UK Body Composition Core Laboratory
Application Form:
University
of Kentucky
Body
Composition Core Laboratory
Please
complete the following Body Composition Core Laboratory Protocol Application. Our Mission is
to provide support to Principal Investigators and Study Coordinators to
facilitate the implementation of body composition research. If you need assistance, contact Jody L. Clasey, PhD, FACSM, Director of
the Body Composition Core Laboratory at 257-8055. Additional support staff available for consultation are:
Ralph
Miller, MD, ScD Medical
Supervisor 323-5821
Adrienne
L. Janowiak, MS Laboratory Manager 257-5347
Protocols
will be reviewed 2 weeks following submission.
Protocols
are reviewed by the BCCL Committee on the 2nd and 4th
Fridays of each month. Please submit your application to the Body Composition
Core Laboratory, 100 Seaton Center. Please attach the following to the Body
Composition Core Laboratory Application:
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PAPER COPY |
DISKETTE COPY (Word, PC) |
DOCUMENT |
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X |
X |
·
Copy of Body Composition Core
Laboratory application |
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X |
X |
·
Copy of the research protocol which
should include the following information: ·
Abstract ·
Specific
Aims ·
Background/significance ·
Preliminary
Studies ·
Experimental
Design/Methods (include a flow sheet or schema) ·
Statistical
Design ·
Biographical
sketch of PI and Co-Investigators (2 pages each) - No diskette version
required of the Biosketches. ·
Literature
cited |
X |
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·
Copy UK IRB application, including consent form. Upon IRB approval, submit a copy of the
approval notice and stamped, dated, approved consent form to Jody L. Clasey,
Ph.D. (100 Seaton Center). Projects
can be submitted to the IRB and Body Composition Core Laboratory
simultaneously but cannot be initiated until notice of IRB approval has been
received. |
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X |
X |
·
Copy of study flowsheet
(chronological list of study procedures) |
You will be asked to present a
brief description of your protocol
at the Body Composition Core Laboratory Committee meeting if requested. Jody L. Clasey, Ph.D., Director, Body
Composition Core Laboratory will notify you of the date and time of the
meeting. You will be notified of the
results of the review within 2 weeks.
Prior to study
implementation you will need to
meet with the Body Composition Core Laboratory director and pertinent Body
composition Core Laboratory staff to review the final implementation details of
your project and if necessary schedule an in-service for the Body composition
Core Laboratory staff.
PUBLICATION CREDIT: Since the
continued growth and success of the Body Composition Core Laboratory is
dependant on documented of need and use, it is respectfully requested that
acknowledgement and/or citation of the Body Composition Core Laboratory support
in all publication of research that results from utilization of Body
Composition Core Laboratory resources.
The reprint citing the Body Composition Core Laboratory support should
be sent to Jody L. Clasey, Ph.D., 100 Seaton Center.
Access
our World Wide Web site at www.uky.edu
for further detailed information regarding Body Composition Core Laboratory
resources.
Body
Composition Core Laboratory Protocol Application
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For Body Composition
Core Laboratory Use Only: Project
Number: _______________ Priority Score: ____________________ Date
Received: ________________
Date Approved:
__________________ IRB Approval Date: _____________ |
Project Title:
Project Title:
Principal
Investigator:
Phone:
Department:
Pager:
Co-Investigators
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Department
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Phone/Pager
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Names of individuals approved to
obtain consent:
Research Coordinator:
Phone/Beeper
Contact person billing/financial
questions: Phone/Beeper:
Estimated duration of project
SUBJECTS: Age range: Diagnosis:
Demographics:
Gender and Minority Inclusion - Study Population Projections
Most funding agencies (including The
National Institutes of Health) requires that all proposals include a
description of the anticipated racial or ethnic and male or female compositions
of your study population. If women and
minorities, or children will not be included in your study populations, a
specific justification for this exclusion must be provided. Jody L. Clasey, Ph.D., Director, can help
the investigator with this section, if needed.
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NATIONAL
DEMOGRAPHICS |
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American Indian or Alaskan native |
Asian or Pacific Islander |
Black, not Hispanic Origin |
Hispanic |
White, not Hispanic Origin |
Other or unknown |
Total |
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Female |
0.4 |
1.4 |
6.3 |
4.3 |
38.7 |
0 |
51 |
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Male |
0.4 |
1.4 |
5.5 |
4.5 |
37.1 |
0 |
49 |
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Unknown |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Total |
0.8 |
2.8 |
11.8 |
8.8 |
75.8 |
0 |
100 |
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University
of Kentucky INPATIENT POPULATION DEMOGRAPHICS (excluding maternity and OB
admissions) |
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American Indian or Alaskan native |
Asian or Pacific Islander |
Black, not Hispanic Origin |
Hispanic |
White, not Hispanic Origin |
Other or unknown |
Total |
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Female |
0.04 |
0.5 |
6.2 |
0.4 |
48.2 |
0.8 |
56.1 |
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Male |
0.03 |
0.4 |
4.8 |
0.4 |
37.7 |
0.6 |
43.9 |
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Unknown |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Total |
0.07 |
0.9 |
11.0 |
0.8 |
85.9 |
1.4 |
100 |
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PROJECTED
STUDY SUBJECTS DEMOGRAPHICS |
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American Indian or Alaskan native |
Asian or Pacific Islander |
Black, not Hispanic Origin |
Hispanic |
White, not Hispanic Origin |
Other or unknown |
Total |
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Female |
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Male |
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Unknown |
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Total |
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Body Composition Core Laboratory Application:
Resource Request
Director (Jody
L.Clasey, Ph.D. 7-8055; fax 3-1090)
Patient Category: Indicate type of research
subject (A,B, D, or combination):
“A” - Patients/Subjects admitted
solely for research purposes; all study costs are provided by the
investigator’s grant and/or Body Composition Core Laboratory.
“B” - Patients admitted for
routine medical care and who simultaneously participate in a research project;
non-research hospital costs are covered by the third party carrier.
“D” - Patients/Subjects who
participate in industry-initiated studies; all hospital and/or Body composition
Core Laboratory costs are provided by the drug company. (Please contact Jody L. Clasey, Ph.D. to
discuss current Body Composition Core Laboratory charges for industry sponsored
studies.)
Please identify the screening process for eligible subjects
/ patients and how Body Composition Core Laboratory resources will be utilized
for screening purposes versus patients/subjects enrolled in the study:
Please indicate if additional support, resources, or
laboratories of the University of Kentucky (or other institutions) are being
utilized for this investigation:
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Body
Composition Core Laboratory Time and Space requested. Include anticipated requirements for subjects recruited who do
not complete the study as well as subjects who will complete the study. |
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Type of
Visit |
Number of
Subjects |
Number of
Visits/Studies per Subject |
Total Number of Visits/Admissions |
Average Time
per Visit/Study |
Total Time: |
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Write brief justification for the
use of the Body Composition Core Laboratory:
PI Signature _______________________________________ Date _____________________
Procedures and Personnel Request
Please summarize your request for duties to
be performed by the Body Composition Core Laboratory personnel:
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Available
Procedures |
4 |
Comments |
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Hydrostatic
Weighing |
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Residual Lung Volume |
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Air Displacement
Plethysmography |
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Thoracic Volume |
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Single Frequency
Bioelectric Impedance (BIA) |
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Multi-Frequency
Bioelectric Impedance (BIA) |
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Foot-to-Foot
Bioelectric Impedance (BIA) |
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