunity to bridge the gap in training between pre-doctoral students and established investigators in b-BSSR, and further build and promote early career b-BSSR training programs.
Ultimately, interdisciplinary institutional research education programs can offer early stage investigators the opportunity to develop a multidisciplinary training program to promote better cross-disciplinary communication and integration among basic (and even applied) disciplines. Such a program has the potential to lead to more productive collaborative efforts and greater use of b-BSSR methods in studies of behavioral and social processes; methodology/measurement; and complex models of biological, behavioral, and social interactions. Further, a well-trained workforce has the potential to contribute to new discoveries that will enhance understanding of the etiology of a broad spectrum of health-related disorders as well as implications for developmental trajectories and prevention and treatment.
The ultimate goal of this solicitation is to increase the number of scientists in b-BSSR by developing effective cross-disciplinary research education programs. An increase in trained scientists allows for the acceleration of research to better understand the etiology, pathology, and progression/remission of every disease and/or disorder. The focus of basic behavioral and social science research (b-BSSR) is to clarify and expound upon knowledge of underlying mechanisms and processes that can improve understanding, prediction, prevention and management of disease, and promotion of health and well-being. Behavioral and social factors encompass both the social and biological context of behavior, and often interact with biological factors (bi-directionally) to influence health and illness outcomes at the level of the individual, ethnic or cultural group, organization, community or population. B-BSSR also involves the development and refinement of procedures for measuring and analyzing behavior, psychological functioning or the social environment. A recent inquiry of the health care research community indicated that improvement of the quality of training in b-BSSR is strongly needed. While basic behavioral and social science research has been supported by NIH for a number of years, the advancement of basic biomedical technologies, computational resources, and other research promotes emergent opportunities to foster research that further examines the intersection of b-BSSR with biomedical and other fields of research (e.g., physical sciences, engineering, and mathematics). Thus, this solicitation provides an opportunity to build and strengthen capacity in new and early-stage investigators for b-BSSR, thereby accelerating the availability of a competent biomedical research workforce.
Such approaches would include establishment of new collaborations for cross-disciplinary translation of knowledge in the basic behavioral and social sciences. These interdisciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments such as those with research center support grants, schools of public health, departments of community and preventive medicine, and other departments and institutions that have the necessary expertise and resources to fulfill the objectives of this FOA. Any of these entities may act as the applicant organization, as long as the qualifications of the participants and the focus of the program are on the education of early-stage researchers to incorporate basic behavioral and social science principles, theories and methods into their research projects. Applicants should seek to conduct small research grants relevant (but not limited) to the following b-BSSR research areas:
OppNet expects applicant institutions to propose their own creative and innovative research education programs. Examples of potential programs include, but are not limited to, the following:
Answers to frequently asked questions for OppNet funding opportunity announcements will be posted at this site: http://oppnet.nih.gov/funding-current-funding.asp.
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 Program 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” information 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.
Education Program grant support is for new projects only; renewal applications will not be accepted. Resubmission of a previously reviewed education program grant application may not be submitted.
Because the nature and scope of the proposed research 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
OppNet has dedicated $1.5 million to capacity-building grants in FY2011. The nature and scope of proposed projects will vary across applications; OppNet expects the awards to vary accordingly. Consequently, the total amount awarded and the number of awards pursuant to this funding opportunity will depend on the submission of sufficient numbers of meritorious applications and the availability of funds.
Budgets for direct costs of up to $150,000 for up to one-year project duration may be requested. The total project period for an application submitted in response to this FOA may not exceed 1 year. Although the size of award may vary with the scope of the education program proposed, it is expected that applications will not exceed total direct costs of $150,000.
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.
These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Individuals (PDs/PIs) designing, directing, and implementing the education program may request salary and fringe benefits appropriate for the person months devoted to the program. 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 participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).
Other Program-Related Expenses:
These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed education program and must not duplicate items generally available for educational programs at the applicant institution.
Participants are those individuals who benefit from the proposed education program. In some instances, participants may be paid if specifically required for the proposed education program and sufficiently justified. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget. Amounts for all participants must conform to the established, consistently applied salary and wage policies of the institution and reflect the percentage of time/effort devoted to the program.
Participants in the education program may receive partial costs of meals unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, and other education-related expenses.
Expenses for foreign travel must be exceptionally well justified.
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, 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.
Individuals supported by NIH training and career development mechanisms (K) 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 an education program.
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 education program as an individual supported for 40 hours/week for a continuous, 12-month period.
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.
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.
The PD/PI should possess the research and education expertise, and leadership and administrative capabilities required to develop, implement or enhance, evaluate, and disseminate an a curriculum or education project of behavioral and social science for use in other academic or research institutions. Further, the PD/PI must have demonstrated a commitment to education for early stage investigators in b-BSSR and have a regular appointment (i.e., not adjunct) at the rank of associate or full professor or the equivalent in the academic department or research institution. The PD/PI will be expected to monitor and assess the program and submit all required documents and reports.
The leader at a partner institution (if applicable) should meet these criteria as well.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
The sponsoring institution must assure support for the proposed education program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned education program. The application must have a strong research program in the area(s) proposed for the education program and should include a letter explaining the institutional commitment to the proposed education program.
Describe who the intended participants are, and the eligibility and/or specific educational background characteristics that essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for
Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).
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 NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
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.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
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
For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.
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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).
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/PI’s 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:
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 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6 regarding appropriate required budget component.)
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States (U.S.) or that augment existing U.S. resources.
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 on 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.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
The R25 application must include a plan delineating the working relationship between the applicant and partner institutions. The plan must describe the governance, organization, communication, decision-making, and conflict-resolution structures and procedures linking the two institutions.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 6, 2010 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): December 6, 2010
Application Due Date(s): January 6, 2011
Peer Review Date(s): June/July 2011
Council Review Date(s): August 2011
Earliest Anticipated Start Date(s): December 30, 2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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:
William N. Elwood, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of the Director
31 Center Drive,
Suite B1-C19 (MSC 2027)
Bethesda, MD 20892- 2027
Fax: (301) 402-1150
3.B. Submitting an Application Electronically to the
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. 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.
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. All applications must meet the following criteria to be considered “on-time”:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive 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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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 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 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 theNIH Grants Policy Statement).
Page limitations must be followed as outlined in the SF424 (R&R) Application Guide.
Research education program applications will use the non-modular budget format and "Just-in-Time" concepts. See Sections II.2 and IV.2 for budgetary guidance.
Items 2-5 of the Research Plan of the research education program application may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
Specific Aims (Item 2) is limited to 1 page.
The Research Education Program Plan must be uploaded using the Research Strategy section (Item 3 of the Research Plan). This section may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts as well as the partnership arrangement, if applicable.
Institutional Environment and Commitment (Component of Item 3): Describe the institutional environment of the applicant and partner institutions, including facilities and educational resources that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research education program is required. Letters of institutional commitment from the applicant and partner must 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.
Key Personnel must include the PDs/PIs as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed education program) participating in the education program. Key Personnel at both the applicant and partner institution should be included. List separately for each institution.
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.
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 must be followed as outlined in the SF424 (R&R) Application Guide.
All application instructions outlined in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm) are to be followed, with the following requirements for R25 applications:
Research Education Program Plan (Item 3): The Research Education Program Plan must be uploaded using the Research Strategy section, and must include the following components:
Proposed Research Education Program (Component of Item 3): While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed education program and the research training supported by the training program. The information should include a description of the education and career levels of the planned participants.
Institutional Environment and Commitment (Component of Item 3): Describe the institutional environment, including facilities and educational resources, that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must 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. The following subcomponents are part of Institutional Environment and Commitment:
Program Direction (subcomponents of Institutional Environment and Commitment): Describe arrangements for administration of the program; provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to drug abuse and addiction, and can organize and administer the research education program, as well as evidence of institutional and community commitment and support for the proposed program.
If multiple sites are involved in the proposed R25 program, the applicant institution must be one of those sites and a strong justification must be included for the use of multiple sites.
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.
Collaboration or Partnership with Another Research Institution (subcomponents of Institutional Environment and Commitment): Interdisciplinary approaches to the development, adaptation, and modification of research designs to enhance and facilitate the rapid advancement of research that addresses intractable health-related problems. These cross-disciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments such as those with research center support grants, schools of public health, departments of community and preventive medicine, and other departments and institutions that have the necessary expertise and resources to fulfill the objectives of this FOA. Any of these entities may act as the applicant organization, as long as the qualifications of the participants and the focus of the program are on the education of early-stage researchers to incorporate basic behavioral and social science research from basic to clinical and other research settings.
This FOA further encourages collaborative programs involving academic clinical research departments and basic science departments, as well as multiple academic or research institutions such as schools of public health, departments of preventive and community medicine, primary care organizations or other entities with appropriate expertise for the development and establishment of educational programs in basic behavioral and social science principles, theories and methods.
Applicants should describe planned processes for: (a) conducting and monitoring recruitment and selection of participants, (b) planning research activities and selecting mentors for participants, (c) evaluating participant progress, and (d) assessing the quality and effectiveness of the overall education program. Institutions, departments, and clinical sites participating in joint applications should be involved in the planning, implementation, and assessment processes listed above.
In the Education Program Plan applicants must include a description of the proposed working relationship with a partner research institution, if appropriate. The description should include such topics as goals of the partnership, rationale for the choice of the partner, the strengths the partner institution would bring to the relationship, structures and procedures for implementing the partnership, as well as key personnel at the partner institution. (To be included within the 25 page limitation of the Education Program Plan.) Include a description of plans for exchange and sharing of resources, including faculty, equipment, and facilities. If multiple sites are to be used, the applicant institution must be one of those sites and for other sites a strong justification must be included.
Program Director/Principal Investigator (Component of Item 3): For multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership Plan section of the Research Plan. Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the participating NIH components, 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. Provide evidence that PDs/PIs have experience and expertise in the development, implementation, evaluation, and dissemination of basic behavioral and social science curricula, workshops, seminar series or educational materials and techniques.
Program Faculty/Staff (Component of Item 3): Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty are actively engaged in research or other scholarly activities related to the mission of the participating NIH components and the goals of this FOA.
Program Participants (Component of Item 3): Provide details about the proposed targeted pool of individuals to be exposed to the curriculum, educational materials and techniques. Include a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups, women and persons with disabilities.
Recruitment and Retention Plan to Enhance Diversity (Component of Item 3): Provide a detailed recruitment and retention plan to enhance diversity for the research education program. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI should indicate that this requirement is not applicable.
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 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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. 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 (C1 and C2) 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. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.
Peer reviewers will separately evaluate the 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 groups underrepresented in biomedical science—including underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. If the 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 participating ICs, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
Applications without a recruitment and retention plan to enhance diversity will be considered incomplete and may be delayed in the review process or not reviewed. An award cannot be made if an application lacks this component.
Training in the Responsible Conduct of Research (Component of Item 3): For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI should indicate that this requirement is not applicable.
Every participant supported by this Research Education program grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html).
Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed. An award cannot be made if an application lacks this component. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.
An award cannot be made if an application lacks this component.
If such instruction is not appropriate for the proposed education program, then the PD/PI must provide a strong justification for its exclusion.
Evaluation Plan (Component of Item 3): Although education program grants 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 their effectiveness. 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 short or long-term outcome measures that would determine the success of the education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.
Dissemination Plan (Component of Item 3): If a dissemination plan is proposed, a specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.
Select Agent Research (Item 11): If participating faculty proposed in the Education program are conducting or plan to conduct research involving select agents in which participant are involved, follow the instructions in SF424, Section 5.5, and include the appropriate information.Resource Sharing Plan(s) (Item 15): 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 should 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: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which 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 (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.
The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”
Appendix (Item 16): 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.
SF 424 Research & Related Other Project Information
Item 9 (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.
SF 424 Research & Related Senior/Key Person Profile
Key Personnel must include the PD/PI (or multiple PDs/PIs) 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 program.
Research & Related Budget
U.S. applicants submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.
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 (or multiple PDs/PIs) must be included here. Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the percent of time devoted to the program. Normally, all personnel costs (including administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 25% of the total direct cost. 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 are considered a regular part of an individual's academic duties, then mentoring and other interactions with students 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.
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.
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. Because this is an educational and not a training mechanism, non-US citizens may participate in this program. However, requests for participation of non-US citizens under the auspices of this program announcement 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 mission, research education programs should be used primarily for the education of US citizens. Participants in the education program may receive a subsistence allowance, including partial costs of meals and lodging unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, other education-related, and travel expenses. Expenses for foreign travel must be exceptionally well justified. 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 an R25 program.
F. Other Direct Costs: itemize as appropriate and allowed for the research education program. Consultant costs, equipment, supplies, travel, 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.
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.
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, or at the actual F&A cost rate, whichever is less.
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration. Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
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 participating ICs in meeting their objectives. Applicants are strongly encouraged to contact 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.
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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 education program address an important problem or critical question in education program or other critical issues as 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 achieve the intended purpose of this FOA?
Investigator(s). Are the PDs/PIs, collaborators, and other researchers/educators appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator/educator 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 education 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? If Early Stage Investigator or New Investigator, does the PD/PI have appropriate experience to lead the program?
Innovation. Is the proposed research education program characterized by innovation and scholarship? Does the proposed research education program challenge and seek to shift current education program paradigms; 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 education program or training activities currently supported at the applicant institution or available elsewhere? Adaptations of existing 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.
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed 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 the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program? 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 program 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?
Environment. Will the scientific/educational environment at the applicant and partner institutions, in which the proposed 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? Are adequate plans provided for coordination and communication between sites? Are appropriate structures and procedures in place to assure the success of the partnership?
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
Resubmission Applications. Not Applicable.
Renewal Applications. Not Applicable.
Revision Applications. Not Applicable.
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/priority score.
Diversity Recruitment and Retention Plan: Reviewers will examine the strategies to be used in the recruitment and retention of individuals from groups underrepresented in biomedical clinical, behavioral, and social sciences, including underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency) taking into account the characteristics of the proposed Research Education program. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Applications from Foreign Organizations. As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select 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).
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).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
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.
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 awarding component to the grantee business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”
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.
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Progress Report should provide information on the development and implementation of the proposed research education program, modifications to the research education program as originally proposed, 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. To facilitate and standardize reporting, programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 additional instructions for preparing a Progress Report for an institutional training grant.
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 participants 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 Education 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.”
Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm
Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
David Banks, Ph.D., M.P.H., M.S.S.W., RN
Research Training Officer, Program Director
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 496.9558
Marcia S. Scott, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane
Room 2083, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 402-6328
2. Peer Review Contact(s):
3. Financial/Grants Management Contact(s):
Grants Management Specialist
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-2807
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health, DHHS
5635 Fishers Lane, Room 3023
Bethesda, MD 20892
Telephone: (301) 443-4704
FAX: (301) 443-6077
Required Federal Citations
Use of 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.
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
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).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
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 And Minorities in Clinical Research:
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 Medicine’s 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.
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/.
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