Part I Overview Information

Department of Health and Human Services

Issuing Organization
National Library of Medicine (NLM), (http://www.nlm.nih.gov)

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Library of Medicine (NLM), (http://www.nlm.nih.gov)

Title: Institutional Grants for Research Training in Biomedical Informatics (T15)

Announcement Type
This is a modification of RFA-LM-01-001 which was previously released March 29, 2001.

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

Request For Applications (RFA) Number: RFA-LM-06-001

Catalog of Federal Domestic Assistance Number(s)
93.879 Medical Library Assistance

Key Dates

Release Date: Januray 12, 2006
Technical Assistance Conference Call: January 26, 2006
Letters of Intent Receipt Date(s): February 17, 2006
Application Receipt Dates(s): March 17, 2006
Peer Review Date(s): May 24-26, 2006
Council Review Date(s): July 31, 2006 – August 18, 2006 (range)
Earliest Anticipated Start Date: July 1, 2007
Expiration Date: March 18, 2006

Due Dates for E.O. 12372
N/A

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Library of Medicine is inviting training grant applications in a single competition for support of pre-doctoral and post-doctoral training programs in biomedical informatics. Applications may be for the creation of entirely new training programs, for the purpose of adding NLM-supported trainees to existing training programs, or for the renewal of existing NLM training program grants. Such programs will help meet a growing need for investigators trained in biomedical computing and related fields as they directly relate to application domains including health care delivery, basic biomedical research, clinical and translational research, public health, and other areas. Informatics training is multi-disciplinary. Trainees will come to these programs with a range of educational and professional backgrounds and receive the training they need to prepare them for research careers in biomedical informatics.

Graduates of the NLM-supported programs should be able to conduct original basic or applied research at the intersection of computer, information and behavioral sciences with one or more application domains. Successful graduates of these programs will be prepared for research-oriented roles in academic institutions, not-for-profit research institutes, governmental and public health agencies, pharmaceutical and software companies, and health care organizations. This initiative is not intended to prepare trainees for careers emphasizing deployment, maintenance, or administration of computer systems in health care, public health, or research. The emphasis in this program is on the development of new knowledge that advances informatics as a field.

While there is no single formula for research training in biomedical informatics and no single preferred career path after training, all graduates of these programs should be formally trained in computer, information, and behavioral science as well as other relevant basic fields that comprise the methodological and conceptual foundations of informatics. The proposed training in these basic methods should be articulated as a “core curriculum”. Trainees should also acquire an appropriate depth of knowledge, as necessary, about one or more specific application domains. They should have experiences specifically designed to promote the integration of basic informatics methods and the relevant application domain(s). Beyond the core curriculum, trainees should have advanced training in those fields basic to informatics (computer, information, behavioral science and other fields) that prepares them for their research projects and their thesis or dissertation work. Throughout their training, they should have relevant, supervised research experiences of gradually increasing sophistication—culminating in an independent research project that may be a thesis or dissertation pursuant to an academic degree. Graduates of these programs are expected to be capable of carrying out independent research at a level of sophistication compatible with publication of results and competition for research grants and contracts.

The training offered by a program must lead to one or more of the following educational end-points, depending on the educational background of the trainee. The first end-point is pertinent to predoctoral trainees; the other two end-points are pertinent to postdoctoral trainees:

Applicants must propose training in informatics pertinent to one or more of the following specific application domains:

As long as they propose programs addressing one or more of the above domains, applicants may also include within their proposed program training in one or more of the following areas:

In addition, as described below in Section IV.2, applicants may propose training in specialized categorical tracks for research training of health science librarians and training in dental informatics.

The descriptions above are designed to portray generally the space spanned by each application domain, and should not be interpreted as imposing strict boundaries on these domains. Prospective applicants are encouraged to contact NLM if they have any questions as to whether their proposed training falls within the scope of this RFA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the T15 award mechanism. These awards are authorized by the Medical Library Assistance Act and are not a part of the National Research Service Awards Program (NRSA) of the Public Health Service. However, the policies and requirements of the NLM program are similar in many respects to NRSA awards.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The NLM intends to commit approximately 15 million dollars in FY 2007 to fund 16-20 new and/or competing continuation grants in response to this RFA. Participation by additional NIH Institutes and Centers (ICs) may increase the amount of funding for the program. Awards are normally made in 12-month increments with support for additional years based on satisfactory progress and the continued availability of funds. Awards--all with starting date of July 1, 2007 and termination date of June 30, 2012--will be announced in the fall of 2006. This RFA is not expected to be reissued prior to 2011.

Applicants must request a project period of five years. As described in Section IV.2 below, program budgets are primarily determined by the numbers and types of training positions requested. Single institution (non-consortial) applications may request NLM funding for a maximum of 18 full-time training positions, and a maximum of 4 short-term positions, in each year. Applications from consortia may request a maximum of 24 NLM-funded full-time training positions and 7 short-term positions. Applicants requesting positions for special training tracks described in Section IV.2 may exceed these limits to the extent of their requests for positions in these special tracks.

Because the nature and scope of the proposed training will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of NLM provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. NLM program staff will determine the number of training positions awarded to each applicant site, and reserves the authority to modify the number of positions awarded in any given year based on site performance and availability of funds. The number of slots awarded will depend upon a number of factors, including: faculty size, the amount of ongoing informatics research at the site in each application domain, the site’s previous recruiting experience, the experience of previous trainees, and other factors.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has all of the following characteristics:

To prepare trainees for research careers in demanding biomedical environments, the applicant institution must have, at the time of application, a strong established research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. Applications that require all entering trainees to have a single specific health professional background (e.g. physicians only, nurses only, or pharmacists only) will be considered outside the scope of this RFA.

Groups (or consortia) of health-related institutions are also eligible to apply. An application is considered consortial if it consists of multiple institutions, each of which will appoint a separately identified cohort of trainees. (If trainees appointed at a single institution take courses or conduct research at multiple institutions, by special arrangement with those institutions, this does NOT constitute a consortial program.) For a consortial application, a single, lead institution, naming a single principal investigator, must apply on behalf of the group. Letters of agreement defining each site’s roles and responsibilities must be provided in the application, as part of Section H of the application, and signed by authorized officials of each participating institution. The consortium must show evidence of active cooperation and integration of its component sites. Each site must be separately justified. (See Section IV.2) Based on reviewer recommendations, NLM program staff may elect not to fund training at one or more consortial sites within a funded application. When multiple sites are involved, the applicant institution must be the primary site of the training program, and the application must include a Resources Format Page (PHS 398) for each participating site.

Failure to meet an eligibility criterion by the time of an application deadline will result either in the return of the application without review; or in some cases, even though the application may be reviewed, failure to meet an eligibility criterion will preclude the NLM from making an award.

NLM encourages applications that include organizations with substantial numbers of students and faculty from populations currently underrepresented in informatics such as those from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his or her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The principal investigator will be responsible for the selection and appointment of trainees to receive NLM support and for the overall direction of the program. A principal investigator must, at the time of application, be a senior-level (at the rank of associate professor or higher), full-time faculty member at the applicant institution. The principal investigator should have an established history of funded research in biomedical informatics or a closely allied field (such as computer science, information science, or computational biology), as well as experience in training of researchers as demonstrated by numbers of trainees who studied under the PI and who themselves have undertaken successful research careers. A principal investigator should also have experience in the planning and management of graduate-level educational programs that emphasize preparation for research careers.

Trainees supported by NLM may be of three types: full-time predoctoral, full-time postdoctoral, and short-term predoctoral. Full-time is normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

Full-time Predoctoral Trainees.

Predoctoral trainees must have received, by the beginning date of their NLM appointment, a baccalaureate degree from an accredited domestic or foreign institution. With two specific exceptions, all predoctoral trainees must be enrolled as doctoral students in a program leading to a Ph.D. in informatics or an informatics-related research doctoral degree. Examples of informatics-related doctoral degree areas include computer science, information or library science, or a behavioral science with appropriate emphasis. Predoctoral trainees must be admitted to a doctoral program prior to the time that they receive a commitment of NLM support; admission to a masters program that could lead to future doctoral studies is not sufficient. (Note: The two exceptions to the requirement are specific to trainees who are enrolled in the specialized track for health sciences librarians, who may be supported for non-degree studies or studies leading to a masters degree; and to trainees who are matriculated in programs leading to doctoral-level health professional degrees, who may be supported for studies leading to a masters degree.)

Full-time Postdoctoral Trainees.

Postdoctoral trainees must have received, as of the beginning date of the NLM appointment, a Ph.D., M.D. or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.D.S., D.M.D., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr. P.H., D.N.Sc., D. Pharm., D.S.W., and Psy.D. In lieu of a diploma, completion of a doctoral program may be established through documentation by an authorized official of the degree-granting institution that all degree requirements have been met.

Short-Term Trainees.

Short-term trainees receive appointments of 2 or 3 months’ duration. To be eligible for short-term predoctoral research training positions, potential trainees must have demonstrated interest and potential to pursue a career in biomedical informatics. Students enrolled in baccalaureate or masters programs in relevant scientific fields (such as biology, computer science or library science) and students pursuing health professional or librarianship degrees are eligible for short-term appointments. Individuals matriculated in a formal research degree program, or those holding a research doctorate or masters degree or a combined health-professional/research doctorate are not eligible for short-term training positions. No individual may receive more than one NLM-sponsored short term appointment.

Positions on NLM institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees. Trainees enrolled in an integrated program that leads simultaneously to a Ph.D. and doctoral-level health professional degree may be supported with NLM funds during those years of study that are preponderantly dedicated to meeting the requirements of the Ph.D. degree. Similarly, postdoctoral trainees may not accept NLM support for studies that are part of residency training leading to certification in a medical or dental specialty or subspecialty, except when the residency program credits a period of full-time, postdoctoral research training toward board certification.

Trainees are required to pursue their research training on a full-time basis, devoting to the program at least 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Research trainees who are clinicians must undertake any patient care activities outside the scope and time commitment of their research training. Stipends payable to trainees through this program must carry no expectation of direct provision of patient care.

Appointments of full-time trainees are normally made in 12-month increments. No full-time trainee may be appointed for less than 9 months during the initial period of appointment, except with the prior approval of NLM. An NLM traineeship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NLM program.

Pre-doctoral and postdoctoral trainees seeking a doctoral degree in informatics or related fields may receive up to 4 years of NLM support. All other postdoctoral trainees—those in non-degree programs and those seeking masters degrees--are limited to 3 years of support. No trainee may receive more than 4 years of aggregate NLM support from any combination of NLM institutional training grants and individual fellowship awards. Predoctoral and postdoctoral appointments in any combination (but not short term appointments) count against this four year limit. NLM support is limited to two years for trainees in the specialized track for health sciences librarians who are pursuing masters degrees or who are in non-degree programs of study. A two year limit also applies to trainees in doctoral-level health professional training who are pursuing masters degrees in informatics.

To be appointed to a training position supported by an NLM research training grant, an individual must be a citizen or non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551)--or must be in possession, at the time of their appointment, of other governmental verification that permanent residency status has been attained. Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Applicants for permanent residency status, who, for whatever reason, have not received Card I-551, are not eligible.

2. Cost Sharing or Matching

N/A

3. Other-Special Eligibility Criteria

Institutions may submit no more than one application in response to this RFA. Multiple applications from a single metropolitan area are strongly discouraged. Institutions from a single metropolitan area are, accordingly, strongly encouraged to submit a consortial application. The applicant institution must be the primary site of the training program, and the application must include a Resources Format page (PHS 398) for each participating institution/organization.

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) 435-0714, 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.

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.

Applications should follow the format for Ruth L. Kirschstein National Research Service Award (NRSA) applications, as detailed in Section IV of the Instructions for Form PHS 398 (http://grants1.nih.gov/grants/funding/phs398/phs398.pdf). Certain elaborations on and modifications to the instructions in the NSRA application form, specific to this RFA, supersede the instructions in the NRSA application where applicable. These elaborations and modifications are detailed below. Applicants must therefore refer to both the NRSA application instructions and the instructions below when completing their applications. Where no superseding instructions appear below, applications should follow the NRSA instructions. The numbered sections and sub-sections below refer specifically to their counterparts in Section IV of the Instructions for Form PHS 398, beginning on Page 58.

The core of the applicant’s research training plan is presented in Section 8 of the application. Note that single-institution applicants are restricted to 25 pages in Section 8, exclusive of required tables. Consortial applications are allowed some additional pages, as detailed below.

4. Detailed Budget for Initial Budget Period

With reference to the Kirschstein-NRSA substitute budget page (http://grants.nih.gov/grants/funding/phs398/nrsafp4.doc), each program’s direct cost budget consists of four parts: 1) trainee stipends; 2) tuition, fees, and insurance; 3) trainee travel; 4) trainee related expenses.

As noted earlier, applications from a single site may request NLM funding for up to 18 full-time trainees and up to 4 short-term trainees per year (24 full-time and 7 short-term positions for consortial programs). As described below, programs should “right size” their requests based on their history of training and available resources. With appropriate justification, a program may request any combination of predoctoral and postdoctoral positions. Requests for trainee positions within specialized categorical tracks allow program requests to exceed the limits stated above.

The program budgets as submitted are estimates. Awards to each funded program will be based on the number of slots awarded to the program and the actual numbers and types of trainees the program recruits in each year.

Trainee Stipends: NLM training awards provide funds in the form of stipends to predoctoral and postdoctoral trainees, as well as short-term trainees. A stipend is provided 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.

Each funded site will receive a stipend allowance for each trainee as stipulated by NLM stipend schedules. For predoctoral trainees, the schedule is a sliding scale based on trainee backgrounds and number of full years of relevant experience at the time of appointment. (In FY2005, annual stipends for NLM-supported predoctoral trainees averaged about $28,000.) For postdoctoral trainees, the stipend schedule is based on the NRSA schedule and is determined by the number of full years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. (In FY2005, annual stipends for NLM-supported postdoctoral trainees averaged about $45,000.) The stipend for short-term trainees is prorated, based on the appropriate predoctoral stipend level. (Once the trainee’s annualized stipend level is established from the NLM scale, his/her stipend is 1/12 of that amount times the number of months of the actual appointment.)

Once a trainee is appointed, the stipend for each additional full year of NLM support is determined by the experience levels of the NLM scale. (For example, a trainee who enters with a Level 3 postdoctoral stipend receives a Level 4 stipend in his/her second year of training.) Receipt of masters degrees by predoctoral trainees who do not enter the program with masters degrees does not result in a stipend increase.

Since programs cannot know in advance what the actual stipend levels of their recruited trainees will be, applicants’ stipend budgets for the initial budget year will be estimated based on an inflation-adjusted average for all programs in FY2005. Programs must use the following per-trainee stipend estimates in their submitted budgets:

On the initial “budget period page”, list requested stipends in the appropriate areas. List stipends for short term trainees under “other”. If full-time predoctoral or postdoctoral positions in specialized categorical tracks are requested, itemize these separately from the “NLM-funded” positions in the predoctoral and postdoctoral stipend boxes.

Note on stipend supplements: The grantee institution may provide stipend supplements to help offset a trainee’s cost of living on the condition that such supplementation does not require from the trainee any specific additional responsibilities. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may Department of Health and Human Services (DHHS) funds be used for stipend supplementation.

An institution may also provide to a trainee additional compensation for services such as teaching, clinical care, 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, these additional compensated services should occur on a limited, part-time basis apart from the required normal full-time research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a grant supporting research that is part of the research training experience. Under no circumstances may the conditions of stipend supplementation or additional compensation interfere with, detract from, or prolong the trainee's approved training program.

A full description of the NIH policy regarding supplementation and compensation can be found in the NIH Grants Policy Statement at: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm

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.

Any intended stipend supplements or additional trainee compensation should not appear in budgets submitted in response to this RFA.

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 the tax liability of all individuals supported under the NLM supported training programs. 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 NLM training programs or awards. A NLM stipend is provided as a subsistence allowance for the NLM supported fellows and trainees to help defray living expenses during the research training experience. NLM training program recipients are not considered employees of the Federal government or the grantee institution for purposes of the award. We must note that NLM and the NIH take 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 is the domain of the IRS.

Tuition, Fees, and Health Insurance: NLM will award 100% of the combined annual costs of tuition, fees, and health insurance up to $3,000; and 60 percent of the combined costs above $3,000. In preparing their budgets, applicants should provide best estimates of these items based on the numbers of trainees they expect to recruit, and the tuition and fee schedules for programs of studies these trainees are expected to follow. The amount of funding each program receives will be adjusted based on recruitment experience.

NLM’s tuition reimbursement policy currently follows applicable NIH guidelines for NRSA awards. This policy is currently being revisited and may change during the lifetime of awards made through this RFA. The NIH will provide a notice in the NIH Guide informing grantees of changes applicable to their grants. NLM’s policy may change accordingly, should NIH’s policy change. Please see NIH Notice OD-05-059 dated August 2, 2005, located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html, which addressed the NIH Fiscal Year 2006 tuition policy.

NLM will allow costs associated with family health insurance for trainees who have families and are eligible for family health insurance coverage at the sponsoring institution. Self-only health insurance will continue to be an allowable cost for trainees without families. Applicants may include the cost of family health insurance, for a reasonable fraction of trainees, in their estimations of the combined cost of tuition, fees, and health insurance.

Trainee Travel: Sites should budget $2000 per full-time trainee to be used for relevant costs for trainee travel to the annual NLM training meeting and relevant professional meetings. After supporting travel to the NLM training meeting, funds remaining from this budget line may be used to support trainee travel to relevant professional meetings, at the program director’s discretion. The two-day NLM training meeting, held either at the National Library of Medicine in Bethesda or at one of NLM’s training sites, is a mandatory activity for all trainees appointed under a T15 NLM training award. No travel allowance should be budgeted for short-term trainees.

These travel budgets may also be used to support a research training experience away from the primary institution. Such experiences are acceptable as a complement to the course work, expertise, and experiences available at the parent institution. Letters requesting such training may be submitted to NLM at any time during the award period, and should explain the type of opportunities for training available, how these opportunities differ from those offered at the parent institution, and the relationship of the proposed experience to the trainee's career stage and goals.

Trainee-related expenses: NLM provides institutional costs of $6500 per year per full-time trainee to help defray the costs of other research training expenses, including faculty salaries, staff salaries, consultant costs, equipment, research supplies, and faculty travel.

Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request additional training-related expenses. Consultation with NLM program staff in advance of such requests is required. Unless an applicant receives advance permission to do so, no exceptional expenses should be included in a submitted budget.

For each short-term trainee, applicants may request trainee-related expenses of $200 per month to offset the cost of tuition, fees, health insurance, travel, supplies, and other expenses.

5. Budget for Entire Proposed Period of Support

Stipends, tuition/fees/insurance, travel and training related expenses should not be increased in future year budgets.

A facilities and administration allowance (indirect cost allowance) based on eight percent of total allowable direct costs may be requested. Allowable total direct costs are equal to the budgeted total of direct costs minus the budgeted total of tuition, fees, health insurance, and equipment.

All budget calculations and requests should be clearly explained in the budget justification. Consortial applicants should detail in their budget justification the numbers and types of positions being requested at each site.

6. Biographical Sketches

Include biographical sketches for the core faculty of the proposed program. Applications from individual sites may include up to 12 core faculty biosketches. Applications from consortial programs may include up to 6 core faculty biosketches per site. Brief descriptions of core faculty members whose biosketches are not included due to these limitations may be included in the “program faculty” section (Section 8.B.2) of the research training program plan.

8. Research Training Program Plan

Training plans, with accompanying tables, should be described in this section by following the NRSA application guidelines, as modified or supplemented by the instructions below. The NRSA application instructions stipulate several required tables; the instructions below request modifications and/or simplifications of several of these tables. NLM’s required contents of each table are summarized at the end of this section of this RFA.

Applicants for single institution programs must observe the 25-page limit on this narrative section, exclusive of required tables. Consortial applications may use, for this section, three additional pages for each site beyond the home institution. (So, for example, a consortium with four sites is allowed up to nine additional pages: three pages each for the three additional sites.) These additional pages are to be used for describing the faculty and resources at each site and explaining its role in the consortium. Consortial applicants should organize their descriptions in a way that allows reviewers to make a separate evaluation of the training at each site, including numbers and types of training slots requested for each site, as well as an evaluation of the consortium as a whole.

Background: In addition to the material requested in the NRSA instructions, applicants should clearly describe the educational program(s) that will be home to the NLM-supported trainees. All applicants should provide an estimate, over the period of requested funding (2007-2012), of the fraction of all trainees in these program(s) who will be supported by the positions requested in this application.

In this section, the information provided in Table 1 should be limited to the unit(s) that directly sponsor the proposed training. For example, in programs that propose to offer academic degrees, the table should be limited to the department(s) or division(s) from which students in the program will routinely obtain degrees. Table 2 should list the other training grants currently supporting trainees who are directly supervised by the program’s core faculty members listed in Section B.2.

B.1 Program Administration: In addition to the material requested in the NRSA instructions, each application must describe in detail the organizational entity in which the program will be based. This may be a department, center, division, institute, or other organization as appropriate. If the home organization for the program is not authorized to confer academic degrees and the proposed training is to be degree-granting, the application should contain appropriate certifications from the leadership of the degree-granting unit(s) to the effect that the proposed curricula have been approved to enable students to earn the stipulated academic degrees. Applicants should not predicate their training plans on any degree-granting programs that are pending approval at the time of submission.

B.2 Program Faculty: Each program must list separately a core faculty and any additional faculty members who will directly support the program as teachers of important courses or advisors to trainees. If the biosketches of some core faculty members were not included in Section 6 due to space limitations, brief descriptions of the additional core faculty members may be included here. However, include in Table 3 only the research grant and contract support of faculty whose biosketches are included in Section 6. In Table 4, include the trainees of only those faculty for whom biosketches are provided. Trainees should be listed in Table 4 if and only if the faculty member was the trainee’s thesis advisor or primary research supervisor in the case of a non-degree trainee. (No student should appear twice in this table.) Include all students currently in training and those who completed training after March, 1996.

B.3 Proposed Training: Acceptable applications must be clearly designed such that the primary intent of the program is preparation for careers in informatics research.

Applicants must specify which of the specific end-points (see Section I.1) apply to their proposed programs and consequently, which categories of trainees they will seek to recruit.

Applicants must also, in this section, specify the application domain(s) of informatics that will be addressed by their training program, with specific reference to the following list introduced in Section I.1. Applicant programs must emphasize at least one of the areas in the top four items of this list.

Applicants may describe their proposed training domain-by-domain, or they may describe an overall program that spans domains and then specify how training in each domain varies the general theme. All proposed training descriptions must include details regarding:

For degree-granting programs, tables specifying the proposed programs of studies are highly recommended. Applicants are also encouraged to describe experiences that seek to integrate informatics methods and the application domain, including details about how these experiences will be structured. For all courses listed as part of the program that are not under the direct control of the principal investigator’s home academic unit (e.g. his/her home department), applicants must document through appropriate letters that their trainees will have routine access to these courses.

The application must specify a core curriculum addressing informatics concepts and methods that supports the entire program, spanning all application domains that are addressed. While the proposed core curriculum may include variations that customize it to specific domains, the preponderance of courses and other educational elements comprising the core must apply to all application domains. The description of the core curriculum should include details about all component courses and other experiences, including the specific goals and objectives of each component.

Requests for numbers of trainees in each year should be justified based on faculty size and availability, space, other program resources, and, for programs filing continuation applications, their recent recruitment experience. Programs are strongly encouraged to “right size” their requests based on these resources. A program may request any combination of predoctoral and postdoctoral positions, but their allocation of slots to predoctoral and postdoctoral levels should be carefully explained and justified in relation to program structure and priorities.

B. 5 Trainee candidates: All applicants must describe in detail their plans to recruit highly-qualified trainees of the type and number they are requesting. They should describe pre-requisites that all applicants must possess. Tables 5-7 should address the same departments/units as Table 1. In Table 6, applicants may provide aggregate data rather than anonymized lists of applicants. Provide numbers of applicants for each department, their average GPA and GRE scores, a list of the most prevalent previous institutions, the fractions of applicants who were admitted and matriculated, and the fraction who were U.S. citizens or permanent residents.

All NLM-supported programs must advertise and recruit nationally for both predoctoral and postdoctoral trainees. While they may recruit into NLM-supported positions students already matriculated at their own institutions, they cannot restrict access to NLM-funded positions to such students unless required to do so by institutional policy. (For example, if all graduate students who might later study informatics are required to enter a generic first year of graduate studies before they can specialize into the relevant informatics curriculum, recruitment for NLM-supported positions can be limited to students in the generic first year program. In this case, programs would still be required to advertise their informatics program nationally, so that potential trainees outside the institution would know that the informatics option exists following the generic first year.)

C. 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. While applicants may base their plans on multi-disciplinary diversity programs in place at their institutions, they must also indicate how the informatics programs will participate in these recruitment activities, and how these activities will meet the needs of potential applicants with interests in informatics. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

D. Responsible Conduct of Research: Applicants may base their plans in part on generic programs that are offered at their institutions, but they must also indicate how the proposed program addresses ethical and compliance issues that are emphasized in biomedical informatics research (e.g. confidentiality of personal genetic information and medical records).

E. Progress Report: For programs currently funded by NLM, construct your progress report as described in the NRSA application instructions, with the modifications described below. The progress report does not count against the page limit.

Table 9 should be expanded to include, for each year, both the total number of complete applications to the biomedical informatics program, and the subset of these complete applications filed individuals who were eligible for NLM funding at the time they applied. Include in Table 9 only those applicants who, based on some objective criterion or justified estimate, had interest specifically in studying biomedical informatics. For example, if the computer science department is the organizational home of the informatics program, do not represent all applicants to the computer science department’s graduate program as applicants to the informatics program.

Table 10 should be expanded to include the publications of NLM-supported trainees that resulted directly from the research performed during their training. Include in this table only peer-reviewed papers or abstracts in journals or proceedings. List only publications that were published or in press at the time of submission.

Applicants should present data collected via any program evaluations that were conducted, and the changes that were implemented as a result.

Sites receiving supplemental funding for public health informatics through the NLM-Robert Wood Johnson initiative should include a section that describes their progress in implementing this program.

Summary of Required Tables

All applications:

Table 1: Number of faculty in the unit(s) that directly sponsor the proposed training, and total of all pre- and postdoctoral students in those units.

Table 2: Training grants currently supporting trainees who are directly supervised by the program’s core faculty members.

Table 3: Active and pending grants and contracts for faculty whose biosketches are included in Section 6.

Table 4: Past and current students of program faculty for whom biosketches are provided.

Table 5: For the same units as listed in Table 1, numbers of trainees who applied, were offered admission, entered training, completed training, and left the program.

Table 6: For the same units as listed in Table 1, credentials of predoctoral applicants in aggregate form.

Table 7: For the same units as listed in Table 1, credentials and outcome for most recent postdoctoral applicants: individual applicants listed anonymously.

Table 8: Recruitment information.

Continuation applications only:

Table 9: Year-by-year report of number of appointees, level, months appointed, empty slots—including the numbers of completed applications to the informatics program.

Table 10: Report of all trainees who were/are supported for the past 10 years with source of support, mentor, current positions, and other items as detailed in NRSA instructions as well as a list of trainees’ peer-reviewed publications.

Specialized Training Tracks

The specialized tracks are described in detail below. Applicants interested in providing training in one or more of these tracks, as an option within their general program, should describe in Section 8.B.3 their proposed programs of study and related educational plans for each special track their program seeks to include. In Sections 8.B.1 and 8.B.2 they should describe organizational and faculty resources supporting the special track. To the extent that programs request positions for these special training tracks, they may exceed the maximums of 18 full-time slots (single site) and 24 full-time slots (consortial programs).

Research Training of Health Science Librarians: Programs may request up to two predoctoral training slots specifically for graduates of ALA-approved masters programs in library/information science. The purpose of this track is to prepare librarians to participate in informatics research or to conduct informatics research. Trainees appointed to this track must be enrolled in a masters degree program or doctoral program in informatics or related field, or, under exceptional circumstances, they may be enrolled in a non-degree program that clearly emphasizes preparation for a career emphasizing research. It is important to emphasize that these slots are not intended to train generically prepared librarians for careers in health science libraries, unless these careers specifically emphasize informatics research. A trainee pursuing a masters degree or in a non-degree program within this track may receive up to two years of NLM support.

Dental Informatics: The objective of this effort is to develop highly qualified investigators committed to research careers in oral health informatics, which integrates and applies the computer, information, and cognitive sciences to oral health and disease. The National Institute of Dental and Craniofacial Research (NIDCR) plans to support up to three trainees per year, at NLM-funded sites, to pursue training in dental informatics. These training positions will be distributed among one or more sites proposing dental informatics tracks, based on assessment of the relevance and quality of the proposed educational program. Trainees can be individuals with a D.D.S., D.M.D., M.D., or equivalent degree, or pre- and post-Ph.D. It is essential that research training activities specifically apply informatics to areas pursued by the NIDCR. These include: (1) the etiology, epidemiology, pathogenesis, prevention, diagnosis and treatment of dental caries, periodontal and oral soft tissue diseases, oral cancer, oral manifestations of AIDS and HIV infection, salivary gland conditions, craniofacial anomalies, orofacial pain, and temporomandibular disorders; (2) the molecular and cellular study of the development, structure and function of teeth, jaws, oral mucosa, bone, connective tissue, and salivary glands; (3) behavioral, social, cultural, economic, and health care delivery issues related to oral health and disease; (4) biomaterials, dental implants, biometics, and tissue engineering; (5) fluoride and nutrition; and (6) oral conditions prevalent among older Americans, a particular gender, minorities, people with particular systemic diseases, and other individuals and groups at high risk for oral health problems. For more detail regarding NIDCR’s scientific priorities, applicants are directed to the NIDCR strategic plan at http://www.nidcr.nih.gov/AboutNIDCR/Strategicplan/default.htm. Programs proposing dental informatics tracks may exceed by up to three slots per year the 18/24 limit on full-time training positions.

Other Application Instructions

URLs in 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.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 17, 2006

Application Receipt Date(s): March 17, 2006
Peer Review Date(s): May 24-26, 2006
Council Review Date(s): July 31, 2006 – August 18, 2006 (range)
Earliest Anticipated Start Date: July 1, 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent (by standard mail or fax) to:

Arthur Petrosian, Ph.D.
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4253
FAX: (301) 402-2592
Email: petrosia@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Arthur Petrosian, Ph.D.
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4253
FAX: (301) 402-2592
Email: petrosia@mail.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 be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Library of Medicine. Incomplete and 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

No stipend or other allowance may be paid until the appointment form has been submitted to the NLM; and therefore, pre-award costs authority is unallowable. The NLM will only allow pre-award cost authority up to 90 days prior to the start date, for travel expenses associated with the NLM Annual Training Meeting. Pre-award cost authority for travel is granted for the purposes of accounting flexibility as the date of the training meeting is during a period of transition between budget periods. Travel costs related to the annual meeting can be charged as pre-award costs to the upcoming budget period, or as unliquidated costs to the previous budget period, depending upon the organization’s accounting system.

Applicants responding to this RFA are not required to make a special request to NLM for permission to submit a grant with direct costs exceeding $500,000 per year.

6. Other Submission Requirements

All PIs and trainees will be required to attend the NLM training meeting held each summer. Travel budgets for trainees include funding to attend this meeting.

Plan for Sharing Research Data

A data sharing plan is not required for and is not a review factor for this training program.

Sharing Research Resources

A plan for sharing research resources is not required for and is not a review factor for this training program.

Section V. Application Review Information


1. Criteria

The following will be considered in making funding decisions:

In addition to the above, funding decisions will be directed in part by geographic distribution and NLM’s priorities for distributing training opportunities across informatics domains.

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 NLM in accordance with the review criteria stated below.

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

Following the selection of the sites to be funded, the NLM will allocate specific numbers of NLM-supported training positions to each funded program. The ICs sponsoring special tracks in the program will be consulted regarding the awarding of specialized track positions to those sites requesting them.

For consortial applications that are selected for funding, separate decisions will be made to fund or not fund each proposed site within the consortium.

The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. For this specific funding opportunity, these individuals must be highly trained in computational and information science methods, specific application domains, with cross-training in both directions between methods and domains. Each of the review criteria below will be addressed and considered in assigning an application’s overall score, weighting them as appropriate to each application:

2.A. Additional Review Criteria:

For existing programs proposing renewal:

For consortial applications:

Support of training slots in special tracks will be based on the Initial Review Group's recommendation as well as a review by NLM staff and NIH staff representing the Institute or Center sponsoring the track.

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant’s plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plans will be discussed after the overall determination of merit, and the review panel’s evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plans will be described in an administrative note in the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component, will determine whether amended plans are acceptable.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversity the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NIH awarding component, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

A data sharing plan is not required for or a review factor for this training program.

2.D. Sharing Research Resources

A plan for sharing research resources is not required for or a review factor for this training program.

3. Anticipated Announcement and Award Dates

NLM expects to announce awards in the fall of 2006. In this way, funded programs will have the opportunity to recruit trainees to begin training in the 2007-2008 academic year, with trainee appointments to begin as early as July 1, 2007. This timing will also provide sufficient advance notice to enable any currently-funded programs to suspend recruitment in the event they are not refunded. Because of the panel that will be convened to allocate numbers of NLM-supported training slots and the need for ICs to participate in awarding specialized training slots, it is likely that sites will be notified of their allocated number of training slots some time after they receive the general notification that they will be funded.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 12 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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

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.

Note that 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.

Expand the application for continuation to contain the following information:

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:

Charles P. Friedman, Ph.D.
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 594-4927
FAX: (301) 402-2592
Email: friedmanc@mail.nih.gov

2. Peer Review Contacts:

Arthur Petrosian, Ph.D.
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4253
FAX: (301) 402-2592
Email: petrosia@mail.nih.gov

3. Financial or Grants Management Contacts:

Dwight Mowery
Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301
Bethesda, MD 20892
Telephone: (301) 496-4222
FAX: (301) 402-2592
Email: moweryd@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (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.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 64 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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