Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Dental and Craniofacial
Research (NIDCR), (http://www.nidcr.nih.gov/)
Title: Oral Health
Research Education Grants (R25)
Announcement Type
This is a reissue of PAR-06-160, which was previously released February 24, 2006.
Update: The following update relating to this announcement has been issued:
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.
Program Announcement (PA) Number: PAR-06-506
Key Dates
Release/Posted Date: August 3, 2006
Opening Date: September 1, 2006 (Earliest
date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): 30 days
before submission date
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation
Date): Not Applicable
Expiration Date: June
2, 2009 (now September 8, 2009 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
This funding opportunity announcement (FOA) solicits Oral Health Research Education (R25) grant applications from applicant organizations that propose to infuse an appreciation of science and the results of scientific research into the dental school curriculum and to develop a pipeline of students interested in pursuing a career in oral health research. The main emphases of this program are to strengthen the research component of dental education, to enhance the application of basic and clinical research findings to clinical training and to encourage both dental school and undergraduate students to pursue careers in oral health research. Projects funded through this grant should encourage students and faculty to participate in broadly defined scholarly activity and monitor the latest science, and provide undergraduate, dental and postgraduate students with an appreciation for oral health research so they may be more likely to pursue academic careers, advanced research degrees and research training. Through these grants, clinical, basic and behavioral science researchers will become an active part of the educational fabric and interact with students throughout all four years of dental school as well as during the postgraduate specialty training period.
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
Several recent reports have considered the rationale for and ways to strengthen the interaction between research and dental education. These reports include "Dental Education at the Crossroads - Challenges and Change" (Institute of Medicine, 1995), "Oral Health in America: A Report of the Surgeon General" (Department of Health and Human Services, 2000) and the "Future of Dentistry" (American Dental Association, 2001). Each of these documents reinforced the fundamental importance of research to oral health, the dental profession and dental education. Major recommendations of these reports were related to the creation and expansion of oral health knowledge, the importance of research and scholarship and the interaction between research and education. OHRE grants should create, develop, design, implement and evaluate educational experiences in research in dental schools at the predoctoral and postdoctoral levels that enhance the education process, cultivate future scientists and encourage the participation of clinician graduates in oral health research and academic careers.
To develop a stimulating dental curriculum and supportive internal environment in which the creation and acquisition of new scientific and clinical knowledge are valued and actively pursued, goals and activities such as the following may be included in the grant:
The NIDCR expects applicant institutions to propose their own creative and innovative programs encompassing topics such as those listed above.
Individuals supported by NIH training and career development mechanisms (K, T or F grants) may receive educational experiences funded by these mechanisms as participants, but may not receive salary or stipend supplementation from the R25 program. In addition, the OHRE Grants may not be used for support of non-research clinical training.
The proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
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.
Awards are renewable one time only.
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
Institutes and Centers (ICs) 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 are not included in the direct cost limitation. See NOT-OD-05-004.
All awards are subject to the availability of funds. The
estimated amount of funds available for support of projects awarded as a result
of this announcement is $800,000
for fiscal year 2007. Future
year amounts will depend on annual appropriations.
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 for an R25.
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, NIDCR does not allow the use of the R25 mechanism to circumvent or as a substitute for an institutional research training program properly supported using the National Research Service Award (T32) mechanism. The NIDCR does not allow stipend support for participants/trainees under the R25 support mechanism.
If multiple sites are involved in the R25 program, the applicant institution must be the primary site for the research education 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.”)
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
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are required to include a plan for Training
in the Responsible Conduct of Research (see Section
IV.6).
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
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
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
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
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 the primary site for the research education program, 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 research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.
Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.
Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.
Participant Costs: Participant costs must be justified as specifically required for the proposed research education program.
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. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.
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 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 for the R25 program as an individual supported for 40 hours/week for a continuous, 12-month period.
Institutional Commitment: Evidence of institutional commitment to the R25 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
Opening Date: September 1, 2006 (Earliest date an application may be
submitted to Grants.gov).
Letters of Intent Receipt Date(s): 30
days before submission date
Application Submission Date(s): Standard dates apply,
please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is
not required, is not binding, and does not enter into the review of a subsequent
application, the information that it contains allows IC staff to estimate
the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
email: Lynn.King@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.
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 or
renewal 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
renewal award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission Requirements
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.”
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:
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 R25 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 to be used, the applicant institution must be the primary site for the research education 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 R25 program. The PD/PI must be included here.
B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the R25 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 R25 program.
E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the R25 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 in the R25 program.
F. Other Direct Costs: itemize as appropriate and allowed for the R25 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. A Progress Report must be included in renewal applications.
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 is actively engaged in research and/or teaching in an area related to the mission of the NIDCR, 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 participating Institute.
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 the NIH awarding component, 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, other than the dissemination
plan requested above.
Sharing Research Resources
Research education programs are not generally expected to generate research resources. However, applications submitted in response to this FOA must include a plan to disseminate curricula and educational tools developed for the program, if such activities are planned. In addition, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
The initial review group will comment on the appropriateness of the proposed dissemination plan. Program staff will also consider the adequacy of the dissemination plan as one of the criteria for award.
The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.
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 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
NIDCR 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 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. The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research education program will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. These criteria are not listed in any order of priority.
R25 grant applications submitted
in response to this funding opportunity announcement should be characterized
by innovation, scholarship and responsiveness to the priorities and/or changing
needs of the NIDCR in meeting its
objectives. Applicants are strongly encouraged to contact this Institute
for current information about targeted priorities and policies before preparing
an R25 application (see Section VII).
Significance: Does this proposed research education program address scientific/education
areas and/or topics important to the mission of the NIDCR? The program must
demonstrate how is implementation will advance the objectives of this funding
opportunity announcement as well as the mission of the NIDCR.
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 bound 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 strong and of high quality?
For renewal 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 research education program 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? 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 renewal applications only: Has the program been innovative in the past and does it continue to demonstrate innovation?
Program Directors and Faculty: Are the program directors and faculty appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the program director and other faculty? Does the project team bring complementary and integrated expertise to the project (if applicable)? Is there evidence of a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, or other measures of success? 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 research education program 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, 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?
Pipeline Partnerships: Do proposed partnerships involve appropriate undergraduate colleges and universities and dental schools? Does the partnership include the appropriate departments at each of the partner institutions? Is there evidence that the partner institutions have collaborated previously or will work collaboratively in the future to encourage undergraduate students to pursue careers in oral health research?
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:
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 item
6 of the Research Plan component of the SF424 (R&R).
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 item 7 of the Research Plan component
of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under item 11 of the Research Plan component of the SF424 (R&R) will be
assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, the adequacy
of the proposed protection will be assessed.
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 will be assessed by the reviewers. Is the effort listed
for the PD/PI appropriate for the work proposed? Is each budget category realistic
and justified in terms of the aims, methods, educational opportunities, and
participant activities?
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.
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 diversity 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 awarding component, 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
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
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 awarding component 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 Principal Investigator: 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 streamlined non-competing application process (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:
Kevin S. Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial
Research
45 Center Drive, Room 4AS13
Bethesda, MD 20892
Telephone: (301) 594-2765
Fax: (301) 402-7033
Email: kevin.hardwick@nih.gov
2. Peer Review Contacts:
Lynn Mertens King, Ph.D.
Chief, Scientific Review Branch
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AN 32F
Bethesda, MD 20892-6402
Voice: (301) 594-5006
FAX: (301) 480-8303
email: Lynn.King@NIH.gov
3. Financial or Grants Management
Contacts:
Dede Rutberg, MBA
Grants Management Specialist
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN44J
Bethesda, MD 20892-6402
Telephone: (301) 594-4798
Fax: (301) 480-3562
Email: dr258t@nih.gov
or rutbergd@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 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 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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