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)
Title: NIMH Research Education Grants (R25)
Announcement Type
This is a reissue of PAR-02-087, which was released March 21, 2002.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-05-153
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: August 11, 2005
Letters of Intent Receipt Date(s): 30 days prior to the application receipt date
Application Submission Dates(s): October 1 annually for new applications; November 1 annually for revised and competing renewal applications ; January 2 annually for AIDS related applications
Peer Review Date(s): February/March annually
Council Review Date(s): May annually
Earliest Anticipated Start Date:: July 1st annually
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: July 20, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part II. Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section 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. Address to 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. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
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 Announcement1. Research Objectives
The overall goal of NIMH's research training and research education programs is to ensure that highly trained scientists will be available in adequate numbers and in appropriate scientific areas to reduce the burden of mental disorders and HIV/AIDS through research on mind, brain, and behavior. The NIMH Research Education Grant is a flexible and specialized mechanism designed to foster the development of mental health researchers through creative and innovative research educational programs including regional and national programs. NIMH especially encourages research education programs that will attract, train and advance the career development of physician-scientists and pediatric and geriatric researchers committed to pursuing research careers relevant to the mission of the NIMH. NIMH also encourages research education programs that will help prepare researchers for interdisciplinary research careers, including translational research careers, that are relevant to the mission of the NIMH. Applications will be accepted in response to this funding opportunity from organizations that propose creative and innovative educational research experiences at the following levels of professional career development: medical/graduate student, postdoctoral fellow, medical resident, and/or independent scientist. The NIMH strongly encourages all proposed programs to foster the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women.
There is a continuing need in the mental health research arena for clinician-scientists, e.g., psychiatrists, social workers, and clinical psychologists. The number of physician-scientists who are psychiatrists appears to be insufficient to address research questions regarding mental disorders. The numbers of child and adolescent psychiatrist-researchers and geriatric psychiatrist-researchers are particularly small (Mental Health: A Report of the Surgeon General, 1999; Mental Health for a Lifetime: Research Needs of Older Adults; Report of the National Advisory Mental Health Council Workgroup on Aging Research). Because a significant time investment is required to develop outstanding research skills, a recent report from the Institute of Medicine (Research Training in Psychiatry Residency: Strategies for Reform, 2003; http://books.nap.edu/catalog/10823.html) suggested that more and enhanced research residency training is needed to redress the small numbers of psychiatrists who participate in research. Therefore, innovative clinical residency research education programs at the institutional, regional, and national level are encouraged that will attract psychiatry residents to careers as physician-scientists during a period in their training when they decide whether to pursue an academic medical career. The proposed research education experiences are expected to provide critical skills that will significantly enhance the residents' ability to compete in the research arena and to foster their retention in the cadre of physician-scientists.
Biomedical research increasingly requires scientists to work in an interdisciplinary scientific environment and to participate in broad, collaborative research teams (Facilitating Interdisciplinary Research, National Academies of Science, 2005; http://www.nap.edu/catalog/11153.html). Moreover, many fundamental scientific advances are ripe for translation to clinical research and to the development of effective interventions. Therefore, the NIMH encourages innovative research education programs that provide educational/research experiences needed for individuals to be prepared to conduct interdisciplinary and/or translational (basic-clinical and/or clinical-services) research that is related to the mission of the NIMH.
The NIMH encourages highly innovative programs that are designed to achieve the goals stated above. A diverse array of programs, including those that are regional or national in scope, may be appropriate. The proposed programs may be of short (e.g., three months with or without provisions for further ongoing contacts) or long duration. However, NIMH does not allow the use of the R25 mechanism as a substitute for an institutional training program (T32). Formats for these programs may also vary, e.g., short courses, a series of seminars, workshops, structured short-term or long-term research experiences, or curriculum development, implementation, and evaluation.
The NIMH expects applicant institutions to propose their own creative and innovative programs. Examples of programs that are of potential interest to the NIMH include, but are not limited to, the following:
The NIMH strongly suggests that potential applicants contact program staff listed in Section VII to discuss potential research education programs to make sure that the topics are relevant to the NIMH mission prior to submission of an application. Applications with little or no relevance to NIMH's mission will be returned without review. See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the Research Education (R25) award mechanism.
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information1. 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 many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which students may gain relevant experiences. Institutions with existing Ruth L. Kirschstein National Research Service Award 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, NIMH does not allow the use of the R25 mechanism as a substitute for an institutional training program properly supported using the T32 mechanism. The NIMH does not allow support for full-time participants under the R25 mechanism, where a full-time participant is defined as an individual supported for 40 hours/week for a continuous 12-month period.
If multiple sites are involved in the proposed R25 program, the applicant institution must be one of these sites. 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 is invited to work with their institution 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 programs.
This individual should be an established investigator capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Applications must follow the supplementary instructions provided in Section IV.6.
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
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 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.
Although R25 education grants are not typical research instruments, they do involve experiments in education 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 course development proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.
Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the 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.Other Program-Related Expenses: 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.
Participant Costs: 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 NIMH mission, research education programs should be used primarily for the education of US 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-US citizens.
Participant Support Costs: 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.
Because the R25 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 as an individual supported for 40 hours/week for a continuous 12-month period.
Evidence of institutional commitment to the 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, or at the actual F&A cost rate, whichever is less.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Submission Date: 30 days before the submission date
Application Submission Date(s): October 1 annually for new applications; November 1 annually for amended and competing continuation applications; January 2 annually for AIDS related applications
Peer Review Date: February/March annually
Council Review Date: May/June annually
Earliest Anticipated Start Date: July 1st
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document.
The letter of intent should be sent to:
Mark Chavez, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Blvd., Room 7101, MSC 9621
Bethesda, MD 20892-9621 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-8942
FAX: (301) 443-6000
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional copies of the application and all copies of any appendix material must be sent to:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation 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 or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Supplementary Application Instructions
Applications must be prepared using the current PHS 398 research grant application instructions and forms, with the exceptions listed below. Note that the page limitations given in the instructions apply to this mechanism. Applications that do not conform to the specific instructions detailed below will be returned without review.
1. Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells): Under Performance Sites, include Consortium/Contractual Arrangements and a list of collaborating sites, if appropriate. If multiple sites are to be used, the applicant institution must be one of those sites. A justification must be included for sites other than the applicant institution. Key Personnel should include the principal investigator, other key faculty participating in the research education program, as well as any staff integral to the program.
2. Resources (Resources Format Page): 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 Other Support described in the PHS 398. Use continuation pages, as necessary.
3. Research Plan: Part "C" of this section should be retitled "Preliminary Data and Activities" and included if applicable. This section should contain information on steps that have led to the proposed Research Education program. A section entitled "Progress Report" is required for competing continuation and supplemental applications.
4. Research Plan: Part "D" of this section should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings, as appropriate to the specific program:
a) Program Direction: 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 NIMH, and can organize and administer the education program, as well as evidence of institutional and community commitment and support for the proposed program.
b) 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.
c) Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula), including a description of plans to provide education to participants regarding the responsible conduct of research.
d) 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 principal investigator must provide a strong justification for its exclusion.
e) Program Participants: Provide details about the proposed participants, including a description of plans for recruiting as participants individuals from underrepresented racial/ethnic groups, women and persons with disabilities. The NIH remains strongly committed to increasing the participation of individuals from underrepresented racial and ethnic groups and individuals with disabilities in biomedical and behavioral research. At the present time, the following racial and ethnic groups are considered to be underrepresented in biomedical and behavioral sciences include: Alaskan Natives, African Americans, Hispanics, Native Americans, and Pacific Islanders. Other racial and ethnic groups may be underrepresented within particular disciplines or at particular institutions. Competing continuation 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 underrepresented racial/ethnic groups as defined above. For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the principal investigator must explain why this information is not appropriate.
f) 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. Please note that applications that lack an adequate evaluation plan will be considered non-responsive to this program announcement.
g) 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. However, a dissemination plan is a required program component.
1. Criteria
Only 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 to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
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:
The following will be considered in making funding decisions:
The goals of NIH supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation's biomedical, behavioral, and clinical research needs. 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 to the Mental Health Research Education Program should be characterized by innovation, scholarship, and responsiveness to the priorities and/or changing needs of the NIMH in meeting its objectives.
Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NIMH? The program must demonstrate how its implementation will advance the objectives of this program announcement as well as the mission of the NIMH.
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Is the dissemination plan of high quality?
For competing continuation applications only: Has the R25 program successfully achieved its stated objectives during the prior project period? Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for R25 support for this program? Is the approach for the next project period responsive to the results of the program's evaluation?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is the research education program innovative conceptually and/or in implementation for scientific areas pertinent to the NIMH mission? 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 research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.
For competing continuation applications only: Has the program been innovative in the past and does it continue to demonstrate innovation?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? 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 work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, schools and universities? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the research educational experiences provided? Are adequate plans provided for coordination and communication between multiple sites?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items , when appropriate, will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. 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.
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.
2.C. Sharing Research Data
Not applicable
2.D. Sharing Research Resources
Not applicable
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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 Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
Termination of Award: When a grantee institution plans to terminate an award, 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 to a specific institution for a specific program under the guidance and leadership of a particular PI. A change in any of these parameters requires prior approval by the responsible NIMH program officer. 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 Principal Investigator: If change of PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIMH, provided that the following conditions are met. The current PI or the grantee institution must submit a written request for the change, countersigned by the appropriate institutional business official, to the responsible NIMH program officer describing the reasons for the change. The Biographical Sketch of the proposed 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 PI and that the new PI has the appropriate research and administrative expertise to lead the research education 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 notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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, the number of applicants and participants (as well as their career level, gender, and racial/ethnic background), updates on the evaluation of the research education program and dissemination activities, and a list of any publications arising from the research education program.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIMH 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.
Section VII. Agency ContactsWe 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:
Nancy L Desmond, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7197, MSC 9645
Bethesda, MD 20892-9645 (Rockville, MD 20852 for express/courier service)
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: [email protected]
Mark Chavez, Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7101, MSC 9621
Bethesda, MD 20892-9621
Telephone: (301) 443-9700
FAX: (301) 443-6000
Email: [email protected]
Enid Light, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7155, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-3599
FAX: (301) 594-6784
Email: [email protected]
Cheryl A. Boyce, Ph.D.
Division of Pediatric Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 6200, MSC 9617
Bethesda, MD 20892-9617
Phone: (301) 443-5944
FAX: (301) 480-4415
Email: [email protected]
Donna Mayo, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6228, MSC 9621
Bethesda, MD 20892-9621
Phone: (301) 443-1829
FAX: (301) 443-6000
Email: [email protected]
David M. Stoff, Ph.D
Center for Mental Health Research on AIDS
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6210, MSC 9619
Bethesda, MD 20892-9619
Telephone (301) 443-4625
FAX (301) 443-9719
Email: [email protected]
2. Peer Review Contacts:
David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9606
Bethesda , MD 20892-9606
Telephone: (301) 443-3534
FAX: (301) 443-4720
Email: [email protected]
3. Financial or Grants Management Contacts:
Rita Sisco
Grants Management Branch
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: [email protected]
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 (45CFR46) 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).
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).
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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA 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 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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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NIH Funding Opportunities and Notices
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