PS2 - Research Scholars Program in Patient Servicesgrant Application & Instructions 2013

PS2 - Research Scholars Program in Patient ServicesGrant Application & Instructions 2013

Cincinnati Children's Hospital Medical Center

Department of Patient Services

In collaboration with

The University of Cincinnati

Center for Clinical and Translational Science and Training

PS2 - Research Scholars Program inPatient Services

Grant Application & Instructions 2013

DEADLINES

Letters of Intent: March15, 2013by 5:00pm

Applications: May 10, 2013by 5:00pm

Notification of Awards: June 15, 2013

Funds available: July 1, 2013

For questions regarding these instructions, please contactScott K. Holland, PhD, Director: Research in Patient Servicesat 513-636-4780 or by email at: >

Background: The Department of Patient Servicesin collaboration with theCenter for Clinical and Translational Science and Training (CCTST) supported by the NIH Clinical and Translational Sciences Award (CTSA), has established a Research Scholars Program for scientists in nursing and the allied health professions at CCHMC. Integral to the mission of the CCTST is totrain selected junior faculty members in the Academic Health Center (AHC) to conduct clinical and translational research. The PS2 Research Scholars Program in Patient Services parallels the KL2 Research Scholars Program of the CTSA and represents a career step between completion of the PhD and readiness for application for grants from the NIH such as K01, K08, and K25, and R01. The PS2 program is targeted at nursing and allied health professionals employed in the Department of Patient Services at CCHMCand will support doctoral level scientists with nursing and other allied health backgrounds who aim to focus their career on research. At least 75% of the Scholars’ full-time professional effort must be devoted to the PS2plan for its duration. The PS2 is designed to support additional mentored research training for clinical health professionals who have already completed the PhD but who need additional training prior to achieving independence in the academic research setting. The primary goal of the PS2 grant award mechanism is to provide protected time for research career development for a period of 2 years, under the guidance of an established research mentor, in order to obtain the training and publication record needed to compete successfully for extramural grant funding. The program will provide salary support for 75% effort of the Scholar during this 2-year period, along with mentorship and specific expectations for publications and applications for extramural grants.

1)Definitions:

a. T1 research is the component in the continuumof translational research in which scientificadvances made in the laboratory are translatedinto applications relevant for the improvementof human health. This includes developments indiagnosis, therapy, and prevention, throughtheir initial testing in humans, up to the end ofPhase II in the drug development milieu,incorporating detailed phenotyping in smallnumbers of patients.

Common T1 Research Activities

i. Studies, often mechanistic, in cell-basedsystems.

ii. Studies in animal models of disease.

iii. Human studies, often proof of conceptstudies in small numbers of subjects, wellcharacterizedin terms of phenotype andgenotype.

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PS2 - Research Scholars Program in Patient ServicesGrant Application & Instructions 2013

b.Clinical research encompasses 3 areas:

i.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. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.

ii.Epidemiologic and behavioral studies.

iii.Outcomes research and health services research.

c. T2 research is aimed at enhancing the adoption of best practices in the community.

d. T3 research attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research.Phase 3 of the translation process, builds on the clinical efficacy work conducted in T2, and translates T2 research into clinical practice.

e. T4 research seeks to evaluate the "real world" health outcomes of a T1 application in practice.Phase 4 of the translation process, builds on the results of T3, helps identify the best approach to reach clinicians and patients nationwide so that they not only understand the new treatment but will start to use it.

2)Types of Grants Available:

1. New research proposals: These grants are for 2 years of support, contingent on sufficient progress during the first year. First year funds will be available July 1, 2013and will need to be spent prior to June 30, 2014.
2. 2nd year renewal applications: Applications for second year support must include a “Progress to Date” section demonstrating progress in career development and research and progress towards applying for an individual K award or R award. In rare circumstances, a third year of support might be granted. Scholars requesting a third year will not only have to show sufficient progress in the first 2 years but will also have to compete for funding against new applicants.

3)Eligibility: To be eligible, the applicant must have a faculty appointment at the University of Cincinnati (UC), and be a full-time employee of Cincinnati Children’s Hospital Medical Center (CCHMC) at the time of the application; the position cannot be contingent upon obtaining the PS2 award. The applicant must also be a U.S. citizen or have permanent resident status. Faculty researcherswho 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 and Trustee Grant recipients are ineligible. PS2 applicants may not have any other career development award (e.g., K08, K01, K23)pending at any time during the review process. CCTST membership is required prior to submitting the Letter of Intent (LOI). To join the CCTST free of charge, go to http://cctst.uc.edu/user/register.

4)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 1-2 page LOIs will be submitted for review to determine the number of review panelists needed and range of expertise required as well as to determine the eligibility of the applicants. During the second phase, the 12-page applications will be reviewed by 2-3 scientific reviewers, who will score the applications following CCTST KL2 program guidelines. The PS2 proposals will be reviewed according to the same criteria as the KL2. The 1-5 point scoring system used for the PS2 proposals is based on the current NIH scoring rubric for K-grants and can be found on the NIH website at: http://grants.nih.gov/grants/peer/critiques/k.htm.

Specific funding is earmarked for the PS2 program during each cycle to insure that high quality PS2 proposals will be funded. During the third and final phase, applicant scores will be tabulated and ranked, and PS2 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.

5)Letter of intent: The LOI consists of the application face page 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 by email to. The LOI must be received by 5 pm on Friday, March15, 2013.

6)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.

7)Letters of Support: Applications must include letters of support from (1) the applicant’s primary mentor, and (2) division director or department chairperson. Included in the letters 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.

8)Primary Mentor Requirements: Primary PS2 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 the CCTST Cadre of Mentors must be pre-approved before submission. A list of mentors meeting those criteria is available at http://cctst.uc.edu.Additional mentors or advisors from others institutions may also be included on the mentorship committee to complement expertise of the primary mentor to fill specific gaps in the candidate’s training.

9)Required format: Applications must be submitted electronically (the letter of support may be submitted either on paper or electronically as a PDF file). Send a PDF file of the assembled application to by 5 PM Friday, May 10, 2013.

10)Budget Guidelines: The award provides up to 2 years of funding in the amount of 75% (up to $75,000) salary support plus fringes, and $25,000 for research-related expenses. Allowable research-related expenses include: (a) tuition and fees related to career development; (b) research expenses, such as supplies, statistical data analysis, equipment and technical personnel; (c) travel to research meetings, 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 Research Training (ACRT)/ Society for Clinical and Translational Science (SCTS) joint annual meeting. Facilities and administrative (F&A)costs, as well as salaries for mentors, secretarial and administrative staff, etc. are not allowed as part of the PS2 Program.

11)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 13pages (career development plan – 4 pages, research plan – 8 pages, specific aims & hypotheses - 1 page), including figures but excluding animals and human subjects protection and references. Standard PHS 398 forms for budget, biosketch, and other support should be used.

12)Composition of PS2 application for both new scholar research proposals and competing renewals. See following forms. Create files that are labeled with appropriate parts.

File #1 Application and grant proposal

1. Face page (check all appropriate IBC, IACUC, IRB, or Radiation Safety approvals or indicate pending if submitted)
2. Abstracts

a)Scientific 200 words

b)Lay person description 100 words

1. Detailed Budget (2 years; use PHS 398 form provided)
2. Budget Justification
3. Biosketch(es) (include PI and primary mentor; use PHS 398 form, 4 page limit for each)
4. Other support (PHS 398 form)
5. Included in the thirteen (13) page limit for the application

a)Career Development Plan (suggested 4 pages)

1. Candidate’s Background
2. Career Goals and Objectives
3. Career Development/Training Activities During Award Period
4. Training in the Responsible Conduct of Research (not included in the 4 page limit)
5. Mentoring Plan
6. Planned publication schedule
7. Grant application plans and timeline

b)Research Strategy (suggested 9 pages)

1. Hypotheses and Specific Aims (1 page required)
2. Significance (suggested 1 page)
3. Innovation
4. Preliminary Results or, if 2nd year renewal, Progress Report
5. Approach

1. Facilities and other Resources Available for the Project (no page limit)
2. Statement of how the research is translational(1 page recommended)
3. Statements regarding human subjects and/or animals
4. Literature cited
5. Diversity questionnaire-see form
6. Checklist-see form

File #2 Letters of support

1. Letter of support from division director or department chairperson
2. Letters of support from collaborators or consultants, and/or letters of access from core directors, etc.

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PS2 - Research Scholars Program in Patient ServicesGrant Application & Instructions 2013

University of Cincinnati PS2 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
07/01/13 / 06/30/15
12.The undersigned reviewed this application for a PS2 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
07/01/13 / 06/30/14
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
PS2 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 / N/A
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
07/01/14 / 06/30/15
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
PS2 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 / N/A
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 10, Face Page) / $
Program Director/Principal Investigator (Last, First, Middle):

BUDGET JUSTIFICATION

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

BIOGRAPHICAL SKETCH

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: http://publicaccess.nih.gov/submit_process_journals.htm. 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

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.