Department of Health and Human Services
Title: The NEI Mentored Clinical Scientist Development Program Award (K12)
This Funding Opportunity Announcement (FOA) is a reissue of PAR-03-068.
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. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ().
Program Announcement (PA) Number: PAR-09-083
Catalog of Federal Domestic Assistance Number(s)
Release/Posted Date: January 22, 2009
Opening Date: May 13, 2009
Letters of Intent Receipt Date: Not Applicable
Application Due Date(s): May 13, 2009, May 13, 2010, and May 13, 2011
Peer Review Date(s): Oct/Nov 2009, 2010, and 2011
Council Review Date(s): January 2010, January 2011, and January 2012
Earliest Anticipated Start Date(s): April 2010, April 2011, and April 2012
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: (Now Expired March 24, 2010 per NOT-OD-10-069), May 14, 2011
Due Dates for E.O. 12372
Additional Overview Content
The goal of this Funding Opportunity Announcement is to support the development of a diverse pool of highly trained clinician scientists and patient oriented investigators in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs in vision research.
Table of Contents
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
Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
V. Application Review Information
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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
1. Research Objectives
Purpose: The NEI Mentored Clinician Scientist Development Award (K12) is an award to an educational institution or professional organization to facilitate and support career development experiences which lead clinician scientists to research independence. It is expected that scholars appointed to the program will subsequently apply for their own individual research support.
Program Objectives: The program should be designed to accommodate candidates with varying levels of research experience who require an individualized career development program ranging from two to five years. Applications for this award should propose a structured, phased development plan overseen by a Program Director and a Program Advisory Committee. A designated period of didactic training should be followed by a period of supervised research experience. Candidates should be exposed to both research that is typically undertaken with a few investigators and to research approaches that require a multidisciplinary team to address complex research questions as appropriate. It is expected that at the end of the career development period, appointees will transition successfully into positions as independent investigators.
This award provides five years of potentially renewable support. The subsequent continuation will depend in part on the progress made by the Scholars in achieving independent research support. Renewal applications must contain a progress report documenting the accomplishments and current career activities of former Scholars.
1. Program Director/Principal Investigator (PD/PI): The proposed PD/PI should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary career development program relevant to vision research. The Program Director should also be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of scientists for independent research careers (see Section III. 1B).
2. Program Advisory Committee: A committee with representatives from the appropriate academic and or clinical departments should be established to advise the Program Director and to monitor the progress of participants. Committee composition, responsibilities, frequency of meetings, and other relevant information should be included in the application. An annual evaluation of the program by the Program Advisory Committee is recommended. This on-going evaluation should include an assessment of the curriculum, active mentors, and program staff; general recruitment and retention goals, including a plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women; completion success; and overall outcome.
3. Mentors: The application should identify mentors capable of guiding the research candidates admitted to the program. Each candidate appointed in the program must have a primary mentor who is recognized as an accomplished investigator, is actively involved in basic or clinical research, and has a successful record of providing the type of training required under this award. This Lead Mentor must be committed to continue this involvement throughout the candidate's total period of development under this award. The Lead Mentor will assist the appointee in developing an individualized career plan based on the candidate's research experience. For example, a candidate with limited research experience would require a structured, phased developmental program, including a block of time devoted to didactic training followed by a period of mentored research. Because a critically important aspect of the training should include mentoring in grant writing, and because Scholars are expected to apply for independent grants, the Lead Mentor should also have a strong track record in obtaining NIH funding for research. If the Lead Mentor’s research funds come primarily from outside the NIH system, Scholars should have a co-mentor with a strong history of NIH support..
4. Scholar Candidates: Appointees must hold a clinical doctorate (such as DO, DVM, MD, MD/PhD, OD, or PhD) and must have completed their clinical training (i.e., completed residency/fellowship and are board-eligible). At least 75% of the candidate's full-time professional effort must be devoted to the program, with the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. The recruitment and retention of underrepresented minorities, individuals with disabilities, and women into the program should be a continuing program goal.
5. Recruitment Plan: Applicants should include a plan describing selection procedures for recruiting the best possible Scholars. These plans must include recruiting efforts to enhance diversity.
6. Evaluation and Tracking: A process of evaluating and tracking of each Scholar’s progress must be established and should be described. Programs are encouraged to track applicants after they have left the program and obtain information from program graduates that could be used to improve the program.
7. Research Environment/Institutional Commitment: Beyond the research activities described in the Research Plan, the institution must describe current and future resources that are or will be used to encourage research by junior faculty and facilitate development of their research careers. It should document equipment, facilities, and resources that will be made available to Scholar candidates (See Resource Format Page in PHS 398). In addition, for candidates described in the application and for future appointments to the K12 program, the institution must submit the institutional commitment agreement to support the candidate as described in the PHS 398 form, with signatures as described in that section. For candidates named in the application, the form must be included with the application. It is not part of the 25-page limit for the Research Plan components.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding opportunity announcement (FOA) will use the NIH K12 Mentored Clinical Scientist Development Program Award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see ). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
2. Funds Available
The total annual direct costs requested may not exceed $1,125,000, for up to five years of support.
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 the NEI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
2.A. Allowable Costs
Allowable costs must be consistent with NIH policy and must 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.
PD/PI: Salary support for up to 5% effort for the Program Director may be provided.
Candidates/Scholars: Clinician research candidates may be provided salary support plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. It should be noted that the NEI does not impose any salary restriction beyond that imposed legislatively. The institution may supplement the NEI contribution; however, supplementation may not be from Public Health Service funds. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary required must be based on a full-time, 12 month staff appointment for at least 75% effort.
Up to $30,000 per candidate may be requested for the following types of expenses: research supplies, equipment, and technical personnel; tuition, fees, and books related to didactic courses or career development; travel to research meetings or training; and statistical services including personnel and computer time. These costs must be specifically documented for each proposed candidate and must be specifically and directly related to the candidate's research activities and individualized career development program. Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees.
Ancillary Personnel Support: Salary for mentors, secretaries, and administrative staff is not allowed.
Indirect Costs: These costs also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs.
NIH Grants Policy: NIH grants policies
as described in the NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. Applicant institutions may submit only one application.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016
Renewals. Applicants may submit a renewal application.
Scholar candidates appointed to the proposed program must be U.S. citizens, non-citizen nationals, or permanent residents. Individuals who were former Principal Investigators (PI) on NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) are eligible. However, former PIs on NIH individual career development awards (K08, K23, K24); research project grants (R01,); or subprojects on Program Project Grants (P01), center grants and their equivalent, and cooperative clinical trials are not eligible. Candidates who have been supported on NIH or non-NIH career development awards dedicated to training clinician scientists and patient-oriented researchers are not eligible. Candidates may not have more than five years of research training experience beyond their last doctoral degree nor have held a tenure track position for more than four years.
Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review and Anticipated Start Dates
Application Receipt Date(s): May 13, 2009, May 13, 2010, May 13, 2011
Peer Review Date(s): Oct/Nov 2009, Oct/Nov 2010, Oct/Nov 2011
Council Review Date(s): January 2010, January 2011, January 2012
Earliest Anticipated Start Date(s): April 2010, April 2011, April 2012
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
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 three
signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix materials must be sent to:
Samuel C Rawlings, PhD
Chief, Scientific Review Officer, NEI/NIH
635 Fishers Lane, MSC9300 Suite 1300
Building Number, Room Number
Bethesda, MD 20892
Telephone: (301) 451-2020
3.C. Application Processing
Applications must be received on or before the application receipt dates described above (Section IV.3.A.). If an application is received after that date, it will not be reviewed.
Upon receipt applications will be evaluated for completeness by 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 review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
Information on the status of an application should be checked by the PD/PI 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.
Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)
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 the NEI Mentored Clinician Scientist Development Program Award (K12). The application should be organized as per PHS 398 instructions, with specific additional information as detailed below.
2. Form Page 2: 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 Description of the application must provide the registry identifying numbers of the hESC lines to be used. Key Personnel, include the Program Director/Principal Investigator, members of the Program Advisory committee, and all other individuals contributing substantively to the mentoring activities. Do not include the candidates.
3. Career Development Program
The application should describe the overall theme of the program, the particular career development activities planned for Scholar Candidates, and the expected outcomes for candidates.,It should document the experience of the PD/PI and other faculty as mentors, including information on the career outcomes of former Scholars. It should include a clear commitment of staff time. Course offerings should be relevant to diverse areas of clinical and patient-oriented vision research and should provide opportunities in more than one discipline (e.g., genetics, neuroscience, biostatistics, psychology, bioethics, and epidemiology). Particular developmental activities mentioned such as seminars, scientific meetings, training in responsible conduct of research, and presentations should be linked to the overall theme and goals of the program. Opportunities to learn how to communicate research results and develop coherent research applications that are essential to future success in an independent research career should be provided. Skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, drug development, etc., are indispensable to a research program and therefore candidates must be provided the opportunity to participate in such activities.
This section should explicitly identify the advantages to this site of a program-based career development award as opposed to, or in addition to creating environments supportive of individual efforts by junior faculty to obtain career development and similar awards.
4. Research Activities
In all cases, the candidates must participate in an intensive research experience under the guidance of qualified mentors distinguished in vision research. The relationship should optimize the opportunity for interdisciplinary communication and collaboration. Applicants should describe the funded research activities of the mentoring team. The description should include an account of how the ongoing research offers opportunities for Scholar candidates to develop research ideas and strategies and offer ways for them to combine methods or concepts from different funded projects that will further their own research careers. The research plan should show how the ongoing research exemplifies the theme of the program and offers the Scholar candidates ways to establish research consonant with that theme.
The research plan should detail how individual candidates’ research experiences will be/have been solicited and evaluated prior to initiation. Competing continuation and supplemental applications should use this section to provide a progress report on the current funded activities. The aims of the current award should be briefly summarized. Significant accomplishments of current and past candidates should be described, including present appointment, past faculty positions, and grant funding. Published work relevant to their training should be summarized. Emphasis should be placed on how the program aspects of the K12 have facilitated or are facilitating the progress of the candidates.
Applications should describe the qualifications and research plans for at least one candidate. The individual description should be no more than three pages and should include: (1) a statement of Hypothesis and Specific Aims, (2) Background, Significance, and Rationale, and (3) Research Design and Methods. No preliminary data is expected in this description. Literature citations are not a part of the 3-page limit. Supporting material (not part of the page limit) should include a description of how the individual plans relate to both the K12 program and to the career objectives of the candidate. They should describe the particular mentors and mentoring resources that will be assigned to the candidate during this project. A similar report for subsequent Scholar candidates once the grant has been awarded will be administratively reviewed by NEI.
5. Program Advisory Committee
A committee with representatives from the appropriate academic and or clinical departments should be established to advise the PD/PI and to monitor the progress of participants. Committee composition, responsibilities, frequency of meetings, and other relevant information should be included in the application. An annual evaluation of the program by the Program Advisory Committee is recommended. This on-going evaluation should include an assessment of the curriculum, active mentors, and program staff; general recruitment and retention goals, including a plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women; completion success; and overall outcome.
6. Institutional Commitment
Applications must contain a description of institutional commitment to the program and to the candidates, or will be considered incomplete and will not be reviewed. Applications may be from a regional consortium, submitted by a lead institution. Such a consortium could provide cross-disciplinary opportunities through local collaborations. All institutional members of the consortium need not be equally strong in the entire range of research areas to be offered, but the lead institution must have the requisite staff and facilities to carry out the proposed program. A commitment statement from each member of the consortium must be included in the application. A Resource Format Page must be included in the PHS 398 for each proposed site.
7. Training in the Responsible Conduct of Research
This section should document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction. Applications without such a plan will be considered incomplete and may not be reviewed. Plans must detail the proposed subject matter, format, frequency, and duration of instruction, and amount and nature of senior staff participation. No award will be made if an application lacks this component. Although the NIH does not establish specific curricula or formal requirements, all programs may wish to explore the availability of courses offered by the NIH Intramural Research Program (see http://ori.dhhs.gov). Applicants must follow the instructions found on page 49 of the PHS 398 application package and refer to the NIH website (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.
8. Recruitment and Retention Plan
Applications must contain a description of the recruitment and retention plan.
9. Tracking and Evaluation Plan
Applications must contain a description of the tracking and evaluation plan.
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not applicable.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and .
Only the review criteria described below will be considered in the review process.
Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate peer review group(s) convened by the NEI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH-supported research are to advance ourunderstanding of biologic systems, to improve the control of disease, and enhance health. The scientific review group will address and consider each of the following criteria in assigning your application's 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 impact and thus deserve a meritorious priority score. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the planned activities adequately developed, consistent with the theme of the program, and sufficient to achieve the aims of the program? Are they appropriately tailored to the experience and interests of the candidates? For renewal applications: Do current and past activities demonstrate prior success in advancing the careers of candidates?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is the proposed PD/PI an acknowledged research leader/administrator with the scientific expertise and capabilities required to coordinate and supervise an interdisciplinary career development program relevant to vision research? Do the proposed mentors have a strong track record in preparing scientists for independent research careers? Do the mentors have active, well-funded research programs? Is the need for particular mentors well justified by the aims of the program? Has the mentoring team committed sufficient time to ensure the success of the program?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Do the existing facilities and resources enrich the potential of the proposed K12 award to provide strong research mentoring and development experiences for the candidates? Are there support letters from individuals who control access to these resources that show their willingness to collaborate? Does the institution state that the Scholar Candidates will be provided a minimum of 9 person-months (equivalent to 75% time) for the career development experiences and show how they will be protected from other administrative, teaching or clinical duties? In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating:
Training Record: For new applications, what is the past clinical training record of the program, the PD/PI, and the designated mentors? For a competing continuation, what is the success of former Scholar candidates in seeking further career development and in establishing productive scientific careers? What is the track record of success of the individuals proposed as PD/PI and mentors in directing 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 renewal application, is the past record of retention of past scholars acceptable and does the placement and achievements of previous Scholars demonstrate a commitment to clinical research?
Scholar Candidates: Are the recruitment and selection processes adequate to achieve high-quality candidates? Are the accomplishments of any named Scholar Candidates and the quality of their planned research activities appropriate to their level of experience and expected progress during the award? Are the efforts to recruit Scholar Candidates from racial or ethnic groups underrepresented in biomedical, behavioral or clinical research adequate? Competing continuations and supplements: Do current and past appointments show evidence of success at recruitment and training?
Evaluation and Tracking: Does the application describe a sufficiently strong plan that meets the evaluation and tracking objectives?
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 rating.
Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 on Human
Subjects in the PHS 398 instructions).
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 on Human Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan 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.
Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
Training in the Responsible Conduct of Research: Does the proposal include a plan for every candidate to receive 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 Scholar 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 Scholar candidates and faculty participation?
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the 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.
A formal notification in the form of a Notice of Award (NOA) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental 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:
? The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
? Funds may be used for health-related research.
? Funds may be paid to the miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH, and forwarded to the Director, Division of Financial Management, NIH Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for payment.
Usually, funds budgeted in an NIH-supported research or research training grant for 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 approval of the NIH.
Leave policies: In general, appointees may receive salary during the normal periods of vacation and holidays observed by individuals in comparable positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and is not considered to be a vacation or holiday. Appointees may receive salary from annual and sick leave, according to the institution's policy. Appointees also may receive salaries for up to 30 calendar days of parental leave per year for the adoption or birth of a child when those in comparable positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the PD/PI.
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 of such leave does not exceed three months. For longer periods, prior written approval of the NEI 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/archive/grants/policy/nihgps_2003/index.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 will continue during such leave.
Leave without award support may not exceed 12 months. Such leave requires the prior approval of the NEI and will only be granted in unusual circumstances. 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.
A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research career development experience longer than specified here must seek prior approval from the NEI for an unpaid leave of absence.
Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by NEI. 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 PD/PI: If change of the PD/PI is necessary, support of the award is not automatic. The award may be continued with prior written approval by NEI, provided the current PD/PI or the grantee institution has submitted a written request for the change, describing the reasons, countersigned by the appropriate business official, to the program contact listed on the Notice of Award. The biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the specific aims of the original peer-reviewed program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the intensive supervised research training and career development experiences for clinicians leading to research independence. This request must be submitted 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 NEI 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 thereof, 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 NEI. When required, such requests must include compelling justification, including the status of candidates/scholar appointments to the program.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
The 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. The following topics must be addressed:
Scholar Reporting Requirements: Progress reports are submitted using form PHS 2590, which can be obtained at 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 five years 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 Scholars in each component of the overall program, tracking information for those who have completed the program. 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 Scholar candidates and faculty participation.
Recruitment Plan: Report on recruitment strategies implemented and/or planned.
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.
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 progress report must provide the registry identifying numbers of any hESC lines used.
Additional Reporting Requirements
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. Evaluation and tracking results should be included as part of the Final Progress Report.
Evaluation: In carrying out its stewardship of human resource-related programs, NEI may request information essential to an assessment of the effectiveness of this program.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished or terminated.
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
1. Scientific/Research Contacts:
Neeraj Agarwal, Ph.D.
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
2. Peer Review Contacts:
Samuel C. Rawlings, Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
3. Financial or Grants Management Contacts:
William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 496-9997
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).
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
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/archive/archive/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.
Access to Research Data through the Freedom of
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.
Inclusion of Women And Minorities in Clinical
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
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
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.
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at .
Standards for Privacy of Individually Identifiable
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA 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. 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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