Center for Clinical and Translational Science and Training

The University of Cincinnati

Center for Clinical and Translational Science and Training

KL2 Grant Application Instructions

2013

IMPORTANT DATES:

Letters of Intent (LOIs) due: November 16, 2012by 5:00pm

Notification to apply: November 30th, 2012

Applications due: January 11, 2013by 5:00pm

Notification of Awards: late February 2013

Funds available: April 1, 2013

For questions regarding these instructions, please visitor contact Susan Moore at (513) 803-1044 or

1)Deadlines: All deadlines for submissions are firm, with no exceptions other than 1) death in the PI's immediate family, 2) acute severe illness of the PI, or 3) a natural disaster. Approvals will not be granted for delays that were foreseeable and avoidable by the applicant.

2)CCTST Membership: All applicants for KL2 grant consideration, including the LOI stage,must be CCTST members. CCTST membership is free and open to all. For more information and our online membership registration form go to

3)Background: The Center for Clinical and Translational Science and Training (CCTST) is supported by the NIH Clinical and Translational Science Award (CTSA). Integral to the mission of the CCTST is to train selected junior faculty members in the AHC to conduct clinical and translational research. The CTSA KL2 Research Scholars Program represents a career step between MD fellowship training or post-doctoral PhD training and application for mentored grants such as K01s, K08s, and K23s, and R01 awards or their equivalents. The program will support KL2 Scholars for 2 consecutive 12-month appointments; at the end of each grant year, Scholars must submit a “Progress to Date” report demonstrating sufficient progress and need for continued support. Throughout the award period, at least 75 percent of the Scholars’ full-time professional effort must be devoted to the KL2 Program. The remainder of the KL2 Scholar’s time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award. KL2 Scholars may not accept or hold any other Public Health Service (PHS) award that duplicates the provisions of this career award. Scholars are encouraged to apply for independent research grant support during the period of KL2 support.

4)Definitions of translational research:

Translation 1 (“T1”): from basic science to health application

Translation 2 (“T2”): from health application to evidence-based guideline

Translation 3 (“T3”):from evidence-based guideline to health practice

Translation 4 (“T4”):from health practice to health impact in the population

5)Eligibility:To be eligible, the applicant must have a full-time faculty appointment at the University of Cincinnati (UC), Cincinnati Children’s Hospital Medical Center (CCHMC), or the Cincinnati Veterans Affairs Medical Center (VAMC) at the time of the application; the position cannot be contingent upon obtaining the KL2 award. The applicant must also be a U.S. citizen or have permanent resident status. Faculty who have been a principal investigator on an R01 oron another K award, or project leader on a P01 or P50, or their equivalents, are not eligible. Those who have been a PI on an R03 or R21 award are still eligible. CCHMC Procter Scholars, Trustee Grant, PS2 grant, or CCTST T1 pilot award recipients are ineligible. As with other K awards, KL2 applicants may not have any other career development award (e.g., K08, K01, K23)pending at any time during the review process. This includes a concurrent submission to the Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) K12 program.Scholars are encouraged to apply for independent research grant support during the period of KL2 support. Members of underrepresented racial and ethnic groups and candidates with disabilities are encouraged to apply.

6)Overview of Review Process: The review of applications is performed in 3 phases: (1) Letters of Intent (LOI), (2) Scientific Review, and (3) Administrative Review. During the first phase, the 2-page LOIs will be scored and ranked, and the top applicants will be invited to submit formal 12-page applications. The number of applicants invited to apply will vary, judged by number and merit of applications received. No critiques will be provided to applicants during the LOI stage. During the second phase, the 12-page applications will be reviewed by 2-3 scientific reviewers, who will score the applications following KL2 program guidelines. During the final phase, applicant scores will be tabulated and ranked, and the top applicants will be interviewed by KL2 program leaders. Following interviews, KL2 program leaders will meet to discuss and determine awardees. Critiques from the second phase of the review will be provided to the applicants after awards are announced.

7)Letter of intent: The LOI consists of the application face page (see page 5) plus 1 page outlining the applicant’s career development and research objectives. No supplemental material will be accepted for the LOI. All LOI applications must be submitted as one, collective email to . The LOI must be received by 5 pm on Friday, November 16, 2012. LOIs received after the deadline will be considered unresponsive and will not be reviewed.

8)Primary Mentor Requirements: Primary KL2 mentors should meet the following criteria: at least $300,000 in annual grant support for clinical or translational research, a strong record of mentorship, and protected time for mentorship. Mentors not included in either the KL2 or BIRCWH Cadre of Mentors must be pre-approved before submission. A list of mentors meeting those criteria is available at

9)Budget Guidelines: The award provides up to 2 years of funding in the amount of 75% (up to $75,000) salary support plus fringes, $25,000 for research-related expenses and 8% facilities and administrative costs. Allowable research expenses include: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) travel to research meeting, workshops, or training; and (d) statistical services including personnel and computer time. Applicants must allow $1,500 for travel to the annual Association for Clinical and Translational Science (ACTS) annual meeting. Salaries for mentors, secretarial and administrative staff, etc. are not allowed as part of the KL2 Program. First year funds will be available April 1, 2013 and will need to be spent prior to March 31, 2014.

10)Letters of Support: Applications must include a letter of support from the applicant’s primary mentor and division director or department chairperson. Included in the letter of support must be a statement regarding the priority of the research proposal for the division or department, and a guarantee of at least 75% protected time for research and career development.

11)Signatures: For the applications, the signature of the investigator and his/her respective division director or departmental chairperson(s) are required. No signatures are required for the LOI.

12)Application forms (modified from PHS 398) are attached or may be downloaded from the CCTST website.

Applications must be submitted in single spaced text, one-half inch margins, and no smaller than an 11-point font. Arial or Helvetica typefaces are preferred. The primary applicant’s name must appear in the upper right hand corner of each page. Applications are limited to 12 pages (career development plan – 4 pages, research plan – 8 pages), including figures but excluding animals and human subjects protection and references. Standard PHS 398 forms for budget, biosketch, and other support should be used.

13)Composition of research proposal: Research proposals and competing renewals should include:

1. Face page (check all appropriate IBC, IACUC, IRB, or Radiation Safety approvals or indicate pending if submitted)
2. Abstracts
3. Detailed Budget (2 years)
4. Budget Justification
5. Biosketch(es) (PI and primary mentor)
6. Other support (PI and primary mentor)
7. Specific Aims (1 page)
8. Career Development Plan (4 pages)

a)Candidate’s Background

b)Career Goals and Objectives

c)Career Development/Training Activities During Award Period

d)Mentoring Plan (plan for being mentored)

1. Training in the Responsible Conduct of Research (1 page)
2. Research Strategy (8 pages)

a)Significance

b)Innovation

c)Approach

1. Description on Institutional Environment (1 page)
2. Statement of how the research is translational
3. Statements regarding human subjects and/or animals
4. Literature cited
5. Letter of support from division director or department chairperson
6. Letters of support from collaborators or consultants
7. Diversity questionnaire
8. Checklist

14)Required format: Invited applications must be submitted electronically (the letter of support may be submitted either on paper or electronically as a pdf file). Send onePDF file of the assembled application to by 5 PM Friday, January 11, 2013.

1

University of CincinnatiKL2 Grant Program

Grant Application
1.TITLE OF PROJECT (Do not exceed 56 characters, including spaces and punctuation.)
1a.Type of application:New Application Renewal Application
2. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR / New CCTST Investigator No Yes
2a.NAME (Last, first, middle) / 2b.DEGREE(S)
2c.POSITION TITLE / 2d.MAILING ADDRESS (Street, city, state, zip code)
2e.DIVISION
2f.DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
2g.TELEPHONE AND FAX (Area code, number and extension) / E-MAIL ADDRESS:
TEL: / FAX:
3. PRIMARY MENTOR
3a.NAME (Last, first, middle) / 3b.DEGREE(S)
3c.POSITION TITLE / 3d.MAILING ADDRESS (Street, city, state, zip code)
3e.DIVISION
3f.DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
3g.TELEPHONE AND FAX (Area code, number and extension) / E-MAIL ADDRESS:
TEL: / FAX:
4.Human Subjects Research
No Yes / 4a.Research Exempt
No Yes
If “Yes,” Exemption No. / 4b.Human Subjects Assurance No.
4c.NIH-Defined Phase I Clinical Trial
No Yes / 5. Human Subjects Protection Certification:
No Yes
5a.Certification Date:
6.Vertebrate Animals
No Yes
6a.If “Yes,” IACUC Approval Date
6b.Animal Welfare Assurance No. / 7.IBC Protocol
No Yes
7a.If “Yes,” Approval Date:
7b.Approval Number: / 8.Radiation
No Yes
8a.If “Yes,” Approval Date
9.DATES OF PROPOSED PERIOD OF
SUPPORT (month, day, year—MM/DD/YY) /

1. COSTS REQUESTED

Direct Costs ($)
From / Through
04/01/13 / 03/31/14
12.The undersigned reviewed this application for a KL2 research award and are familiar with the policies, terms, and conditions concerning research support and accept the obligation to comply with all such policies, terms, and conditions.
Primary Applicant: / Division Chair of Primary Applicant:
Signature of Primary Applicant / Date: / Signature of Division Chair of Primary Applicant / Date:

Principal Investigator/Program Director (Last, First, Middle):

Scientific Abstract: Using technical language, briefly describe the proposed project in 200 words or less.
Lay Abstract: Using non-technical language, briefly describe the proposed project in 100 words or less.
Principal Investigator/Program Director (Last, First, Middle):

DETAILED BUDGET FOR BUDGET PERIOD

DIRECT COSTS ONLY

/ FROM / THROUGH
04/01/13 / 03/31/14
PERSONNEL (Applicant organization only) / % / DOLLAR AMOUNT REQUESTED (omit cents)
NAME / ROLE ON
PROJECT / TYPE
APPT.
(months) / EFFORT
ON
PROJ. / INST.
BASE
SALARY / SALARY
REQUESTED(75% up to 75,000) / FRINGE
BENEFITS / TOTAL
KL2 Scholar / 12 / 75%
SUBTOTALS
CONSULTANT COSTS
EQUIPMENT (Itemize)
SUPPLIES (Itemize by category)
TRAVEL
PATIENT CARE COSTS / INPATIENT
OUTPATIENT
OTHER EXPENSES (Itemize by category)
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD / $
CONSORTIUM/CONTRACTUAL COSTS / DIRECT COSTS
FACILITIES AND ADMINISTRATIVE COSTS
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 10, Face Page) / $
Principal Investigator/Program Director (Last, First, Middle):

DETAILED BUDGET FOR BUDGET PERIOD

DIRECT COSTS ONLY

/ FROM / THROUGH
04/01/14 / 03/31/15
PERSONNEL (Applicant organization only) / % / DOLLAR AMOUNT REQUESTED (omit cents)
NAME / ROLE ON
PROJECT / TYPE
APPT.
(months) / EFFORT
ON
PROJ. / INST.
BASE
SALARY / SALARY
REQUESTED (75% up to 75,000) / FRINGE
BENEFITS / TOTAL
KL2 Scholar / 12 / 75%
SUBTOTALS
CONSULTANT COSTS
EQUIPMENT (Itemize)
SUPPLIES (Itemize by category)
TRAVEL
PATIENT CARE COSTS / INPATIENT
OUTPATIENT
OTHER EXPENSES (Itemize by category)
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD / $
CONSORTIUM/CONTRACTUAL COSTS / DIRECT COSTS
FACILITIES AND ADMINISTRATIVE COSTS
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 10, Face Page) / $
Program Director/Principal Investigator (Last, First, Middle):

YEAR 1 BUDGET JUSTIFICATION

Program Director/Principal Investigator (Last, First, Middle):

YEAR 2 BUDGET JUSTIFICATION

Program Director/Principal Investigator (Last, First, Middle):

BIOGRAPHICAL SKETCH

(required for KL2 Scholar Applicant; Primary Mentor)

Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME / POSITION TITLE
eRA COMMONS USER NAME (credential, e.g., agency login)
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION / DEGREE
(if applicable) / YEAR(s) / FIELD OF STUDY

NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions on the attached sample.

1. Personal Statement

Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subject of the application.

1. Positions and Honors

List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee.

1. Selected peer-reviewed publications

NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15. Do not include manuscripts submitted or in preparation. The individual may choose to include selected publications based on recency, importance to the field, and/or relevance to the proposed research. When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PMCID numbers along with the full reference (note that copies of publicly available publications are not accepted as appendix material.)

1. Research Support

List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.

Principal Investigator/Program Director (Last, first, middle):
OTHER SUPPORT
(required for KL2 Scholar Applicant; Primary Mentor)

Provide active support for all key personnel. Other Support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual's research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes, or gifts do not need to be included.

There is no "form page" for other support. Information on other support should be provided in the format shown below, using continuation pages as necessary. Include the principal investigator's name at the top and number consecutively with the rest of the application. The sample below is intended to provide guidance regarding the type and extent of information requested. Refer to the specific instructions in Section I.

For information pertaining to the use of and policy for other support, see “Policy and Additional Guidance.”

Format

NAME OF INDIVIDUAL
ACTIVE/PENDING
Project Number (Principal Investigator)
Source
Title of Project (or Subproject)
The major goals of this project are… / Dates of Approved/Proposed Project
Annual Direct Costs / Percent Effort
OVERLAP (summarized for each individual)

ACTIVE

PENDING

OVERLAP

Diversity Questionnaire (Required by NIH)

What is your sex/gender? Female Male

What is your ethnic background?

Hispanic or Latino? Yes No

Not Hispanic or Latino? Yes No

Unknown or Not Reported Yes No

What is your racial background?
American Indian or Alaska Native

Native Hawaiian or other Pacific Islander

Asian

Black or African American

White (non-Hispanic)

More Than One Race

Unknown or Not Reported

Do you have a disability? Yes No Do Not Wish to Provide

Are you from a disadvantaged background?

Yes No Do Not Wish to Provide

Individuals from disadvantaged backgrounds are defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at For individuals from low-income backgrounds, the institution must be able to demonstrate that such candidates (a) have qualified for Federal disadvantaged assistance; or (b) have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program; or (c) have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Program Director/Principal Investigator (Last, First, Middle):

CHECKLIST

TYPE OF APPLICATION (Check all that apply.)
NEW application. (This application is being submitted for the first time.)
RENEWAL of grant number: / KL2TR000078
Applicants must fulfill the following criteria:
I am a CCTST member
I am a U.S. citizen OR a non-citizen national OR can provide proof oflawful admission for permanent
resident.
I am NOT on a temporary or student visa.
I have completed my MD or PhD.
I have a guaranteed faculty appointment (not contingent on receipt of theKL2 award)
I have not been the Principal Investigator of an NIH grant or contract(including R01, P, and K awards;
previous R03 or R21 awards arepermissible).
I am willing and able to spend a minimum of 75% of my full-timeprofessional effort on research and
research career developmentactivities.
I intend to seek independent grant support during the award period.
I have the full support of my supervisor and division director for thisprogram (letter of support required with full application).
I do not have another career development award pending (e.g. K08, K01, K23).
I am not a CCHMC Procter Scholar,Trustee Grant, or PS2 awardee, or CCTST T1 awardee.
APPLICANT CERTIFICATION AND ACCEPTANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. / SIGNATURE OF APPLICANT.
(In ink. “Per” signature not acceptable.) / DATE

PHS 398/2590 (Rev. 06/09)Page 1 Biographical Sketch Format Page