and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Mental Health (NIMH), ( http://www.nimh.nih.gov)
National
Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov)
Office
of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov)
Title: Programs
of Excellence in Scientifically Validated Behavioral Treatment (R25)
Announcement Type
New
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 weeks prior to the grant submission date. See Section IV.
Request for Applications (RFA) Number: RFA-MH-08-080
Catalog
of Federal Domestic Assistance Number(s)
93.242,
93.279, 93.273
Key Dates
Release/Posted Date: October 19, 2007
Opening Date: December 17, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 17, 2007
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 Submission/Receipt Date(s): January
17, 2008
Peer Review Date(s): February 2007
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): July 1, 2008
Additional Information To Be
Available Date (Activation Date): Not Applicable
Expiration Date: January 18, 2008
Due Dates for E.O.
12372
Not
Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1.Research Objectives
Scientifically validated behavioral treatments are an important resource for the amelioration of mental and substance disorders. Nonetheless, the number of clinician-scientists who are able to contribute to the development, testing, and dissemination of such scientifically validated interventions is too low given the need for effective care in mental and addictive disorders. NIMH, NIDA, NIAAA, and OBSSR seek to speed the translation of psychotherapy findings into better clinical care by establishing programs of excellence to train more clinician-scientists in the development and provision of empirically-validated behavioral interventions for children, adolescents, and adults.
Awareness of and training in scientifically validated behavioral treatments is an important foundation for clinicians. Ideally, research and clinical practice are mutually informative in the clinical training environment. Yet, exciting research findings on effective treatment may not be translated immediately into clinical training programs, and treatments with little scientific validation may continue to be emphasized if clinical researchers and clinical trainers do not share their respective expertise. Bridging this gap is difficult, and requires novel training efforts to develop clinician-scientists with both research and clinical skills.
This R25 funding opportunity supports the development of curricula in science-based behavioral interventions for the addictive and mental disorders. For the purposes of this announcement, behavioral interventions refers to various learning-based psychotherapies, including, for example, cognitive, interpersonal, reinforcement, and skills training procedures. The goals in establishing the Programs of Excellence Award are to recognize and enhance clinical training programs that teach and develop research-based clinical practices and to provide a model for clinician education nationwide. Hallmarks of Programs of Excellence will be greater integration of science and practice than in the pre-award training program and immediate improvements in the competence of graduates to work in the area of psychotherapy treatment practice and innovation. In addition, curricula developed with the support of these R25 awards should be made publicly available so that the awardee programs can serve as models for other training programs.
A pre-requisite for these R25 awards is a strong research training program in clinical behavioral science. Such programs are characterized by active research programs that already have NIH research support. The proposed clinical training curriculum must be well integrated with research training in relevant aspects of clinical behavioral science, yet distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
The proposed curriculum must lead to independent competency in one or more interventions of scientifically established efficacy. Examples of interventions of documented efficacy that could be included in an integrated curriculum include, but are not limited to:
To be successful, applications must satisfactorily address several challenges for curriculum development: 1) selecting interventions that will constitute curriculum core elements, 2) recruitment of expert clinical supervision in the selected treatments, 3) arranging the availability of necessary clinical populations in sufficient numbers to support clinical training in the selected interventions, and 4) establishing criterion-based methods to evaluate achievement of student competency.
The NIH encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals from disadvantaged backgrounds, individuals with disabilities, and women.
See Section VIII, Other
Information - Required Federal Citations, for policies related to
this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the NIH Research Education Grant
(R25) award mechanism. As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. 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.
Research education grant support is for new projects only. Competing renewal (formerly competing continuation ) applications will not be accepted. Renewals and resubmissions are not allowed in response to this FOA.
2.
Funds Available
The NIMH intends to commit approximately $300,000 in fiscal year 2008 to fund up to 8 applications in response to this funding opportunity. The NIDA intends to
commit approximately $200,000 to fund up to 5 applications. NIAAA intends to commit approximately $100,000 to fund up
to 3 awards. OBSSR intends to commit approximately $50,000 in FY 2008. An applicant may request a project period of up to 5
years. The earliest anticipated award date is July
1, 2008.
Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIMH, NIAAA, NIDA, and OBSSR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity announcement.
Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation. See NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
Foreign institutions are not eligible to apply in response to this FOA.
The proposed research education program must complement other ongoing clinical research training occurring at the applicant institution. It is expected that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., Reporting. )
The PD/PI should be an established clinical investigator in mental and/or addictive disorders and capable of providing both scientific leadership, training expertise, and administrative excellence to the development and implementation of the curriculum.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedure 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 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 single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, 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 PD/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.nihi.gov/grants/multi_pi.
2. Cost Sharing or Matching
This program does not require cost sharing as defined
in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Sponsoring
Institution: The sponsoring institution must assure support for the
proposed research education project. Appropriate institutional commitment to
the project includes the provision of adequate staff, facilities, and
educational resources that can contribute to the planned research education
project.
Participants: Describe who the intended participants are, and what eligibility and/or specific educational background characteristics are essential for participation in the proposed program. For this award, the participants may be clinical psychology students or established clinicians in the treatment of mental and/or addictive disorders.
Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).
Evaluation and Dissemination Plan: Applications must contain an evaluation plan and a dissemination plan. Applications submitted without these sections will not be reviewed.
Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: 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 and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section of the research plan describing the leadership plan approach for the proposed research education program.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), 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, including 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. (See also: NOT-OD-07-017).
Research Education Program
While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.
Although research education 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 the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives.
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.
Allowable Costs
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Travel expenses are allowed for the PD/PI to attend annual awardee meetings and should be included for each year.
Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.
Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget
Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.
Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens. Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.
Participants in the research education program may 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 a research 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 research education program as an individual supported for 40 hours/week for a continuous, 12-month period.
Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.
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.
3.
Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: December 17, 2007
(Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: December 17, 2007
Application Submission/Receipt Date(s): January 17, 2008
Peer Review Date(s): February 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date: July 1, 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows 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:
Michael J. Kozak, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7127, MSC 9625
Bethesda, MD 20892-9625
Telephone: (301) 443-6471
FAX: (301) 443-4611
Email: mkozak@mail.nih.gov
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are
requested to notify the NIMH Referral Office by email NIMHReferral@mail.nih.gov when the application has been
submitted. Please include the FOA number and title, PD/PI name, and
title of the application.
3.C. Application
Processing
Applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later
than 5:00 p.m. local time (of the applicant
institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and
time, the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project, and
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 the NIH
Grants Policy Statement.
6. Other
Submission Requirements
Annual Meetings: Annual meetings will be held for all awardees for
the purpose of sharing opportunities and recent advances. Applications should
budget for one annual meeting per year for the PD/PI.
The NIH requires the PD/PI 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) and Resubmission (formerly amended ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used
Supplementary Research Education Program Application Instructions
Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form. Applications that do not conform to the specific instructions detailed below will be returned.
1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.
2. 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.
3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.
4. Research & Related Budget: Complete for each budget period requested.
A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI must be included here.
B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.
C. Equipment: self-explanatory.
D. Travel: include here any travel funds requested for senior/key persons and other personnel (i.e., those persons identified in Sections A. and B.) associated with the research education program.
E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. See Section IV.2 for additional information.
F. Other Direct Costs: itemize as appropriate and allowed for the research education program.
K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.
5. PHS 398 Research Plan Attachments:
Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program.
Part 5 of this section (Research Design and Methods) should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.
Program Director(s): Describe arrangements for administration of the program, provide evidence that the Program Director(s) is actively engaged in research and/or teaching in an area related to the mission of the NIMH, NIDA, NIAAA, and/or OBSSR, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.
Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NIMH, NIDA, NIAAA , and/or OBSSR.
Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).
Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction.
If such training is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.
Diversity Recruitment and Retention Plan: Provide a detailed diversity recruitment and retention plan for the research education program. Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period. Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate.
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.
Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within NIMH, NIDA, NIAAA, and OBSSR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will be returned.
Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc.
Plan for Sharing Research Data
Not applicable
Sharing Research
Resources
Not applicable
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and
Selection Process
Applications that are complete will be evaluated for
scientific and technical merit by an appropriate review group convened by NIMH in accordance with the review criteria stated below.
As part of the initial merit review, all
applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals in establishing the Programs of Excellence Award are to recognize and enhance current clinical training programs that teach and develop research-based clinical practices and to provide a model for clinician education nationwide. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are not listed in any order of priority.
Grant applications submitted in response to this FOA
should be characterized by innovation, scholarship, and responsiveness to the
priorities and/or changing needs of NIMH, NIDA, NIAAA, or OBSSR in meeting its objectives.
Applicants are strongly encouraged to contact NIMH, NIDA, NIAAA, or OBSSR program staff for current
information about targeted priorities and policies before preparing an
application (see Section VII).
Significance: Does the proposed curriculum development project address
scientific/education areas and/or topics important to the mission of the NIMH, NIDA,
NIAAA, OBSSR? How will
implementation of the proposed program advance the objectives of this funding
opportunity announcement as well as the mission of the NIMH, NIDA,
NIAAA, or OBSSR?
Approach: Is the program’s direction based on current empirical work
in clinical science and education? Does the applicant acknowledge potential
problem areas and consider alternative tactics? Is there evidence that
the program’s content is based on sound research concepts and research in
effective training? Is the approach feasible and appropriate to achieve the
stated education goals? Are the recruitment,
retention, and follow-up activities adequate to ensure a highly qualified and
diverse participant pool?
Innovation: Is the curriculum development plan original and innovative? For
example: Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in training
empirically validated treatments? Does the project develop or employ novel
concepts, approaches, methodologies, tools, or technologies for this area?
Does this program duplicate, or overlap with, existing research education,
training and/or career development activities currently supported at the
applicant institution or available elsewhere? Adaptations of existing 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.
Investigators/Trainers: Are the investigators
appropriately trained and well suited to carry out this work? Is the proposed
program appropriate to the experience level of the PD(s)/PI(s) and other
researchers? Does the investigative team bring complementary and integrated
expertise to the program? Is there evidence that an appropriate level of
effort will be devoted by the program leadership to ensure the program's
objectives?
Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed curriculum development plan benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?
Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Current Training Activities: Are the applicant’s on-going training and research activities in related basic and clinical science innovative as exemplified by public and private grant support, faculty s empirical publications in peer-reviewed journals, and other research awards and honors.
Evaluation Plan: Will the proposed evaluation of the curriculum indicate the successes and needs of the program that are appropriate within the grant period? Can the plans provide the foundation for more long-term assessment of the program s accomplishments?
Dissemination Plan: Is the dissemination plan strong and of high quality?
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
2.B. Additional
Review Considerations
Budget and
Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research education program will be assessed by the reviewers. The priority
score should not be affected by the evaluation of the budget.
Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. Since a pre-requisite for application is an ongoing clinical research training program, it is expected that this requirement will be met through the current program and not the R25 activities.
The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.
Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the 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.
Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.
2.C. Sharing Research Data
Not Applicable
2.D.
Sharing Research Resources
Not applicable
3. Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
Notice of Award (NoA) are at the recipient's risk. These costs may be
reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the NIH to the grantee business
official.
2. Administrative and National Policy Requirements
Termination
of Award: When a grantee institution plans to terminate an award,
program and grants management staff at the NIH funding component must be
notified in writing as soon as possible.
Change of Institution: The research education program may not be transferred from one institution to another.
Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.
Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the Specific Aims of the original peer-reviewed research education program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.
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.
3. Reporting
Awards
made in response to this FOA are subject to SNAP.
When multiple years are involved, awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
The Progress Report should provide information on the development and implementation of the proposed research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted during and after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.
Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ________. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research
Contacts:
Michael J. Kozak, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7127, MSC 9625
Bethesda, MD 20892-9625
Telephone: (301) 443-6471
FAX: (301) 443-4611
Email: mkozak@mail.nih.gov
Lisa Onken, Ph.D.
Division of
Clinical Neuroscience and Behavioral Research
National
Institute on Drug Abuse
6001 Executive
Boulevard, Room 3172, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301)
443-2235
FAX: (301)
443-6814
Email: lonken@mail.nih.gov
Peter Delany,
Ph.D.
Division of
Treatment and Recovery Research
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers
Lane, Room 2039, MSC 9403
Bethesda, MD 20892-9593
Telephone: (301)
443-0788
FAX: (301)
443-8774
Email: delanyp@mail.nih.gov
Dara Blachman,
Ph.D.
Office of
Behavioral and Social Sciences Research
National
Institutes of Health
Building 31,
Room B1C19
Bethesda, MD 20892-2027
Telephone: (301) 435-6780
FAX: (301)
402-1150
Email: blachmanand@od.nih.gov
2. Peer Review Contacts:
David
Armstrong, Ph.D.
Division of
Extramural Activities
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9609
Telephone:
(301) 443-3534
Email: armstrda@mail.nih.gov
3. Financial or
Grants Management Contacts:
Rita
Sisco
Division of
Extramural Activities
National
Institute of Mental Health
6001 Executive
Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone:
(301) 443-2805
FAX:
(301)443-6885
Email: siscor@mail.nih.gov
Deborah S. Wertz
Grants
Management Branch
National
Institute on Drug Abuse
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301)
443-6710
FAX: (301)
594-6849
Email: dwertz@nida.nih.gov
Judy Fox, Chief
Grants
Management Branch
National
Institute on Alcohol Abuse and Alcoholism
5635 Fishers
Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Telephone:
(301) 443-4704
Fax:
(301) 443-3891
Email:
jfox@mail.nih.gov
Section VIII. Other Information
Required
Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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.
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.
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-02-005.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. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
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 DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, internet addresses (URLs) must be
used for publicly accessible on-line journal articles. Unless
otherwise specified in this solicitation, Internet addresses (URLs)
should not be used to provide any other information necessary for the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised when
they directly access an Internet site.
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 and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards
are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH
Grants Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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