HLVI Clinical and Outcomes Research Pilot Program

University of Cincinnati College of Medicine

Application Instructions (2016-2017)
DEADLINES
Applications Due: May 22, 2016 (before Midnight)
Applications must be received before midnight on May 22, 2016. Applications received
after the deadline will be considered non-responsive and will not be reviewed.
Notification of Awards: June 15, 2016. Funds available: June 30, 2016
For questions regarding these instructions, please contact Laura Hildreth (hildrele@uc.edu)
1. Deadlines: The deadline is final.
2. Funding Pools: Funding for this program is derived from the UC Heart, Lung and Vascular Institute, UC
Health and the Division of Cardiovascular Health and Disease. It is anticipated that 1 award, not to exceed
$25,000, will be awarded in FY16. In order to be eligible for these funds, the Principal Investigator on the
application must either hold a full-time faculty appointment at the UC College of Medicine or be employed as a clinical fellow or post-doctoral fellow in the College of Medicine, in a department or
division currently participating in the Heart, Lung and Vascular Institute - specifically, Cardiovascular Health
and Disease, Pulmonary Critical Care and Sleep Medicine, Vascular Surgery - or be a member of the
HLVI Cardiovascular Research Center of Excellence (or by permission of the HLVI director). Co-Investigators
can be from other UC Colleges/departments or affiliated entities, such as Cincinnati Childrens Hospital
Medical Center or the Cincinnati Veterans Affairs Medical Center.
3. Background: This program seeks to support the development of studies with potential for future extramural funding, and is designed to enhance new or current faculty clinical research programs. A research study
is responsive if it:
i.
ii.
iii.

is related to the development or advancement of a patient-centered outcomes research project,

a comparative effectiveness clinical research project, or similar clinical outcomes or improvement science-based research project;
uses new approaches or discoveries to address relevant clinical problems in the field of cardiovascular or pulmonary medicine;
contributes critical data to a clinical research program that will enhance external funding success.

4. Project priorities: To be considered, proposals need to focus on important problems in the field of cardiovascular or pulmonary medicine. A wide spectrum of projects can be considered relevant. Priority will be
given to those projects that carry the highest potential for a major advancement and are most likely to lead
to a successful application for extramural funding, as well as projects with well-developed concepts where
additional data are required for proposal submission and where innovative ideas require additional testing.
The strategy for advancement of the research project for subsequent submission of an NIH proposal or
similar application should be clearly indicated.
5. Collaborations: The HLVI Clinical and Outcomes Research Pilot program encourages applications that
include interactions between clinicians and population scientists to foster the development of investigations
for patients with serious diseases and chronic illnesses. Interdisciplinary studies that include participation of
researchers from other UC colleges and affiliates are encouraged.
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6. Eligibility: Applications will be accepted from any full-time faculty member, clinical fellow or post-doctoral
fellow whose appointment is at the University of Cincinnati College of Medicine, in a department or division
currently participating in the Heart, Lung and Vascular Institute - specifically, Cardiovascular Health and
Disease, Pulmonary Critical Care and Sleep Medicine, Vascular Surgery - or who is a member of the HLVI
Cardiovascular Research Center of Excellence (or by permission of the HLVI director). Collaborations among
investigators spanning disciplines and programs are encouraged. Clinical and postdoctoral fellows should
include a co-investigator with appropriate research expertise.
7. Letters of support: Applicants should include a letter from their supervisor, Division Chief, or Chair as
part of the application. Dedicated time to complete the project should be included. If the applicant is
a postdoctoral fellow, (1) the letter should clearly state that the applicant would have appropriate release
time dedicated to the project (25% is suggested for most projects) and (2) a letter of support from the fellows mentor should be included, outlining the applicants qualifications, the mentors commitment to the
applicant and resources available for completion of the project (e.g., equipment, lab space, infrastructure,
including statistic supports).
8. Overview of Review Process: The review of applications will be performed in two phases: (1) Scientific
Review, and (2) Administrative Review. During the first phase, the applications will be reviewed and discussed by 2 or 3 independent scientific reviewers. During the second phase, the applicant rankings will be
reviewed by HLVI research administrators and awards will be determined. Collaborative applications may
be given priority during this administrative review. Critiques will be provided to the applicants after awards
are announced.
9. All applications must be submitted as one collective email attachment to Laura Hildreth (hildrele@uc.edu).
An email confirmation of receipt will be sent to the applicant. Applications must be received before midnight on May 22, 2016. Applications received after the deadline will be considered non-responsive
and will not be reviewed.
10. Composition of Applications: Applications should include:
1.

Face page (check all appropriate IBC, IACUC, IRB, or Radiation Safety approvals or indicate pending
if submitted on the attached form)

2.

Budget (use PHS 398 form, see https://grants.nih.gov/grants/funding/phs398/phs398.html)

3.

Budget justification

4.

Biosketch(es) (include PI and co-investigators; use PHS 398 form)

5.

Other support (PHS 398 form)

6.

Hypothesis and Specific Aims

7.

Background and Significance

8.

Research Design and Methods

9.

Statements regarding human subjects and/or animals

10. Literature cited

11. Letter/s of support

NOTE: ITEMS 6-8 LISTED ABOVE MUST NOT EXCEED 3 PAGES.

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HLVI Clinical and Outcomes Research Pilot Program

University of Cincinnati College of Medicine
Application Face Page

1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and punctuation.)

2. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR

2a. NAME (Last, first, middle)

2b. DEGREE(S)

2c. POSITION TITLE

2d. PRINCIPAL INVESTIGATORS MAILING ADDRESS (Street, city, state, zip

code)

2e. DEPARTMENT
2f. DIVISION OR EQUIVALENT
E-MAIL ADDRESS:

2g. TELEPHONE (Area code, number and extension)

3. CO-INVESTIGATOR
3a. NAME (Last, first, middle)

3b. DEGREE(S)

3c. POSITION TITLE

3d. OTHER CO-INVESTIGATORS (PLEASE PROVIDE INFORMATION AS IN SECTIONS 3A TO 3G; IF MORE THAN 2 CO-INVESTIGATORS, USE BOTTOM OF THIS FORM
TO SUPPLY THE INFORMATION)

3e. DEPARTMENT
3f. DIVISION OR EQUIVALENT
3g. TELEPHONE AND FAX (Area code, number and extension)
4.

Human Subjects Research 4a.

No
Yes

E-MAIL ADDRESS:

Research Exempt 4b.

No
Yes
If Yes, Exemption 4c.

Human Subjects Assurance No.

5.
tection
Yes
5a.

NIH-Defined Phase I Clinical Trial

No.
No
6.
6a.
Date
6b.
No.

Vertebrate Animals
No
Yes
If Yes, IACUC Approval

7.
7a.

IBC Protocol
No
Yes
If Yes, Approval Date:

7b.

Approval Number:

8.
8a.
Date

Animal Welfare Assurance

9. DATES OF PROPOSED PERIOD OF

SUPPORT (month, day, yearMM/DD/YY)
From

10. COSTS REQUESTED

Direct Costs ($) ONLY

Through

06/30/2016

Yes

06/30/2017

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Radiation
No

Yes

If Yes, Approval

Human Subjects ProNo

Certification:
Certification Date: