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RFA-DE-05-008: NIDCR Kirschstein-NRSA Institutional Clinical Research Training Award

NIDCR Kirschstein-NRSA Institutional Clinical Research Training Award

RFA Number: RFA-DE-05-008

Part I Overview Information

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/)

Announcement Type

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)

Key Dates

Release Date: November 10, 2004
Letters Of Intent Receipt Date(s): February 22, 2005
Application Receipt Dates(s): March 22, 2005
Peer Review Date(s): June 2005
Council Review Date(s) : August 2005
Earliest Anticipated Start Date: September 15, 2005
Expiration Date: March 23, 2005

Due Dates for E.O. 12372
Not Applicable

Executive Summary

Telecommunications for the hearing impaired: TTY 301-451-5936.

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(s) of Support
    2. Funds Available

  Section III. Eligibility Information
    1. Eligible Applicants
      A. Eligible Institutions
      B. Eligible Individuals
    2.Cost Sharing
    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
      A. Receipt and 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
    6. Other Submission Requirements

  Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. 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

Purpose of this RFA

The NIDCR Kirschstein-NRSA Institutional Clinical Research Training Award supports the development of a Program for training in clinical dental, oral and craniofacial research. The NIDCR invites institutions with well-established clinical research infrastructures to submit applications for the establishment of clinical research training programs. For the remainder of this RFA, "Program" refers to the constellation of "programs" established at individual institutions. Proposed programs in response to this RFA must include a structured core didactic component and a practical training component in various aspects of the design, conduct, and analysis of clinical research. Programs should endeavor to strengthen partnerships among schools in academic health centers and to foster training of clinical researchers for the detection, diagnosis, prevention, management, and treatment of oral, dental, and craniofacial diseases and conditions.

Training Objectives

Background and Description

Recent scientific advances have the potential to promote rapid transition from the research bench to applied preventive, diagnostic, and therapeutic modalities. In the genomic era, translational and clinical research plays an important role in bringing laboratory observations into the clinical setting. This new research paradigm requires an inter- and multi-disciplinary team approach, with well-trained clinical researchers as integral team members and leaders.

A shortage of clinical researchers spans the health professions and is acutely felt in oral health research. The growing chasm between research opportunities and numbers of trained clinical researchers has been recognized and documented through numerous reports, providing a framework for the NIH to stimulate clinical research training and career development opportunities for clinical researchers. These existing training opportunities include individual and institutional Career Development Awards (K-series awards), and the Clinical Research Curriculum Development Award (K30), created to assist academic health centers in developing a core curriculum and mentoring for training clinical investigators. While these programs provide a sound basis for an infrastructure and mechanism for clinical research training, they have not been fully utilized by oral health researchers, particularly dentist scientists.

The objective of this Program is to provide clinical research training in multidisciplinary research settings. The overarching goal is to promote clinical investigation that will have a significant impact on improving oral and craniofacial health and preventing disease. For the purpose of this initiative, “clinical research” refers to all aspects and kinds of clinical research meeting the NIH definition. NIH defines human clinical research as: “(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research." (http://grants1.nih.gov/archive/grants/policy/nihgps_2003/index.htm - _Toc54600038) (https://grants.nih.gov/grants/funding/398_ver0501/section_3.html#a_definitions)

Clinical research is a complex endeavor that is ideally performed by a multidisciplinary team using an integrated team approach. This Program will support clinical research training to enhance knowledge and develop skills in the discipline of clinical research, specific to oral and craniofacial diseases that are founded in principles of clinical investigation. Proposed programs should be designed to provide a flexible and efficient entrance into clinical research for individuals at a variety of educational levels (predoctoral students, postdoctoral trainees, faculty) with a variety of backgrounds. By providing this training experience in a multidisciplinary setting, it is hoped that trainees will be better prepared for the multidisciplinary real world requirements of clinical research.

This training Program is pursued in parallel with the NIH Director's activities to re-engineer the Clinical Research Workforce, and with NIDCR-initiated infrastructure and curriculum development activities designed to build the research capacity of U.S. dental schools. The Program also complements recent initiatives in clinical research that have been introduced by the NIDCR in an effort to stimulate high-quality clinical research in the oral and craniofacial health community. The NIH is engaged in a series of initiatives collectively known as the “NIH Roadmap” (http://nihroadmap.nih.gov/), the goal of which is to accelerate both the pace of discovery of new knowledge in the prevention, detection, diagnosis, management, and treatment of disease and the translation of these discoveries into applications that will improve the health of the nation. In addition, 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 RFA, NIDCR Institutional Clinical Research Training Award, is related to one or more of these priority areas. Applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. NIDCR areas of scientific focus are detailed in the Institute's strategic plan (http://www.nidcr.nih.gov/AboutNIDCR/StrategicPlan/) and the plan to eliminate oral health disparities also provides areas of scientific focus (http://www.nidcr.nih.gov/Research/HealthDisparities/).

Specific Objectives

The objectives of this Program are to: (1) stimulate and accelerate collaborative, multidisciplinary clinical research training and education applicable to oral and craniofacial diseases, conditions, and disorders; (2) provide clinical research training for clinical investigators; and (3) establish an integrated, multidisciplinary and diverse workforce that will meet the current and future clinical research needs of the nation.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH Ruth L. Kirschstein National Research Service (T32) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity does not use the just-in-time budget concepts. It uses the non-modular budget format described in the PHS 398 application instructions.

Institutional NRSA research training grants (T32) may be made for periods up to 5 years and are renewable. Awards within an approved competitive segment are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds.

2. Funds Available

Because the nature and scope of the proposed research training 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 costs are not included in the direct cost limitation, see NOT-OD-04-040.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization meets the following criteria:

An eligible institution (e.g., university) may submit only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH.

Applicant institutions must demonstrate capacity for clinical research training through a strong clinical research faculty; sufficient ongoing clinical research projects to serve as the platform for mentorship and training; extensive clinical research facilities; and a track record of competing for clinical research support to meet the purposes of this program, namely, to provide clinical research training and career development that promotes health and prevents disease. Integration with an existing NIH K30 Clinical Research Curriculum Award grantee, or an equivalent clinical research curriculum program is required. (Information regarding the K30 program, including a listing of eligible K30 grantees is available at http://grants1.nih.gov/training/K30.htm.) Proposed programs should indicate the flexibility to provide both short-term and long-term training opportunities for a continuum of training and development that spans the research career stages of the trainees. The program should have the capacity to provide clinical research training at various educational levels such as 1) short-term research training programs, 2) predoctoral training for a combined D.D.S./D.M.D. and Ph.D. degree, (i.e., through a dual-degree earning Dental Student Training Program [DSTP]), 3) training for dentists in pursuit of the Ph.D. degree, and 4) postdoctoral training leading to a masters degree or certificate in clinical research. Postdoctoral slots must be dedicated to individuals with the D.D.S./D.M.D. degree, with or without the Ph.D. degree. The program should provide training opportunities for junior and mid-career faculty that wish to gain new research skills in topics relevant to the NIDCR areas of emphasis or update existing skills and knowledge. The emphasis in all cases must be on inter- and multi-disciplinary and inter-professional research training opportunities through well-integrated core and supplemental curricula. Programs are strongly encouraged to develop ways for trainees who are at different levels of experience and are funded by various mechanisms of training (e.g., the F or T types of NRSAs) or career development (e.g., the K series of NIH research career awards), to collaborate and work together during the training experience.

1.B. Eligible Individuals

Program Directors

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. The Program Director will be responsible for planning, directing, and executing the proposed training program for the institution. Program Directors should have a strong and active track record in clinical research and administration that demonstrates the skills, knowledge, and experience necessary to develop and manage the proposed program.

2. Cost Sharing
Cost sharing is not required.

3. Other-Special Eligibility Criteria

An eligible institution (e.g., university) may submit only a single application in response to this RFA. Multiple applications from different divisions, faculties, centers, schools, etc. at the same university will be returned without further consideration by the NIH.

Eligible Trainees

Trainees appointed to the training program must have the opportunity to carry out supervised clinical research with the primary objective of developing or extending their research skills and knowledge in preparation for a career in clinical research.

Eligible trainees must be educated minimally to the baccalaureate level and demonstrate a commitment towards clinical research related to oral and craniofacial health. Training positions are open to predoctoral students and dentists with and without doctoral-level or advanced research degrees, but training must be distinct from clinical fellowships with specific requirements leading to clinical certification. At the time of appointment, trainees must: (1) be U.S. citizens or non-citizen nationals, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent resident. Individuals in the process of applying for such status or on temporary or student visas are not eligible; (2) be able to commit full-time effort in the program and its related clinical research activities, consonant with NRSA guidelines (described further in PERIOD OF SUPPORT); (3) have a mentor with extensive clinical research experience; (4) not be or have been a Principal Investigator on an R01 or R21 award or on a subproject of a Program Project (P01), Center (P50, P60, U54), or other equivalent research grant awards. Trainees may have had support on a NRSA grant (F or T), mentored career development (K-series) grant, or NIH small grant (R03).

Predoctoral Trainees. For dual-degree predoctoral DSTP training, trainees must be enrolled in a formal, combined program that leads to the award of a D.D.S./D.M.D. and a Ph.D. or an equivalent degree in one of the priority NIDCR research fields. Trainees must enter the program not later than their third year of professional school, although preference will be given to earlier appointment. Individuals already enrolled in a joint D.D.S./Ph.D. program are eligible for consideration as trainees. Dental students who wish to interrupt their studies to engage in full-time research training before completing their professional degrees are also eligible. Individuals who obtained a Ph.D. prior to entering dental school and desire to pursue another research doctorate while in dental school are not eligible for the DSTP, but may be eligible for appointment under other categories. All trainees must have received a baccalaureate degree by the beginning date of their appointment.

Postdoctoral Trainees. Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a D.D.S./D.M.D. degree, either with or without a Ph.D., or comparable doctoral degree from an accredited domestic or foreign institution.

Long-term positions (i.e., greater than three months) on NRSA institutional grants may not be used for study leading to the D.D.S., MD, or other clinical, health-professional degrees, except when those studies are part of a formal combined research degree program, such as the D.D.S./Ph.D. Similarly, trainees may not accept NRSA support for studies that are part of residency training leading to clinical certification in a dental specialty or subspecialty. It is permissible, however, for clinicians to engage in NRSA supported full-time, postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board, if the trainee has shown a clear interest in a research career.

Short-Term Health-Professional Trainees. Short-term research training positions can support individuals for a time period not greater than three months in a grant year. Positions must involve full-time research training (i.e., at least 40 hours per week) for clinical faculty who wish to gain clinical research experience or learn clinical research methodologies. Short-term research training positions may also support mid-career scientists who want to update their knowledge of clinical research methods.

Predoctoral short-term training may also be included as a component of the program. To be eligible for short-term predoctoral research training positions, dental students should be enrolled and in good standing and have completed at least one quarter in a program leading to a D.D.S. degree prior to participating in the program.

Highly motivated health professional students and clinical faculty wishing to pursue a research career can be supported for additional three-month appointments beyond the initial training period.

Trainees are also encouraged to apply to the NIH Loan Repayment Program (http://www.lrp.nih.gov/) if eligible.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Specific instructions for Institutional NRSA applications begin on page 65. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 11/2004). Applicants should use the T32 guidelines and the PHS 398 application. Specific instructions for Institutional NRSA Applications begin on page 65 of the PHS 398 Instructions http://grants1.nih.gov/grants/funding/phs398/phs398.pdf.

Applications must have a Dun and 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 website at http://www.dnb.com. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

See Section VI.2 Administrative Requirements for additional information.

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.

NIDCR Kirschstein -NRSA Institutional Clinical Research Training Award
RFA Number: RFA-DE-05-008

Special Program Requirements, Allowable Costs and related information

A. Trainee Appointments

Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of the NIH awarding unit or when trainees are appointed to approved, short-term research training positions.

No individual trainee may receive more than 5 years of aggregate NRSA support at the predoctoral level or 3 years of support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards.

Any exception to the maximum period of support requires a waiver from the NIH awarding office based on review of a justification from the individual and sponsoring institution. The fellow must make the request in writing to the NIH awarding office. The fellow's sponsor and an AOO must endorse the request. The request must specify the amount of additional support for which approval is sought. Individuals seeking additional support beyond the third year of postdoctoral support are strongly advised to consult with their PO before submitting a waiver request.

Some generally recognized categories under which NIH may grant exceptions include the following:

Requests for additional time that do not arise from either of the above-described circumstances will be considered only if they are accompanied by an exceptionally strong justification.

B. Budget and Related Issues

Allowable Costs:

1. Stipend: The NIH will provide stipend for each trainee position according to NRSA guidelines. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted periodically and current stipend levels are available on the NIH website at: https://grants.nih.gov/training/nrsa.htm. The total stipend must be based on a 12-month appointment. The institution may supplement the NIH stipend up to a level that is consistent with the institution's scale from non-Federal sources only. It is expected that total stipends must be consistent with the level of effort, with the established stipend structure at the institution, and with stipends actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

Please refer to the NIH Grants Policy Statement for a discussion of all policies related to Institutional NRSA Training Grants, https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_iib_4.htm.

Stipend supplementation, or additional support to offset the cost of living, may be provided by the grantee institution. Supplementation does not require any additional effort from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may DHHS funds be used for supplementation.

An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including a DHHS research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that constitutes the research training experience.

An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (G.I. Bill). Such funds are not considered supplementation or compensation.

2. Tuition, Fees, and Health Insurance: The NIDCR will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the current rates as published at https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc5460018. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the training grant. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: https://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm.

3. Training Related Expenses: Institutional costs of $5,000 per full-time non-DSTP predoctoral trainee and $5,500 per full-time postdoctoral trainee may be requested to defray the costs of other expenses related to research training, such as equipment, research supplies, curriculum development, support staff salaries and consultant costs. Expenses for short-term trainees are prorated on the annual costs. Institutional costs of $10,000 per DSTP-trainee per year may be requested. Applicants may request compensation for up to 20% of a program director's direct salary and fringe benefits and up to 15% for additional primary faculty time, not to exceed a total of 35% total compensation on the grant. This compensation is based on the total effort spent performing activities specifically related to implementing and conducting the proposed training program. No other institutional faculty or professional employees can be reimbursed through this award. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NIDCR program staff in advance of such requests is strongly advised.

4. Trainee Travel Costs: Trainee travel to scientific meetings that the institution determines to be necessary for the individual's research training is an allowable trainee expense at $800 per trainee per year. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified considering the type of opportunities for training available, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals. This type of research training requires prior approval from the NIDCR. Letters requesting such training may be submitted to the NIDCR at any time during the award period. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate.

5. Facilities and Administrative Costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH website at: https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600187.

6. The number of trainees proposed in the application must be justified by available mentorship and recruitment and training track record of the applicant institution. The number of trainees by category suggested by study section is considered the ceiling, and may be further decreased by NIDCR Program Staff based upon availability of funds, track record for filling positions as assessed by annual progress reports and statements of appointment, and needs of the overall Program.

7. Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval by NIDCR.

3. Submission Dates

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 22, 2005
Application Receipt Date(s): March 22, 2005
Peer Review Date: June 2005
Council Review Date: August 2005
Earliest Anticipated Start Date: September 15, 2005

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:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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 the appendix material must be sent to:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

A lthough 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.

5. Funding Restrictions

All 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 https://grants.nih.gov/grants/policy/policy.htm. See especially the section regarding the Ruth L. Kirschstein National Research Service Awards, https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600204 (See also Section VI.3. Award Criteria)

6. Other Submission Requirements

The NIDCR recognizes that individual institutions will be positioned to respond in different ways to the opportunities presented in this RFA. However, all programs are expected to provide a multidisciplinary clinical research training experience.

A. Special Programmatic Requirements

1. Overall Approach : Programs must have a strong and broad base of on-going clinical research and available mentors. The Program must include: (1) a didactic clinical research education component, and (2) a practicum component. Both components should include core and elective elements. It is expected that programs will include didactic and practical training in various aspects of the design, conduct and analysis of clinical research. Programs must include a fundamental and advanced didactic curriculum that builds upon the foundations of clinical research, containing theoretical, technical, and practicum components that represent the spectrum of clinical research and related activities from hypothesis generation to quality assurance to analysis and reporting. Training programs must utilize existing K30 program curricula or curricula from an equivalent educational program. Applicants must demonstrate K30 equivalence by accreditation or other criteria.

Examples of a theoretical core curriculum may include:

Examples of a technical curriculum may include:

Examples of practicum components may include one or more of the following:

Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see https://grants.nih.gov/grants/guide/notice-files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. See also Section V.3.B. Additional Review Considerations.

The NIDCR encourages institutions to provide instruction in the responsible conduct of research to all graduate and postdoctoral students in a training program or department, regardless of the source of support.

2. Program Director: The Program Director must possesses the scientific background, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary clinical research training program of this scope. For example, the Program Director may be a senior faculty member, Associate Dean for Research, Director of a research center or institute, or research training Director.

3. Advisory Committee: The application must describe an Advisory Committee representative of the scope and composition of the program. The Program Director will serve as Executive Director of the Advisory Committee that should contain clinical research and training expertise from within and outside of the applicant institution (e.g., from another university), and may include an internal subcommittee responsible for the programmatic activities, with ad hoc and/or external members for monitoring and evaluation. The Advisory Committee will be responsible for recruiting and selecting trainees to the program; reviewing the curriculum; approving the research projects and mentorship, and providing monitoring and evaluation of progress for degree-seeking trainees. The Advisory Committee may set criteria to award graduates of the program a certificate of completion. The Advisory Committee should meet regularly and keep written minutes. Meeting reports, including an evaluation of areas of strengths and weaknesses, may be reviewed as part of an NIH site visit, or in review of a competing or non-competing continuation application. Summaries of the meetings will be submitted as part of the annual progress report. Projects supported from this grant are expected to comply fully with all Federal policies, rules, and guidelines applicable to research involving human subjects and animals.

4. Mentors: Trainees conducting research projects should be supervised by at least two mentors with complementary expertise. It is desirable that mentorship be available in the scientific area, in the clinical area, and in the methodological area. Depending on the course of study, this type of mentorship may be achieved in the form of a thesis committee, or as a mentoring team. For example, mentors may be from different disciplines or specialties (for example, one clinical/translational and the other basic science; or a sub-specialist clinical researcher and a clinical trialist). When the trainee has sufficient expertise in one of the three areas, mentorship in that category may not be necessary. The primary mentor should be recognized as an independent investigator actively involved in clinical research, and demonstrate a successful track record of mentoring. The mentors must be committed to continue involvement with the trainee for the duration of his/her appointment in the program. Each application should demonstrate a representative sample of mentors sufficient to support the proposed number of trainees.

5. Clinical Research Capability and Infrastructure: The institution must demonstrate that it has a broadly funded clinical research base, the infrastructure to support clinical research (for example, K30 program, GCRC, biostatistics expertise, etc.), and the facilities (e.g., inpatient and outpatient facilities, affiliate hospitals etc.) and patient resources to support research relevant to oral and craniofacial diseases and conditions.

6. Institutional Commitment: Applicant institutions should show commitment to the program's goals, and provide assurances that the institution intends the program to be an integral part of its research and research-training endeavor. Research facilities and training opportunities are a critical part of the environment. Institutional commitment in support of the proposal must be evidenced by letters from high-ranking institutional officials (e.g., Provost, President and/or Vice-President) that: (1) describe how the proposed program will be an integral component of the institution's broader vision with respect to clinical research; (2) outline how institutional barriers for clinical research and clinical researchers will be or are being addressed (i.e., promotion and tenure, etc.); and (3) provide a guarantee of 100 percent protected time for the trainees, equivalent to 40 hours per week. The letters should provide evidence of an active clinical research faculty, statistical and other relevant support, and associations with K30 or equivalent programs, schools of medicine and/or public health, departments of behavioral and/or social sciences, and other resources. Applications should describe interactions with GCRCs and existing disease-focused NIH-funded Centers and other clinical research programs (Program Project grants, Center grants, Foundation-sponsored Centers, etc.). Applications that have existing comprehensive T32 programs should describe how the new component will be integrated into the existing training program, particularly with regard to mentors, shared resources, and interaction of trainees. The application should describe plans to provide support for trainees beyond the five-year project period in the event that funding from NIDCR is no longer available.

7. Evaluation and Tracking Component: The application should describe a strong evaluating and tracking component that will review the effectiveness of all aspects of the program (including curriculum, mentors, Advisory Committee members and activities, Program Directors), and a system for tracking trainees for a five year period following program completion to determine program outcomes. Outcomes measures may be defined differently according to the level of training received. Examples of such outcomes may include relevant positions obtained, current activities related to clinical research, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. Data for tracking should include annual application, enrollment, and appointment information (including degrees, disciplines, and specialties) and course of study (e.g., short-term, long-term, degree-seeking, etc.). While by necessity the Advisory Committee and Program Directors will be involved with providing the information for evaluation and tracking, it is desirable that the application describes a prospective evaluation plan for process and outcome measures. The evaluation report will be due at the time of termination of the award as part of the final report. If five years have not passed at the time the evaluation report is due, an interim evaluation report will be substituted.

8. Recruitment Plan: Applicants must submit a recruitment plan that includes a scheme for recruiting trainees from both outside and inside their institution(s).

Minority Recruitment and Retention Plan: The NIH remains committed to increasing the participation of individuals from underrepresented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain underrepresented minorities in the training program. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (see https://grants.nih.gov/grants/guide/notice-files/not93-188.htm).

Non-competing grant progress reports (refer to Section VI.4. Special Reporting Requirements) must include a detailed account of experiences in recruiting individuals from under-represented groups during the previous funding period.

B. Special Administrative Requirements

1. Leave: In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the program director.

A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research training experience longer than specified here must seek approval from the NIH awarding component for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first twelve months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence.

2. Off-site training: Training in another institution may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such training does not exceed three months. For longer periods, prior written approval of NIDCR staff is required. To obtain prior approval, the Program Director must submit a letter to NIDCR Program Staff describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the off-site training is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such training, provided that it relates to the training program.

3. Change of Institution: The Program may not be transferred from one institution to another. Trainees seeking to change institutions must terminate their current appointment following guidelines for termination as described above, and apply directly to the desired program.

4. Change of Program Director: If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIDCR prior approval, provided:

5. Changes of Program: Awards are made to a specific institution for a specific program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NIDCR Program Staff. A rationale must be provided for any proposed changes in the aims of the original peer-reviewed program. Programmatic changes will be evaluated by NIDCR Program Staff to ensure that the program remains within the scope of the original peer-reviewed application. If the new program does not satisfy this requirement, the award will be terminated.

Plan for Sharing Research Data

Not applicable to Training Grants.

Sharing Research Resources

Not applicable to Training Grants.

Section V. Application Review Information

1. Criteria

The role of peer review is to assess the extent to which the applicant is likely to develop and run a successful training program. Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR . Incomplete and/or nonresponsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDCR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

3. Merit Review Criteria

The goals of NIH-supported research training and career development programs are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research training plan will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The 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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does the training plan address the need for training clinical investigators? If the aims of the application are achieved, how do they address the shortage of well-trained oral health clinical investigators? What will be the effect of the proposed training program on studies, concepts, or methods that drive oral health clinical research?

Approach: Are the conceptual framework and design adequately developed, well-integrated, and appropriate to the aims of the training program ? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the development and implementation of the didactic curriculum and practicum experience provide core competencies for all members of the clinical research team? Does the application include required training in the conduct of clinical research? Does the training plan organized to promote quality cross-disciplinary and inter-professional research training of all trainees? Will the project encourage the interaction among predoctoral, post-doctoral and short-term trainees during didactic and/or research activities?

Innovation: Does the project employ novel concepts, approaches or methods?

Program Director: Does the Program Director possess the scientific background, expertise, experience in or potential to coordinate and supervise a multidisciplinary clinical research training program of this scope? Has the Program Director devoted an adequate time commitment towards program administration and other research support?

Training Environment: Does the environment in which the training program will be conducted contribute to the probability of success? Is there evidence of adequate institutional commitment and partnering with schools within the academic health center and/or other universities? Is there evidence of collaboration with an existing NIH K30 Clinical Research Curriculum Award grantee, or an equivalent clinical research curriculum program? Is there evidence of inter- and multi-disciplinary and inter-professional research training opportunities through well-integrated core and supplemental curricula? Is there evidence of ongoing fundamental and clinical research, and availability of research support, equipment, facilities, and clinical research resources? This also includes past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development can include receipt of fellowships, career awards, additional training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received.

3.A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Mentors: The application should demonstrate a representative sample of mentors sufficient to support the proposed number of trainees; the mentors' roles and time commitment now and for the duration of the program; accomplishments in translational and/or clinical research; current and pending research grant holdings; and mentoring experience of graduate researchers and clinicians.

Advisory Committee: The application must describe the composition and role of an advisory committee in development of the program; assignment of mentors and projects; and evaluation of progress.

Short-Term Research Training Positions: Applications that request short-term research training positions will be assessed using the following criteria:

DSTP Component: Applications that propose DSTP research training positions will be assessed using the following criteria:

Recruitment Plan: Well-defined recruitment procedures (including potential sources of high-quality candidates), trainee selection criteria and retention strategies. Number of trainees proposed in the application must be justified by available mentorship and recruitment and training track record of the applicant institution.

Evaluation Plan : The application must describe a prospective Evaluation Plan; refer to Section IV.6.A.7.

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 also Section VIII - Other Information.

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 also Section VIII-Other Information.

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 398 research grant application instructions (rev. 5/2001) will be assessed.

3.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.

Minority Recruitment And Retention Plan : The success of efforts to recruit and retain minority trainees is a factor in the assessment of the quality of the trainee pool and thus will be included within the priority score. In addition, peer reviewers will separately evaluate the minority recruitment plan and report after the overall score has been determined. The review panel's evaluation will be included in an administrative note in the summary statement. If the plan or the record of minority recruitment and retention 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.

Training in the Responsible Conduct of Research : 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. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program.

NIH initial review groups will assess the applicant's plans 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, so that 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. Staff within the NIH awarding component will judge the acceptability of the revised plan.

Following initial review, the appropriate NIH institute or center council, board, or other advisory group also reviews applications. These advisory groups will consider the assessment of the scientific and educational merit of the research training grant application as well as the initial review group's comments on the recruitment of individuals from underrepresented minority groups and the plan for instruction in the responsible conduct of research.

3.C. Sharing Research Data

Not applicable to Training Grants.

3.D. Sharing Research Resources

Not applicable to Training Grants.

Section VI. Award Administration Information

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.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

NGAs are sent via e-mail to the office of the Administrative Official named in item 12 on the Face Page of the PHS 398 (rev. 9/2004) application form.

2. Administrative Requirements

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 https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

3. Award Criteria

The following will be considered in making funding decisions:

4. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually:
https://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the NIH Grants Policy Statement.

Special Reporting Requirements:

The T32 award is not subject to the streamlined non-competing application process (SNAP).

1. Trainee Reporting Requirements : The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in his or her first twelve months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

2. Payback Provisions: As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply:

3. Progress Reports : An Annual Progress Report is required. This report should provide information about changes in the program, a summary report by the Advisory Committee, and a description of the research and career progress of each trainee. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the overall Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: https://grants.nih.gov/grants/funding/2590/2590.htm. Expand the application for continuation to contain the following information:

4. Final Reports : A final progress report and Financial Status Report are required within 90 days after the end of the grant project period or upon relinquishment of an award.

5. Evaluation : In carrying out its stewardship of human resource-related programs, the NIDCR may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients are hereby notified that they may be contacted during and after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program.

6. Publications and Sharing of Research Results : NIH supports the practical application and sharing of outcomes of funded research. Therefore, PDs and trainees should make the results and accomplishments of their Kirschstein-NRSA institutional training grant activities available to the research community and to the public at large. The grantee organization should assist trainees in these activities, including the potential commercialization of inventions. No restrictions should be placed on the publication of results.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice. Responsibility for direction of the project should not be ascribed to NIH. However, NIH IC support must be acknowledged by a footnote in language similar to the following: “This investigation was supported by the National Institutes of Health under Ruth L. Kirschstein National Research Service Award (number) from the (name of NIH IC).” In addition, Federal funding must be acknowledged as provided in “ Public Policy Requirements and Objectives—Availability of Information—Acknowledgment of Federal Funding.”

7. Copyright : Except as otherwise provided in the conditions of the award, when a publication or similar copyrightable material is developed from work supported by NIH, the author is free to arrange for copyright without the approval of the NIH awarding office. Any such copyrighted materials shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Federal government to reproduce them, translate them, publish them, and use and dispose of them, and to authorize others to do so for Federal government purposes.

8. Inventions and Patents : All Kirschstein-NRSA institutional research training grants and other funding agreements awarded primarily for educational purposes are not subject to invention reporting requirements nor does NIH have any rights to inventions under those grants and agreements (as specified in 45 CFR 74.24(h) and in 37 CFR 401.1(b)).

Section VII. Agency Contacts

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
Office of the Director
National Institute of Dental and Craniofacial Research
Building 45, Room 4AS-13
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
Email: kevin.hardwick@nih.gov

2. Peer Review Contacts:

H. George Hausch, PhD
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: George.Hausch@nih.gov

3. Financial or Grants Management Contacts:

Ms. Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research, NIH, HHS
45 Center Drive, MSC 6402
Bldg. 45, Rm. 4AN44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
Fax: 301-480-3562
email: md74u@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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (https://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.

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. https://grants.nih.gov/grants/policy/data_sharing

Investigators should seek guidance from their institutions, on issues related to institutional policies, 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.

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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://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 acial/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 that is available at https://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 https://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 https://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 (see 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.

Public 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 public 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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.

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 https://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 Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal

Regulations, Part 66, is applicable to this program. 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 https://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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