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Part I Overview Information
Department of Health and Human Services
Participating Organizations National Institutes of Health (NIH), (http://www.nih.gov)
This RFA was developed as an NIH Roadmap initiative. All NIH Institutes and Centers (ICs) participate in NIH Roadmap initiatives and activities. The RFA will be administered by the National Institute on Drug Abuse (NIDA) on behalf of the NIH.
Components of Participating Organizations National Institutes of Health (NIH), (http://www.nih.gov)
Title:Training for a New Interdisciplinary Research Workforce (T90)
Announcement Type This RFA is a reissuance of RFA-RM-04-015, which was published in the NIH Guide on December 16, 2003 and requests new and amended applications.
Request For Applications (RFA) Number:RFA-RM-06-006
Catalog of Federal Domestic Assistance Number(s) 93.849
Key Dates Release Date: December 16, 2005
Letters of Intent Receipt Date(s): February 14, 2006
Application Receipt Dates(s): April 7, 2006
Peer Review Date(s): May June, 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information To Be Available Date (URL Activation Date):
Expiration Date: April 8, 2006
Due Dates for E.O. 12372 Not Applicable
Additional Overview Content
Executive Summary
This RFA is an initiative of the NIH Roadmap (http://nihroadmap.nih.gov/), a series of activities whose goal, in keeping with the NIH mission of uncovering new knowledge about the prevention, detection, diagnosis, and treatment of disease and disability, is to accelerate both the pace of discovery in these key areas and the translation of therapies from bench to bedside. Towards the goal of catalyzing the production of a scientific workforce capable of integrative research crossing traditional disciplinary boundaries, the National Institutes of Health invites applications for developing and implementing novel training programs focused on interdisciplinary science. These programs will support a variety of new and innovative didactic and research experiences designed to provide students with the knowledge and research experiences necessary to develop interdisciplinary solutions to complex health problems and to increase quality and years of healthy life and eliminate health disparities.
This funding opportunity will support programs that will enable the development of novel research training and education programs that provide integrated interdisciplinary training for undergraduates, predoctoral and/or postdoctoral trainees, or independent faculty-level investigators.
This funding opportunity supports basic and clinical research to develop an interdisciplinary knowledge base for care across the life span, across disciplines, across settings during states of illness and health.
This funding opportunity will use the T90 mechanism that includes linked research training and education programs. Applicants will submit a single unified grant application and, if selected for funding, two separate awards may be issued, an R90 (Research Education award) and a T90 (Research Training award), based on distinct research training- and education- related funding authorities.
Each application may include any one or combination of the following full-time training programs:
an undergraduate institutional research training component that will combine coursework and hands-on laboratory/field experiences (R90)
a short-term faculty education component for independent faculty-level scientists who are interested in interdisciplinary research (R90)
a Ruth L. Kirschstein National Research Service Award (NRSA) institutional predoctoral and/or postdoctoral training component (T90)
a non-NRSA institutional predoctoral and/or postdoctoral research component (R90)
The National Institutes of Health has committed approximately $2.6 M to support this RFA in FY 06. However, the total amount awarded and the number of awards made will depend upon the number, quality, and cost of the applications received.
It is anticipated that 8 - 10 awards will be made. An applicant may request a project period of up to four years with annual direct costs of new funds not to exceed $325,000.
Eligible organizations include domestic non-profit public or private institutions such as universities, colleges, hospitals, and laboratories. Although foreign institutions are not eligible to apply as the applicant organization, they may participate as a collaborative or consortium organization for the research education component. NIH Intramural laboratories may participate as collaborators.
Eligible Program Directors include established researchers with acknowledged accomplishments in interdisciplinary research and training.
Applicant organizations may submit no more than one application. In addition, applications submitted in response to a previous RFA (RM-04-015) that were not funded may be submitted as amended applications and should include an introduction of no more than three pages.
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, 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
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
The National Institutes of Health (NIH) is engaged in a series of activities collectively known as the NIH Roadmap whose goal, in keeping with the NIH mission of uncovering new knowledge about health promotion and disease prevention, detection, diagnosis, treatment of disease and disability, and delay the onset or slowing the progression of disease and disability, is to accelerate both the pace of discovery in these key areas and the translation of therapies from bench to bedside. In the course of developing the NIH Roadmap, it has become increasingly clear that scientific advances are being made at the interfaces of traditional disciplines and that approaches to science are becoming more integrative. Success requires a cooperative effort among a new workforce, typically in the form of investigators from diverse research backgrounds working collectively across traditional disciplinary boundaries to answer scientific questions and achieve specific endpoints. Building research teams for the future has therefore emerged as one of the major themes in Roadmap implementation. (Additional information about the NIH Roadmap can be found on the NIH website at: http://nihroadmap.nih.gov/)
An interdisciplinary approach is distinguished from a multidisciplinary approach in that a multidisciplinary approach brings experts from diverse disciplines to address collectively a common complex problem, each from his or her unique perspective. By contrast, an interdisciplinary approach is what results from the melding of two or more disciplines to create a new interdisciplinary science. Biophysics, epidemiological topography, regenerative medicine, biostatistics, bioinformatics, bioengineering, social neuroscience, and psychoneuroimmunology are just some examples of existing interdisciplinary sciences. NIH recognizes the value and enormous contributions that existing interdisciplinary approaches have made, and are continuing to make, to our understanding of health, disease, and disability.
Program Objective
The goals of NIH supported research training and research education 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 goal of this initiative is to promote fresh, innovative, and novel training approaches using existing, emerging, or under-developed interdisciplinary sciences. The goal of training interdisciplinarians is to ensure that each researcher will be able to speak the language of the interdiscipline, understand the basis of each discipline component, be able to train others in the interdiscipline, and emerge as leaders in the development of interdisciplinary science.
This RFA solicits applications to establish new research education and training programs in interdisciplinary research. Programs may target undergraduate, graduate, postdoctoral or faculty-level training. Proposed programs should span NIH Institute- or Center-specific missions. Applications proposing programs that fall within the purview of current Institute or Center training mechanisms will be considered non-responsive to this RFA and will not be reviewed. Moreover, NIH recognizes that multidisciplinary approaches may be a necessary step in the evolution of interdisciplinary research training, and currently offers traditional opportunities and mechanisms to support multidisciplinary research training (e.g., see http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html). However, for the purposes of this RFA, activities that facilitate communication among different disciplines and promote, but do not completely achieve integration of different disciplines in the proposed project period, or propose training in multidisciplinary approaches as a precursor to interdisciplinary research training, will be considered non-responsive and will not be reviewed. We encourage applicants to discuss their plans with the relevant program staff well in advance of the application receipt date (see Section VII. Agency Contacts).
Annual Training for a New Interdisciplinary Research Workforce Meeting
All T90/R90 Program Directors are required to attend annual Training for a New Interdisciplinary Research Workforce meetings. If a Program Director is unable to attend, prior programmatic approval of a suitable alternate is required. The goal of this meeting is to promote collaboration and cooperation between Centers, promote the sharing and dissemination of curricula, discuss progress and future plans, etc. This meeting will take place in the Bethesda, MD/Washington DC area.
Research Training (T90) versus Research Education (R90)
This initiative takes advantage of two distinct grant mechanisms: research training and research education. Research Training refers to the Ruth L. Kirschstein NRSA predoctoral and postdoctoral components, and utilizes the T90 mechanism. Research Education refers to undergraduate, non-NRSA predoctoral and postdoctoral components, and the short-term faculty education component, and utilizes the R90 mechanism. These are administrative distinctions only; they are not conceptually distinct components. All undergraduate, predoctoral, and postdoctoral participants will be referred to as trainees , and participants of the short-term faculty education component will be referred to as participants . For more detail on NRSA and non-NRSA eligibility, please see Section III. Eligibility Information.
All programs should include novel methods and approaches for providing integrated and flexible research education and training for individuals interested in careers in interdisciplinary, team-based health science. Programs must be structured to promote the recruitment, training, advancement, and retention of new investigators in interdisciplinary research careers and to allow more established investigators to become interdisciplinary scientists. Programs may include any one or combination of the following:
Undergraduate Research Education Program (R90)
Interdisciplinary training at the undergraduate level provides a mechanism for attracting nascent scientists when they might be open to learning interdisciplinary science. This program will allow institutions, including four-year colleges, to establish extramurally-funded research training in interdisciplinary science for undergraduate junior and senior students majoring in the sciences, and who have expressed an interest in a career in interdisciplinary health research.
The objective of this component is for junior and senior level undergraduate students to become educated in interdisciplinary science and to foster their interest in interdisciplinary research careers. In addition, it is essential that students appointed as trainees in this component gain hands-on experience with interdisciplinary science; thus students appointed to this component must have the opportunity to carry out supervised research in interdisciplinary science. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to their studies and coursework, the program and its related research activities, which can include coursework necessary to complete their major. Undergraduate research education programs should be designed for a minimum of 2 academic years of student participation. Two years of participation of undergraduate students in their junior and senior years will be encouraged. With prior approval from NIH program staff, students may be appointed as trainees during the summer before their junior year or during the summer after their senior year.
For information on eligibility, please see Section III.1.B. Eligible Individuals.
Predoctoral Research Training and Education Programs (T90 and R90)
The objective of this program is to develop students research skills and knowledge in preparation for a research career in interdisciplinary research.
Students in the program must receive supervised research training and education in interdisciplinary science. The primary objective of this program must be to develop their research skills and knowledge in preparation for a career in interdisciplinary science. Programs focused at the predoctoral level should be designed to support graduate students enrolled in a relevant doctoral degree program at the applicant institution. Trainees appointed to the predoctoral training program must have the opportunity to carry out supervised research in interdisciplinary research.
This funding opportunity will permit the appointment of both NRSA-eligible and non-NRSA-eligible predoctoral trainees. However, due to funding authority limitations, non-NRSA trainees are included as part of the Research Education component, not subject to the NRSA policies. In years 1 and 2 of the institutional education program, a maximum of one non-NRSA eligible predoctoral individual may be appointed to the training program. In years 3 and 4, a maximum of two non-NRSA eligible predoctoral individuals may be appointed.
Trainees are appointed for full-time, 12-month continuous periods. No trainee may be appointed for less than nine months. All trainees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies. This funding opportunity allows for support of up to four years.
For information on eligibility, please see Section III.1.B. Eligible Individuals.
Postdoctoral Research Training and Education Programs (T90 and R90)
A major goal is to foster the development and implementation of an interdisciplinary research training program that trains students from multiple disciplines in an integrated program. Trainees are expected to participate in a formal, integrated, multiple-year curriculum that provides integrated, cohesive and novel approaches to interdisciplinary research, including theories, techniques, and applications of that research. The product of the program should be independent interdisciplinary scientists who are adept at, not just combining, but integrating multiple approaches, theories and principles as part of their research interests, goals, and career paths.
Trainees appointed to the postdoctoral research training and education program must have the opportunity to carry out independent interdisciplinary research. The primary objective should be to develop trainees research skills and knowledge in preparation for an independent research career in interdisciplinary science.
This funding opportunity will permit the appointment of both NRSA-eligible and non-NRSA-eligible postdoctoral trainees. However, due to funding authority limitations, non-NRSA trainees are included as part of the Research Education component, not subject to the NRSA policies. In years 1 and 2 of the institutional research program, a maximum of one non-NRSA eligible postdoctoral individual may be appointed to the training program. In years 3 and 4, a maximum of two non-NRSA eligible postdoctoral individuals may be appointed.
Trainees are appointed for full-time, 12-month continuous periods for up to three years. No trainee may be appointed for less than nine months. All trainees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.
For information on eligibility, please see Section III.1.B. Eligible Individuals.
Short-term Faculty Education Component (R90)
The objective of the short-term faculty education component is to provide rapid and intensive education for independent investigators who desire to expand their expertise in interdisciplinary science. Participants must be faculty-level researchers. The program should be designed to take advantage of the strengths in interdisciplinary research at the applicant institution and may include faculty from other institutions. The program must be distinct from those research training and education programs currently receiving federal support.
For information on eligibility, please see Section III.1.B. Eligible Individuals.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the new T90 grant mechanism that includes linked research education (R90) and research training (T90) programs. Applicants will submit a single, unified T90 grant application for the Interdisciplinary Research Training Program and if selected for funding, two separate awards will be issued: an R90 (Research Education award) and a T90 (Research Training award), based on distinct research training and education, and related funding authorities. Applicants may request a project period of up to four years. This RFA is part of the NIH Roadmap activities. At the end of the four-year project period, acceptance of applications for competing renewals or for new programs will be at the discretion of individual NIH Institutes and Centers.
As a Principal Investigator (Program Director) you will be responsible for planning, directing, and executing the proposed training program.
This funding opportunity uses the just-in-time concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). For this combined program, two separate detailed categorical budgets for the Initial Budget Period and four separate budgets for the Entire Proposed Period of Support may be required to be submitted with the application, dependent upon the components of the program. Budgets are to be included for the: Research Education Component, the Predoctoral NRSA Research Training Component (if included), the Postdoctoral NRSA Research Training Component (if included), and a Summary Budget for all requested direct costs.
2. Funds Available
The NIH intends to commit approximately $2,600,000 in FY 2006 to fund approximately 8 10 new training programs in response to this RFA. An applicant may request a project period of up to four years, with direct costs not to exceed $325,000 for the first year. Depending on future years budgets, there may be an opportunity for limited programmatic growth. Because the nature and scope of the proposed research education and 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 RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
The anticipated award date is no later than 09/30/2006 and the project period will terminate by 09/29/2010.
Short-term Faculty Education Component (R90)
Undergraduate Research Training Component (R90)
1. Allowable Costs
Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.
2. Personnel: Individuals participating in the design and implementation of the research education program may request compensation and fringe benefits appropriate for the percent of effort devoted to the program. Compensation requested may not exceed the levels commensurate with the institution’s policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with students are considered a regular part of an individual’s academic duties, then mentoring and other interactions with students are non-reimbursable from grant funds. Limited administrative and clerical compensation 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. All personnel costs (including Program Director, faculty leadership team, and administrative and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 10% of the total direct costs of the overall R90 program.
3. Other Program-Related Expenses: Consultant costs, equipment, supplies, travel, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available at the applicant institution.
A. Short-term Faculty Education Component (R90)
1. Participant Support Costs: Participants in a short-term education program may receive a subsistence allowance, including costs of meals and lodging (based on institutional travel policies) unless such costs are charged 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 participate in the educational experiences supported by this program as participants, but may not receive salary or stipend supplementation from this program.
2. Program Development and Dissemination Costs: Up to $50,000 in direct costs may be requested in year 1 for development of the program and up to $100,000 annual direct costs thereafter for implementation and planned dissemination costs, including funds to defray the costs of attendance and enrollment of participants from outside the grantee institution. It is expected that the grantee organization will contribute in-kind resources associated with these programs, such as classroom or laboratory space; the applicant must identify and describe planned contributions in the application in Section IV.6; the application should include a letter from the grantee institution official confirming availability of such resources.
Short-term positions for research education experiences should last at least 8 weeks, but must not exceed 12 weeks, of full-time education and training.
B. Undergraduate Research Training Component (R90)
1. Undergraduate student support costs: Compensation to help defray expenses during the research training experience will be awarded to each full-time upper (junior and senior) level undergraduate student participant, comparable to their experience, not exceeding $11,000 per year. Additionally, up to $1,000 per year may be requested for domestic or international travel to relevant seminars, workshops, research sites, etc. directly related to the program. No other undergraduate support costs can be requested.
NRSA Predoctoral Research Training Program (T90)
All regulations and policies governing NRSA awards must be followed. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm.
The NRSA component will support research training experiences for trainees who are interested in pursuing research careers in interdisciplinary science for up to four years. Trainees are normally selected by a Program Director for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds.
An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.
Allowable Costs for each predoctoral trainee for a 12-month appointment period include:
1. Stipend: 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. The NIH will provide stipends for each predoctoral trainee position selected for the predoctoral research training component according to the appropriate fiscal year predoctoral NRSA stipend schedule. Stipend levels are adjusted periodically. The current NRSA stipend schedule can be found on the NIH Web site at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html. The total stipend must be based on a 12-month appointment. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid in the form of stipend supplementation, or in the form of compensation. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee’s approved NRSA training program.
Stipend supplementation: Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require additional effort from the trainee. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.
Compensation: An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training 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. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application.
Educational Loans or G.I. Bill: 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 NIH will offset the combined costs of tuition, fees and health insurance (either self-only or family as appropriate) at the rate in place at the time of the award. The rate currently in place provides 100% of all costs up to $3,000 and 60% of costs in excess of $3,000 per trainee. Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. A full description of the NIH tuition policy is in the NIH Grants Policy Statement and at the NIH website: http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.
3. Trainee Travel: Trainee travel to attend foreign or domestic scientific meetings, workshops, research sites, etc. that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. This RFA will allow up to $1,000 annually for travel for each trainee for attendance at relevant scientific meetings, workshops, etc. that the institution determines necessary for the individual’s research training experience.
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 compliment those, offered by 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 NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period.
4. Training Related Expenses: Institutional costs of $2,200 per year per predoctoral trainee may be requested to help defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years.
Under exceptional circumstances, requests for additional training related expenses must be explained in detail and strongly justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.
5. Facilities and administrative costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total modified direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Web site at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.
Non-NRSA Predoctoral Research Education Program (R90)
The non-NRSA component will support research training experiences for predoctoral trainees who are neither U.S. citizens nor permanent U.S. residents. The funding authority directs that the funding be considered as part of the research education program (R90). Trainees are typically appointed for a 12-month period, with support for additional years based in satisfactory progress and continued availability of funds. This funding opportunity allows for up to four years of predoctoral R90 training. To quality for support, a trainee must be appointed full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. See Section III for eligibility.
Allowable costs for this Component should be entered on the R90 budget pages of the application.
1. Trainee support costs: Allowable cost for this component should follow the NIH policy on Graduate Student Compensation. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html for further guidance about compensation for graduate students on research grants. The amount provided for compensation includes salary or wages, fringe benefits, and tuition remission. Additionally, up to $2,200 per year may be requested for each predoctoral trainee for other education-related expenses. This RFA allows requests up to $1,000 per year for foreign or domestic travel to seminars, workshops, research sites, etc. directly related to the program.
Education 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 compliment those offered at the parent institution and the relationship of the proposed experience to the trainee’s career stage and goals. This type of off-site research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period.
Under exceptional circumstances, requests for additional trainee support costs must be explained in detail and strongly justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.
2. Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participant will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less.
NRSA Postdoctoral Research Training Program (T90)
The NRSA component will support research training experiences for postdoctoral trainees who are interested in pursuing research careers in interdisciplinary research. Trainees are selected by a Program Director normally for 12-month appointment periods, with support for additional years based on satisfactory progress and the continued availability of funds. A maximum of three years of postdoctoral NRSA support is allowed.
All regulations and policies governing NRSA awards must be followed. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm.
Allowable Costs for each postdoctoral trainee for a 12-month appointment period include:
1. Stipend: 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. The NIH will provide stipends for each postdoctoral trainee position selected for the postdoctoral research training component according to the appropriate fiscal year predoctoral NRSA stipend schedule. Stipend levels are adjusted periodically. The current NRSA stipend schedule can be found on the NIH Web site at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html. The total stipend must be based on a 12-month appointment. No departure from the established stipend schedule may be negotiated by the institution with the trainee. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid. Such funds may be provided either in the form of stipend supplementation, or in the form of compensation. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee’s approved NRSA training program.
Stipend supplementation: Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require additional effort from the trainee. DHHS funds may not be used for supplementation under any circumstances. Additionally, no funds from other Federal agencies may be used for supplementation unless specifically authorized by the NIH and the other Federal agency.
Compensation: An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services performed outside of the responsibilities of the full-time NRSA-supported training 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. In addition, compensation may not be paid from a research grant that supports the same research that is part of the trainee’s planned training experience as approved in the institutional training grant application.
Educational Loans or G.I. Bill: 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 NIH will offset the combined costs of tuition, fees and health insurance (either self-only or family as appropriate) at the rate in place at the time of the award. The rate currently in place provides 100% of all costs up to $3,000 and 60% of costs in excess of $3,000 per trainee. Costs associated with this category are allowable only if they are required for specific courses as part of the approved research training program and are applied consistently to all persons in a similar research training status at the institution regardless of the source of support. A full description of the NIH tuition policy is in the NIH Grants Policy Statement and off the NIH website at: http://grants.nih.gov/training/nrsaguidelines/nrsa_toc.htm.
3. Trainee Travel: Trainee travel to attend foreign or domestic scientific meetings, workshops, research sites, etc. that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. This RFA allows requests will allow up to $1,000 annually for travel for each trainee for attendance at scientific meetings, workshops, research sites, etc. that the institution determines to be necessary for the individual’s research training experience.
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 compliment 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 NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period.
4. Training Related Expenses: Training-related expenses of $3,850 per year per postdoctoral trainee may be requested to help defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and travel expenses for the training faculty. Training related expenses may be adjusted in future fiscal years.
Under exceptional circumstances, requests for additional training related expenses must be explained in detail and strongly justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.
5. Facilities and administrative costs: A facilities and administrative allowance (indirect cost allowance) based on 8 percent of total modified direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Web site at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm.
Non-NRSA Postdoctoral Research Education Component (R90)
The non-NRSA component will support research training experiences for postdoctoral trainees who are neither U.S. citizens nor permanent U.S. residents. The funding authority directs that the funding be considered as part of the research education program (R90). Trainees are normally selected by a Program Director for 12-month appointment periods, with support for additional years based on satisfactory progress and the continued availability of funds, and may receive a total of 3 years of R90 training support. See Section III for eligibility.
Allowable costs for this Component should be entered on the R90 budget pages of the application.
1. Trainee support costs: A salary may be provided to the selected non-NRSA postdoctoral trainee. The salary must be consistent both with the established salary structure at the institution and salary actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. Fringe benefits, based on the sponsoring institution’s rate, may be provided in addition to the salary. Additionally, for each trainee, annual amounts of up to $3,850 may be requested for other education-related expenses and up to $1,000 for foreign or domestic travel to seminars, workshops, research sites, etc. directly related to the program.
Education 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 compliment those offered at the parent institution and the relationship of the proposed experience to the trainee’s career stage and goals. This type of off-site research training requires prior approval from the NIH. Letters requesting such training may be submitted to the NIH awarding component at any time during the award period.
Under exceptional circumstances, requests for additional trainee support costs must be explained in detail and strongly justified in the application. Consultation with NIH program staff in advance of such requests is strongly advised.
2. Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participant will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
Non-profit organization
Public or private institution, such as universities, colleges, hospitals, and laboratories
Domestic Institution
Only domestic, non-profit, public or private institutions/organizations are eligible to respond to this RFA. Foreign institutions are not eligible to apply, however they may be collaborators with the applicant institution. The applicant institution must be the primary site and must have adequate numbers of highly trained faculty researchers working in an environment that will stimulate and allow for interactions among the involved disciplines and must support interdisciplinary research opportunities. An eligible institution (e.g., a university) may submit only one application in response to this funding opportunity. For the purposes of this RFA, components of a large or multi-component organization that are sufficiently independent to constitute, in effect, separate organizations are considered separate institutions and thus may not submit separate applications. For example, the multiple campuses of the University of California system are considered separate institutions. However, the medical school, engineering school, or dental school, etc., of a university, even if on different campuses, constitute a single institution. Multiple applications from different divisions, faculties, schools, centers, etc. at the same institution will be returned without review.
A single institution may lack strengths in all areas needed to mount an integrated research training and research education program. This funding opportunity allows the participation of multiple sites. When other sites are involved, the applicant institution must be the primary site, and the application must include a resource format page for each site as described in the PHS 398 application.
Applicant institutions with currently active federally funded research training grants (e.g., an NIH T32 or T90, or an NSF IGERT award) in interdisciplinary research or one that includes a significant interdisciplinary component are eligible to apply only if the new application significantly and substantively expands on the current program(s). For example, applicant institutions with an existing predoctoral training program in this area would be eligible to apply for the undergraduate research training, postdoctoral research training, and short-term faculty education components of this funding opportunity, but not the predoctoral research training component. Similarly, applicant institutions with an active R25 research education grant for interdisciplinary research would be eligible to apply for the undergraduate, predoctoral research training and postdoctoral research training components. In the application, applicants must address any real or apparent overlap with existing sources of support for research training or research education in interdisciplinary research.
1. B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training 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.
Program Director: The Program Director will be responsible for the planning, directing, and executing the proposed research education and training program. This individual should be an established researcher with acknowledged accomplishments in interdisciplinary research and in training, and should be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The Program Director will be responsible for the selection of trainees and participants into the research education and training program components and the submission of all required forms. The Program Director must have current research funding.
Faculty Leadership team: A faculty leadership team may facilitate the development of the proposed program and help increase involvement of faculty with diverse expertise in this effort. The members of the faculty leadership team are together likely to provide the breadth of expertise and leadership needed to develop and implement the proposed training and education programs. Personnel costs for the faculty leadership team, including those for the Program Director, and any administrative and clerical costs, are limited to 10% of the total direct costs of the T90 program budget.
Mentors: Mentors must have current research funding and experience mentoring at the level in which they will be participating (e.g., mentoring undergraduate, predoctoral and/or postdoctoral students).
Trainee and Participant Eligibility
Undergraduate Research Education Program (R90)
Any full-time upper-level (junior or senior) undergraduate student enrolled at the grantee institution is eligible to be appointed as a trainee in this component. Trainees must be able to commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to their studies and coursework, the program and its related research activities, with can include coursework necessary to complete their major. Undergraduate research education programs should be designed for a minimum of 2 academic years of student participation
NRSA Institutional Predoctoral Training Component (T90)
At the time of appointment to the training program, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment.
Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at a post-baccalaureate level and enrolled in a program leading to a Ph.D. in a research doctoral degree program, or a combined clinical degree program, such as M.D./Ph.D. NRSA traineeships are not provided for study leading to a M.D., D.O., D.D.S., or other similar professional clinical degree, or master's degree. Individuals currently supported by other Federal funds are not eligible for concurrent trainee support from this program.
An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.
Individuals selected as non-NRSA predoctoral trainees in this component should satisfy all of the conditions for NRSA trainees, except for those pertaining to citizenship.
NRSA Institutional Postdoctoral Training Component (T90)
At the time of appointment to the training program, individuals selected to participate in the training program must be citizens or non-citizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551) or other legal verification of admission for permanent residence. Non-citizen nationals are persons born in lands that are not States but are under U.S. sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible for NRSA support. In addition, trainees must be able to commit full-time effort in the program at the time of appointment. A Payback Obligation must be signed by postdoctoral trainees supported by a T90 grant (please see section 6. Other Submission Requirements).
Postdoctoral research training is for individuals who have received a Ph.D., D.N.Sc., D.V.M.,, M.D., D.M.D., D.C., D.O., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., N.D., D.S.W., Psy.D., D.D.Ss, allied health doctoral degrees such as the D.P.T., or a comparable doctoral degree with a significant research component from an accredited domestic or foreign institution. Individuals currently supported by other Federal funds are not eligible for concurrent trainee support from this program.
An individual trainee may receive no more than three years of NRSA support in the aggregate at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.
Individuals selected as non-NRSA postdoctoral trainees in this component should satisfy all of the conditions for NRSA trainees, except for those pertaining to citizenship.
Short-term Faculty Education Component (R90)
Independent faculty-level research scientists may participate in the 8-12 week research education component. Because this is an educational program, non-U.S. citizens may also participate in this program. However, the research education program component should be used primarily for the education of U.S. citizens.
2. Cost Sharing or Matching
This program does not require cost-sharing as defined in the NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria Applications must follow the instructions provided in Section IV.6.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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 most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
Applications that include an NRSA predoctoral and/or postdoctoral research training component must use the Institutional Ruth L. Kirschstein NRSA guidelines and the specific instructions for Institutional NRSA Applications, PHS 398, Section IV, which begins on page 55, for that component. Instructions on how to include a non-NRSA predoctoral research training component within the overall application are provided in Section IV.6 of this announcement. Applications that include only R90 components (undergraduate research training and short-term faculty education) should use the NRSA instructions as a guide to the format of the application, even though these components are not authorized under the NRSA. More detailed instructions about integrating all components of the application are provided in Section IV.6 of this announcement.
See Section VI.2. Administrative and National Policy 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.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: February 14, 2006
Application Receipt Date(s): April 7, 2006
Peer Review Date: May June, 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
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:
Norman S. Braveman, Ph.D.
Assistant to the Director
National Institute of Dental and Craniofacial Research
Building 31 Room 5B55
31 Center Drive
Bethesda, MD 20892
Telephone (cellular): (301) 594-2089
FAX: (301) 480-0964
Email: Norman.Braveman@nih.gov
3.B. Sending an Application to the NIH
Applications must be prepared using the instructions and forms for the NRSA research training and research grant applications, as applicable, found in the PHS 398. 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:
Norman S. Braveman, Ph.D.
Assistant to the Director
National Institute of Dental and Craniofacial Research
Building 31 Room 5B55
31 Center Drive
Bethesda, MD 20892
Telephone (cellular): (301) 594-2089
FAX: (301) 480-0964
Email: Norman.Braveman@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: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3. C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will not be reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIH Program Staff. Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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. However, applications submitted in response to RFA RM 04-015 (a previous version of this RFA) that were not funded may be submitted as amended applications, and should include an Introduction of no more than three pages.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable only for the R90 program. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
NRSA Institutional Predoctoral and/or Postdoctoral Training Component (T90)
The policies of the National Research Service Award (NRSA) apply to the T90 components of the integrated program. Awards are contingent upon availability of funds. Furthermore, the duration of the award and the number of awarded training positions may be less than the levels recommended by the peer review group, based on programmatic and budgetary considerations. Funds for continuation support beyond the initial year are determined by the success of the integrated training program as described in the annual progress report, the timely submission of required forms, and the availability of funds.
Concurrent Awards
An NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.
Service Payback Agreement
As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Kirschstein-NRSA postdoctoral support. See Section VI.2. for more details.
Taxability of Stipends
Internal Revenue Code Section 117 applies to the tax treatment of all scholarships and fellowships. The Tax Reform Act of 1986, Public Law 99-514, impacts on the tax liability of all individuals supported under the NRSA program. Under that section, non-degree candidates are now required to report as gross income all stipends and any monies paid on their behalf for course tuition and fees required for attendance. Degree candidates may exclude from gross income (for tax purposes) any amount used for tuition and related expenses such as fees, books, supplies, and equipment required for courses of instruction at a qualified educational organization.
The IRS and Treasury Department released regulations in January 2005 (Revenue Procedure 2005-11) clarifying the student exception to the FICA (Social Security and Medicare) taxes for students employed by a school, college, or university where the student is pursuing a course of study. Our understanding is that these final regulations do not apply to or impact Kirschstein-NRSA programs or awards. An NRSA stipend is provided by the NIH as a subsistence allowance for Kirschstein-NRSA fellows and trainees to help defray living expenses during the research training experience. NRSA recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NIH takes no position on the status of a particular taxpayer, nor does it have the authority to dispense tax advice. The interpretation and implementation of the tax laws are the domain of the IRS. Individuals should consult their local IRS office about the applicability of the tax laws to their situation and for information on their tax obligations.
Non-NRSA Institutional Predoctoral and/or Postdoctoral Training Component (R90)
This component will support research training experiences for up to one full-time non-NRSA predoctoral and postdoctoral trainees. Predoctoral students should follow the NIH policy for Graduate Student Compensation. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html for further guidance about compensation of graduate students on research grants. Individuals in postdoctoral training should follow the information provided in Section II for the non-NRSA postdoctoral research education component which provides guidance for allowable compensation.
6. Other Submission Requirements
All Program Components (T90 and R90)
Scientific Environment: It is expected to be strongly collaborative and with many opportunities to engage in interdisciplinary research, such as journal clubs, seminar series and other activities. There should also be adequate infrastructure which may be evidenced by co-authored publications, collaborative research projects, joint service on dissertation committees, team teaching of courses, etc.
Institutional Environment and Commitment to the Program: It is expected that a rich institutional environment will be present, and evidence of interdepartmental interaction/collaboration, adequate coursework, research support, equipment, facilities, etc. should be provided. The program should take advantage of all opportunities present in the overall institutional environment, and should be an integral component of the institution’s overall research program/mission. The institutional environment should make itself available and accessible to the faculty, staff, and students participating in the program. Institutional commitment may be indicated by providing funds, space, materials, and protected time to the Program Director, etc. Documentation of commitment may include letters from the institution, such as Department Chairs, Deans, or other appropriate institutional administrators.
Evaluation and Tracking Plan: The program evaluation and tracking plan should include measures to evaluate the effectiveness of each training and education component, and should build on strengths and correct weaker areas. Should specific weaker areas be identified, the program should be able to specifically address them. The evaluation and tracking report should be included annually as part of the Progress Report and as part of the Final Report.
External Advisory Committee: All components are required to have an external advisory committee with detailed information regarding the number and expertise of persons who will serve (without naming anticipated members), a meeting timeline, and what the content of these meetings might include.
Applicant Recruitment, Selection and Retention Plans: Applicants must describe how they will recruit appropriate trainees/participants from both inside and outside their sponsoring institution to the program. A selection plan outlining how they will select from the pool of potential trainees/participants must be presented.
Diversity Recruitment and Retention Plan
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as; individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:
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 and 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, which are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds which 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 candidates 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. 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.
This RFA requires all applicants to submit a diversity recruitment and retention plan, including those that do not include NRSA components. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.
Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research training and education programs, e.g., Web postings, presentations at scientific meetings, workshops, the annual Training for a New Interdisciplinary Research Workforce meeting, etc.
Training in the Responsible Conduct of Research: Formal or informal instruction in scientific integrity and ethical principles in research is a required component of the training program and must be present in every year of trainee participation. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed. The plan should provide specific information with respect to seminars, courses and other training opportunities, the degree of faculty participation, trainee attendance and the frequency of instruction.
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 trainees appointed to the program.
The rationale for the proposed plan of instruction must be provided.
Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and non-competing applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all undergraduate students, graduate students, postdoctorates, and research staff regardless of their source of support.
Budget pages: Each application may submit two budget pages. If the training program consists of only NRSA-qualified individuals (i.e., predoctoral candidates or postdoctoral trainees, who are U.S. citizens or U.S. permanent residents), then only one budget page (NRSA SUBSTITUTE FORM PAGE 4) is required. If awarded, funds will be issued under a T90 grant mechanism. Programs may not be designed to only support non-NRSA predoctoral or postdoctoral trainees.
If trainees who are not U.S. citizens or U.S. permanent residents, or who are undergraduate students or short-term faculty education participants, are included in the overall training program, then PHS 398, FORM PAGE 4 must be submitted. In addition, if the Program Director requests any salary support, include PHS 398 FORM PAGE 4. Awarded grant funds will be issued under an R90 grant mechanism for these requested training costs.
If the T90 application requests support for both NRSA-qualified and non-NRSA qualified trainees or salary support for the Program Director, then both budget pages must be submitted.
Statement of Appointment forms: PHS 2271 (Statement of Appointment) must be used to initiate each trainee enrolled in either the predoctoral or postdoctoral T90 NRSA programs. A Payback Obligation must be signed by postdoctoral NRSA trainees supported by a T90 grant. PHS416-7 will be used for termination notices for all levels of trainees supported by the T90/R90 grants.
Undergraduate Research Education Component (R90)
Predoctoral Research and Education Components (T90 and R90)
Postdoctoral Research and Education Components (T90 and R90)
Curriculum and Degree Requirements: For undergraduate and predoctoral students, curriculum and degree requirements should avoid extending time to degree; alternatively, a plan for tailoring degree requirements and a description of milestones for accomplishing the plan should be included. For undergraduate, predoctoral and postdoctoral students, specific courses and attendance requirements should be identified.
Trainee Interactions: Trainee interactions must be of sufficient quantity and quality to ensure that the students and associated faculty develop an internal sense of the identity of their interdisciplinary field and its rewards and challenges. Examples of mechanisms for fostering program cohesiveness include seminar series with presentations from students, faculty and invited guests; retreats; and journal clubs.
Leadership and teambuilding skills:
Leadership and teambuilding skills will be critical to the future success of the students produced by these programs. Plans should be developed and put in place to help students and interested faculty develop the leadership skills and understanding of the challenges of group dynamics necessary to establish and maintain a genuinely integrated research program.
Academic and career advice: Academic and career advice will be an important factor in the success of these training programs since they will be producing the first generation of students in new interdisciplinary sciences. Students should be apprised of the broad range of career options as well as instructed in how to apply successfully for research funding.
Undergraduate Research Education Component (R90) Undergraduate students are expected to participate in a full-time, formal, integrated, multi-year curriculum that combines research experiences with the principles, theories and applications of their interdisciplinary scientific area. Program components should include:
Training Program
Program Director
Mentors
Research Training and Education Record
Training Program: The training program should provide broad-based, integrated training in interdisciplinary science.
Didactic Training: It is expected that trainees will take both general and specialized courses in all the disciplines represented in their training.
Laboratory/Field experience: It is expected that trainees will receive hands-on training in interdisciplinary research. This may involve laboratory/field rotations, or a research project in a single laboratory or field setting. Experienced researchers, from graduate students to senior investigators, should provide the mentoring and training needed for the trainee to gain supervised, hands-on experience in the design, data collection, data analysis, evaluation and presentation (e.g., oral and/or written form) of an interdisciplinary research project.
Programmatic Activities: Such activities include formalized interactions of participating departments and programs that will foster the development of interdisciplinary scientists that may include, but are not restricted to, journal clubs, seminar series, and the annual Training for a New Interdisciplinary Research Workforce meeting.
Program Director: The Program Director should have the scientific background and experience to run the training program, and should be committed to its coordination and supervision. The Program Director must be a funded investigator and evidence of ongoing research funding during the requested award period must be provided.
Mentors: Trainees research projects must be supervised by appropriate faculty mentors. Each trainee is expected to have a mentoring team that includes at least two co-mentors, from different disciplines, that combine to form the backbone of the interdisciplinary research training team. Mentors should be funded investigators in an appropriate research area and evidence of ongoing research funding during the requested award period must be provided.
Research Training and Education Record: It is expected that the Program Director and mentors will demonstrate a history of successful mentoring of undergraduate students.
Predoctoral Research Training and Education Program (T90 and R90)
Programs focused at the predoctoral level should be designed to support graduate students enrolled in a relevant doctoral degree program at the applicant institution for up to four years.
Trainees in the program must receive supervised education and research training in interdisciplinary science. The primary objective of this program must be to develop their research skills and knowledge in preparation for a career in interdisciplinary science. Trainees must commit full-time effort, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies, to the program and its related research training activities. NRSA (T90) and non-NRSA students (R90) may be supported by the program. In years 1 and 2 of this Predoctoral Component, a maximum of one non-NRSA-eligible predoctoral graduate student may be appointed to the research education program. In years 3 and 4, a maximum of two non-NRSA-eligible predoctoral graduate students may be appointed. Programs to train only non-NRSA eligible individuals are not allowed.
A major goal of this funding opportunity is to foster the development and implementation of an interdisciplinary research training and education program that trains students from multiple disciplines in an integrated program. Trainees are expected to participate in a formal, integrated, multi-year curriculum that provides integrated, cohesive and novel approaches to interdisciplinary science, including theories, techniques, and applications of that research. The product of the predoctoral research training program should be interdisciplinary scientists who are adept in not just combining, but integrating multiple approaches, theories and principles as part of their research interests, goals, and career paths.
Program components should include:
Training Program
Program Director
Mentors
Research Training and Education Record
Training Program: The training program should provide broad-based, integrated training in interdisciplinary science.
Didactic Training: It is expected that trainees will take both general and specialized courses in all the disciplines represented in their training.
Laboratory/Field experience: It is expected that trainees will receive hands-on training in interdisciplinary research. Although not a required component of the predoctoral research training and education program, one scenario would be to recommend at least two rotations for each trainee, involving each of the disciplines of interest. Experienced researchers, from senior postdoctoral fellows to senior investigators, should provide the mentoring and training needed for the trainee to gain hands-on experience in the design, data collection, data analysis, evaluation, and presentation (e.g., in oral and written form) of an independent research project.
Programmatic Activities: Such activities include formalized interactions of participating departments and programs that will foster the development of interdisciplinary scientists that may include, but are not restricted to, journal clubs, seminar series, and the annual Training for a New Interdisciplinary Research Workforce meeting. In addition, activities that are likely to improve career success, such as grantsmanship workshops, mock grant reviews and job interviews, job negotiation and survival skills, and other professional development activities are strongly encouraged.
Program Director: The Program Director should have the scientific background and experience to run the training program, and should be committed to its coordination and supervision. The Program Director must be a funded investigator and evidence of ongoing research funding during the requested award period must be provided.
Mentors: Trainees research projects must be supervised by appropriate faculty mentors. Each trainee is expected to have a mentoring team that includes at least two co-mentors, from different disciplines, that combine to form the backbone of the interdisciplinary research training team. Mentors should be funded investigators in an appropriate research area and evidence of ongoing research funding during the requested award period must be provided. Trainees input into decisions regarding the direction of the science, research protocol, interpretation, etc. is strongly encouraged.
Research Training and Education Record: It is expected that the Program Director and mentors will demonstrate a history of successfully mentoring graduate students.
The number of trainee slots requested must be justified in terms of the available pool of NRSA-eligible and non-NRSA eligible trainees, the training track record of the mentors, and the design of the training program. The number of trainees recommended by the RFA review panel is considered the ceiling and may be decreased by NIH program staff based on availability of funds and the track record for filling positions as assessed by annual progress reports and statements of appointments.
Full-time NRSA Institutional Predoctoral Training Component (T90)
The NRSA component will support research training experiences for up to four years for U.S. citizens or permanent residents who are interested in pursuing research careers in interdisciplinary research. Trainees are selected by a Program Director normally for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds. Appointments for less than 9 months are not allowed.
An individual trainee may receive no more than five years of NRSA support in the aggregate at the predoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.
All regulations and policies governing NRSA awards must be followed. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm.
The non-NRSA component will support research training experiences for up to four years for students who are neither U.S. citizens nor U.S. permanent residents. The funding authority directs that the funding be considered as part of the Research Education Program (R90). See Section III for eligibility. In years 1 and 2 of this award, a maximum of one non-NRSA eligible graduate student may be appointed to the research education program. In years 3 and 4, a maximum of two non-NRSA-eligible graduate students may be appointed. Appointments for less than 9 months are not allowed.
Postdoctoral Research Training and Education Program (T90 and R90)
Postdoctoral research training and education components are for individuals who have received a Ph.D., D.N.Sc., D.V.M, D.D.S., M.D., D.M.D., D.C., D.O., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., N.D., D.S.W., Psy.D., D.D.Ss, allied health doctoral degrees such as the D.P.T., or a comparable doctoral degree with a significant research component from an accredited domestic or foreign institution. Research training at the postdoctoral level must emphasize interdisciplinary research training to meet national research priorities in the biomedical, behavioral, or clinical sciences.
Research training grants are a desirable mechanism for the postdoctoral training of physicians and other health professionals who may have extensive clinical training but limited research experience. For such individuals, the training may be a part of a research doctoral level degree program. In all cases, since the duration of training has been shown to be strongly correlated with post-training research activity, postdoctoral trainees should agree to engage in at least 2 years of research, research training, or comparable activities beginning at the time of appointment. NRSA (T90) and non-NRSA (R90) components may be proposed. In years 1 and 2 of this Postdoctoral Component, a maximum of one non-NRSA eligible postdoctoral student may be appointed to the training program. In years 3 and 4, a maximum of two non-NRSA-eligible post-doctoral students may be appointed.
A major goal of this funding opportunity is to foster the development and implementation of an interdisciplinary research training program that trains students from multiple disciplines in an integrated program. Trainees are expected to participate in a formal, integrated, multi-year curriculum that provides integrated, cohesive and novel approaches to interdisciplinary research, including theories, techniques, and applications of that research. The product of the postdoctoral research training program should be independent interdisciplinary scientists who are adept in not just combining, but integrating multiple approaches, theories and principles as part of their research interests, goals, and career paths.
Program components should include:
Training Program
Program Director
Mentors
Research Training and Education Record
Training program: The training program should provide broad-based, integrated training in interdisciplinary science.
Didactic Training: It is expected that trainees will take both general and specialized courses in all the disciplines represented in their training.
Laboratory/Field experience: It is expected that trainees will receive hands-on training in interdisciplinary research. It is anticipated that the postdoctoral fellow will bring his/her unique background and training to the research experience. More senior postdoctoral trainees might be encouraged to assist in the mentoring to more junior trainees.
Programmatic Activities: Such activities include formalized interactions of participating departments and programs that will foster the development of interdisciplinary scientists that may include, but are not restricted to, journal clubs, seminar series, and the annual Training for a New Interdisciplinary Research Workforce meeting. In addition, activities that are likely to improve career success, such as grantsmanship workshops, mock grant reviews and job interviews, job negotiation and survival skills courses, and other professional development activities are strongly encouraged.
Program Director: The Program Director should have the scientific background and experience to run the training program, and should be committed to its coordination and supervision. The Program Director must be a funded investigator and evidence of ongoing research funding during the requested award period must be provided.
Mentors: Trainees research projects must be supervised by appropriate faculty mentors. Each trainee is expected to have a mentoring team that includes at least two co-mentors, from different disciplines, that combine to form the backbone of the interdisciplinary research training team. Mentors should be funded investigators in an appropriate research area and evidence of ongoing research funding during the requested ward period must be provided. Trainees input into decisions regarding the direction of the science, research protocol, interpretation, etc. is expected.
Research Training and Education Record: It is expected that the Program Director and mentors will demonstrate a history of successfully mentoring graduate students.
The number of trainee slots requested must be justified in terms of the available pool of NRSA-eligible and non-NRSA eligible trainees, the training track record of the mentors, and the design of the training program. The number of trainees recommended by the RFA review panel is considered the ceiling and may be decreased by NIH program staff based on availability of funds and the track record for filling positions as assessed by annual progress reports and statements of appointments.
Full-time NRSA Institutional Postdoctoral Training Component (T90)
The NRSA component will support research training experiences for up to three years for U.S. citizens or permanent residents who are interested in pursuing research careers in interdisciplinary research. Trainees are normally selected by a Program Director for 12-month appointment periods with support for additional years based on satisfactory progress and the continued availability of funds. Appointments for less than 9 months are not allowed. An individual trainee may receive no more than three years of NRSA support in the aggregate at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Exceptions to this limitation require a waiver from the director of the funding Institute based on a review of the justification provided by the awardee, and must be submitted for prior written approval.
All regulations and policies governing NRSA awards must be followed. This includes a payback obligation for every month of training up to the first 12 months. Detailed information regarding NRSA policies and procedures can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/policy.htm.
Full-time non-NRSA Institutional Postdoctoral Training Component (R90)
The non-NRSA component will support research education experiences for up to three years for trainees who are neither U.S. citizens nor U.S. permanent residents. The funding authority directs that the funding be considered as part of the Research Education Program (R90). In years 1 and 2 of this award, a maximum of one non-NRSA eligible graduate student may be appointed to the training program. In years 3 and 4, a maximum of two non-NRSA-eligible graduate students may be appointed. Appointments for less than 9 months are not allowed. See Section III for eligibility.
The short-term faculty education component should provide a rapid, intensive education component for independent investigators who desire to expand their expertise in a more interdisciplinary direction. Participants must be faculty-level researchers. A short-term education component should be designed to take advantage of the strengths in interdisciplinary research at the applicant institution and may include faculty from other institutions. However, this program should be willing to accept as participants persons not employed at the applicant institution. While the proposed research education program may complement other, ongoing research training and educational opportunities occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.
The duration of the short-term faculty education activities should be at least 8 weeks, but not more than 12 weeks, and must be appropriately justified.
Program components should include:
Education Program
Program Director
Education Program: The program should provide broad-based, integrated training in interdisciplinary research to established faculty-level researchers. This should be varied and interesting enough to attract participants back for multiple appointments (competing continuation applications).
Program Director: The education Program Director should have the scientific background and experience to run the education program, and should be committed to its coordination and supervision.
Section V. Application Review Information
1. Criteria Not Applicable
2. Review and Selection Process
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:
Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by NIDA
The following will be considered in making funding decision:
The merit of the proposed research training and education program will be evaluated by peer review of the following:
Objectives, design, and direction of the research training and education program;
Caliber of mentors as researchers, including successful competition for research support
Institutional research training and education environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support
Recruitment and selection plans for trainees and the availability of high quality candidates
Relevance to Program priorities
Availability of funds
Only the review criteria described below will be considered in the review process.
The goals of NIH supported research training and research education programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation's biomedical, behavioral, and clinical research needs. In their written critiques, reviewers will be asked to comment on the following criteria in order to judge the likelihood that the proposed 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.
All Program Components (R90 and T90)
Scientific Environment:
Is the scientific environment strongly collaborative and with many opportunities to engage in interdisciplinary research, such as journal clubs, seminar series and other activities?
Is there evidence of adequate infrastructure? This may be evidenced by co-authored publications, collaborative research projects, joint service on dissertation committees, team teaching of courses, etc.
Institutional Environment and Commitment to the Program:
Does the environment in which the program will be conducted (i.e., the quality of the participating departments and the extent of their participation), contribute to the probability of success?
Is there evidence of interdepartmental interaction/collaboration?
Is there evidence of adequate coursework, research support, equipment, and facilities?
Is there evidence of adequate institutional commitment for the proposed program to be an integral component of its overall research program/mission?
Is the Institution’s plan for the proposed program to be an integral component of its overall research program/mission adequate?
Are there letters of commitment from the institution, such as Department Chairs, Deans, or other appropriate institutional administrators? Commitment may be indicated by providing funds, space, materials, providing protected time to the Program Director, etc.
Evaluation and Tracking:
Is the plan adequate to determine progress and outcome measures for each of the research education and research training components?
Does it include a system for tracking participants following program completion to determine success or failure of the program, such as program publications, grant proposals and awards, and career trajectory of supported trainees?
External Advisory Committee:
Is detailed information given regarding the expertise of persons who will be recruited for the External Advisory Committee (without naming anticipated members), along with details about when it will meet and the content of meetings?
Are plans for the proposed advisory committee adequate and appropriate to ensure proper monitoring of the research education and research training components?
Are there means in place to modify the research education or research training component based on appropriate recommendations from the advisory committee?
Applicant Recruitment, Selection and Retention:
What is the quality and size of the applicant pool? Is there access to appropriate, high quality candidates?
Are the recruiting procedures, selection criteria, and retention strategies appropriate and well defined?
Monitoring trainees and participants should be an integral part of the program, with close attention paid to retention in the program and to time to degree (for undergraduate and pre-doctoral students). Is a plan in place such that, should a term of appointment be terminated prior to completion, the program can determine if the failure to retain the trainee/participant is due to dissatisfaction with the program? Is the Program able to address problems or issues that appear multiple times?
Dissemination Plan:
Is there a specific plan to disseminate nationally any materials developed under the auspices of the research training and education programs, e.g., web posting, presentations at national meetings, workshops, etc?
Undergraduate Research Education Component (R90)
Institutional Predoctoral and/or Postdoctoral Training and Education Components (T90/R90)
Reviewers will be asked to address and discuss the following criteria in assigning the overall score of the application for the undergraduate, predoctoral and/or postdoctoral research training and education programs, weighting each as appropriate. Reviewers will first determine the quality of the proposed training program and then consider whether the requested number of trainee positions is appropriate for the number of high-quality trainees likely to be accepted in the planned research training and education program in interdisciplinary science.
Training Program
Program Director
Mentors
Trainee Recruitment and Selection
Training Program:
Does the proposed training program provide broad-based, integrated training in interdisciplinary research?
If coursework is proposed, are appropriate courses available to provide a broad, early curriculum that spans the breadth of approaches to interdisciplinary science?
Are there any interdisciplinary and inter-professional research training opportunities, or novel concepts, approaches, methodologies, or technologies to be utilized for the proposed research training and education program?
Is there an evaluation plan sufficiently detailed to track career outcomes of trainees and determine it the program is successful? Are there plans to make changes that improve performance and outcomes?
For predoctoral programs, are appropriate courses and activities available to provide a focused training experience in an area of institutional strength in interdisciplinary research?
Are appropriate programmatic activities incorporated into the training program?
Program Director:
Does the Program Director have the scientific background, expertise, and experience to coordinate and supervise an interdisciplinary training program?
Has the Program Director committed adequate time to program administration?
Has the Program Director shown evidence of ongoing research funding during the requested award period?
Mentors:
Is there appropriate expertise available in the scientific community at the institution or among the participating institutions (if applicable)?
What is the caliber of the mentors as researchers, including the overall quality of their research, their publication record, and their successful competition for research support in areas directly related to the proposed training program?
What is the record of the mentors, especially of undergraduate and/or predoctoral students, if programs targeted at these levels are proposed?
What is the record of the mentors in an interdisciplinary training program?
What is the success of former trainees in seeking further career development and in establishing productive scientific careers? Evidence of further career development can include successful completion of the Ph.D., receipt of fellowships or 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 or awards, 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.
Have the mentors provided evidence of ongoing research funding during the requested award period?
Trainee Recruitment and Selection:
Is there large enough base of highly qualified, interested students from which to select high quality trainees?
Short-Term Faculty Education Component (R90)
Reviewers will be asked to address and discuss the following criteria in assigning the overall score for the short-term faculty education component of the application, weighting each as appropriate.
Short-Term Faculty Education Program:
Does the proposed education program provide broad-based, integrated training in interdisciplinary research?
Is the program likely to promote the incorporation of interdisciplinary science into the research portfolio of the established scientists who participate?
Are appropriate resources available to provide a broad curriculum that spans the breadth of interdisciplinary research approaches?
Is there commitment and availability of the participating faculty, program design, availability of research support, and training environment?
Education Program Director:
Does the Program Director have the scientific background, expertise, and experience to coordinate and supervise a short-term education program?
Has the Program Director committed adequate time to program administration?
2.A. Additional Review Criteria:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Training in the Responsible Conduct of Research: Applications must include a description of programs designed to provide formal and informal instruction in scientific integrity or the responsible conduct of research relevant to all components of the program. Applications without plans for instruction in the responsible conduct of research for each component will be considered incomplete and may be returned to the applicant without review.
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 undergraduate or predoctoral trainees appointed to the program. Plans must address the subject matter of the instruction, the format of the instruction, the degree of training faculty participation, trainee attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.
Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in progress reports and future competing continuations. The NIH encourages institutions to provide instruction in the responsible conduct of research to all undergraduate students, graduate students, postdoctorates and research staff regardless of their source of support.
The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as; individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH 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.
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research training and research education programs, and the number of trainees and participants requested for each program. The priority score should not be affected by the evaluation of the budget.
Software Dissemination and Sharing Plan: If a software dissemination and sharing plan is included in the application, then reviewers will be asked to comment on the appropriateness of the proposed plan. However, they will not factor the plan into the determination of the scientific merit or the priority score.
2.C. Sharing Research Data No data sharing plan is necessary.
2.D. Sharing Research Resources
Research education programs are not generally expected to generate research resources. However, applications in response to this RFA must include a plan to disseminate curricula and teaching 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:
Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
The initial review group will comment on the appropriateness of the proposed plan for software dissemination; however, this will not factor into the determination of the scientific merit or the priority score. Program staff and advisors 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 software dissemination practice by the grantee.
If unique research resources are developed, 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 curricula, teaching tools, and research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plan with the awardee before recommending funding of an application. The final version of the resource sharing plan negotiated by both will become a condition of the award of the grant. 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
It is anticipated that applicants can expect to learn about the outcome of their applications, whether successful or unsuccessful, by September 30, 2006.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, a written critique will be available to the Principal Investigator through the eRA Commons (NOT-OD-05-075).
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
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 NIH 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 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.
Change of Program Director
If change of a Program Director is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided:
The current Program Director has submitted a written request for a change of Program Director, countersigned by the Principal Investigator and the appropriate institutional business official, to the NIH Program Staff describing the reasons for the change. The Biographical Sketch of the proposed new Program Director, including a complete listing of active research grant support, is provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new Program Director will remain unchanged, and that the new Program Director has the appropriate interdisciplinary research and administrative expertise to lead the program.
The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.
Transfer of Program
Neither the program as a whole nor any component of the program may be transferred to another institution.
Termination
The Program Director must consult with NIH staff when termination of the program is being considered. When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.
Service Payback (NRSA postdoctoral trainees only)
As required by the NIH Revitalization Act of 1993, postdoctoral fellows incur a service obligation of 1 month for each month of support during the first 12 months of the Kirschstein-NRSA postdoctoral support. The 13th and subsequent months of Kirschstein-NRSA support are acceptable postdoctoral payback service. Thus, individuals who continue under the award for 2 years will have paid off their first year obligation by the end of the second year.
Applicants accepting an award for the first 12 months of Kirschstein-NRSA postdoctoral support must sign a payback agreement (PHS Form 6031) in which they agree to engage in health-related research training, research, and/or teaching for 12 months.
Those who do not pay back their obligation through continued Kirschstein-NRSA supported training may satisfy their obligation by serving in a position in which health- related research, research training, or teaching are the primary activities. Such individuals must engage in research, research training, or teaching at a rate of 20 or more hours per week averaged over a full work-year. Payback service may be conducted in an academic, governmental, commercial, or nonacademic environment, in the United States or in a foreign country. Examples of acceptable payback service include research associateships/assistantships, postdoctoral research fellowships, and college or high school science teaching positions. Examples of unacceptable payback service include clinical practice and administrative responsibilities not directly related to scientific research.
Payback service positions are arranged by the individual, not by the NIH. The NIH will review and approve the activity at the end of the year in which it occurs. Service to satisfy any outstanding obligation must be initiated within 2 years after termination of Kirschstein-NRSA support, and must be performed on a continuous basis. For individuals who fail to fulfill their service obligation, the United States is entitled to recover the total amount of Kirschstein-NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the U.S. Department of Treasury. Financial payback must be completed within 3 years, beginning on the date the United States becomes entitled to recover such amount.
Under certain conditions, the Secretary, DHHS, may extend the period for starting service, permit breaks in service, extend the period of repayment, or otherwise waive the payback obligation when compliance would constitute a substantial hardship against equity and good conscience. Policies regarding the Kirschstein-NRSA payback obligation are explained in the Kirschstein-NRSA Section of the NIH Grants Policy
Trainees supported by academic institutions should refer to the NIH NRSA guidelines at: http://grants.nih.gov/grants/guide/pa-files/PA-02-109.html for guidance regarding leave. Undergraduate and non-NRSA predoctoral trainees should also follow these guidelines and institutional policies.
Carryover of Unobligated Balances
The carryover of funds from one budget period to the next requires prior written approval of NIH
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
This program is not subject to Streamlined Non-competing Application Process (SNAP).
The annual progress report should provide information about changes in the integrated program, a summary report by the Advisory Committee, and a description of the training and education, research and career progress of each trainee and participant. They must include a detailed account of experiences in recruiting individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide aggregated information on the racial/ethnic distribution of all applicants and those accepted and appointed. The aggregated report should also include information on individuals with disabilities and those from disadvantaged backgrounds.
For all trainees who were enrolled in the academic program, the report should include information about the duration of research training and education, and whether those trainees finished their training in good standing. Similar information should be provided separately for the research education component of the program.
The NRSA instructions for the non-competing grant progress report (starting on page 19, Form 2590) should be followed, with any necessary modifications for other program components.
Note that for programs that include NRSA predoctoral and postdoctoral research training programs, a substitute budget page and a summary of trainee page are to be included in the request for continuation support. The non-competing budget page should list the names of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions.
Advisory Committee Report:
A report from the Advisory Committee should be separately attached summarizing its actions during the last year, evaluating the performance of the program in meeting its objectives and intent, evaluating the effectiveness of recruitment strategies, and providing recommendations for improving the program (e.g. new mentors, changes in core requirements, changes in recruitment strategies, etc.)
Undergraduate Research Training Component (R90)
Expand the application for continuation to contain the following information:
A brief introductory description reiterating the program objectives and research training and education component (if applicable);
A summary table delineating which faculty, mentors, and Advisory Committee members have left the program and which, if any, new individuals have been added or are taking their places. Include for each person his/her degree and departmental affiliation (or equivalent);
Biographical sketches of new participating faculty, mentors, and Advisory Committee members;
Evaluation and tracking report of current and previous trainees;
A detailed account of experiences in recruiting individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide aggregated information on the racial/ethnic distribution of all applicants and those accepted and appointed. The aggregated report also should include information on individuals with disability and those from disadvantaged backgrounds. For those who were enrolled in the program, the report should include aggregated information about the duration of research training and whether those trainees completed their training in good standing.
Progress of individual trainees: A brief paragraph for each trainee describing the research and didactic training experiences completed and ongoing, as well as specific future plans for satisfying the requirements of the program;
Any recommended changes to improve the program (e.g. new faculty or mentors, changes in didactic components or programmatic activities, changes in core requirements, recruitment strategies, etc.).
Short-term Faculty Education Component (R90)
Briefly describe any courses or workshops that were developed and offered. In addition, list the faculty involved in the course and the course participants. Provide information about how course participants were selected and whether they received support from the program to attend the course. Provide information about the number of applicants, the number offered admission, the number attending, and their career level, gender and racial/ethnic background of participants, relative to the recruitment plan of the program. If any evaluations of courses or workshops were conducted, provide information about the outcomes. Describe any dissemination to the wider scientific community of any materials developed for this component.
Predoctoral and Postdoctoral Research Training Program (T90 and R90)
NRSA Institutional Predoctoral and/or Postdoctoral Training Components (T90) and
Non-NRSA Institutional Predoctoral and/or Postdoctoral Training Components (R90)
The NRSA instructions for the Non-Competing Grant Progress Report (Form 2590, starting on page 19) should be followed. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program. Information on each trainee should also be included in the narrative portion of the progress report as described in the PHS Form 2590 instructions. An evaluation and tracking report as described in Section VI.3. of this announcement should be included annually as part of the Progress Report. Additional information should be reported in concert with the PHS 2590 Progress Report instructions. This information is applicable to all trainees (NRSA and non-NRSA), except where noted below:
A brief introductory description of the predoctoral research training program objectives
Information describing mentor changes, if any, and mentors who have been added to the program; for new faculty or mentors, biographical sketches should be included in the application
A detailed account of experiences in recruiting individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide aggregated information on the racial/ethnic distribution of all applicants and those accepted and appointed. The aggregated report also should include information on individuals with disability and those from disadvantaged backgrounds. For those who were enrolled in the program, the report should include aggregated information about the duration of research training and whether those trainees completed their training in good standing.
Any recommended changes to improve the program for the continuation years
Trainee Reporting Requirements: The institution must submit a completed Statement of Appointment (PHS 2271) for each NRSA trainee appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. Additionally, a completed Payback Agreement Form (PHS 6031) must be submitted for each NRSA postdoctoral trainee in his or her first 12 months of NRSA support. No funds may be provided until this document is submitted and accepted by the funding Institute. Within 30 days of the end of the total support period for each trainee (NRSA and non-NRSA), the institution must submit a Termination Notice (PHS 416-7) to the NIH. Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.
Trainee Reporting Requirements (non-NRSA): The institution should provide information about each trainee appointed to the non-NRSA predoctoral and postdoctoral training component of the program in the form of an NIH Biosketch (PHS 398).
Evaluation and Tracking Report: Provide information annually collected under the evaluation and tracking plan proposed in the initial application. Information to be provided includes the number of students in each component of the overall program, tracking information for students who have completed the program, and evaluation and tracking information for the short-term faculty education component, if applicable.
Additional Reporting Requirements:
Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and reviewed.
Evaluation: In carrying out its stewardship of human resource-related programs, the NIH Roadmap 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 contacts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Program.
Publication and Sharing of Research Results: Trainees are encouraged to submit reports of their findings for publication in the journals of their choice. For each publication that results from a trainee’s research, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ______ which is part of the NIH Roadmap. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
Inventions: Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants.
Copyrights: Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.
Final Reports: A final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award. Note that an evaluation and tracking report is required as part of the Final Progress Report.
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
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:
Allison L. Chausmer, Ph.D. Division of Basic Neuroscience and Behavior Research National Institute on Drug Abuse 6001 Executive Blvd Suite 4282 MSC 9555 Bethesda, MD 20892 Telephone: (301) 402-5088 FAX: (301) 594-6043 Email: achausme@nida.nih.gov
2. Peer Review Contacts:
Norman S. Braveman, Ph.D. Assistant to the Director National Institute of Dental and Craniofacial Research
Building 31 Room 5B55
31 Center Drive Bethesda, MD 20892
Telephone (cellular): (301) 594-2089
FAX: (301) 480-0964 Email: Norman.Braveman@nih.gov
3. Financial or Grants Management Contacts:
Deborah S. Wertz Senior Grants Management Specialist Grants Management Branch/OPRM National Institute on Drug Abuse 6101 Executive Blvd Room 270, MSC 8403 Bethesda, MD 20892-8403 (If using overnight delivery, change city/zip to Rockville/20852) Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: DW80C@NIH.GOV
Human Subjects Protection: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy: NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
Standards for Privacy of Individually Identifiable Health Information: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Kirschstein-NRSA awards are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288), and Title 42 of the Code of Federal Regulations, Part 66. Awards for the Research Education Components are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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.
