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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)

Components of Participating Organizations
National Institute on Drug Abuse (NIDA) (http://www.drugabuse.gov)

Title: NIDA Mentored Clinical Scientists Development Program Award in Drug Abuse and Addiction (K12)

Announcement Type
This is a reissue of PAR-02-076, which was previously released March 11, 2002.

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications using those mechanisms electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html ). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-07-346

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release Date: March 30, 2007
Letters of Intent Receipt Date(s): A letter of intent is not required.
Application Submission Date(s): Standard receipt dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): Standard AIDS application receipt dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for details.
Peer Review Date(s): Standard review dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard Council review dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date(s): Standard dates apply. Please see: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: (Now Expired February 2, 2010 per NOT-DA-10-008), May 8, 2010

Due Dates for E.O. 12372

Not Applicable

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 of Support
2. Funds Available

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

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission Review and Anticipated Start Dates
1. Letter of Intent
B. 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

Purpose

The purpose of the NIDA Mentored Clinical Scientists Development Award in Drug Abuse and Addiction (K12) is to support intensive supervised research training and career development experiences for clinicians leading to research independence in the area of drug abuse and addiction. For the purpose of this announcement, institution is defined as an educational (academic) institution or a professional organization. Clinical research is defined in this FOA as: patient-oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials (see http://www.nih.gov/news/crp/97report/execsum.htm). Using this definition, clinical research areas of interest at NIDA in drug abuse and addiction include, but are not limited to: epidemiology; health services; prevention; treatment; clinical neurosciences; genetics; and medical consequences of drug abuse, including HIV/AIDS.

Under this award, newly-trained clinicians (referred to as scholars in this program announcement) will be selected and appointed to this program by the Program Director and grantee institution, with guidance from the required Advisory Committee. This institutional career development award program provides for 5 years of potentially renewable support. The award is intended to support scholars for 3-5 years of consecutive 12-month appointments. As long as the K12 has been renewed, individual scholars can be supported for up to a maximum of 5 years under this K12 program.

Research Objectives

Programs should provide for comprehensive career development and research training in research designs and methodologies in the area of drug abuse and addiction. Programs should include didactic training and supervised research experiences, designed to accommodate research candidates with varying levels of experience and at different stages of their career. For example, a prospective scholar with limited experience in a given field of research may find it appropriate to engage in a structured, phased developmental program, including a designated period of didactic training (Phase I) followed by a period of supervised research experience (Phase II). Prospective scholars with more experience may begin research activities as appropriate to their level of career development. With respect to varying levels of prior research training and career development, candidates, who will be referred to as scholars when appointed to the program, should resemble those candidates supported by the individual Mentored Clinical Scientist Development Award (K08) or the Mentored Patient-Oriented Career Development Award (K23).

Applications for this award should propose a career development and research plan that has: (1) intrinsic research importance in the area of drug abuse and addiction, (2) will serve as a suitable vehicle for learning the methodology, theories, and concepts needed for a well-trained independent clinician-researcher in the area of drug abuse and addiction; (3) will ensure high research productivity; and (4) is in an area of drug abuse and addiction research of high priority to NIDA. A research project should be proposed for each scholar. These must be designed to provide a strong foundation for applications for independent research funding. The candidate, mentors and sponsoring institution must develop a career development and training program that maximizes the use of available research, educational resources, and qualified research faculty as mentors. The entire program should be designed to rigorously monitor and provide well-defined policies and a structure to ensure progress towards independent funding and high research productivity for all mentored scholars. The plan must be designed to facilitate and expedite the scholar achieving independence in conducting drug abuse-related research funding during the period of the award.

Program Components

1. Program Director

The Program Director should be an established clinical-researchers in the area of drug abuse and addiction with a documented record of superior accomplishment, scientific expertise, leadership and administrative skills. (For a detailed description, see Section III.1B.)

2. Mentors

A primary mentor must be assigned for each scholar appointed to the program. (For a detailed description, see Section III.1B.)

3. Candidates

Once selected, candidates will be referred to as scholars for this program. (For a detailed description, see Section III.1B.)

4. Advisory Committee

An Advisory Committee consisting of a chair and four or more other members (no more than the corresponding number of scholars on the respective K12 program) appointed by the Program Director will be responsible for general oversight and evaluation of the Program. The chair of the Advisory Committee will be appointed by the Program Director. Advisory Committee members must be: (1) recognized as accomplished investigators in the area of drug abuse and addiction, (2) actively involved in drug abuse related basic or clinical research, (3) have a successful record of providing the type of training required under this award, and (4) have a successful record of engendering scholars independence as evidenced by scholars research productivity and their ability to obtain independent research funding. Members may be internal to the applicant s institution or external. Appointment of at least some external members is encouraged. Proposed external Advisory Committee members should not be specifically identified in the competing application because doing so limits availability of qualified peer reviewers not in conflict. However, the types of expertise expected for the Advisory Committee should be described. Advisory Committee members may not request compensation. One annual K12 Advisory Committee member meeting is required additional meetings throughout the year are highly encouraged. The K12 mechanism will support up to $1200 per Advisory Committee member to help defray travel costs to the required annual meeting, which may be requested in the budget. Supplemental duties that may be assigned to the Advisory Committee, at the discretion of the Program Director, include: establishing selection criteria for candidates; reviewing education and career development plans (e.g., formal coursework, mentors, and research experiences) and providing interim monitoring and evaluation of each scholar's progress with recommendations for modifications in the plan.

5. Short-term rotations [optional]

Short-term rotations are encouraged but not required. Short-term rotations should be designed to take advantage of drug abuse related educational or research experiences not available at the applicant institution. The proposed short-term rotations should complement other career development, research training and education occurring at the applicant institution. The proposed activities must be distinct from those otherwise available at the applicant institution. During their appointment, a scholar may undertake a one or more supervised short-term rotations at different institutions for a minimum of two months to a maximum of three months at a given institution during the specified award budget period. This must be based on the individual research scholar’s level of experience and documented need for the specific research training and career development activities. The short-term rotations options and overall plan proposed by the applicant institution for scholars must be designed to fall within the scope of the goals of the proposed K12 program and must be described in each scholar’s career development plan. In the proposal, the scholar should describe the purpose, goals and activities of each short-term rotation. They must present a clear justification that they will serve to gain knowledge and/or experience in areas that are not available at the site of the K12, but that will clearly complement his or her career goals. The proposal should also indicate how the program will evaluate the pertinence of each short-term rotation proposed by a scholar to their individual career goals, and also how success in meeting these goals will be monitored and measured. If the short-term rotation option is included in the proposed program, a Resource Format page (PHS 398) must be included in the application for each participating site.

6. Evaluation and Tracking

The application must describe a strong evaluation plan that includes a system for tracking each scholar appointee during the K12 award and for a period of 5 years (subject to annual reporting) following each scholar’s termination from this K12 program award. The evaluation component must include information on the career trajectories of the research scholars, including positions obtained, publications, and independent research grant submissions/awards. If short-term rotations are being proposed, then the program evaluation and tracking plan should include measures to evaluate the effectiveness of these short-term rotations.

7. Recruitment Plan

Applicants must describe a recruitment plan that includes a strategy for recruiting candidates both from inside and outside of their sponsoring institution. The application should describe a recruitment and outreach plan to increase the depth and diversity of the applicant pool, including those underrepresented in biomedical, behavioral, and clinical research. These individuals may include 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.

8. Research Environment/Institutional Commitment

The sponsoring institution should have a well-established record of success in developing independent clinical investigators, and assure protected time necessary for the scholars to complete the approved career development program. The applicant should also have a track record of collaborations inside the institution(s) proposed and may also have such a record with outside institutions. The sponsoring institution must be the primary site for the career development program and allow faculty to be mentors and provide the necessary facilities and other educational/training resources essential to carry out the program.

Other Background Information

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

Section II. Award Information

1. Mechanism of Support

This FOA will use the NIH Mentored Clinical Scientist Development Program Award or Institutional K12 award mechanism. Planning, direction and/or execution of the program will be the responsibility of the Program Director, with the advice of the Advisory Committee on behalf of the applicant institution. Awards are renewable.

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

2. Funds Available

Because the nature and scope of the proposed research 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 NIDA 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. Applications submitted in response to this K12 FOA will compete for available funds with all other NIDA recommended applications.

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.

1. Candidates/Scholars

NIDA provides a salary for K12 scholars of up to 100% of the individual’s institutional base annual salary, up to a maximum of $90,000 annually. Note that the salary allowance will be commensurate with the actual level of effort up to 100% (for details go to NIDA Policy Update for Mentored and Career Development Awards at http://grants.nih.gov/grants/guide/notice-files/NOT-DA-06-013.html

The total salary requested for each proposed candidate must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries 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.

For each appointed K12 scholar, NIDA will allow for funds up to $50,000 annually for research-related costs--examples include consultants, supplies, equipment, technical personnel, travel, and statistical services, and other program-related expenses. These costs must be justified as specifically required by the proposed program and must not duplicate items generally available at or through the grantee institution.

Short-term rotation costs are included in the allowed $50,000. However, costs allowed for the short-term rotation may not duplicate any costs/benefits allowed for the salaried scholars in the K12 program. These expenses must be specifically identified, reasonable, and justified. Expenses for foreign travel must be exceptionally well justified.

2. Personnel

The Program Director may request salary and fringe benefits appropriate for the percent of effort devoted to the program. Salaries requested may not exceed the levels commensurate with the institution’s policy for similar positions and may not exceed the congressionally mandated cap. Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant institution may be direct charges to the grant only when specifically identified, reasonable and justified. It is expected that the Program Director will devote not less than 10% and no more than 20% effort to this K12 program, and staff assistance (e.g., program/administrative assistant, program coordinator) up to a total of 100% combined effort. Mentors may not receive any salary support for effort; however, the applicant may request modest laboratory expenses directly attributable to the scholar’s research projects. Advisory Committee members also may not receive compensation; however, the applicant can request up to $1200 per Advisory Committee member to help defray travel costs for the required annual meeting set by the K12 Program Director.

3. Facilities and Administrative (F&A) Costs

F & A costs for the applicant institution and consortium participants (for short-term rotations) will be reimbursed at 8 percent of modified total direct costs, or at the actual F&A cost rate, whichever is less. See NOT-OD-05-004 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html).

4. Streamlined Noncompeting Application Process (SNAP)

Under this PA, the K12 grant is not subject to the Streamlined Noncompeting Application Process (SNAP). In general this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. While the K12 is subject to Expanded Authorities, the one exception to this is that carryover of funds from one fiscal year to the next must be approved by the NIDA Grants Administration staff (see INQUIRIES).

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply.

1. B. Eligible Individuals

Program Director

Any individual with the skills, knowledge, scientific expertise, and resources necessary to develop and implement the proposed institutional research career development program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The Program Director should be an established clinical-researcher in the area of drug abuse and addiction with a documented record of superior accomplishment, scientific expertise, leadership and administrative skills. The Program Director should have experience in the design, implementation and management of drug abuse related research training programs for developing clinical investigators, and must be able to demonstrate a superior record of preparation of post doctoral clinicians for independent research and high research productivity. The Program Director must be able to demonstrate access to departmental or other funds for a scholar in the event of a gap in his or her mentor’s research funding.

Mentors

Each scholar appointed to the program must have a primary mentor. All proposed mentors must be: (1) recognized as accomplished investigators in the area of drug abuse and addiction, (2) actively involved in drug abuse related clinical research, (3) have a successful record of providing the type of career development and training activities required under this award, and (4) have a successful record of engendering his or her scholars independence as evidenced by scholars research productivity and their ability to obtain independent research funding. Proposed mentors must have an NIH research grant (R01 or R01-like funding) or equivalent at the time of the K12 award and commit to mentoring of the individuals throughout their total period of development under the award.

Candidates

Note that once selected to the program, candidates will be referred to as scholars. The research experience of the candidates selected for support under this award should resemble those supported by the individual Mentored Clinical Scientist Development Award (K08) or the Mentored Patient-Oriented Career Development Award (K23). These FOAs can be viewed at http://grants.nih.gov/grants/guide/pa-files/PA-06-512.html and http://grants.nih.gov/grants/guide/pa-files/PA-05-143.html, respectively.

Candidates must be U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence, and who have earned a clinical or research doctorate, including Ph.D., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.N.S. or equivalent doctoral degree.

Candidates must be willing to commit at least 75 percent of their full-time professional effort (9 person months) to the program, with the remainder devoted to developing activities consonant with the objectives of the award. A candidate for the K12 award may not simultaneously submit or have an application pending for any other NIH career award (e.g., K01, K07, K08, K18, K22, K23, K24, K25, K99) or any PHS award that duplicates any of the provisions of the K12 award. Ineligible individuals include current and former principal investigators on NIH research project grants, comparable individual career development awards (e.g., K01, K07, K08, K22, K23, K24, K25, K99), equivalent non-PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.

K12 Scholars should be strongly encouraged to apply for independent research grant support (e.g., R01, R21, R03) during the award. K12 Scholars in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director. See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

K12 award candidates should also be aware that both during and following the K12, a K12 award recipient may not submit an application for any other mentored NIH career award (e.g., K01, K07, K08, K22, K23, K25, K99) or any PHS award that duplicates any of the provisions of the K12 award.

Institutional Eligibility and Commitment

The applicant institution must be the primary site for the Institutional Career Development program and should demonstrate a commitment to the Program’s goals, submitting with the application documentation of faculty, facilities and other resources that will be available on site to the program.

2. Cost Sharing or Matching

Not applicable.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Applications lacking an Advisory Committee (Section I for details), a recruitment plan, an evaluation and tracking plan, a plan for training in the responsible conduct or research, or a description of institutional commitment to the program and to the candidates will be considered incomplete and will not be reviewed. Applications proposing short-term rotations must also include a statement of institutional commitment to the program by the other institution where the short-term rotations will take place. A Resource Format page must be included in the PHS 398 application for each proposed short-term rotation site.

Award Termination

The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH will notify the grantee institution and career award program director in writing of this determination, the reasons therefore, the effective date, and the right of the program director to appeal the decision.

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: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the 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. 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.

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, please follow the modified instructions below in preparing an application for a NIDA Mentored Clinical Scientists Development Program Award in Drug Abuse and Addiction (K12):

1. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Program Announcement (PA) Number: PA-(Number Here), and check the YES box. The Program Director will be the Principal Investigator (PI) of the grant application.

2. Description/Performance Site(s)/Key personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. Information should be provided for the Program Director, Mentors, and internal Advisory Committee members participating in the Program. Proposed external Advisory Committee members should not be specifically identified in the competing application because doing so limits availability of qualified peer reviewers not in conflict. However, the types of expertise expected for the Advisory Committee should be described.

3. The application should be organized as per PHS 398 with specific additional information as detailed below (if questions arise when following this format, applicants should refer regularly to those sections of this announcement that delineate Other-Special Eligibility Criteria ):

Detailed Budget Page for Initial Budget Period: This should include any budget needed for the first year of the planned program.

Budget for Entire Proposed Period of Support.

Biographical Sketches in the standard NIH format for the Program Director, Mentors, and Consultants to, this Program.

Other Support for the Program Director, Mentors, and Consultants to this Program. Any changes in Other Support will be requested just prior to award.

Clinical Research Career Development Program (not to exceed 40 pages):

(1) Overall Aims

Applicant institutions should demonstrate their commitment to the Program's goals. Applications should include letters from appropriate institute officials addressing the following issues: (1) faculty, facilities and other drug abuse related research and educational resources that will be available to the Program; (2) statements about how the institution will integrate the proposed Program with its other drug abuse related clinical research activities and programs; (3) statements about how the institution encourages clinical research (e.g., promotion and tenure, etc.); (4) assurance of protected time for candidates (75%), mentors (up to 10%) and the Program Director (up to 20%); (5) plans to build upon the specific strengths of existing programs;(6) letter of intent to participate by key personnel not directly affiliated with the applicant institution; and (7) statements assuming responsibility for the continued tracking of the scholars career progression as described in the Evaluation and Tracking Plan. In addition, where Short-Term Research Rotations are proposed, applicants should describe how sites would coordinate activities, share resources, communicate and otherwise address logistical issues. Applicants should provide evidence of past collaborations both within the institution and with persons outside the institution. Publications and other evidence such as working on grants together are examples. In addition, applicants should describe plans as concretely as possible to further develop collaborations which will enhance the career training and developing research independence of their candidates/scholars.

The program should provide for the development or maintenance of strong and stable clinical research education opportunities. If this is a new application, any innovative aspects of the program must be appropriately identified. If it is a renewal application, aspects of the program must either be identified as inappropriate for change or appropriate for introducing innovative elements. If it is a renewal and some elements will not be changed, the applicant must provide an adequate case for not changing aspects of the program on the grounds that those elements are currently working well. If innovation is introduced, these elements are expected to be well organized and logically developed.

(2) Major Program Elements

The Program Director and mentors must be appropriately trained and supported in drug abuse and addiction research and well suited to carry out this program. The applicant must show that they have adequate access to research funding for the candidates. Demonstrate that an appropriate level of effort will be devoted by the program leadership to ensure the program’s objectives. The applicant must demonstrate that the Program Director and mentors have appropriate scientific expertise in the area of drug abuse and addiction with a documented record of superior accomplishment, leadership and administrative skills.

The application must demonstrate that the institution has a well-funded clinical research base, the infrastructure to support clinical research, and the facilities (e.g., inpatient and outpatient facilities, affiliate hospitals, etc.) and access to patient resources to expose candidates to patients. If other institutions are involved, each must provide written commitments of resources that they will provide to the Program and required information to be included on the Resource format page (PHS 398). The purpose of this award is to support an educational or professional institution in providing intensive supervised career development and research training experiences for clinicians leading to research independence. In a drug abuse related field of research. This NIDA announcement uses the following definition of clinical research as adopted by the NIH: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research.

An Advisory Committee consisting of a chair and four or more other members appointed by the Program Director will be responsible for general oversight and evaluation of the Program. The chair of the Advisory Committee will be appointed by the Program Director. Advisory Committee members must be: (1) recognized as accomplished investigators in the area of drug abuse and addiction, (2) actively involved in drug abuse related basic or clinical research, (3) have a successful record of providing the type of training required under this award, and (4) have a successful record of engendering scholars independence as evidenced by scholars research productivity and their ability to obtain independent research funding. Members may be internal to the applicant’s institution or external. Appointment of at least some external members is encouraged. Proposed external Advisory Committee members should not be specifically identified in the competing application because doing so limits availability of qualified peer reviewers not in conflict. However, the types of expertise expected for the Advisory Committee should be described. Advisory Committee members may not request compensation. One annual K12 Advisory Committee member meeting is required additional meetings throughout the year are highly encouraged. The K12 mechanism will support up to $1200 per external Advisory Committee member to help defray travel costs to the required annual meeting, which may be requested in the budget. Supplemental duties that may be assigned to the Advisory Committee, at the discretion of the Program Director, include: establishing selection criteria for candidates; reviewing education and career development plans (e.g., formal coursework, mentors, and research experiences) and providing interim monitoring and evaluation of each scholar's progress with recommendations for modifications in the plan.

While participating in the Program, preferably in the first and second years, each scholar should receive didactic training in clinical research trial design and methodology at the appropriate level for the scholar, biostatistics, bioethics, responsible conduct of research, and grantsmanship. The career development/research training program must be individualized, depending upon the level of experience of the individual. Selected scholars should be encouraged to attend national scientific meetings and present their research. Every candidate/scholar supported in this K12 award must receive instruction in the responsible conduct of research. (For more information on this provision, see http://grants2.nih.gov/training/responsibleconduct.htm. Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research. Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, candidate attendance, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided.

The mentored research project, designed by the candidate scholar, should be completed within the second or third year, and allow sufficient time for analyzing data, writing a manuscript, and planning additional research suitable for an R01, R03, R21 or similar grant application. The research project must be reviewed by the Program Director and Advisory Committee. This project must provide a suitable experience for the scholar to generate preliminary data, present preliminary results, and develop a grant application on the path to an independent research career. K12 award recipients are strongly encouraged to apply for a drug abuse related independent research grant support during the award. Each scholar’s activities must be reported on annually in the progress report.

(3) Candidate/Scholar Pool and Recruitment Plans

Applicants must submit a recruitment plan that includes a scheme for recruiting candidates from both outside and inside their sponsoring institution. The application should describe any recruitment and outreach plan to increase the depth and diversity of the applicant pool including those underrepresented in the current scientific research workforce. The application should also describe mechanisms to retain candidates in the institutional training program. If this is a competing continuation, the application should describe the past record of recruitment and retention, including success in meeting diversity goals as described below. 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.

(4) Short-term rotations [optional]

Short-term rotations should take good advantage of strengths of programs not available at the applicant institution. Short-term rotations should enhance the career development plan at the applicant institution and complement other clinical scientist research training and education. Plans for these short-term rotations should detail how the drug abuse related career development and research training of the individual scholar will be enhanced. Clearly show the purposes, goals, and activity plans and describe a procedure for monitoring them.

(5) Evaluation and Tracking

The application must describe a strong evaluation and tracking plan including the review of the effectiveness for all program components for which funding is being requested. If short-term rotations are being proposed, then the program evaluation and tracking plan should include measures to evaluate the effectiveness of these short-term rotations. The initial application as well as competing continuation applications must provide a prospective evaluation plan for process and outcome measures. Outcome measures regarding career progression and development by the scholar must include relevant positions obtained, current activities related to research, publication record, and the success rate of applying for and obtaining Federal and non-Federal research grant support. Detailed plans and procedures must be described for capturing, analyzing, and reporting outcome measures. The plan must include a system for tracking the scholars for a 5-year period following program completion to determine the relative success of the research training program. Program Directors are encouraged to develop plans to obtain feedback from all funded scholars to help identify weaknesses in the program and to encourage suggestions for program improvements. An evaluation and tracking report must be included annually as part of the Progress Report as well as part of competing applications and the Final Progress Report.

(6) Planning and Milestones

The applicant should develop a timetable for managing and monitoring the entire project as well as program progression. The use of a milestone chart is required. In addition, timelines should be developed for managing and monitoring individual candidate/scholars proposed. A general plan is acceptable for those candidates exclusively on short-term rotations. These short-term candidates can be described as a group or cohort. The applicant should show how short-term rotations, if used, will be incorporated into the overall program and the individual career development plan of proposed candidates/scholars. It is strongly advised that the applicant include a detailed publication plan as part of the milestone chart. This should give suggested titles, targeted journals, and targeted dates of publication.

(7) Training in the Responsible Conduct of Research

Applications must include a description of a program that will provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and 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, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

3. Submission Dates and Times

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

3.A. Submission, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for this FOA.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

3.C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

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).

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

NIDA support beyond the initial five-year project period is not guaranteed and is dependent upon the availability of appropriated funds and success in any competition for renewed support. In the event that there is no further support, no phase-out funds will be provided. Thus, the applicant institution must have plans in place to provide continued support to remaining scholars in the event that funding from the NIDA is not available.

6. Other Submission Requirements

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact NIDA program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from NIDA staff that NIDA will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the NIDA staff member who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

Plan for Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to NIDA on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

As part of the initial review, all applications will:

Grant applications should be characterized by scholarship and responsiveness to the NIDA mission in meeting the goal of increasing the number of scientists and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs. The reviewers will be asked to provide an overall assessment of the K12 program as an integrated effort as well as to evaluate the individual components of the program.

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed K12 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.

Significance: Does the proposed program address important drug abuse related scientific/education areas and/or topics?

Approach: Does the program provide for sufficiently comprehensive drug abuse related career development and training in research designs and methodologies, and clinical research experiences that will lead to scientific independence? Is the program in an area of high research priority for NIDA? Does the plan show good evidence of preparing candidates to address drug abuse related scientific research areas with intrinsic research importance? Does the plan include a suitable core curriculum and didactics? Does the program properly accommodate research candidates with varying levels of experience? Have adequate steps been taken to ensure high research productivity? Is the program well designed to rigorously monitor, evaluate and provide well-defined policies and a structure to ensure progress towards independent funding and high research productivity for all mentored candidates?

Investigators: Are the Program Director and mentors appropriately trained and supported in drug abuse and addiction research and well suited to carry out this program? Does the Program Director have a documented record of superior accomplishment, leadership and administrative skills? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program’s objectives? Have the Program Director and mentors adequately provided for access to research funding for the candidates? Is there a plan to access other funding in the event that there is a gap in the mentor’s research funding?

Candidates/Scholars: Will candidates be appropriately recruited and selected for support under this award? Is the program appropriate to their experience level? Is their level of effort appropriate? Is there good evidence to suggest that the scholars selected will proceed to research independence and exhibit a high level of research productivity? If this is a competing continuation, do previous K12 award recipients exhibit a high level of research productivity and commitment to drug abuse related research in their current positions, and are they on track for achieving research independence?

Advisory Committee: Are the proposed Advisory Committee chair and members appropriately selected and well suited to provide general oversight and evaluation of the drug abuse and addiction K12 program? Is the proposed mix of internal and external members appropriate to the program proposed? If external members have been included, are the types of expertise expected for the Advisory Committee adequately described and appropriate? Given that some members may be external and therefore cannot be identified, are there adequate assurances of the qualifications, expertise, and availability of proposed members to participate at an appropriate up to 10% level of effort?

Short-term rotations [optional]: Do short-term rotations take good advantage of strengths of programs not available at the applicant institution and do they enhance the career development plan at the applicant institution? Do they appropriately complement other clinical scientist research training and education in the area of drug abuse and addiction research occurring at the applicant institution? Are the short-term rotations within the overall scope of the proposed K12 program? Are they appropriate for the individual scholar and is adequate justification provided regarding how the short term rotation will enhance the drug abuse related career development and research training of the individual scholar? Do the short-term rotations proposed present clear purposes, attainable goals, and feasible activity plans? Do they have an emphasis on reaching the career goals of the scholars, and present clear and measurable indicators with which their success in achieving these goals can be monitored?

Evaluation and Tracking: Does the application describe a sufficiently strong evaluation plan that meets the evaluation and tracking objectives? If short-term rotations are being proposed, does it appropriately include measures to evaluate the effectiveness of these short-term rotations?

Research Environment/Institutional Commitment: Does the scientific/educational environment of the sponsoring institution contribute to the probability of success? Does the proposed program benefit from unique features of the scientific environment, unique subject populations, or employ useful collaborative arrangements, including interdepartmental interaction/collaboration? Is there strong, documented evidence of institutional commitment to clinical research training and particularly to this drug abuse related clinical career development/research training program? The sponsoring institution must be the primary site for the overall institutional career development program, however, if multiple sites are participating (e.g. for short-term rotations) is the institutional commitment to the proposed program appropriate in each case, and is this adequately justified in terms of the research educational experiences provided? Are adequate plans provided for coordination and communication between multiple sites? Is there evidence of adequate research support, equipment, and facilities? Is the information provided for each site adequate to determine appropriateness of the site?

Training Record: This criterion evaluates the past drug abuse related clinical research training record of the program, the Program Director, and the designated mentors. If a competing renewal, what is the success of former clinical candidates in seeking further career development and in establishing productive scientific careers? Evidence of a productive drug abuse related 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. What is the track record of success of the individuals proposed as Program Director, mentors, and Advisory Committee members in directing drug abuse related clinical research training? What is the potential of those mentors who lack a track record and are there appropriate measures proposed to assure their success?

Applicant Recruitment, Selection and Retention: What is the quality and size of the applicant pool? Are the recruiting procedures, candidate selection criteria, and retention strategies appropriate and well defined? Are the research aptitude and commitment to clinical research of applicants prominent in recruitment and selection? Is the racial and ethnic diversity of the applicant pool in keeping with the availability of individuals from underrepresented groups in the relevant scientific disciplines? Are other underrepresented groups such as individuals with disabilities and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds appropriately represented in the applicant pool? If this is a competing continuation, is the past record of retention of past scholars acceptable and does the placement and achievements of previous trainees demonstrate a commitment to clinical research?

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see 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 institutional career development program may be assessed by the reviewers. Is the percent effort listed for the PI/PD appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims, methods, and number of proposed scholars?

Training in the Responsible Conduct of Research: Does the proposal include a plan for every candidate to receive annual formal instruction in the responsible conduct of research? Are the plans adequate to insure adequate 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 subjects, tissues and other specimens? Have sufficient discussion of the relationship and the specific responsibilities of the institution and the candidates appointed to the program been planned. Do plans address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, candidate attendance, and the frequency of instruction? Have they provided an adequate rationale for the proposed plan of instruction? If it is a competing continuation, is there a report showing good progress in training in the responsible conduct of research per: the type of instruction provided, topics covered, and other relevant information, such as attendance by candidates and faculty participation?

2.C. Sharing Research Data

Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant 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://ott.od.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 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 data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans 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

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

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 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).

The following related administrative policies apply to NIH Research Career ( K ) programs:

Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.)

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K12 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Changes of Program: Awards are made for a specific program under the guidance and leadership of a particular Program Director. A change in any of these parameters requires prior approval by NIDA. 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 the Program Director is necessary, support of the award is not automatic but may be continued with prior written approval by NIDA, provided: The current Program Director or the grantee institution has submitted a written request for the change, countersigned by the appropriate institutional business official, to the program contact listed on the Notice of Grant Award describing the reasons for the change. The Biographical Sketch of the proposed Program Director, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new Program Director and that the new Program Director has the appropriate research and administrative expertise to lead the intensive supervised research training and career development experiences for clinicians leading to research independence. This request must be submitted in writing and sufficiently in advance of the requested effective date to allow the necessary time for review.

Transfer of Program: Neither the integrated career development/training program nor any component of the K12 program may be transferred from one institution to another.

Termination: When a grantee institution plans to terminate an award, the NIDA Grants Management Specialist listed on the NoA 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.

Carryover of Unobligated Balances: The carryover of funds from one budget period to the next requires prior written approval of NIDA. When required, such requests must include compelling justification including the status of candidate/scholar appointments to the program.

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. This K12 program is not subject to the Streamlined Non-competing Application Process (SNAP). In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report.

Scholar Reporting Requirements

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant. This Form must be completed at the beginning of the initial appointment and annually thereafter. No funds may be provided until this document is submitted and accepted by the funding Institute.

Progress Reports

An annual Progress Report for the grant is required, to include: A brief introductory description reiterating the program objectives and research training component; a summary table delineating which mentors and Advisory Committee members have left the program and which, if any, new individuals have been added or are taking their places, including for each person his/her degree and department affiliation (or equivalent); biographical sketches of new participating mentors and Advisory Committee members; an account of efforts to recruit candidates to the program, including efforts to recruit candidates that are described in the Diversity Recruitment and Retention Plan; a brief paragraph for each funded scholar 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 mentors, changes in didactic components or programmatic activities, changes in core requirements, recruitment strategies, short-term rotations, if applicable, etc.). Provide information on the progress of each scholar who has left the program for a period of 5 years following termination: including the positions obtained and publications; and (optional) independent research grant submissions and awards. If a short-term rotation is offered as a part of your program: provide information about how short-term rotation scholars were selected and their career level; briefly describe any courses or workshops and research experiences offered; and list the scholars and respective mentors involved. For each scholar, describe each short-term rotation taken, planned or completed in the past year. This description must include the purpose, goals and activities of the rotation, and for each rotation, an evaluation of the pertinence to the goals of the scholar and its success in meeting these goals. An evaluation of the scholar’s progress provided by the mentor where the short-term rotation takes place should be incorporated into the annual report. For all candidates who were enrolled in the program, the report should include aggregated information about the duration of career development activities and whether those candidates finished their training clinical scientist development program in good standing.

Additional information should be reported in concert with the PHS 2590 Progress Report instructions. Progress reports are submitted using Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/forms.htm

Evaluation and Tracking Report: The strong evaluation plan must include a system for tracking each appointee during the K12 award and for a period of 5 years (subject to annual reporting) following each appointee’s termination from this K12 program award. Provide information 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 research education component, if applicable. Each candidate s progress must be reported on annually.

Report on Training in the Responsible Conduct of Research: Report the type of instruction provided, topics covered, and other relevant information, such as attendance by candidates and faculty participation.

Additional Reporting Requirements

Progress of Individual Candidates/Scholars: Provide a brief paragraph for each selected scholar describing the research and didactic training experiences completed and ongoing, as well as the specific future plans for satisfying the requirements of the program. Provide a list of publications for each scholar resulting from their work in the program. Provide information on each scholar’s progression to research independence, including grant applications, and grant awards.

Mentors: Information should be included describing any mentors who have left the program or any who have been added. For new mentors, biographical sketches should be included in the application. Also include any recommended changes to improve the program for the continuation years.

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.

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.

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

Publication and Sharing of Research Results: Scholars are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from a scholar’s research, NIH support should be acknowledged by a footnote in language similar to the following: This project was supported by NIH grant number ______. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Human Embryonic Stem Cells (hESC): Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for clinical research training activities. The abstract of the application must provide the registry identifying numbers of the hESC lines to be used.

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 Contact:

Debra Grossman, M.A.
Behavioral and Integrative Treatment Branch
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Rm. 3153 MSC 9551
Bethesda, Maryland 20892-9551
Phone: (301) 443-0107
Fax: (301) 443-6814
E-mail: mailto:[email protected]

2. Peer Review Contact:

Teresa Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]

3. Financial or Grants Management Contact:

Carol Alderson
Deputy Grants Management Officer
Grants Management Branch/OM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard
Suite 270
Bethesda, MD 20892-8403
Telephone: (301) 594-5614
FAX: (301) 594-6849
Email: [email protected]

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 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; 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 career development award mechanisms. 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 can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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NIH Funding Opportunities and Notices


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